L. Karimi1; C. Miller2,3; L. Donohue2; R. Nunn2; W. McGuiness3; T. Czech4; C. A. Arnold5; J. Sunderland6

1. Resolving Wound Pain with
Low Intensity Laser Therapy
Findings from a Proof of Concept Study
L. Karimi1; C. Miller2,3; L. Donohue2; R. Nunn2; W. McGuiness3;
T. Czech4; C. A. Arnold5; J. Sunderland6
1 School of Public Health, La Trobe University
2 Royal District Nursing Service Helen Macpherson Smith Institute of Community Health
3 Alfred Health Clinical School, School of Nursing and Midwifery, La Trobe University
4 Australian Institute of Laser Therapy
5 Caulfield Pain Management & Research Centre / Alfred Health
6 Royal District Nursing Service

2. Low Intensity Laser Therapy (LILT) is:
 effective for pain associated with
- acute injuries
- surgical wounds.
? No trials for chronic wound pain.
BUT… there have been favourable
case study and single sample pre/
post evaluations.
Wound Pain

3. Study Aim
Examine the feasibility of a Randomised
Controlled Trial and generate more
precise effect size estimates upon which
power analyses for future research could
be based.

4. Study Design
• Non-blinded, RCT study design (ACTRN12608000503325)
• Recruitment / data collection (2008-2010)
• Implemented in 2 ‘clinics’ of an Australian community nursing service
• 3 study groups =
1. Control 2. Polylaser Trion™ 3. Photonic 500 Acumed™
(hand held laser) (scanning laser)

5. Study Design (cont’d)
Education
Treatment
Data Collection
Primary
outcome
measure
 Best Practice Wound Pain Management Education for staff
 Wound Management Clinical Nurse Consultants were
certified in LILT
0-6 weeks (Treatment Phase) / 6-12 weeks (Monitoring Phase)
Baseline and two weekly data collection (for 12 weeks)
Reduction of pain (Brief Pain Inventory (BPI – Short Form) (©
C.S. Cleeland & Pain Research Group, 1991): generates ‘pain
severity’ and ‘pain interference’ scores

6. Study Design (cont’d)
Eligibility Criteria
 Aged ≥18 years.
 Chronic leg wound of either pressure, venous, arterial, mixed venous/arterial, injury, burn, or
vasculitis aetiology.
 Wound was older than 6 weeks, ≤10cms in diameter, and ≤2cms in depth.
 Wound was healing by secondary intention (Carville, 2005).
 Experienced wound pain (≥1 on a 0-10 numeric pain rating scale).
 Wound pain at times other than (but could be in addition to) wound dressing changes.
 Wound pain that had not responded to a minimum of 2 weeks of standard pain
management.
 Client was willing to attend a clinic setting for their care during the study period.
 Diagnosis of, or in receipt of treatment for, a malignancy (wound or other).
 Lack of support for client participation from the local medical officer / wound specialist.
 Planned absences during the 12 week study period.

7. Participant Flow Diagram
Ave. 79 years.
Female (66.1%).
Wound duration = 9 months ave.
Wound pain = 7+ months ave.
Most wounds were leg ulcers
The treatment groups were comparable:
Exception 1. Pain duration at baseline.
[F(2,51)=3.15, p=0.05]. Statistically controlled.
Exception 2. Diabetes greater in scanning laser
group. Too few cases to formally test for
statistical differences or control for.
Randomised (n=57)
Lost to follow-up: n/aLost to follow-up: (n=2)Lost to follow-up: (n=1)
Scanning Laser (n=19)Hand Held Laser (n=20)Control (n=18)
Analysed (n=17)
Insufficient data (n=1)
Analysed (n=18)
Insufficient data (n=2)
Analysed (n=19)
Enrolment
Allocation
Follow-up
Analysis

8. 0
1
2
3
4
5
0 1 2 3 4 5 6
Fortnight
BPIPainInterference
Control Handheld Laser Scanning Laser
Results: Pain Interference
Results favoured
pain reduction in
the hand held laser
group, however…
No significant
difference between
the study groups
for their level of
pain interference
nor for the pain
severity scale.

9. Effect
size
Per group
n=
Total n=
Pain
Interference
0-1 fortnight 0.36 34 102
0-3rd fortnight (treatment) 0.22 89 267
0-6th fortnight (total) 0.16 168 504
Pain
Severity
0-1 fortnight 0.43 24 72
0-3rd fortnight (treatment) 0.29 51 153
Effect / Sample Size
Estimates
Sml effects
favoured
handheld laser.
Sml / Mod
effects
favoured
handheld laser.

10. • A small short-term benefit of the hand held laser to resolve
wound pain was found
• Recommendations re study design
• More homogenous sample
• Consideration of a placebo (blinded trial)
• Extended data on ‘usual treatment’, population, and cost
of care
Key conclusions
Karimi, L., Miller, C., Donohue, L., Nunn, R., McGuiness, B., Czech, T., Arnold,
C., & Sunderland, J. (2012). Evaluating the Effect of Low Intensity Laser
Therapy on Chronic Wound Pain: A Proof of Concept Study. Wound Practice
and Research, 20(3), 159-168