Cognitive Functional Therapy Versus Exercises for Chronic Shoulder Pain

NCT06854809 | Recruiting DMC

• 1 other identifier: CFTandShoulderPain
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Shoulder Pain

Keywords

shoulder pain; Psychosocial Rehabilitation; exercise therapy

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  The intensity of shoulder pain will be assessed during arm movement in which the patient reports, pain using the Numeric pain rating scale (NPRS). The scale consists of an 11-point ordinal system, ranging from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain.

  Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up

• Shoulder disability

  Disability will be assessed using the Shoulder Pain and Disability Index (SPADI). The instrument is self-administered and consists of 13 items divided into 2 subscales (5 items for pain; 8 items for disability) and each item is scored from 0 to 10 points. The final score ranges from 0 to 100, with higher scores indicating greater shoulder disability.

  Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up

Secondary Outcomes (8)

• Patient Specific Function

  Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up

• Kinesiophobia

  Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up

• Pain Self-Efficacy

  Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up

• Sleep Quality

  Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up

• Expectations with Treatment

  Baseline

Study Arms (2)

Cognitive functional therapy

EXPERIMENTAL

Behavioral: Cognitive functional therapy

Therapeutic exercise

ACTIVE COMPARATOR

Other: Therapeutic exercise

Interventions

Cognitive functional therapy BEHAVIORAL

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, promoting understanding and self-efficacy. Graded Exposure with Control - Gradual exposure to functional activities, aiming to modify maladaptive associations between movement and pain, fostering the development of movement confidence. Lifestyle Change - Discussion and implementation of strategies to promote a healthy lifestyle, including physical activity, sleep habits, and stress management. All three components are integrated from the first session, with initial focus on building the therapeutic all.

Cognitive functional therapy

Therapeutic exercise OTHER

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 Thera-Bands®. Resistance will increase when pain is ≤2 on the Numerical Rating Scale and perceived exertion is \<3 on the Borg Scale. The protocol was designed based on scientific literature and shoulder pain treatment guidelines to address muscle activation deficits and rotator cuff and scapulothoracic imbalances.

Therapeutic exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead

Study Sites (1)

Universidade Federal de Sao Carlos

São Carlos, São Paulo, 13568-110, Brazil

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Matheus Dias Gregorio

CONTACT

+55 (14) 99679-3919; matheusgregorio@estudante.ufscar.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluators will be blinded to the treatment group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a superiority randomized controlled trial, single-blinded, with two parallel groups.

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: From December 1, 2027, to December 1, 2028, the data will be available for one year.
• Access Criteria: The data will be shared with anyone who requests it via the responsible researcher's email.

Locations

BR (1)