Rotator Cuff Unloading Versus Loading Exercise Program in Patients With Shoulder Pain and Rotator Cuff Tear: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Change from Baseline Quality of Life at 12 weeks and 1 month (follow-up) - The Western Ontario Rotator Cuff Index (WORC)
研究概览
简要总结
Introduction: Atraumatic and degenerative rotator cuff tears are common in individuals over 55 years of age. This condition can have a high impact on social life and is associated with chronic pain, weakness and dysfunction of the upper limb. There is evidence that conservative approaches should be the first treatment option. Conservative treatment usually addresses a variety of therapeutic behaviors without providing scientific arguments for the choice and progression of exercises. At that, there is a gap in the literature on the best exercises for this population, whether they are exercises to strengthen the remaining fibers of the rotator cuff or exercises focused on strengthening other shoulder muscles with rotator cuff unload exercise program. Objective: To compare the effects of two different exercise programs based on the load of the rotator cuff on a population with shoulder pain and rotator cuff tear. Methods: This is a controlled, randomized, blinded clinical trial. In this study 78 individuals with shoulder pain and presence of atraumatic rupture of the rotator cuff muscle tendon will participate and will be randomly distributed between two groups. The primary outcome will be quality of life (WORC index), and secondary outcomes will include pain, function (DASH), fear avoidance beliefs (FABQ-Brazil), kinesiophobia (Tampa Scale), pain catastrophizing scale, muscle strength of abductors, lateral and medial rotators of the shoulder, range of motion of arm elevation and patient satisfaction. All outcomes will be measured before and after 12 weeks of treatment (2x/week), and 1 month after the end of treatment. The normality of the data will be verified by the Kolmogorov Smirnov test. The differences between the groups will be verified using the mixed linear models with the terms of interaction versus time. The effect size will be calculated for the variables between the groups. The level of significance will be 5%.
详细描述
BACKGROUND The presence of atraumatic and degenerative ruptures in the rotator cuff is a common finding in imaging studies due to the natural aging process. Several exercise protocols have been proposed for this population. However, there is still a gap in the literature about what exercises are best for these individuals: exercises to strengthen the remaining fibers of the rotator cuff or exercises focused on strengthening other shoulder muscles with little emphasis on the rotator cuff. Both types of exercises are performed jointly in most treatment programs, or the tension in the rotator cuff is not taken into account during exercise selection.
Despite the lack of consensus on which exercises or exercises are more effective in conservative treatment, there is evidence that therapeutic exercises should be the first treatment option in individuals with chronic, atraumatic, degenerative, and rotator cuff tears. Thus, it is expected that this study may contribute to filling the existing gap, re-adjusting treatment techniques for this population and provide scientific bases that support the clinical practice of physiotherapists.
RESEARCH QUESTION:
Are the results of a rotator cuff unloading exercise program different than rotator cuff loading exercise program in individuals with shoulder pain and rotator cuff tear? This research question is relevant to clinical practice once that so far there are no specific treatment guidelines for patients with degenerative ruptures of the rotator cuff tendons.
Primary Aim The primary aim of this study will be to verify the effects of 12-week unloading rotator cuff exercise program compared to an usual exercise program with an emphasis on the rotator cuff on quality of life in patients with shoulder pain and and rotator cuff tear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 55 years or over;
- •shoulder pain;
- •at least 90° of arm elevation;
- •atraumatic rotator cuff tear.
排除标准
- •Individuals with a history of trauma associated with onset of symptoms;
- •fracture and/or previous surgery on upper limbs;
- •pain related to the cervical spine;
- •inflammatory arthritis;
- •adhesive capsulitis;
- •cognitive alteration that makes it impossible to perform the questionnaires.
结局指标
主要结局
Change from Baseline Quality of Life at 12 weeks and 1 month (follow-up) - The Western Ontario Rotator Cuff Index (WORC)
时间窗: Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)
The Western Ontario Rotator Cuff Index (WORC) contains 21 questions distributed in five domains, each question can be scored between 0 and 100 on the Analogic visual scale. The final result of WORC varies from 0 to 2100, higher value indicates worse the quality of life of the individual.
次要结局
- Change from Baseline Shoulder Pain at 12 weeks and 1 month (follow-up)(Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up))
- Change from Baseline Pain Catastrophizing at 12 weeks and 1 month (follow-up)(Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up))
- Change from Baseline self-perception of improvement at 12 weeks and 1 month (follow-up)(Post treatment (12 weeks) and after 1 month (follow-up))
- Change from Baseline Fear Avoidance Beliefs at 12 weeks and 1 month (follow-up)(Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up))
- Change from Baseline Kinesiophobia at 12 weeks and 1 month (follow-up)(Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up))
- Change from Baseline Upper Limb Function at 12 weeks and 1 month (follow-up)(Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up))
- Change from Baseline Muscle Strength at 12 weeks and 1 month (follow-up)(Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up))
- Change from Baseline Range of Motion at 12 weeks and 1 month (follow-up)(Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up))
研究者
Larissa Pechincha Ribeiro
Principal Investigator
Universidade Federal de Sao Carlos