Ferreira de Meneses Sarah Rubia, Hunter David John, Young Docko Eunice, Pasqual Marques Amelia
Department of Physiotherapy, Occupational Therapy and Speech Therapy, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.
Royal North Shore Hospital, Rheumatology Department, and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, NSW, Australia.
BMC Musculoskelet Disord. 2015 Sep 14;16:252. doi: 10.1186/s12891-015-0709-9.
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 LLLTACTIVE+Stretch, LLLTPLACEBO+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.
背景：骨关节炎（OA）是一种高度流行且使人致残的疾病。据估计，到2030年，有症状的OA患病率在60岁以上人群中可能达到30%。这项随机对照试验将研究低强度激光疗法（LLLT）和静态拉伸运动单独及联合使用对膝骨关节炎患者的疼痛、生活质量、功能、活动能力、膝关节活动范围（KROM）和腘绳肌缩短的影响。 方法：本研究将纳入145名年龄在50 - 75岁、有症状性 - 影像学膝骨关节炎的患者。将包括两种治疗类型：低强度激光疗法（LLLT）和拉伸运动。患者将被随机分配到五组：LLLT活性 + 拉伸组、LLLT安慰剂 + 拉伸组、拉伸组、LLLT组和对照组（每组n = 29）。所有治疗组的治疗频率均为每周3次。LLLT组中，单治疗组将在24次治疗中使用砷化镓激光（904纳米，40毫瓦，3焦耳/点，27焦耳/膝），LLLT + 拉伸组为9次。拉伸运动将包括在24次治疗中完成的7项运动。对照组将收到一本手册。参与者将接受2个月的治疗（拉伸组、LLLT组和对照组）或3个月的治疗（LLLT + 拉伸组）。在整个研究过程中，参与者和结果评估者将对治疗分配情况不知情。主要结局是通过视觉模拟量表测量的疼痛。次要结局包括通过西安大略和麦克马斯特大学骨关节炎指数评估的生活质量、通过Lequesne功能指数评估的功能、通过计时起立行走测试评估的活动能力、通过膝关节屈曲角度测量评估的KROM以及通过腘窝角评估的腘绳肌缩短情况。统计方法将遵循符合方案分析的原则。 讨论：尽管运动疗法被认为是膝骨关节炎患者的一种有效治疗方法，但对于该人群哪种运动方式最合适仍缺乏了解。LLLT已被用作增强物理治疗效果的手段。然而，具体剂量和治疗频率需要进一步明确。这项随机对照试验的结果将为LLLT和拉伸运动在管理膝骨关节炎症状方面的疗效提供证据。 试验注册：ClinicalTrials.gov上的NCT01738737 。
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