Pilot Study of Massage in Veterans with Knee Osteoarthritis
1. Pilot Study of Massage in Veterans
with Knee Osteoarthritis
Michael Juberg, BA,1
Kristin K. Jerger, MD, LMBT,1
Kelli D. Allen, PhD,2,3
Natalia O. Dmitrieva, PhD,4
Teresa Keever, BSN, RN,1
and Adam I. Perlman, MD, MPH1
Abstract
Objectives: To (1) assess the feasibility and acceptability of Swedish massage among Department of Veterans
Affairs (VA) health care users with knee osteoarthritis (OA) and (2) collect preliminary data on efficacy of
Swedish massage in this patient group.
Design: Experimental pilot study.
Setting: Duke Integrative Medicine clinic and VA Medical Center, Durham, North Carolina.
Patients: Twenty-five veterans with symptomatic knee OA.
Interventions: Eight weekly 1-hour sessions of full-body Swedish massage.
Outcome measures: Primary: Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and
global pain (Visual Analog Scale [VAS]). Secondary: National Institutes of Health Patient Reported Outcomes
Measurement Information System-Pain Interference Questionnaire 6b (PROMIS-PI 6b), 12-Item Short-Form
Health Survey (SF-12 v1) and the EuroQol health status index (EQ-5D-5L), knee range of motion (ROM), and
time to walk 50 feet.
Results: Study feasibility was established by a 92% retention rate with 99% of massage visits and 100% of
research visits completed. Results showed significant improvements in self-reported OA-related pain, stiffness
and function (30% improvement in Global WOMAC scores; p = 0.001) and knee pain over the past 7 days (36%
improvement in VAS score; p < 0.001). PROMIS-PI, EQ-5D-5L, and physical composite score of the SF-12
also significantly improved ( p < 0.01 for all), while the mental composite score of the SF-12 and knee ROM
showed trends toward significant improvement. Time to walk 50 feet did not significantly improve.
Conclusions: Results of this pilot study support the feasibility and acceptability of Swedish massage among VA
health care users as well as preliminary data suggesting its efficacy for reducing pain due to knee OA. If results
are confirmed in a larger randomized trial, massage could be an important component of regular care for these
patients.
Introduction
Osteoarthritis (OA) affects nearly 27 million
Americans, and its prevalence is expected to rise con-
siderably in the next several decades.1
Knee OA is particu-
larly common, with a lifetime risk of 45%.2
OA in general,
and knee OA in particular, is more common in U.S. military
veterans than in the general population, and Department of
Veterans Affairs (VA) health care users are at particularly
high risk.3
In addition, VA health care users with arthritis
(most commonly knee OA) have more severe symptoms and
activity limitations.4
In veterans, OA (including knee OA)
commonly co-occurs with other chronic pain conditions,
post-traumatic stress disorder, and substance abuse.5
Currently, a variety of conventional treatment options for
knee OA are available, including pain medication, cortico-
steroid injections, physical therapy, exercise, weight man-
agement, and joint replacement surgery.6
When traditional
treatment approaches are used, many patients with knee OA
continue to experience symptoms such as chronic pain and
1
Duke Integrative Medicine, Duke University Medical Center, Durham, NC.
2
Department of Medicine, Division of Rheumatology, and Thurston Arthritis Research Center, University of North Carolina at Chapel
Hill, Chapel Hill, NC.
3
Health Services Research and Development Service, Durham Veterans Affairs Medical Center, Durham, NC.
4
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.
THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE
Volume 21, Number 6, 2015, pp. 333–338
ª Mary Ann Liebert, Inc.
DOI: 10.1089/acm.2014.0254
333
2. functional limitations that reduce quality of life.7
Accord-
ingly, there remains a pressing need to identify additional
effective, conservative treatments for knee OA that improve
pain, functioning, and overall well-being in these patients.
Massage therapy is effective for musculoskeletal disor-
ders, such as chronic back and neck pain,8
and is an effec-
tive treatment for managing pain associated with knee OA.9
For massage to be integrated into a comprehensive pain
management program, a systematic approach and dosage of
massage therapy needs to be established. A prior study dem-
onstrated the efficacy of a specific manualized protocol of
Swedish massage for improving pain, stiffness, and func-
tioning due to knee OA in non-veterans.9
A subsequent study
established an optimal dosage for the protocol: eight weekly
1-hour sessions.10
Although there is promising evidence for massage as an
effective treatment for knee OA, further studies must evaluate
its effectiveness in diverse patient groups. VA health care
users are an important patient group for studying this treat-
ment for several reasons. First, given VA health care users’
particularly high risk for activity-limiting knee OA, it is im-
portant to identify effective interventions for this vulnerable
patient group. Second, the demographic profile of VA health
care users differs substantially from that of participant sam-
ples in previous studies of massage for knee OA.9,10
Most of
these patients are men, and the acceptability of massage in
this group has not been sufficiently evaluated. Third, VA
health care users with knee OA have higher levels of physical
and psychological comorbidities that could influence or be
affected by massage.5
This pilot study evaluated a previously
established massage therapy protocol in a new population:
VA health care users with knee OA. Core objectives of this
study were to (1) assess the feasibility and acceptability of
Swedish massage among VA health care users with knee OA
and (2) collect preliminary data on the efficacy of Swedish
massage in this patient group.
Materials and Methods
This was a single group pilot study, with all participants
receiving a 1-hour-per-week intervention of Swedish mas-
sage for 8 weeks. Assessments were conducted before and
after the intervention. The institutional review boards of
Duke University and the Durham VA Medical Center re-
viewed and approved the study.
Participants
Primary eligibility requirements included (1) VA health
care users; (2) age ‡ 35 years; (3) written confirmation of
OA of the knee per American College of Rheumatology
criteria6
provided by the participant’s physician; (4) ra-
diographically established OA of the knee; and (5) a pre-
randomization score in a specified range on the Visual
Analog Scale (VAS; ‡ 40mm and £ 90 mm on a 40–100 mm
scale). For patients with bilateral knee involvement, the study
knee was determined by the patient as being the more prob-
lematic/painful knee. Exclusion criteria included (1) any intra-
articular knee depo-corticosteroid within the last 3 months, (2)
intra-articular hyaluronate within the past 6 months, (3) ar-
throscopy within the past year, (4) knee replacement surgery,
(5) significant injury within the past 6 months, and (6) pres-
ence of a rash or open wound over the knee. Participants
missing the research visit or three or more massage visits
could be withdrawn from the study at the discretion of the
study principal investigator.
Patients with knee OA at the Durham VA Medical Center
were recruited by using two methods. First, posters were
displayed in clinic waiting rooms and other common areas
of the medical center. Second, invitation letters were sent
to patients who were identified as having knee OA from
Durham VA electronic medical records. These letters pro-
vided basic information about the study and invited patients
to call if they were interested in participating. The first
25 eligible participants to send a letter from their physician
verifying their diagnosis of knee OA were enrolled in the
study. Participants meeting all criteria gave written informed
consent before enrolling in the study.
Study design and treatment
Participants received eight weekly 1-hour Swedish mas-
sages at Duke Integrative Medicine’s clinical facilities, 1 mile
from the Durham VA Medical Center. Massage therapists
were certified by the National Certification Board for
Therapeutic Massage & Bodywork adhered to a manualized
massage protocol previously tested to treat OA of the knee.10
Therapists announced their next technique or position in
order to minimize potential client startle in a population with
high prevalence of post-traumatic stress disorder. Each study
therapist signed a form attesting to adherence to the study
protocol after each massage session.
The primary outcome measure used to assess OA-related
pain, stiffness, and function was the Western Ontario and
McMaster University Arthritis Index (WOMAC) global
score (VAS version). The WOMAC has been subject to
numerous validation studies to assess reliability and re-
sponsiveness to change in therapy, including physical forms
of therapy.11
In addition, participants were asked to respond
to the question, ‘‘How much pain have you had because of
your knee in the past week?’’ using a 100-point VAS.
Secondary outcomes included measures of other domains
of high relevance to patients with knee OA: the National
Institutes of Health Patient Reported Outcomes Measure-
ment Information System-Pain Interference Questionnaire
6b (PROMIS-PI 6b).12
This instrument consists of six
questions that follow the format, ‘‘In the past 7 days, how
much did pain interfere with [insert category]?’’ and allows
responses on a 5-point scale (1 = not at all/never, 5 = very
much/always). The six categories include enjoyment of life,
ability to concentrate, day-to-day activities, enjoyment of
recreational activities, doing tasks away from home (e.g.,
getting groceries, running errands), and socializing with
others. Measures used to assess change in perceived health
status included EQ-5D-5L,13
a non–disease-specific instru-
ment for describing and valuing health-related quality of
life, and the Short Form-12 (SF-12), version 1.14
The SF-12
Health Survey is a 12-item subset of the SF-36 that mea-
sures the same eight domains of health as the longer scale. It
is a brief, reliable measure of overall health status which is
useful in large population health surveys and has been used
extensively as a screening tool. Knee range of motion
(ROM), measured manually with a goniometer to the onset
of stiffness, and 50-foot walk test were also measured.
Maximal walking speed is a more reliable and predictive
334 JUBERG ET AL.
3. measure of walking ability than walking at a comfortable
pace.15,16
Participants were asked to walk as fast as they
safely could with or without a walking aid. They were timed
from a standing start until the point at which they walked
through the 50-foot (15.24-meter) marker. Additional post-
study questions were asked of all participants during the
final visit to assess study acceptability (Appendix 1).
Statistical analysis
Paired-samples t tests were used to examine the effects of
treatment on change in outcomes at baseline and immedi-
ately after the intervention. In all analyses, statistical sig-
nificance is reported using a two-tailed a level of 0.05 or
less, and the 95% confidence interval for all parameter es-
timates are provided. All analyses were carried out by using
SAS software, version 9.3 (SAS Institute, Cary, NC).
Results
Feasibility and participant characteristics
Of the 104 potential participants completing the telephone
screening, 56 were determined to be eligible (41 were ineli-
gible and 7 declined participation), and the first 25 (n = 25) to
submit a letter from their physician confirming the diagnosis
of OA by radiography were enrolled. Among the 25 study
participants, the mean age was 57.0 (standard deviation,
12.0); most participants were men (68%), 52% were black or
African American, and 68% were not employed (Table 1).
During the study, 1 participant withdrew, and another par-
ticipant was withdrawn by the principal investigator after
missing three consecutive appointments. The remaining 23
participants (92%) completed the study. Study feasibility was
established by the 92% retention rate with 99% of massage
visits and 100% of research visits completed.
Primary outcome measures
Participants’ mean WOMAC global score improved by
30% ( p = 0.001), as shown in Table 2. Significant improve-
ment was observed on all subscales of the WOMAC index,
including the pain subscale ( p < 0.001), stiffness subscale
( p = 0.006), and the function subscale ( p < 0.001). Partici-
pants’ VAS scores also showed an average improvement of
36% ( p < 0.001).
Secondary outcome measures
Perceived health status as measured with the EQ-5D-5L
and the SF-12 also improved significantly (Table 3). Im-
provements in the SF-12 physical composite score reached
statistical significance ( p < 0.01). However, improvements
in the SF-12 mental component score only exhibited a trend
toward improvement ( p = 0.080). The PROMIS-PI 6b
(Table 3) showed a 15% improvement ( p < 0.01). A trend
in the expected direction was observed for knee ROM, but this
did not reach statistical significance ( p = 0.087). There was
no significant change in the 50-foot walk test ( p = 0.121).
Responses to post-study questions confirmed acceptabil-
ity, feasibility, and a positive response to the treatment (full
questions and responses listed in Appendix 1; n = 23 for all
questions). These questions were not part of a standardized
instrument but were developed specifically for this study to
assess aspects of patient satisfaction that were important to
evaluate in the context of this pilot/feasibility study. An
overwhelming majority of respondents answered ‘‘yes’’ to
the following questions: ‘‘Would you like to continue mas-
sage as part of the on-going management of your knee ar-
thritis?’’ (91%) and ‘‘Was the schedule of visits (60 minutes/
week) convenient for you?’’ (96%).
When asked about the likelihood that other veterans would
want to try massage if it were offered at the VA, 87% re-
sponded that it was very likely or somewhat likely, and 83% of
respondents answered ‘‘yes’’ to the post-study question: ‘‘Did
you notice any other changes in your health or other aspects of
your life since starting the massage?’’
Table 1. Patient Characteristics
Characteristic Value
Total sample (n) 25
Mean age at baseline (yr) 56.96 – 11.98
Mean BMI (kg/m2
) 31.58 – 7.71
Men, n (%) 17 (68)
Hispanic ethnicity, n (%) 0 (0)
Race, n (%)
American Indian/Alaska Native 0 (0)
Asian 1 (4)
Black or African American 13 (52)
Native Hawaiian or other Pacific Islander 0 (0)
White 11 (44)
Currently employed (working for pay), n (%) 8 (32)
Values are expressed as the mean – standard deviation or number
(percentage) of patients.
BMI, body–mass index.
Table 2. Changes in Primary Outcome Measures
Variable
Mean
before (SD)
Mean
after (SD)
Mean paired difference
(95% CI) p-Value
Percent
improvement
WOMAC
Global 66.4 (13.8) 45.4 (22.6) - 21.0 ( - 32.2 to - 9.9) 0.001* 30
Pain 63.0 (14.8) 42.0 (27.3) - 22.5 ( - 33.6 to - 11.4) < 0.001* 37
Stiffness 69.1 (18.0) 52.8 (24.0) - 16.3 ( - 27.5 to - 5.2) 0.006* 21
Function 65.0 (13.7) 41.5 (21.0) - 23.6 ( - 35.0 to - 12.2) < 0.001* 32
VAS 69.4 (13.8) 43.0 (25.1) - 26.4 ( - 38.5 to - 14.2) < 0.001* 36
*Indicates significance at level p < 0.05.
CI, confidence interval; SD, standard deviation; VAS, visual analog scale; WOMAC, Western Ontario and McMaster University
Osteoarthritis Index.
MASSAGE FOR KNEE OA IN VA HEALTH CARE USERS 335
4. Discussion
This pilot study confirmed the feasibility of delivering a
manualized protocol of Swedish massage for treating VA
health care users with knee OA, with no significant re-
cruitment barriers and both retention and treatment session
completion rates over 90%. Only two participants failed to
complete the full massage intervention, and neither case was
due to perceived inefficacy of the massage therapy. Ac-
ceptability of the intervention was high in this largely male
veteran population, with over 90% of participants indicating
they would like to continue to receive massage as part of
their treatment plan for knee OA.
Although preliminary, the data strongly supported the
potential efficacy of this treatment protocol for improving
outcomes in VA health care users with knee OA. Results
were consistent with findings from our previous studies in a
general population.9,10
Percentages of improvements in
WOMAC scores were well above the minimal clinically
important differences (17%–22%) reported by Angst et al. in
their prospective cohort study of 192 patients with lower
limb OA,17
with a 30% improvement in the global score,
37% improvement on the pain subscale, and 32% im-
provement on the function subscale. Pain interference and
perceived health status also significantly improved over the
course of the study.
This study’s findings raise important considerations for
future studies of massage therapy for chronic pain condi-
tions, such as knee OA. Its strong recruitment, retention, and
feasibility outcomes suggest that veterans need and are
largely receptive to massage as an intervention for pain due
to knee OA. It appears that no study has demonstrated the
feasibility and acceptability of providing professional out-
patient massage for veterans with chronic pain due to knee
OA (or OA in any other joint) and simultaneously provided
strong preliminary results of significant pain reduction.
These combined findings warrant a large-scale randomized
controlled trial to establish the clinical efficacy of massage
for veterans’ knee OA.
Prior studies have also documented the strong interest of
VA patients, providers, and administrators to make massage
therapy available across the VA for patients with chronic
pain. In one large-scale study (n = 401) conducted across
five VA primary care clinics, 202 participants reported
having sought massage for their chronic pain, and 387
participants (97%) reported willingness to try massage
therapy; thus, massage was the most preferred of the com-
plementary and alternative medicine modalities studied
(massage therapy, chiropractic care, herbal medicines, and
acupuncture).18,19
A recent qualitative study of 28 patient
care providers and administrators at a large VA facility rated
massage as the top priority for promotion within the VA
over 18 other modalities.19
In this same study, although
many participants saw lack of funding as a barrier to pro-
viding massage within the VA, others thought funding was
available in response to a well-planned request.
Several strategies for reducing long-term cost of massage
for chronic pain warrant further study. Home-based massage
programs are cost-effective and have demonstrated signifi-
cant reductions in self-reported pain and anxiety in veterans
for conditions that include a substantial mental component
in addition to chronic pain, such as cancer and reintegration
after return from active duty in Iraq or Afghanistan.20,21
Another pilot study in non-veterans recently showed that
home-based massage resulted improved symptoms among
patients with knee OA.22
Larger studies are needed to
evaluate whether home-based massage, either alone or as an
adjunct to professional massage therapy, has benefit for
veterans and others with knee OA. In addition, it would be
useful to evaluate the potential combined effects of massage
therapy (professional or home-based) with other therapies
that could help to sustain benefits, such as mindfulness-
based stress reduction, which is more effective and longer
lasting for mood improvement than massage therapy.23
Finally, this study has several limitations common to pilot
studies, including a small sample size (n = 25), relatively
short intervention duration, and lack of control group.
However, this study provides important preliminary data
about the feasibility and efficacy of Swedish massage in a
vulnerable and understudied patient group. In addition, this
study was limited to Swedish massage techniques. Although
this precludes generalizability to other possible techniques,
it confers the advantage of standardizing the intervention in
a health care system such as the VA.
In conclusion, this pilot study supports the feasibility and
acceptability of Swedish massage among VA health care
users with knee OA. Preliminary data suggest the potential
efficacy of 8 weeks of 1-hour weekly massage for reduced
Table 3. Changes in Secondary Outcome Measures
Variable Pre Post
Patients
(n) p-Value
Change (95% confidence
interval)
EQ-5D-5L 0.60 – .16 0.68 – .15 23 0.002a
0.08 (0.03 to 0.1)
SF-12, PCS 28.1 – 7.5 33.6 – 10.5 13b
0.002a
5.5 (2.4 to 8.6)
SF-12, MCS 43.7 – 18.3 50.7 – 14.9 6b
0.080c
7.0 ( - 1.2 to 15.3)
PROMIS-PI 20.1 – 5.0 17.0 – 5.9 23 0.005a
- 3.2 ( - 5.3 to - 1.1)
Knee range of motion (degrees) 113.9 – 13.0 117.5 – 15.0 23 0.087 3.6 ( - 0.6 to 7.8)
50-ft walk (sec) 13.5 – 2.2 12.8 – 2.4 23 0.121 - 0.7 ( - 1.7 to 0.2)
Values expressed with a plus/minus sign are the mean – standard deviation. Negative values for mean paired difference for PROMIS Pain
Interference and time to walk 50 feet indicate improvement on these measures.
a
Significant at p < 0.05.
b
Standard scoring of the SF-12 specifies that participants with any missing data be dropped from the analysis.
c
Trend in expected direction at p < 0.10.
EQ-5D-5L, the EuroQol health status index; SF-21, 12-Item Short-Form Health Survey; MCS, Mental Composite Score; PCS, Physical
Composite Score; PROMIS-PI, Patient Reported Outcomes Measurement Information System-Pain Interference.
336 JUBERG ET AL.
5. pain and interference of pain on other aspects of one’s life.
If results are confirmed in a larger randomized trial, massage
could be an important component of regular care for these
patients.
Acknowledgments
Special thanks to Dr. Partap Khalsa and the National
Institutes of Health National Center for Complementary and
Alternative Medicine for supporting this work via grant 3
R01 AT004623-05S2. The authors are grateful to Professor
Carl F. Pieper for providing his input on statistical analysis.
Author Disclosure Statement
No competing financial interests exist.
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Address correspondence to:
Kristin K. Jerger, MD, LMBT
Duke Integrative Medicine
Duke University Medical Center
DUMC 102904
Durham, NC 27710
E-mail: kristin.jerger@duke.edu
Adam I. Perlman, MD, MPH
Duke Integrative Medicine
Duke University Medical Center
DUMC 102904
Durham, NC 27710
E-mail: adam.perlman@duke.edu
(Appendix follows/)
MASSAGE FOR KNEE OA IN VA HEALTH CARE USERS 337
6. Appendix 1. Study Acceptability: Responses to Closed-Ended Post-Study Questions (n = 23)
Question No Yes % Yes
1. ‘‘Was the schedule of visits (60 minutes/week) convenient for you?’’ 1 22 96
2. ‘‘Would you like to continue massage as part
of the ongoing management of your knee arthritis?’’
2 21 91
3. ‘‘Did you notice any other changes in your health
or other aspects of your life since starting the massage?’’
4 19 83
4. ‘‘If the VA were to offer massage for knee arthritis, how
likely do you think it is that other veterans you know
would want to try this treatment?’’
Very likely 18 78
Somewhat likely 2 9
Not at all likely 0 0
Don’t know 3 13
VA, Department of Veterans Affairs.
338 JUBERG ET AL.
8. A Randomized Controlled Trial of Koru
health, with meta-analyses documenting medium-to-large ef-
fect sizes.14,15
Although there has been work on developing
programs specifically for children and teens,16
there has been
little discussion about targeting mindfulness training specif-
ically towards other critical developmental stages, such as
emerging adulthood.
Emerging adulthood is the developmental stage from the
late teens through the 20s, which includes most college stu-
dents.17
In 2011, 68.2% of graduating high school students
enrolled in postsecondary education, and in the fall of 2011
there were nearly 21 million students enrolled in either 2-
or 4-year degree-granting institutions.18
College-attending
and non–college-attending emerging adults (EAs) have sim-
ilar developmental characteristics,19
and the overall rate of
psychiatric disorders is roughly equivalent between college-
attending individuals and their non–college-attending peers.4
Because the primary emphasis in emerging adulthood is on
identity exploration, this life stage is associated with frequent
changes and uncertainty in all life spheres.19
Mindfulness meditation offers a promising tool for man-
aging the stress that may be associated with the challenges
of emerging adulthood. However, there are no objective data
about what pedagogical methods may be effective for train-
ing EAs in mindfulness. Due to their unique developmental
stage, EAs may not engage readily in training programs that
are designed for older adults due to time constraints, skepti-
cism about the potential benefits, and difficulty maintaining
motivation to effect behavior change.20
To address this dis-
parity, Rogers and Maytan21
have developed Koru, a manual-
ized training program in mindfulness, meditation, and other
mind-body skills, that specifically targets EAs.
Koru is the New Zealand Maori word for the unfurling fern
frond, which symbolizes balanced growth. Koru differs from
mindfulness programs developed for more general popula-
tions of adults in several key ways. First, the program trains
EAs in certain mind-body skills, such as abdominal breathing
and guided imagery, as well as insight meditation practice.
These mind–body skills, for which studies show a positive
effect on stress and anxiety,22,23
give participants tools for
quickly reducing distress, which in turn builds their motiva-
tion to continue practicing stress management and self-care
in daily life. Second, Koru is relatively brief, with only four
75-minute sessions and 10 minutes of required daily medita-
tion practice. The course is highly structured and attendance
at all 4 classes is required. Third, the program is taught in
a small-group format to capitalize on peer interactions that
EAs value. Fourth, the teaching is very active, addressing
skepticism and building motivation quickly. Finally, the lan-
guage and metaphors used are designed to resonate with
the interests and concerns of EAs. In addition to teaching
mindfulness skills to cope with stress, Koru also empha-
sizes cultivating positive emotions such as self-compassion
and gratitude. Both compassion and gratitude are considered
core qualities of mindfulness,24
and have been associated
with lower levels of stress and psychological symptoms and
greater well-being in prior studies.25,26
Koru has been very
popular with students and those who have participated report
positive outcomes on course evaluations.20,21
However, until
now, Koru has not been subjected to rigorous quantitative
evaluation.
The present randomized controlled trial (RCT), therefore,
aimed to evaluate the effectiveness of Koru for EAs in a
university setting. We hypothesized that college and graduate
students who participate in Koru, when compared with a
control group, would show reduced stress, improved sleep,
and increased mindfulness, self-compassion, and gratitude.
METHODS
Study Design
The RCT had 2 study arms: (1) Koru, the active interven-
tion, and (2) a wait-list control. We chose to use a wait-list
control condition to control for the effects of time, because
levels of stress, sleep problems, and even self-concept can
change during an academic semester. Students who were
randomly assigned to the wait-list control group were of-
fered an opportunity to participate in Koru later the same
semester. We felt that this design struck a balance between
scientific rigor, by benefitting from an experimental design
with random assignment to groups, with the use of a cultur-
ally normal wait-list process for the Koru program, which
should optimize motivation and retention.
Following online informed consent, study participants
completed standardized self-report questionnaires via a sur-
vey Web site within 1 week before and after participating
in the 4-week Koru program. The study protocol was con-
ducted between Fall 2012 and Spring 2013. Full approval
by the university’s Institutional Review Board was obtained
prior to data collection.
Students were eligible for the study if they were (a) cur-
rently enrolled as an undergraduate, graduate or professional
student; (b) at least 18 years of age; (c) proficient in En-
glish; (d) able to use a computer with internet access; and
(e) willing to be randomized to either the Koru group or
the wait-list control group. Blocked randomization (block
size = 2) was used to ensure balanced study groups after
every 2 students enrolled. The randomization schedule was
created using Research Randomizer (www.randomizer.org)
and was performed by the study coordinator who kept group
assignments blinded from other study staff who performed
statistical analyses. Following randomization, the study co-
ordinator contacted students to inform them of their group as-
signment. Subsequently, the Koru instructors contacted stu-
dents enrolled in Koru with an introductory e-mail and a
request to begin reading the required text, Wherever You Go,
There You Are by Jon Kabat-Zinn. To protect against social
desirability bias and potential evaluation bias, Koru course
instructors were not directly involved in subject recruitment,
consent, randomization, or data collection procedures.
Power analyses (G∗
Power version 3.1.5; Kiel, Germany)
based on a difference between 2 independent means (2
groups) at a significance level of .05, a desired power of
.80, and a medium-to-large effect size (ie, Cohen’s d = .6)
based on prior meta-analyses, indicated that 45 students per
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9. Greeson et al
group would be required to detect a significant difference for
the Koru versus wait-list control group.27
Participants
Participants were 90 undergraduate, graduate, and profes-
sional students (Mage = 25.4, SD = 5.7; range = 18–59).
Two graduate students, one who was 59 years old and an-
other who was 42, provided baseline survey data but dropped
out before attending the Koru group to which they were ran-
domly assigned. The oldest student who provided complete
pre- and postsurvey data was 31 years old. Seventy-four stu-
dents provided data on the post-Koru survey, a response rate
of 82%.
As shown in Table 1, the sample comprised mostly women
(66%) who were predominantly white (62%) and non-
Hispanic (85%). Half of students reported having no reli-
gious affiliation or being atheist. Nearly three-quarters were
in graduate or professional school. The 2 randomized study
groups did not differ on any demographic characteristics,
except average hours of sleep per night. The Koru group re-
ported sleeping half an hour less per night, which was statis-
tically significant but still within the normal range of healthy
sleep. We defined program completion as attending at least 3
of the 4 Koru classes. There were no significant differences at
baseline between students who completed Koru versus those
who did not. The only outcome variable that differed sig-
nificantly was the Isolation subscale of the Self-compassion
Scale; the group of students that completed the Koru program
reported a mean decrease in their sense of isolation, whereas
the group that attended 2 or less Koru classes reported a mean
increase in their sense of isolation post intervention.
Procedure
The secure, online survey was administered using Qual-
itrics software (Provo, Utah) and included basic demographic
information and a battery of standardized self-report ques-
tionnaires. The questionnaires assessed symptoms of stress,
sleep problems, mindfulness of thoughts and feelings, self-
compassion, and gratitude. Participants were not offered fi-
nancial compensation for completing the surveys.
Intervention
As detailed in a recently published treatment manual,21
the
Koru program is offered at a large university through Coun-
seling and Psychological Services and consists of 4 required
75-minute classes. The classes include 12 to 14 students
taught by 1 or 2 teachers. Students typically participate in
Koru because they are seeking training in mindfulness and
meditation to help reduce stress and enhance psychological
well-being. The Koru program is free of charge, voluntary,
not graded, and students do not receive course credit for par-
ticipating. In addition to attending all 4 weekly small-group
sessions, the Koru program requires a commitment to prac-
ticing meditation for at least 10 minutes daily, completing
and returning a daily meditation log, as well as reading the
required chapters in the course book, Wherever You Go, There
You Are. The meditation log includes space for daily docu-
mentation of 2 things for which the student feels grateful.
During each class, students learn and practice mindfulness
meditation and 1 or 2 mind–body skills, including breathing
exercises, walking meditation, guided imagery, and eating
meditation.
Measures
Perceived Stress Scale (PSS)
The 10-item Perceived Stress Scale (PSS) measures per-
ceived stress over the past month, defined by the degree
to which one feels like life has been unpredictable, uncon-
trollable, or overwhelming. The PSS scores have demon-
strated reliability and construct validity in student samples
and EAs.28
Cronbach’s α was .83 for PSS scores at both time
points.29
Medical Outcome Study Sleep Scale (MOS SLP9)
The sleep scale is one subscale of the Medical Outcomes
Study (MOS) health status measure.30
It consists of 12 items
to measure 6 sleep dimensions: initiation (time to fall asleep),
quantity (hours of sleep each night), maintenance, respira-
tory problems, perceived adequacy of sleep, and somnolence
(daytime sleepiness). The time frame for the responses is
“the past 4 weeks.” The 9-item summary scale (Sleep Prob-
lems Index II) was used for analysis.30
Higher scores indicate
greater sleep problems. Cronbach’s α was .88 for sleep qual-
ity scores at both time points.29
Cognitive and Affective Mindfulness Scale–Revised
(CAMS-R)
The 12-item Cognitive and Affective Mindfulness
Scale–Revised (CAMS-R) was used to measure 4 aspects
of trait mindfulness, including attention, awareness, accep-
tance, and present-focus. Previous psychometric evaluation
of the CAMS-R found scores to be reliable and valid,31
and
a recent outcome study found that the CAMS-R was sensi-
tive to change following MBSR training.32
Cronbach’s α for
CAMS-R scores was .88 at baseline and .80 post interven-
tion.29
Self-compassion Scale (SCS)
The 26-item Self-compassion Scale (SCS)33
was used to
assess participants’ tendency to treat themselves with kind-
ness and understanding rather than harsh judgment and criti-
cism during difficult times, to perceive difficult experience as
part of common humanity, and to consider difficult thoughts
and experiences as separate from the core self. The SCS has
6 subscales (Self-judgment, Self-kindness, Isolation, Com-
mon Humanity, Mindfulness, Over-identification) that can
be summed to attain a total score. SCS scores have been
shown to be reliable and valid in previous studies of col-
lege students.33
The SCS was also sensitive to change with a
mindful self-compassion (MSC) training program.34
Higher
scores on all scales indicate higher levels of self-compassion.
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10. A Randomized Controlled Trial of Koru
TABLE 1. Baseline Characteristics of Study Participants
Characteristic Koru group (n = 45) Wait-list group (n = 45) Difference statistic
Age t(84) = 0.81, p = .423
M years 25.75 24.76
SD 6.84 4.15
Gender χ2
(1) = 0.05, p = .842
Male 15 16
Female 30 29
Ethnicity See note
Hispanic 4 1
Non-Hispanic 38 38
Prefer not to answer 3 5
Race χ2
(1) = 0.79, p = .375
White 30 26
African American 3 2
Asian American 10 13
Other 1 3
Prefer not to answer 1 1
Religion χ2
(2) = 2.14, p = .343
No religious affiliation 14 19
Atheist 5 7
Buddhist 1 0
Christian 13 7
Jewish 1 2
Hindu 2 1
Muslim 0 2
Unitarian/Universalist 1 1
Other 2 1
Prefer not to Answer 6 5
Education χ2
(2) = 0.32, p = .852
Undergraduate 1st yr 0 3
Undergraduate 2nd yr 6 2
Undergraduate 3rd yr 4 3
Undergraduate 4th yr 2 5
Undergraduate 5th yr 0 1
Graduate student 20 20
Professional Student 13 11
Sleep t(88) = 2.26, p = .027
M hours per night 7.56 8.09
SD 1.09 1.16
Sleep medication χ2
(1) = 0.34, p = .561
n yes 8 6
% 18% 13%
Note. Chi-square could not be computed for ethnicity due to less than 5 Hispanic students per group. Other demographic categories with less than
5 students each were collapsed as follows. Race: white, racial minority. Religion: no religious affiliation, atheist, religious affiliation. Education:
undergraduate, graduate, professional student.
Cronbach’s α for SCS total scores was .94 at baseline and
.95 post intervention.29
Gratitude Questionnaire (GQ-6)
Dispositional gratitude was measured using the GQ-6,35
which has demonstrated good convergent validity with rele-
vant constructs such as positive affect and prosocial traits.36
Cronbach’s α for GQ-6 scores was .88 both pre and post
intervention.29
Other Measures
Demographic characteristics were assessed at the end of
the online survey, and are reported in Table 1.
Data Analysis
All statistics were performed using IBM SPSS version 20
(Armonk, New York). Variables were screened for distribu-
tional assumptions prior to analysis. All continuous outcome
variables approximated a normal distribution with skewness
and kurtosis less than 2.0. Primary analyses of between-
group effects were tested using linear mixed-effects models,
which provide several statistical advantages over traditional
repeated-measures analysis of variance (ANOVA).37
Group
assignment was treated as a fixed effect and outcome vari-
ables were treated as random effects that could vary within-
person and across time. This analytic strategy, based on
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11. Greeson et al
restricted maximum likelihood estimation, allowed all sub-
jects to be included in the models, even those with missing
data. Therefore, mixed-effects models were consistent with
intent-to-treat principles without requiring imputation, such
as last observation carried forward, which can bias parame-
ter estimates. Mixed-effects modeling also provided the ad-
vantage of accounting for dependence of observations in a
repeated-measures design, a phenomenon that frequently vi-
olates an assumption of traditional ANOVA using the general
linear model.
The primary hypothesis of a significant difference between
groups over time was tested using a Group × Time interaction
effect, which indicated the effectiveness of Koru compared
with a wait-list control. Within the same model runs, t tests
were used to test hypotheses about planned contrasts between
pre- and postintervention scores within the Koru and control
groups, and to test for differences between-groups at base-
line and at the postintervention time point. Effect sizes for
between-group differences over time were calculated using
Cohen’s d and η2
.38
Secondary analyses included within-
group mixed-effects models to replicate the effects of Koru
among wait-listed students who took the program later in
the same semester. Secondary analyses also included corre-
lations among changes in outcomes measures as a function
of randomized group assignment. Consistent with recom-
mendations for clinical trials, statistical significance for all
parameter estimates was set at z = 1.96, α = .05, 2-tailed.39
RESULTS
Baseline Characteristics and Preliminary Analyses
Baseline levels of perceived stress fell more than 1 stan-
dard deviation above the norm for adults between ages 18
and 34 and for adults with an advanced degree.28
Baseline
sleep problems fell nearly 1 standard deviation above the
general population norm.30
Mindfulness scores fell approx-
imately 1 standard deviation below a published norm for
college students,31
and was comparable to a sample of adults
who participated in an 8-week, self-pay MBSR program.32
Self-compassion fell nearly 1 standard deviation below the
college student norm33
and the mean gratitude score was
comparable to the mean reported by scale developers for
college students.35
t tests revealed no significant differences
between groups on primary outcome variables at baseline,
except gratitude, which was significantly higher in the Koru
group (see Table 2). One subscale of the SCS (Common Hu-
manity) was higher in the Koru group at baseline. Data were
relatively normally distributed with all z scores for skewness
and kurtosis less than 2.0.
Figure 1 provides a flow diagram for recruitment and re-
tention throughout the trial. Overall, 90% of students who
enrolled in the study completed the baseline survey and
were randomized. Over 82% of randomized students were
retained. Of the 45 students initially randomized to Koru,
33% attended all 4 classes, 38% attended 3 or more classes,
18% attended 2 classes, and 4% attended only 1 class. Seven
percent (n = 3) did not attend any Koru classes after they
were initially assigned to the group. Of the 45 students who
participated in Koru after being randomized to the wait-list
group, 33% attended all 4 classes, 27% attended 3 or more
classes, 11% attended 2 classes, and 2% attended only 1 class.
Twenty-seven percent of students (n = 12) initially assigned
to the wait-list did not attend any Koru classes when they
were offered the opportunity later in the semester. Consistent
with intent-to-treat, all students who were randomized were
analyzed. No adverse events were reported by any participant
during the study.
Primary Analyses
As hypothesized, there was a significant Group × Time
interaction for change in perceived stress scores (see Table 2).
Whereas perceived stress scores for the control group did
not change over time (t = 0.71, p = .48), perceived stress
decreased significantly in the Koru group (t = 3.62, p =
.001). A medium effect size on perceived stress was observed
for Koru compared with the wait-list control (Table 2), as
evidenced by a half standard deviation larger reduction in
perceived stress scores (d = .45), with 5% of the variance in
perceived stress scores over time explained as a function of
group assignment (η2
= .048).
There was also a significant Group × Time interaction for
change in sleep problems (see Table 2). Whereas sleep quality
scores for the control group did not change over time (t =
0.03, p = .98), overall sleep quality improved significantly
in the Koru group (t = 3.04, p = .003). A medium effect size
on sleep problems was observed for Koru compared with the
wait list control (Table 2), as evidenced by a half–standard
deviation larger reduction in sleep quality scores (d = .52),
with 6% of the variance in sleep quality scores over time
explained as a function of group assignment (η2
= .063).
A significant Group × Time interaction was observed for
change in mindfulness scores (see Table 2). Whereas mind-
fulness scores for the control group did not change over time
(t = 0.59, p = .56), mindfulness increased significantly in
the Koru group (t = −6.60, p .001). A large effect size
on mindfulness of thoughts and feelings was observed for
Koru compared with the wait-list control (Table 2), as evi-
denced by a 1 standard deviation larger increase in CAMS-R
mindfulness scores (d = −.95), with 18% of the variance
in mindfulness scores over time explained as a function of
group assignment (η2
= .184).
A significant Group × Time interaction was also observed
for change in self-compassion scores (see Table 2). Whereas
self-compassion total scores for the control group did not
change over time (t = −0.20, p = .84), they improved sig-
nificantly in the Koru group (t = −6.38, p .001). A large
effect size on total self-compassion scores was observed for
Koru compared with the wait-list control (Table 2), as evi-
denced by a three-quarter standard deviation larger increase
in total self-compassion scores (d = −.75), with 12% of the
variance in total self-compassion scores over time explained
as a function of group assignment (η2
= .123).
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13. Greeson et al
Assessed for Eligibility/Enrolled
(n = 101)
Excluded (n = 11)
Lost to Follow-Up (n = 11)
Not meeting inclusion criteria (n = 0)
Declined to participate (n = 0)
Analyzed (n = 45)
Lost to Follow-Up (n = 0)
Discontinued Intervention due to
Scheduling Conflicts (n = 6)
Assigned to Koru Group (n = 45)
Received allocated intervention
(n = 42)
Did not receive allocated intervention (n = 3)
Lost to Follow-Up (n = 7)
Discontinued Intervention due to
Scheduling conflicts (n = 7)
Missed Survey Deadline (n = 1)
Assigned to Wait-List Control (n = 45)
Received allocated intervention later
(n = 33)
Did not receive allocated intervention
(n = 12)
Analyzed (n = 45)
Allocation
Analysis
Follow-Up
Randomized (n = 90)
Enrollment
FIGURE 1. CONSORT flowchart of participants retained at each phase of the trial (color figure available online).
To examine the sources of change in overall levels
of self-compassion, we ran separate mixed-effects models
on each of the self-compassion subscales (see Table 2).
Whereas the wait-list control group only reported a sig-
nificant pre–post change on 1 subscale, Common Human-
ity, the Koru group reported significant pre–post changes
on all 6 subscales: increased Self-kindness, Common Hu-
manity, and Mindfulness, and decreased Self-judgment, Iso-
lation, and Over-identification (see Table 2). Effect sizes
for SCS subscales fell in the medium range for Self-
kindness and Mindfulness, and in the large range for Self-
judgment, Isolation, and Over-identification. The Common
Humanity subscale, which improved significantly for both
groups, showed a small effect size in favor of Koru (see
Table 2).
The Group × Time interaction for change in gratitude
was not statistically significant. Neither group reported a
significant pre–post change in gratitude (see Table 2).
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14. A Randomized Controlled Trial of Koru
Secondary Analyses
Mixed-effects models on students originally assigned to
the wait list (n = 45) who took Koru later in the semester
replicated all significant effects observed among students
who were randomized to take Koru first. Within-subjects
analyses modeled change over 3 time points: baseline, post
wait-list, and post Koru. Significant effects of time (all p val-
ues .005) were accounted for by significant changes from
time 2 to time 3 for the following variables: PSS (t = 3.56,
p = .001), sleep problems (t = 12.75, p .001), mindful-
ness (t = 5.08, p .001), self-compassion total (t = 6.24, p
.001), self-judgment (t = 4.37, p .001), isolation (t =
4.70, p .001), over-identification (t = 4.10, p .001), self-
kindness (t = 3.68, p .001), and mindfulness (t = 4.14, p
.001). Consistent with students randomized to take Koru
first, students randomized to take Koru later in the semester
had large effects sizes (within-subjects Cohen’s d = t/
√
n) for
changes in mindfulness (d = .76) and total self-compassion
scores (d = .93), and medium effect sizes for perceived stress
(d = .53) and most self-compassion subscales (d = .55–.70).
The effect size for improvement in sleep problems was sub-
stantially larger (d = 1.90), and the effect on an increased
sense of common humanity was marginally significant (t =
1.96, p = .054) with a small effect size (d = .29).
As expected, numerous significant correlations were ob-
served between changes in perceived stress, sleep problems,
mindfulness, and self-compassion among students originally
randomized to Koru (see Table 3). Notably, changes in mind-
fulness, self-compassion total scores, self-judgment, and
over-identification were significantly correlated with all other
outcome variables (except gratitude) in the Koru group. In
contrast, compared with students randomly assigned to Koru,
students assigned to the wait-list group reported fewer than
half as many significant correlations (see Table 3). These
findings are consistent with the hypothesis that improvements
in stress, sleep, mindfulness, and compassion are interrelated
during Koru.
COMMENT
Emerging adulthood, the transitional stage between high
school and adulthood, has been defined as a distinct de-
velopmental stage with unique needs and challenges.17,19
This age group struggles with concerning levels of stress-
related psychological conditions, including anxiety,40
depres-
sion,2
and sleep disturbance.5
Mindfulness-based interven-
tions have proved effective for reducing stress in university
students.41
The main results from this RCT found that Koru,
a new mindfulness training program designed specifically for
EAs, produced significant improvements in perceived stress,
sleep quality, mindfulness, and self-compassion in a univer-
sity student cohort of EAs. Gratitude was not measurably
affected. Koru was well liked by students as reflected by
high enrollment and retention in the study.
The results of this trial replicate and extend previous stud-
ies of meditation and mindfulness training for university stu-
dents. For example, the significant effect on lowering per-
ceived stress was similar in magnitude to a published RCT on
college students that compared the effect of 2 meditation pro-
grams with a wait-list control group.9
Lower perceived stress
following participation in Koru is also consistent with another
wait-list controlled trial with medical students.10
Other RCTs
that found significant reductions in perceived stress and psy-
chological distress included a 6-week mind–body program
based on the relaxation response and cognitive-behavioral
therapy skills42
and a 3-arm trial that compared 5 sessions of
mindfulness meditation training, somatic relaxation training,
and a wait-list control.43
Thus, the significant stress reducing
effect of Koru in this study was comparable to other, often
longer, stress management and skill building programs for
students.
Koru also produced a significant decrease in sleep prob-
lems, an effect that has previously been limited to uncon-
trolled studies.44
Whereas RCTs of MBSR and mindfulness-
based cognitive therapy (MBCT) have recently documented
improvements in objective measures of sleep quality among
adult populations with insomnia45
and depression,46
the
present study adds to the literature by demonstrating that
improvement in subjective sleep quality among university
students is directly correlated with increased levels of mind-
fulness and self-compassion.
Consistent with a recent meta-analysis of over 12,000
participants in mindfulness-based therapies, Koru produced
clinically significant effect sizes on multiple measures of psy-
chological well-being.14
The largest effect sizes in this study
were seen for increases in mindfulness and self-compassion.
The increase in mindfulness with Koru was comparable to
increases in mindfulness seen with an 8-week MBSR pro-
gram,32
an 8-week MBCT program,47
and an 8-week MSC
program.34
Although Koru’s relatively large effect size for
self-compassion (d = .75) was substantially less than that for
MSC (d = 1.67), it had somewhat stronger effects on mind-
fulness and stress. This difference may reflect that Koru does
not specifically target self-compassion, but rather mindful
attention, awareness, relaxation, and self-regulation. Nev-
ertheless, changes in self-compassion in this study were
comparable to those seen in other primary mindfulness in-
terventions such as MBSR.48
Given the association between
higher levels of self-compassion and better psychological
well-being,25,34
this study suggests that Koru may promote
student health, in part, by helping EAs develop a health-
ier way of relating to themselves in difficult times—a way
marked by greater self-kindness and less self-judgment; a
greater sense of connection through common humanity and
less isolation; and better emotional balance through greater
mindfulness and less over-identification with one’s problems.
Secondary findings demonstrated that all of the signif-
icant effects observed in a group of students randomized
to receive Koru could be replicated in wait-listed students
later in the same semester. Moreover, correlations among
improvements in perceived stress, sleep problems, mindful-
ness, and self-compassion were predominantly significant
in the Koru group. This finding indicates that Koru-related
benefits in mental and behavioral health are interdependent.
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16. A Randomized Controlled Trial of Koru
Taken together, the significant changes in perceived stress,
sleep, mindfulness and self-compassion with Koru suggest
that tailoring mindfulness training to emerging adulthood by
incorporating other mind–body skills, using fewer class ses-
sions, requiring shorter but mandatory home practice as well
as a course text, and contextualizing mindfulness training to
reflect common interests and concerns of EAs is an effective
strategy.
The relative brevity of the training model may contribute
to the high retention rates and thus effectiveness of Koru. Stu-
dents identify time pressures as one of the primary reasons
for not seeking help for mental health concerns.3
Thus, Koru
was designed to be as efficient as possible. Koru involves
5 hours of class time over 4 weeks, plus the expectation of
10 minutes of practice/day. In comparison, MBSR involves
27 hours of class time over 8 weeks, plus the expectation of
45 minutes/day of meditation practice.49
The decreased time
requirement of Koru appears to work well for young adults
who are juggling competing pressures. The present study
demonstrates that significant results can be achieved within a
relatively short, 4-week time frame. Others have found bene-
fits with brief exposure to mindfulness training. For example,
one 5-session training model that included a daylong med-
itation retreat found significant decreases in psychological
distress and rumination, and significant increases in positive
mood, among undergraduate and graduate students reporting
distress.43
Another recent study found reductions in anxiety
and associated neural correlates with only 4 20-minute mind-
fulness trainings.50
The relatively high retention rate of 82%
in our study may reflect the appeal of Koru for EAs.
Strengths and Limitations
The strengths of the study included a randomized experi-
mental design, adequate statistical power provided by a rela-
tively large sample size, inclusion of all available data from
all randomized subjects, and relatively high levels of program
adherence and survey completion. Limitations included re-
liance on self-report surveys for primary outcome measures,
which are susceptible to recall bias; limited diversity in the
student sample, which precludes broader generalizability;
and use of pre- and postintervention measures, which lim-
its understanding of when beneficial effects started to occur
and how long beneficial effects might last after Koru train-
ing. Future research can build on the present study by using
an objective measure of mindfulness, such as monitoring
breaths or heart beat while practicing meditation,51
enrolling
a more diverse group of students, and including both interim
and follow-up assessments to better describe the process and
durability of change following Koru.
Conclusion
College students make up a substantial fraction of the
EA demographic.18
A large proportion of college students
report significant stress-related mental health concerns, in-
cluding anxiety and depression.41
These types of mental
health concerns impact students both interpersonally and
academically.7
Mindfulness-based interventions are known
to provide significant improvement in anxiety, depression,
and stress reactivity in adults and university student popu-
lations.41,52
Only a small percentage of struggling students
receive treatment from university health centers2,3
; therefore,
it is critical that a broader range of mental-health outreach
services be provided for students. The results of this study
show that Koru, a relatively brief, developmentally targeted
mindfulness program, was effective at reducing symptoms of
stress, enhancing psychological well-being, and promoting
sleep—a key health behavior—for EAs who are students in a
university setting. These findings support Koru as a viable in-
tervention for student counseling centers and other agencies
that seek to provide cost-effective, low-stigma interventions
for students suffering from unmanageable levels of stress.
Further research is needed to explore the effectiveness of
Koru in other EA populations in community colleges, his-
torically black colleges and universities, and nonacademic
settings.
ACKNOWLEDGMENTS
We thank the staff at Duke Counseling and Psychological
Services, including the director of outreach services Gary
Glass, PhD, and the administrative assistant for outreach ser-
vices, Mary Cicinnati. We also thank all of the undergraduate,
graduate, and professional students who volunteered their
valuable time to participate in the trial and complete our sur-
vey. Finally, we thank Karen Caldwell, PhD, for assistance
with SPSS code for the mixed-effects models, and Dennis
Carmody, BA, for technical assistance with randomization
procedures and database management.
FUNDING
This work was supported by grant R00 AT004945 from
the National Center for Complementary and Alternative
Medicine (NCCAM) to JMG. The contents of this article
are solely the responsibility of the authors and do not neces-
sarily represent the official views of the National Institutes
of Health (NIH).
CONFLICT OF INTEREST DISCLOSURE
After completing the current research study, Dr Rogers
co-founded the Koru Center for Mindfulness, of which she
has an ownership share; if Koru is found to be an effective
intervention, she could benefit financially. Dr Maytan has
received compensation for teaching from the Koru Center
for Mindfulness. Dr Greeson, Mr Juberg, and Ms James,
who were responsible for collecting and analyzing the data
for this study, report no financial relationship relevant to the
subject of this article. The authors confirm that the research
presented in this article met the ethical guidelines, including
adherence to the legal requirements, of the United States and
received approval from the Institutional Review Board of
Duke University.
VOL 62, MAY/JUNE 2014 231
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17. Greeson et al
NOTE
For comments and further information, address corre-
spondence to Jeffrey M. Greeson, PhD, Duke Integra-
tive Medicine, Duke University Medical Center, DUMC
Box 102904, Durham, NC 27710, USA (e-mail: jef-
frey.greeson@duke.edu; jeffreymgreeson@gmail.com).
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Received: 22 June 2013
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![Pilot Study of Massage in Veterans
with Knee Osteoarthritis
Michael Juberg, BA,1
Kristin K. Jerger, MD, LMBT,1
Kelli D. Allen, PhD,2,3
Natalia O. Dmitrieva, PhD,4
Teresa Keever, BSN, RN,1
and Adam I. Perlman, MD, MPH1
Abstract
Objectives: To (1) assess the feasibility and acceptability of Swedish massage among Department of Veterans
Affairs (VA) health care users with knee osteoarthritis (OA) and (2) collect preliminary data on efficacy of
Swedish massage in this patient group.
Design: Experimental pilot study.
Setting: Duke Integrative Medicine clinic and VA Medical Center, Durham, North Carolina.
Patients: Twenty-five veterans with symptomatic knee OA.
Interventions: Eight weekly 1-hour sessions of full-body Swedish massage.
Outcome measures: Primary: Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and
global pain (Visual Analog Scale [VAS]). Secondary: National Institutes of Health Patient Reported Outcomes
Measurement Information System-Pain Interference Questionnaire 6b (PROMIS-PI 6b), 12-Item Short-Form
Health Survey (SF-12 v1) and the EuroQol health status index (EQ-5D-5L), knee range of motion (ROM), and
time to walk 50 feet.
Results: Study feasibility was established by a 92% retention rate with 99% of massage visits and 100% of
research visits completed. Results showed significant improvements in self-reported OA-related pain, stiffness
and function (30% improvement in Global WOMAC scores; p = 0.001) and knee pain over the past 7 days (36%
improvement in VAS score; p < 0.001). PROMIS-PI, EQ-5D-5L, and physical composite score of the SF-12
also significantly improved ( p < 0.01 for all), while the mental composite score of the SF-12 and knee ROM
showed trends toward significant improvement. Time to walk 50 feet did not significantly improve.
Conclusions: Results of this pilot study support the feasibility and acceptability of Swedish massage among VA
health care users as well as preliminary data suggesting its efficacy for reducing pain due to knee OA. If results
are confirmed in a larger randomized trial, massage could be an important component of regular care for these
patients.
Introduction
Osteoarthritis (OA) affects nearly 27 million
Americans, and its prevalence is expected to rise con-
siderably in the next several decades.1
Knee OA is particu-
larly common, with a lifetime risk of 45%.2
OA in general,
and knee OA in particular, is more common in U.S. military
veterans than in the general population, and Department of
Veterans Affairs (VA) health care users are at particularly
high risk.3
In addition, VA health care users with arthritis
(most commonly knee OA) have more severe symptoms and
activity limitations.4
In veterans, OA (including knee OA)
commonly co-occurs with other chronic pain conditions,
post-traumatic stress disorder, and substance abuse.5
Currently, a variety of conventional treatment options for
knee OA are available, including pain medication, cortico-
steroid injections, physical therapy, exercise, weight man-
agement, and joint replacement surgery.6
When traditional
treatment approaches are used, many patients with knee OA
continue to experience symptoms such as chronic pain and
1
Duke Integrative Medicine, Duke University Medical Center, Durham, NC.
2
Department of Medicine, Division of Rheumatology, and Thurston Arthritis Research Center, University of North Carolina at Chapel
Hill, Chapel Hill, NC.
3
Health Services Research and Development Service, Durham Veterans Affairs Medical Center, Durham, NC.
4
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.
THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE
Volume 21, Number 6, 2015, pp. 333–338
ª Mary Ann Liebert, Inc.
DOI: 10.1089/acm.2014.0254
333](https://image.slidesharecdn.com/1c385235-b667-43ea-8510-93c0482d6ece-160315195016/85/pilot-study-of-massage-in-veterans-with-knee-osteoarthritis-1-320.jpg)
![functional limitations that reduce quality of life.7
Accord-
ingly, there remains a pressing need to identify additional
effective, conservative treatments for knee OA that improve
pain, functioning, and overall well-being in these patients.
Massage therapy is effective for musculoskeletal disor-
ders, such as chronic back and neck pain,8
and is an effec-
tive treatment for managing pain associated with knee OA.9
For massage to be integrated into a comprehensive pain
management program, a systematic approach and dosage of
massage therapy needs to be established. A prior study dem-
onstrated the efficacy of a specific manualized protocol of
Swedish massage for improving pain, stiffness, and func-
tioning due to knee OA in non-veterans.9
A subsequent study
established an optimal dosage for the protocol: eight weekly
1-hour sessions.10
Although there is promising evidence for massage as an
effective treatment for knee OA, further studies must evaluate
its effectiveness in diverse patient groups. VA health care
users are an important patient group for studying this treat-
ment for several reasons. First, given VA health care users’
particularly high risk for activity-limiting knee OA, it is im-
portant to identify effective interventions for this vulnerable
patient group. Second, the demographic profile of VA health
care users differs substantially from that of participant sam-
ples in previous studies of massage for knee OA.9,10
Most of
these patients are men, and the acceptability of massage in
this group has not been sufficiently evaluated. Third, VA
health care users with knee OA have higher levels of physical
and psychological comorbidities that could influence or be
affected by massage.5
This pilot study evaluated a previously
established massage therapy protocol in a new population:
VA health care users with knee OA. Core objectives of this
study were to (1) assess the feasibility and acceptability of
Swedish massage among VA health care users with knee OA
and (2) collect preliminary data on the efficacy of Swedish
massage in this patient group.
Materials and Methods
This was a single group pilot study, with all participants
receiving a 1-hour-per-week intervention of Swedish mas-
sage for 8 weeks. Assessments were conducted before and
after the intervention. The institutional review boards of
Duke University and the Durham VA Medical Center re-
viewed and approved the study.
Participants
Primary eligibility requirements included (1) VA health
care users; (2) age ‡ 35 years; (3) written confirmation of
OA of the knee per American College of Rheumatology
criteria6
provided by the participant’s physician; (4) ra-
diographically established OA of the knee; and (5) a pre-
randomization score in a specified range on the Visual
Analog Scale (VAS; ‡ 40mm and £ 90 mm on a 40–100 mm
scale). For patients with bilateral knee involvement, the study
knee was determined by the patient as being the more prob-
lematic/painful knee. Exclusion criteria included (1) any intra-
articular knee depo-corticosteroid within the last 3 months, (2)
intra-articular hyaluronate within the past 6 months, (3) ar-
throscopy within the past year, (4) knee replacement surgery,
(5) significant injury within the past 6 months, and (6) pres-
ence of a rash or open wound over the knee. Participants
missing the research visit or three or more massage visits
could be withdrawn from the study at the discretion of the
study principal investigator.
Patients with knee OA at the Durham VA Medical Center
were recruited by using two methods. First, posters were
displayed in clinic waiting rooms and other common areas
of the medical center. Second, invitation letters were sent
to patients who were identified as having knee OA from
Durham VA electronic medical records. These letters pro-
vided basic information about the study and invited patients
to call if they were interested in participating. The first
25 eligible participants to send a letter from their physician
verifying their diagnosis of knee OA were enrolled in the
study. Participants meeting all criteria gave written informed
consent before enrolling in the study.
Study design and treatment
Participants received eight weekly 1-hour Swedish mas-
sages at Duke Integrative Medicine’s clinical facilities, 1 mile
from the Durham VA Medical Center. Massage therapists
were certified by the National Certification Board for
Therapeutic Massage & Bodywork adhered to a manualized
massage protocol previously tested to treat OA of the knee.10
Therapists announced their next technique or position in
order to minimize potential client startle in a population with
high prevalence of post-traumatic stress disorder. Each study
therapist signed a form attesting to adherence to the study
protocol after each massage session.
The primary outcome measure used to assess OA-related
pain, stiffness, and function was the Western Ontario and
McMaster University Arthritis Index (WOMAC) global
score (VAS version). The WOMAC has been subject to
numerous validation studies to assess reliability and re-
sponsiveness to change in therapy, including physical forms
of therapy.11
In addition, participants were asked to respond
to the question, ‘‘How much pain have you had because of
your knee in the past week?’’ using a 100-point VAS.
Secondary outcomes included measures of other domains
of high relevance to patients with knee OA: the National
Institutes of Health Patient Reported Outcomes Measure-
ment Information System-Pain Interference Questionnaire
6b (PROMIS-PI 6b).12
This instrument consists of six
questions that follow the format, ‘‘In the past 7 days, how
much did pain interfere with [insert category]?’’ and allows
responses on a 5-point scale (1 = not at all/never, 5 = very
much/always). The six categories include enjoyment of life,
ability to concentrate, day-to-day activities, enjoyment of
recreational activities, doing tasks away from home (e.g.,
getting groceries, running errands), and socializing with
others. Measures used to assess change in perceived health
status included EQ-5D-5L,13
a non–disease-specific instru-
ment for describing and valuing health-related quality of
life, and the Short Form-12 (SF-12), version 1.14
The SF-12
Health Survey is a 12-item subset of the SF-36 that mea-
sures the same eight domains of health as the longer scale. It
is a brief, reliable measure of overall health status which is
useful in large population health surveys and has been used
extensively as a screening tool. Knee range of motion
(ROM), measured manually with a goniometer to the onset
of stiffness, and 50-foot walk test were also measured.
Maximal walking speed is a more reliable and predictive
334 JUBERG ET AL.](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)