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

Federal University of Paraíba

Status: Enrolling

Conditions: Psychosocial Rehabilitation; Exercise Therapy; Chronic Shoulder Pain

Treatments: Other: Cognitive Functional Therapy; Other: Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT06542666

79422824.0.0000.5188

Details and patient eligibility

About

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?

Full description

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Cognitive Functional Therapy

Experimental group

Description:

Cognitive Functional Therapy will be conducted once a week, in individual and in-person sessions lasting approximately 40 minutes, over eight weeks.

Treatment:

Other: Cognitive Functional Therapy

Exercises

Active Comparator group

Description:

Twelve participants will be allocated to this group. They will perform strengthening and stretching exercises twice a week for eight weeks, with each session lasting approximately 30 to 40 minutes.

Treatment:

Other: Exercises