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Background  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. 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 shortening in participants with knee OA.    Methods  This study will involve 145 people aged 50–75 years with symptomatic-radiographic knee OA. It will consist of two types of treatments: Low-level laser therapy (LLLT) and stretching exercises. The patients will be randomly allocated to five groups LLLT ACTIVE +Stretch, LLLT PLACEBO +Stretch, Stretch, LLLT and Control ( n  = 29 each). Treatment frequency will be three sessions/week for all active groups. LLLT will involve the use of a Gallium-Arsenide laser (904 nm, 40 milliwatts, 3 J/point, 27 J/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. Participants will be treated for 2 months (Stretch, LLLT and Control groups) or 3 months (LLLT + Stretch groups). Participants and the outcome assessor will be blind to treatment allocation throughout the study.  The primary outcome is pain measured by Visual Analogue Scale. Secondary outcomes include quality of life assessed by Western Ontario and McMaster Universities Arthritis Index, function by Lequesne Algofunctional Index, mobility by Timed Up and Go Test, KROM by goniometry of knee flexion and hamstring shortening by popliteal angle. The statistical method will follow the principles of per-protocol analysis.    Discussion  Although exercise therapy is considered an effective treatment in patients with knee osteoarthritis, the knowledge of which exercise modalities would be the most appropriate for this population is lacking. LLLT has been used as resource to increase the effects of physical therapy. However, the specific dose and treatment frequency need to be better defined. The findings from this randomised controlled trial will provide evidence of the efficacy or otherwise, of LLLT and stretching exercises in the management of knee OA symptoms.    Trial registration   NCT01738737  at ClinicalTrials.gov.

Effect of low-level laser therapy (904 nm) and static stretching in patients with knee osteoarthritis: a protocol of randomised controlled trial