Cognitive Functional Therapy Versus Therapeutic Exercises for Treating Individuals With Chronic Shoulder Pain: A Pilot and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
This pilot randomized controlled clinical trial (RCT) will assess the feasibility and identify the key components necessary for conducting the main RCT, which will involve the comparison of Cognitive Functional Therapy with Therapeutic Exercises in individuals with chronic shoulder pain. The main questions it aims to answer are:
- What barriers to the participation of the included individuals might arise?
- Will the assessment procedures and outcome measures be feasible and suitable?
- What time will be necessary to conduct the assessments?
- Will participants be willing to be randomized to the proposed treatment groups?
- What barriers to the clinical delivery of Cognitive Functional Therapy in the healthcare system might exist?
- Will the treatment(s) be acceptable to patients?
- Will participants adhere to the treatment?
- What will the recruitment rates be per week/month?
- Will there be any selection bias?
- Will participant retention be high among the allocation groups?
- Will the data be complete?
- What will the data variability be?
- Will the treatment effects/outcomes be consistent with expectations and previous literature?
详细描述
Shoulder pain is a potentially debilitating musculoskeletal condition, with functional, physical, and psychological impact. Its chronicity has been mainly correlated with affective-emotional and cognitive dimensions of pain. In this scenario, interventions for individuals with chronic shoulder pain should be seen within the biopsychosocial model. In this context, Cognitive Functional Therapy (CFT) emerges as a psychologically informed physiotherapeutic approach directed towards the biopsychosocial and multidimensional nature of pain, which is divided into three approaches to reduce pain and disability: (1) understanding pain, (2) controlled exposure, and (3) lifestyle change. The present study aims to verify the feasibility and viability of a randomized clinical trial to compare the effects of Cognitive Functional Therapy with therapeutic exercises in individuals with chronic shoulder pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women;
- •Age between 18 and 60 years;
- •Presence of shoulder pain for more than 3 months;
- •Pain intensity of 4 points or more on the 11-point Numeric Pain Rating Scale during the past week.
- •High level of disability or moderate level of irritability.
排除标准
- •History of fracture or surgery of the clavicle, scapula, and/or humerus, surgical stabilization or rotator cuff repair;
- •History of dislocation, instability (positive sulcus sign or apprehension test), and/or rotator cuff tear (positive drop arm test);
- •Adhesive capsulitis verified by the presence of gradual onset pain associated with stiffness and reduced passive and active mobility;
- •Ongoing pregnancy;
- •Reproduction of shoulder pain radiating to the entire upper limb during cervical or thoracic spine tests (positive Spurling test);
- •Neurological or systemic diseases that may alter muscle strength and sensitivity such as rheumatoid arthritis, fibromyalgia, lupus, gout, and diabetes;
- •Corticosteroid injection in the shoulder region in the last 3 months;
- •Physiotherapy treatment in the last 6 months.
结局指标
主要结局
Recruitment rate
时间窗: 8 weeks
Analyze the ability to recruit 12 individuals per group, totaling a sample of 24 individuals with chronic shoulder pain;
Retention rate
时间窗: 8 weeks
This will be evaluated through individual follow-up by the responsible physiotherapist during the 8-week treatment period, during which the physiotherapist will fill out an attendance sheet at each session to also characterize the completion of the intervention by each participant;
Acceptability of the intervention
时间窗: 8 weeks
This will be estimated through adherence to the appointment schedule and mainly through questioning after each intervention session.
次要结局
- Tampa Scale for Kinesiophobia(Pre (baseline), 4 weeks, and post Treatment (8 weeks))
- Pain intensity(Pre (baseline), 4 weeks, and post Treatment (8 weeks))
- Shoulder Pain and Disability Index(Pre (baseline), 4 weeks, and post Treatment (8 weeks))
- Pain Catastrophizing Scale(Pre (baseline), 4 weeks, and post Treatment (8 weeks))
- Chronic Pain Self-Efficacy Scale(Pre (baseline), 4 weeks, and post Treatment (8 weeks))
- Pittsburgh Sleep Quality Index(Pre (baseline), 4 weeks, and post Treatment (8 weeks))
- Patients' expectations of the treatment.(Baseline)
- Biopsychosocial aspects(Pre (baseline), 4 weeks, and post Treatment (8 weeks))
- Patient-Specific Functional Scale(Pre (baseline), 4 weeks, and post Treatment (8 weeks))
研究者
Danilo Harudy Kamonseki
Professor
Federal University of Paraíba