Cognitive Functional Therapy Versus Exercises for Chronic Shoulder Pain

Официальное название

Effects of Cognitive Functional Therapy Versus Therapeutic Exercises in Individuals With Chronic Shoulder Pain: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Cognitive functional therapy
  The intervention consists of a Cognitive-Functional Therapy (CFT) program for individuals with shoulder pain, conducted by trained physiotherapists (106 hours of training) under the supervision of an expert with over 8 years of experience. CFT adopts a biopsychosocial approach and is structured into three main components: Making Sense of Pain - A cognitive component aimed at reinterpreting dysfunctional beliefs about pain through a reflective process based on the patient's life history, promoti
• Другое Therapeutic exercise
  Participants in the Therapeutic Exercises Group will engage in individualized exercises targeting the scapulothoracic musculature and rotator cuff. The exercises, performed bilaterally, include lateral arm rotation, T, W, wall hand slide, and diagonal arm movement upwards. Each participant will be guided by one of two physiotherapists, randomly assigned. The exercises will follow a protocol consisting of 3 sets of 12 repetitions, with 1-minute rest between sets, using progressively resistant The

Первичные конечные точки

• Pain intensity [Срок оценки: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up]
• Shoulder disability [Срок оценки: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up]

Вторичные конечные точки (8)

• Patient Specific Function [Срок оценки: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up]
• Kinesiophobia [Срок оценки: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up]
• Pain Self-Efficacy [Срок оценки: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up]
• Sleep Quality [Срок оценки: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up]
• Expectations with Treatment [Срок оценки: Baseline]
• Perception of Change [Срок оценки: 4-week, at the end of treatment (8-week), and 12-week follow-up]
• Satisfaction with treatment [Срок оценки: At the end of treatment (8-week), and 12-week follow-up]
• Exercise adherence [Срок оценки: 4-week, at the end of treatment (8-week), and 12-week follow-up]

Критерии участия

Критерии включения

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).

Критерии исключения

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.

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

• Universidade Federal de Sao Carlos — São Carlos

Идентификаторы

NCT: NCT06854809 · CFTandShoulderPain

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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