Cognitive Functional Therapy for Chronic Shoulder Pain: Pilot and Feasibility Study

Официальное название

Cognitive Functional Therapy Versus Therapeutic Exercises for Treating Individuals With Chronic Shoulder Pain: A Pilot and Feasibility Study

Обзор

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?

Подробное описание

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.

Вмешательства

• Другое Cognitive Functional Therapy
  The intervention focuses on addressing the maladaptive cognitive, physical, and lifestyle behaviors related to the disorder. Cognitive functional therapy will focus on factors considered to contribute to the pain disorder, addressing the following topics: 1. The multidimensional nature of persistent pain, beliefs, emotions, and behaviors (movement and lifestyle) that can reinforce a vicious cycle of pain sensitization and disability. 2. Specific functional training designed to normalize malada
• Другое Exercises
  Individuals allocated to this group will perform stretching and strengthening exercises. The self-stretching exercises will target the upper trapezius and posterior shoulder region. Each stretching exercise will be performed for 3 repetitions of 30 seconds, with an interval of 10 seconds between repetitions. The strengthening exercises will be performed using resistance elastic bands. Three sets of 10 repetitions will be performed for each strengthening exercise, with 1 minute of rest between s

Первичные конечные точки

• Recruitment rate [Срок оценки: 8 weeks]
• Retention rate [Срок оценки: 8 weeks]
• Acceptability of the intervention [Срок оценки: 8 weeks]

Вторичные конечные точки (9)

• Pain intensity [Срок оценки: Pre (baseline), 4 weeks, and post Treatment (8 weeks)]
• Shoulder Pain and Disability Index [Срок оценки: Pre (baseline), 4 weeks, and post Treatment (8 weeks)]
• Chronic Pain Self-Efficacy Scale [Срок оценки: Pre (baseline), 4 weeks, and post Treatment (8 weeks)]
• Tampa Scale for Kinesiophobia [Срок оценки: Pre (baseline), 4 weeks, and post Treatment (8 weeks)]
• Pain Catastrophizing Scale [Срок оценки: Pre (baseline), 4 weeks, and post Treatment (8 weeks)]
• Pittsburgh Sleep Quality Index [Срок оценки: Pre (baseline), 4 weeks, and post Treatment (8 weeks)]
• Biopsychosocial aspects [Срок оценки: Pre (baseline), 4 weeks, and post Treatment (8 weeks)]
• Patients' expectations of the treatment. [Срок оценки: Baseline]
• Patient-Specific Functional Scale [Срок оценки: Pre (baseline), 4 weeks, and post Treatment (8 weeks)]

Критерии участия

Критерии включения

• 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.

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.

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

Двойное слепое

Основная цель

Другое

Центры проведения

Бразилия · 1 центр

• Federal University of Paraíba — João Pessoa

Публикации

• Gava V, da Silva Eugenio JM, Meziat-Filho N, Almeida LA, Maciel DG, do Nascimento JDS, de Andrade PR, Santos Fonseca RN, Medeiros Barbosa G, de Oliveira VMA, Kamonseki DH. Cognitive functional therapy versus therapeutic exercises for the treatment of individuals with chronic shoulder pain: A protocol for a randomized controlled trial. PLoS One. 2025 Apr 21;20(4):e0320025. doi: 10.1371/journal.pone PMID 40258003

Идентификаторы

NCT: NCT06542666 · 79422824.0.0000.5188

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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