Effects of Cognitive Functional Therapy Versus Therapeutic Exercises in Individuals With Chronic Shoulder Pain: A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Universidade Federal de Sao Carlos
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Pain intensity
概览
简要总结
The objective of this clinical trial is to determine whether cognitive functional therapy is superior to therapeutic exercises for the treatment of chronic shoulder pain. The main questions it aims to answer are:
Is cognitive functional therapy superior to therapeutic exercises for pain and disability in individuals with chronic shoulder pain? Is cognitive functional therapy superior to therapeutic exercises for functionality and psychosocial factors?
Participants will:
Receive 4 to 8 sessions of cognitive functional therapy once a week for four to eight weeks.
Follow a therapeutic exercise protocol for eight weeks with a frequency of twice per week.
详细描述
This will be a randomized controlled trial, single-blind, with two parallel groups. 148 individuals with chronic shoulder pain will be randomly assigned to one of two groups: Cognitive functional therapy (CFT) or therapeutic exercises. The interventions will last between four and eight weeks, with the CFT group receiving therapy once a week and the therapeutic exercise group receiving sessions twice a week for eight weeks. The primary outcomes will be pain intensity and disability, while the secondary outcomes will include specific function, kinesiophobia, self-efficacy, sleep quality, treatment expectations, perception of change, treatment satisfaction and exercise adherence.
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 (Outcomes Assessor)
盲法说明
Evaluators will be blinded to the treatment group
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals of both sexes, aged between 18 and 65 years, will be included if they have had shoulder pain for at least 3 months and report a pain intensity of at least 3 points on the Numeric Pain Rating Scale (NPRS) at rest or during arm movement. Additionally, they must have a minimum score of 20 points on the Shoulder Pain and Disability Index (SPADI).
排除标准
- •Individuals will not be included if they have adhesive capsulitis, defined as a loss of more than 50% of passive shoulder range of motion in external rotation; previous shoulder surgery; a history of shoulder fracture; systemic musculoskeletal diseases (e.g., rheumatoid arthritis, fibromyalgia); shoulder pain reproduced by active or passive cervical spine movement; signs of glenohumeral instability identified by a positive sulcus test or a positive apprehension test indicating laxity in the glenohumeral joint; self-reported systemic disease; a positive drop arm test; pregnancy; active cancer treatment; neurological diseases; cognitive impairments; corticosteroid injection within three months prior to the intervention; or physical therapy in the three months preceding the study.
- •Participants will be discontinued from the study if they experience fractures, surgeries, musculoskeletal or neural injuries that prevent access to treatment, or receive corticosteroid injections during the treatment or follow-up period.
结局指标
主要结局
Pain intensity
时间窗: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
The intensity of shoulder pain will be assessed during arm movement in which the patient reports, pain using the Numeric pain rating scale (NPRS). The scale consists of an 11-point ordinal system, ranging from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain.
Shoulder disability
时间窗: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Disability will be assessed using the Shoulder Pain and Disability Index (SPADI). The instrument is self-administered and consists of 13 items divided into 2 subscales (5 items for pain; 8 items for disability) and each item is scored from 0 to 10 points. The final score ranges from 0 to 100, with higher scores indicating greater shoulder disability.
次要结局
- Patient Specific Function(Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up)
- Kinesiophobia(Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up)
- Pain Self-Efficacy(Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up)
- Sleep Quality(Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up)
- Expectations with Treatment(Baseline)
- Perception of Change(4-week, at the end of treatment (8-week), and 12-week follow-up)
- Satisfaction with treatment(At the end of treatment (8-week), and 12-week follow-up)
- Exercise adherence(4-week, at the end of treatment (8-week), and 12-week follow-up)
研究者
Matheus Dias Gregorio
Principal Investigator
Universidade Federal de Sao Carlos