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

NCT06542666 | Recruiting

• 1 other identifier: 79422824.0.0000.5188
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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?

Conditions

Chronic Shoulder Pain; Exercise Therapy; Psychosocial Rehabilitation

Keywords

Shoulder pain; Subacromial pain; Rotator cuff related pain; Shoulder Impingement; Chronic pain; Psychosocial; Rehabilitation; Biopsychosocial

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

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

  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;

  8 weeks

• Acceptability of the intervention

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

  8 weeks

Secondary Outcomes (9)

• Pain intensity

  Pre (baseline), 4 weeks, and post Treatment (8 weeks)

• Shoulder Pain and Disability Index

  Pre (baseline), 4 weeks, and post Treatment (8 weeks)

• Chronic Pain Self-Efficacy Scale

  Pre (baseline), 4 weeks, and post Treatment (8 weeks)

• Tampa Scale for Kinesiophobia

  Pre (baseline), 4 weeks, and post Treatment (8 weeks)

• Pain Catastrophizing Scale

  Pre (baseline), 4 weeks, and post Treatment (8 weeks)

Study Arms (2)

Cognitive Functional Therapy

EXPERIMENTAL

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

Other: Cognitive Functional Therapy

Exercises

ACTIVE COMPARATOR

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.

Other: Exercises

Interventions

Cognitive Functional Therapy OTHER

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

Cognitive Functional Therapy

Exercises OTHER

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.

Exercises

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

Federal University of Paraíba

João Pessoa, Paraíba, 58051-970, Brazil

RECRUITING

Related Publications (1)

• 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.0320025. eCollection 2025.

  PMID: 40258003 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Shoulder Impingement Syndrome; Chronic Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• VALÉRIA MA OLIVEIRA, PhD

  Universidade Federal da Paraíba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VALÉRIA MA OLIVEIRA, PhD

CONTACT

55 83 32167200; valeria.mayaly@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: August 7, 2024
• Study Start: February 17, 2025
• Primary Completion: July 31, 2025
• Study Completion: September 1, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)