Non-Surgical Treatment for Knee Osteoarthritis Pain

Running head: CRITIQUE OF NON-SURGICAL TREATMENT OF KNEE PAIN 1
Quantitative Critique of the Efficacy of Non-Surgical Treatment on Pain and Sensitization in
Patients with Knee Osteoarthritis
James Nichols
University of Central Arkansas
Author Note
James Nichols, Department of Nursing, University of Central Arkansas
Correspondence concerning this article should be addressed to Dr. Che Reed, Department of
Nursing, University of Central Arkansas, and Conway AR, 72205 Email: creed@uca.edu

CRITIQUE OF NON-SURGICAL TREATMENT OF KNEE PAIN 2
Quantitative Critique of the Efficacy of Non-Surgical Treatment of Pain and Sensitization in
Patients with Knee Osteoarthritis
Non-Surgical Treatment of Pain and Sensitization in Knee Osteoarthritis was a very well
written, detailed and interesting study. The pre-defined ancillary analysis of a randomized
controlled trial effectively reduced the cost of administration of the study while planning what
data and how it would be obtained even before the data was accumulated for the original
randomized controlled trial. The pre-defined aspect allowed for a level of accuracy and
cohesiveness seldom seen in most ancillary studies. The detail descriptions of the testing
instruments used add to the credibility of the study while the in-depth discussion section
reviewing the possible reasons for the differences between the current study and predecessor
studies add to the credibility of the authors. The thorough use of data analysis to increase the
comparability of the two small sample groups and the generalizability of the two groups which
were both developed from a focused recruitment process increased the overall study’s validity.
Introduction
Polit and Beck (2012) defines the introduction as communication of the research
problem, central phenomena, concepts, variables, study purpose, study framework, current state
of the evidence and the nursing significance of the study. Skou et al. (2015) provide an in-depth
description of the multidimensional nature of osteoarthritic knee pain and the necessity of a
complex framework to study the problem in order to enhance the limited state of evidence in the
specific area of sensitization of pain in osteoarthritic knee pain patients with lower levels of pain
intensity. Skou et al. (2015) covers effectively the conceptual phase of the study as defined by
Polit and Beck (2012) by reviewing the fact that the study was pre-defined with all data
collection requirements determined and detailed before the beginning of the primary study. The

problem statement and purpose are concise in differentiating the difference between pain and
sensitization showing the need for the new study to focus on the effects of the interventions on
sensitization. The hypothesis is clearly stated as “the MEDIC-treatment would result in greater
improvements in the pain-related measures and sensitization than usual care at 3-month follow
up”. The objective is also directly stated as “to investigate the efficacy of MEDIC-treatment to
improve different pain related measures and sensitization after 3 months compared to usual
care”. The conceptual framework which is a predefined ancillary randomized control trial
following the CONSORT standard was not covered in the introduction. The indirect variables are
well defined as MEDIC-treatment and usual care. The direct variables are stated plainly to be
pain intensity, pain pattern, spreading of pain, usage of pain medication and pain sensitization.
Review of Literature
Polit and Beck (2012) state that a literature review provides a basic understanding of the
current evidence on a topic and areas of needed advancement. Skou et al. (2015) provides a
comprehensive explanation of the review of literature carried out for this study by citing relevant
studies. The article does provide current studies describing research applying non-surgical
interventions to osteopathic knee pain and the sensitization process in relation to osteopathic
knee pain. Skou et al. (2015) justify the current study by highlighting the need for further review
of sensitization of patients with less advanced osteoarthritic knee pain. Review of literature
included all relevant studies as of the date of publication.
Methodology
Ethical Considerations – All patients gave informed consent before enrollment and the
study was conducted in accordance with the Helsinki Declaration and was approved by the local
ethics committee of the north Denmark region. The patients in the treatment group were at no

increased risk of adverse health effects resulting from the interventions provided. The patients in
the control group received the same level of care that would have been rendered had the study
not been conducted.
Design- Skou et al. (2015) used a pre-defined ancillary analysis of the results of a three
month randomized control trial (RCT). Polit and Beck (2012) define the RCT as the gold
standard of research and rank RCT’s only behind systematic reviews or meta-analysis in the
hierarchy of evidence. A predefined ancillary analysis was planned before the data were
collected for the primary study the preplanned aspect of this study allowed for more control over
the study design and accuracy (Polit & Beck, 2012).
Variables- The variables were well defined and clear. The independent variables were the
inclusion in the Medic group which consisted of neuromuscular exercise, education, diet, insoles
and pain medications or the inclusion in the usual care group which consisting of two leaflets
with information on treatment advice. The dependent variables were sensitization assessed at the
knee, lower leg and forearm using an algometer, peak pain intensity in the previous 24 hours
measured by a visual analog scale, pain intensity after 30 minutes of walking measured by a
visual analog scale and the use of pain medication. The direct variables were clearly defined and
identified. The indirect variables were measurable and clearly stated. The measurement plan for
the indirect variables was carried out in a manner which clearly supported the relationship
between the indirect variable, the intervention, and the direct variable (outcome).
Setting-The intervention was conducted at an urban research teaching hospital in
Denmark. Polit and Beck (2012) state that a good site has a sufficient number of people with the
characteristics to be studied and adequate diversity or mix of people to achieve the research
goals. One weakness of the study is the homogeneity of the study group in this case. The limited

diversity and setting in this case make this a preliminary study which will require replication on a
larger scale with a more diverse sample.
Population and sample- The participants were recruited from two specialized public
outpatient clinics from the same hospital. Both groups were appropriately randomized. Blinding
of the participants was not possible because one group was to receive specific treatment
interventions that no placebo could be effectively designed to duplicate. The term
generalizability is used to describe the ability to apply the findings of a study to other groups and
settings (Polit & Beck, 2012). The limited diversity and setting in this case make this a
preliminary study which will require replication on a larger scale with a more diverse sample.
The exclusion of individuals who qualify for total knee replacement and thus have a more severe
level of osteoarthritis reduced the selected study participant’s level of pain and length of chronic
pain experienced thus affecting the studies outcome in relation to sensitization which increases
with the length of time the participant suffers chronic pain (Skou et al., 2016). The needed
sample size to achieve a power level of 90% and a significance level of .05 was calculated as 41
for each group. Power is the probability of detecting the true relationship in a study with the
number of participants involved (Polit & Beck, 2012). The significance level is the percentage of
time with the population size studied that the results would be due to chance (Polit & Beck,
2012). So in this case only 5 times in 100 would the results be a matter of chance. The dropout
rate was set at 20%. The required final group of patients was 50 in each group. Each group was
able to recruit the 50 patient sample size and all original recruits for the study were accounted for
in the paper. The population size was adequate for the study’s aims.
Instrument and tools-Visual analog scales (100 mm) were used to measure patient self-
reported pain in the past 24 hours and pain after walking 30 minutes. Visual analog scales (VAS)

are frequently used in knee pain studies and three academic peer reviewed journal studies that
used visual analog scales are referenced in the article (Skou et al., 2016). The study clearly states
that visual analog scales are reliable, valid, and responsive and offer low interrater variability
because of the ease of administration. Polit & Beck (2016) also clarify the reliability and validity
of visual analog scales. Pain location was self-reported by a body map administered by an
interviewer. The body map has been used successfully in knee studies in the past. Pain
medication use was self-reported by a dichotomized questionnaire. Assessment of sensitization
was measured by using a handheld algometer which applied a constant pressure to the surface
and the patient would register it as pain by pressing a button that recorded the report. The hand
held algometer had a reported level of accuracy of 95%.
All the tests used in the study including the visual analog scale used for assessment of
pain, the visual analog scale used for assessment of pain during function, the knee pain map used
for assessment of pain location, the body site map used for assessment of pain migration, the
dichotomized survey used to report medication and the algometer measurement of sensitization
were consistently administered and recorded leading to increased instrument reliability. Also, the
measurements with the algometer were carried out by one trained assessor who was blinded as to
participants’ group membership.
Data quality- A T test was used to evaluate change in pain intensity and number of
pain sites between and within the groups. T-tests determine the comparability of two groups
(Heiman, 2004). A three way analysis of variance (ANOVA) was used to evaluate change in
pressure pain thresholds from baseline to three months into the study using fixed factors groups
(medic, usual care), Site (knee, lower leg and forearm) and Side (most affected). ANOVA is
appropriate for determining differences in means between more than three groups. The ANOVA

test can compare variability within the group to variability outside the group in order to
determine whether the measured factors are truly relevant to outcome (Heiman, 2004). Levine’s
test was used to test the assumption of the homogeneity of variance. Q plots were used to test
normal distribution of the data points. The data analysis was used effectively in this case to
support the validity of the study results. Validity is defined by Polit and Beck (2012) as the
degree to which a study is accurate and well-founded. The use of one rater in the algometer
sensitivity measurement using very exacting technique allows for both equivalence, defined by
Polit and Beck (2012) as the degree to which two independent observers or coders agree about
scoring, and interrater reliability, defined by Polit and Beck (2012) the degree to which two
different individuals using consistent, measurement approaches come to the same interpretation
of a construct. The use of visual analog scales and body map graphics that are simple and
require very little explanation by the individual administering the test add to interrater reliability.
This is supported by Polit and Beck (2012) Both VAS and body maps are easily interpreted by
the participant are also very good in regards to interrater reliability and equivalence.
Generalizability- Generalizability is defined by Polit and Beck (2012) as the degree to
which the research methods justify the inference that the findings are true for a broader group
than the study participants. The sample in this case was from one site in a small nation with
limited cultural diversity and a unique culture making the generalizability of the results
questionable. The study can best be viewed as a preliminary or pilot study highlighting the need
for a more in-depth study at multiple sites throughout Europe and possibly the United States and
Canada.
Credibility- Credibility is defined by Polit and Beck (2012) as confidence in the truth of
the data. The complexity and inter-relationship between pain and sensitization combined with the

multiple interventions used in this case make the findings in this study questionable. With the
multiple interventions used in the MEDIC-treatment, it is not possible to determine which
interventions are effective and which are superfluous. Also, with the number of interventions and
related measurement activities there is an increasing probability that outside influences may
affect construct validity for example an elderly population with a higher rate of depression may
be more susceptible to reactivity to the study situation (Hawthorne effect), novelty effect, or
treatment diffusion (Polit & Beck, 2016). Reactivity to the study situation would result from the
participants reacting positively to the extra attention and focusing more on the social interaction
than the chronic pain. Novelty effect comes into play if the participants are distracted by the
treatment and focus less on chronic pain. Finally the treatment diffusion would exist if the
participants in both the MEDIC group and the usual treatment group discussed with each other
and shared how the other group was being treated resulting in the usual treatment group
acquiring the same treatment elsewhere. This could also explain why that in this study the usual
treatment group showed improvements that were almost equal to the MEDIC group. The
similarity between pain and sensitization adds to the complexity of this case. The fact that
sensitization increases in occurrence with longer exposures to pain and that of the participants in
this study consisted of individuals with shorter periods of chronic knee pain meaning that they
had less incidents of sensitizations brings the credibility of the results into further question by
limiting the need for the intervention for sensitization in many of the population’s cases.
Feasibility and Cost- Implementation cost for the interventions are limited to additional
manpower required for the teaching, insoles, and pain medication. When compared to the cost of
knee replacement surgery and the required period of rehab and hospitalization, the intervention is
cost effective.

Application & Utilization
The combined treatment of neuromuscular exercise, patient education, diet, insoles
and pain medication showed positive results in lowering pain levels in osteoarthritic patients.
The authors state that holistic measures should be implemented to relieve chronic osteoarthritis
pain in patients (Skou et al. 2016). The study clearly and succinctly explains how the study
findings should be applied to nursing practice. With an aging population with increasing
comorbidity, it is this author’s belief that these interventions should be implemented on medical
surgical units. Skou et al.’s article is an in-depth complex review of an effective treatment
method for a complex condition that more Americans will have to face in an aging population.

References
American Psychological Association (2010). Publication manual of the American Psychological
Association (6th ed.). Washington D.C.: American Psychological Association.
Heiman, G. (2004). Essential statistics for the behavioral sciences. Boston, MA: Houghton
Mifflin & Company.
Melnyk, B. M., & Fineout-Overholt, E. (2011). Evidence-based practice in nursing &
healthcare: A guide to best practice (2nd ed.). Philadelphia, PA: Lippincott, Williams &
Wilkins.
Polit, D. F., & Beck, C. T. (2012). Nursing research: Generating and assessing evidence for
nursing practice (9th ed.). Philadelphia, PA: Lippincott, Williams & Wilkins.
Skou, S., Arendt-Nielsen, L., Laursen, M., Rathleff, M., Roos, E., & Simonsen, O. (2015). The
efficacy of non-surgical treatment on pain and sensitization in patients with knee
osteoarthritis: A pre-defined ancillary analysis from a randomized controlled trial.
Osteoarthritis and Cartilage, 24, 108-116. (Doi:10.1016/j.joca.2015.07.013)

Non-Surgical Treatment for Knee Osteoarthritis Pain

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