N/A
N=145
Low-level Laser Therapy and Static Stretching in Knee Osteoarthritis.
Osteoarthritis, Knee
Bottom Line
View on ClinicalTrials.gov: NCT01738737 ↗Enrolled (actual)
145
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Change From Baseline in Visual Analogue Scale for Pain — 3.2; 3.8; 3.1; 3.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Laser (Device); Stretching exercises (Other); placebo laser therapy (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Sao Paulo General Hospital
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Visual Analogue Scale for Pain |
3.2; 3.8; 3.1; 3.3; 0.7 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index |
8.0; 11.0; 13.0; 16.0; 2.0 | — |
| SECONDARY Change From Baseline in Range of Motion of Flexion of the Knee |
7.0; 10.0; 6.0; 10.0; 1.0 | — |
| SECONDARY Change From Baseline in Lequesne Functional Questionnaire |
2.5; 1.5; 4.0; 3.5; 0.0 | — |
| SECONDARY Change From Baseline in Timed Get Up and Go Test |
2.5; 3.0; 2.6; 3.1; 0.0 | — |
Summary
Osteoarthritis (OA) is a highly prevalent and disabling disease. It is estimated that by 2030 the prevalence of symptomatic OA could reach 30% of the population above 60 years. It is associated with significant morbidity being one of the most common causes of joint pain, functional disability and compromised quality of life. This randomised controlled trial will investigate the effect of low-level laser therapy (LLLT) and static stretching exercises, as monotherapy and in combination, on pain, quality of life, function, mobility, knee range of motion (KROM) and hamstring length in participants with knee OA.
This study will involve 145 people aged 50-75 years with symptomatic radiographic knee OA and will consist of two types of treatments: Low-level laser therapy (LLLT) and stretching exercises. The patients will be randomly allocated to five study groups LLLT active+Stretch, LLLT placebo+Stretch, Stretch, LLLT and Control (with n=29 each). Treatment frequency will be three sessions/week for all active groups. LLLT will involve the use of a Galium-Arsenide laser (904nm, 40 milliwatts, 3 Joules/point, 27 Joules/knee) over 24 sessions for the monotherapy group and 9 sessions for the LLLT+Stretch groups. Stretching will consist of seven exercises completed over 24 sessions. The control group will receive a booklet.
The primary outcome is pain measured by Visual Analogue Scale. Secondary outcomes included quality of life assessed by Western Ontario and McMaster Universities Arthritis Index (WOMAC), function by Lequesne Algofunctional Index, mobility by Timed Up and Go Test (TUG), KROM by goniometry of knee flexion and hamstring shortening by popliteal angle. The statistical method will follow the principles of per-protocol analysis.
Eligibility Criteria
Inclusion Criteria
- radiographic evidence of knee osteoarthritis between 2-4 in Kellgren & Lawrence classification
- pain intensity ≥3 on a 10cm Visual Analogue Scale (VAS)
- knee symptoms for at least 3 months
Exclusion Criteria
- symptomatic hip osteoarthritis
- any disease where laser treatment is contraindicated (cancer and uncontrolled diabetes mellitus)
- continuous use of anti-inflammatory drugs
- other concurrent injury/conditions that will affect their ability to participate in the rehabilitation program and/or assessment procedures.
Data sourced from ClinicalTrials.gov (NCT01738737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.