Cognitive Functional Therapy for Treating Individuals With Chronic Shoulder Pain

Официальное название

Cognitive Functional Therapy Versus Therapeutic Exercises for the Treatment of Individuals With Chronic Shoulder Pain: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Cognitive Functional Therapy (CFT)
  Cognitive Functional Therapy (CFT) is underpinned by a strong therapeutic alliance, active listening, and motivational interviewing style, covering the following domains: i) Making sense of pain involves discussing the multidimensional nature of persistent pain, as well as the beliefs, emotions, and behaviors that can perpetuate the vicious cycle of pain and disability. ii) Exposure with control involves a functional training designed to normalize maladaptive and provocative postural and movem
• Другое Therapeutic exercises group
  Each session will include stretching exercises targeting the following muscles i) Upper trapezius; ii) Pectoralis minor; iii) Posterior shoulder region, and strengthening exercises targeting the following muscles i) Lower trapezius, ii) Middle trapezius, iii) Serratus punch exercise, iv) Shoulder external rotators, and v) Shoulder internal rotators.

Первичные конечные точки

• Pain intensity: Numerical Pain Rating Scale (NPRS) [Срок оценки: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up]
• Disability: Shoulder Pain and Disability Index (SPADI) [Срок оценки: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up]

Вторичные конечные точки (8)

• Shoulder function: Patient Specific Functional Scale [Срок оценки: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up]
• Self-efficacy: Pain Self-Efficacy Questionnaire (PSEQ) [Срок оценки: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up]
• Sleep quality: Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up]
• Biopsychosocial Aspects: Brief Screening Questions for Biopsychosocial Aspects [Срок оценки: 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 [Срок оценки: 4-week, at the end of treatment (8-week), and 12-week follow-up]
• Central pain processing: Pressure Pain Threshold (PPT) [Срок оценки: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up]
• Central pain processing: Temporal summation [Срок оценки: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up]
• Central pain processing: Conditioned Pain Modulation [Срок оценки: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Federal University of Paraíba — João Pessoa

Идентификаторы

NCT: NCT06661681 · 409730/2023-8

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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