Cognitive Functional Therapy Versus Therapeutic Exercises for the Treatment of Individuals With Chronic Shoulder Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Pain intensity: Numerical Pain Rating Scale (NPRS)
研究概览
简要总结
Shoulder pain is a debilitating musculoskeletal condition with functional, physical, and psychological impacts. Interventions for chronic shoulder pain should address the biopsychosocial model, with Cognitive Functional Therapy emerging as a promising physiotherapy approach. Cognitive Functional Therapy approaches the multidimensional nature of pain, integrating physical and cognitive aspects.
The aim of this randomized controlled trial is to compare the effects of Cognitive Functional Therapy with therapeutic exercise on biological aspects of pain (pain intensity, disability, function, perception of improvement/deterioration, and central pain processing), and psychosocial aspects of pain (sleep quality, self-efficacy, and biopsychosocial factors). The hypothesis of this study is that CFT will lead to greater improvements in these outcomes compared to therapeutic exercise.
详细描述
This will be a randomized controlled trial, single-blinded with two parallel groups. Seventy-two individuals with chronic shoulder pain will be randomly assigned to one of two groups: CFT or Therapeutic exercises. The interventions will last eight weeks, with the CFT group receiving therapy once a week and the therapeutic exercise group receiving sessions twice weekly. The primary outcomes will be pain intensity and disability, while the secondary outcomes will include function, self-efficacy, sleep quality, biopsychosocial factors, perception of improvement/deterioration, and central pain processing.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or 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.
- •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.
- •Active treatment for cancer
研究组 & 干预措施
Therapeutic exercises group
Individuals assigned to this group will be treated twice a week for eight weeks, wich each session will last approximately 40 to 60 minutes.
干预措施: Therapeutic exercises group (Other)
Cognitive Functional Therapy
Cognitive Functional Therapy (CFT) will be conducted weekly in sessions lasting approximately 60 minutes over 8 weeks.
干预措施: Cognitive Functional Therapy (CFT) (Behavioral)
结局指标
主要结局
Pain intensity: Numerical Pain Rating Scale (NPRS)
时间窗: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
The pain intensity will be measured with 11 point - Numerical Rating Pain Scale (NPRS) with scores ranging from 0 (no pain) to 10 (maximum pain). Higher scores indicate greater pain intensity.
Disability: Shoulder Pain and Disability Index (SPADI)
时间窗: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Disability will be assessed with Shoulder Pain and Disability Index (SPADI). which is composed of 13 questions related to two domains: disability (eight items) and pain (five items). The final score ranges from 0 to 100, with higher scores indicating greater shoulder disability
次要结局
- Self-efficacy: Pain Self-Efficacy Questionnaire (PSEQ)(Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up)
- Central pain processing: Conditioned Pain Modulation(Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up)
- Shoulder function: Patient Specific Functional Scale(Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up)
- Sleep quality: Pittsburgh Sleep Quality Index (PSQI)(Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up)
- Biopsychosocial Aspects: Brief Screening Questions for Biopsychosocial Aspects(Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up)
- Perception of improvement/deterioration over time: Global Rating of Change Scale(4-week, at the end of treatment (8-week), and 12-week follow-up)
- Central pain processing: Pressure Pain Threshold (PPT)(Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up)
- Central pain processing: Temporal summation(Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up)
研究者
Danilo Harudy Kamonseki
Professor
Federal University of Paraíba