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

Not Applicable

Recruiting

• Conditions: Chronic Shoulder Pain; Exercise Therapy; Psychosocial Rehabilitation
• Interventions: Other: Exercises; Other: Cognitive Functional Therapy

• Registration Number: NCT06542666
• Lead Sponsor: Federal University of Paraíba

Brief Summary

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?

Detailed 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.

Study Timeline

• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2024-08-05
• Study First Posted: 2024-08-07
• Status Verified: 2025-02
• Study Start: 2025-02-17
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-07-31
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Recruitment rate	8 weeks	Analyze the ability to recruit 12 individuals per group, totaling a sample of 24 individuals with chronic shoulder pain;
Retention rate	8 weeks	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;
Acceptability of the intervention	8 weeks	This will be estimated through adherence to the appointment schedule and mainly through questioning after each intervention session.

Secondary Outcome Measures

Name	Time	Method
Tampa Scale for Kinesiophobia	Pre (baseline), 4 weeks, and post Treatment (8 weeks)	Kinesiophobia will be measured using the Tampa Scale for Kinesiophobia (TSK). The total score ranges from 17 to 68 points, with higher scores indicating worse beliefs about pain related to movement.
Pain intensity	Pre (baseline), 4 weeks, and post Treatment (8 weeks)	The pain will be measured with 11 point - Numerical Rating Pain Scale with scores ranging from 0 (no pain) to 10 (maximum pain).
Shoulder Pain and Disability Index	Pre (baseline), 4 weeks, and post Treatment (8 weeks)	Shoulder disability will be measured with Shoulder Pain and Disability Index (SPADI), with score ranging from 0 to 100, with higher scores indicating greater shoulder disability.
Pain Catastrophizing Scale	Pre (baseline), 4 weeks, and post Treatment (8 weeks)	Pain catastrophizing will be measured using the Pain Catastrophizing Scale (PCS). The total score ranges from 0 to 52 points, with higher scores indicating greater pain catastrophizing.
Chronic Pain Self-Efficacy Scale	Pre (baseline), 4 weeks, and post Treatment (8 weeks)	Self-efficacy will be measured using the Chronic Pain Self-Efficacy Scale (CPSS). The total score ranges from 30 to 300 points, with higher scores indicating greater self-efficacy.
Pittsburgh Sleep Quality Index	Pre (baseline), 4 weeks, and post Treatment (8 weeks)	Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21 points. A score greater than 5 indicates poor sleep quality, with significant difficulty in at least two components of the questionnaire or moderate difficulty in three components.
Patients' expectations of the treatment.	Baseline	For the assessment of patients' expectations regarding their treatment, participants will respond to the question, "How much do you expect your shoulder problem to change as a result of treatment?" Their responses will be measured on a 7-point Likert scale, where 1 corresponds to "worse" and 7 corresponds to "completely recovered."
Biopsychosocial aspects	Pre (baseline), 4 weeks, and post Treatment (8 weeks)	Biopsychosocial aspects will be measured with short screening questions on biopsychosocial aspects of chronic pain.
Patient-Specific Functional Scale	Pre (baseline), 4 weeks, and post Treatment (8 weeks)	The Patient-Specific Functional Scale (PSFS) will be used to assess functional status. Individuals will score on an 11-point scale, indicating how difficult it is to perform 3 to 5 activities that are important to them. A score of 0 on the 11-point scale indicates "unable to perform the activity," while a score of 10 indicates "able to perform the activity at the pre-injury level.

Trial Locations

Locations (1)

Federal University of Paraíba; 🇧🇷 João Pessoa, Paraíba, Brazil