Cognitive Functional Therapy for Treating Individuals With Chronic Shoulder Pain

NCT06661681 | Recruiting

• 1 other identifier: 409730/2023-8
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Shoulder pain is a debilitating musculoskeletal condition with functional, physical, and psychological impacts. Interventions for chronic shoulder pain should address the biopsychosocial model, with Cognitive Functional Therapy emerging as a promising physiotherapy approach. Cognitive Functional Therapy approaches the multidimensional nature of pain, integrating physical and cognitive aspects. The aim of this randomized controlled trial is to compare the effects of Cognitive Functional Therapy with therapeutic exercise on biological aspects of pain (pain intensity, disability, function, perception of improvement/deterioration, and central pain processing), and psychosocial aspects of pain (sleep quality, self-efficacy, and biopsychosocial factors). The hypothesis of this study is that CFT will lead to greater improvements in these outcomes compared to therapeutic exercise.

Conditions

Chronic Shoulder Pain; Exercise Therapy; Psychosocial Rehabilitation

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Pain intensity: Numerical Pain Rating Scale (NPRS)

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

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

• Disability: Shoulder Pain and Disability Index (SPADI)

  Disability will be assessed with Shoulder Pain and Disability Index (SPADI). which is composed of 13 questions related to two domains: disability (eight items) and pain (five items). 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)

• Shoulder function: Patient Specific Functional Scale

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

• Self-efficacy: Pain Self-Efficacy Questionnaire (PSEQ)

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

• Sleep quality: Pittsburgh Sleep Quality Index (PSQI)

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

• Biopsychosocial Aspects: Brief Screening Questions for Biopsychosocial Aspects

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

• Perception of improvement/deterioration over time: Global Rating of Change Scale

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

Study Arms (2)

Cognitive Functional Therapy

EXPERIMENTAL

Cognitive Functional Therapy (CFT) will be conducted weekly in sessions lasting approximately 60 minutes over 8 weeks.

Behavioral: Cognitive Functional Therapy (CFT)

Therapeutic exercises group

ACTIVE COMPARATOR

Individuals assigned to this group will be treated twice a week for eight weeks, wich each session will last approximately 40 to 60 minutes.

Other: Therapeutic exercises group

Interventions

Cognitive Functional Therapy (CFT) BEHAVIORAL

Cognitive Functional Therapy (CFT) is underpinned by a strong therapeutic alliance, active listening, and motivational interviewing style, covering the following domains: i) Making sense of pain involves discussing the multidimensional nature of persistent pain, as well as the beliefs, emotions, and behaviors that can perpetuate the vicious cycle of pain and disability. ii) Exposure with control involves a functional training designed to normalize maladaptive and provocative postural and movement behaviors, where individuals will learn strategies to improve their body awareness and control and modify postures and tasks commonly associated with pain. iii) Lifestyle change aims to help patients embrace a healthy lifestyle, which will include promoting a gradual increase in physical activity, sleep hygiene counseling, stress management strategies, and social re-engagement.

Also known as: CFT

Cognitive Functional Therapy

Therapeutic exercises group OTHER

Each session will include stretching exercises targeting the following muscles i) Upper trapezius; ii) Pectoralis minor; iii) Posterior shoulder region, and strengthening exercises targeting the following muscles i) Lower trapezius, ii) Middle trapezius, iii) Serratus punch exercise, iv) Shoulder external rotators, and v) Shoulder internal rotators.

Therapeutic exercises group

Eligibility Criteria

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

You may qualify if:

• Men or 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.
• 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.
• Active treatment for cancer

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

Federal University of Paraíba

João Pessoa, Paraíba, 58051-970, Brazil

RECRUITING

MeSH Terms

Conditions

Shoulder Pain; Shoulder Impingement Syndrome; Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Danilo H Kamonseki, PhD

  Universidade Federal da Paraíba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danilo H Kamonseki, PhD

CONTACT

+55(83) 3216-7200; danilo.kamonseki@academico.ufpb.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: Professor

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

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: February 17, 2025
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): November 25, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: baseline, 4th week, end of treatment (8th week), and 12th-week follow-up.

Locations

BR (1)