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

Federal University of Paraíba24 enrolled

Overview

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?

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

Interventions

Cognitive Functional TherapyOTHER

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 maladaptive and provocative postural and movement behaviors as directed by the individual's presentation. 3. Targeted functional integration into daily activities that are avoided and/or provocative for the patient. 4. Counseling on physical activity and lifestyle, which will include promoting a gradual increase in physical activity based on the individual's preference and availability, advice on sleep hygiene, stress management strategies, and social re-engagement

ExercisesOTHER

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 sets. The strengthening exercises will target the lower and middle trapezius, anterior serratus, and the external and internal rotators of the shoulder.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Recruitment rate

Analyze the ability to recruit 12 individuals per group, totaling a sample of 24 individuals with chronic shoulder pain;

Time frame: 8 weeks

Retention rate

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;

Time frame: 8 weeks

Acceptability of the intervention

This will be estimated through adherence to the appointment schedule and mainly through questioning after each intervention session.

Time frame: 8 weeks

Secondary Outcomes

Pain intensity

The pain will be measured with 11 point - Numerical Rating Pain Scale with scores ranging from 0 (no pain) to 10 (maximum pain).