Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID06542666

Cognitive Functional Therapy Versus Therapeutic Exercises for Treating Individuals With Chronic Shoulder Pain: A Pilot and Feasibility Study

Led by Federal University of Paraíba · Updated on 2025-02-18

24

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the feasibility of conducting a larger randomized controlled trial comparing Cognitive Functional Therapy (CFT) with therapeutic exercises for individuals suffering from chronic shoulder pain. This pilot study aims to identify potential barriers to participation, assess the suitability of assessment methods and outcome measures, and understand recruitment, retention, and adherence rates among participants. The study focuses on the biopsychosocial aspects of chronic shoulder pain, which affects physical function and psychological well-being. The study involves two groups: one receiving Cognitive Functional Therapy through weekly individual in-person sessions lasting about 40 minutes over eight weeks, and the other performing strengthening and stretching exercises twice a week for eight weeks, with each session lasting 30 to 40 minutes. CFT addresses maladaptive cognitive, physical, and lifestyle behaviors contributing to pain, including pain education, functional training, daily activity integration, and lifestyle counseling. The exercise group focuses on targeted stretching and strengthening of shoulder-related muscles using resistance bands. Participants will undergo assessments at baseline, 4 weeks, and after 8 weeks of treatment, including measures of pain intensity, disability, self-efficacy, fear of movement, catastrophizing, sleep quality, biopsychosocial factors, treatment expectations, and functional ability. Researchers will monitor recruitment and retention rates and evaluate the acceptability of interventions. The total study duration for participants is eight weeks, during which adherence and treatment effects will be observed and recorded.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women
  • Age between 18 and 60 years
  • Shoulder pain lasting more than 3 months
  • Pain intensity of 4 or more on the 11-point Numeric Pain Rating Scale during the past week
  • High level of disability or moderate level of irritability
Not Eligible

You will not qualify if you...

  • History of fracture or surgery of the clavicle, scapula, or humerus, including surgical stabilization or rotator cuff repair
  • History of shoulder dislocation, instability, or rotator cuff tear
  • Adhesive capsulitis with gradual onset pain and stiffness
  • Ongoing pregnancy
  • Shoulder pain radiating to the entire upper limb during spine tests
  • Neurological or systemic diseases affecting muscle strength and sensitivity such as rheumatoid arthritis, fibromyalgia, lupus, gout, and diabetes
  • Corticosteroid injection in the shoulder region within the last 3 months
  • Physiotherapy treatment in the last 6 months

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants receive either Cognitive Functional Therapy or therapeutic exercises for chronic shoulder pain. Cognitive Functional Therapy involves weekly individual sessions lasting about 40 minutes each, focusing on pain understanding, controlled exposure, and lifestyle changes. Therapeutic exercises involve stretching and strengthening performed twice a week for about 30 to 40 minutes per session.

Weekly visits for Cognitive Functional Therapy or twice-weekly exercise sessions

Trial Site Locations

Total: 1 location

1

Federal University of Paraíba

João Pessoa, Paraíba, Brazil, 58051-970

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Research Team

V

VALÉRIA MA OLIVEIRA, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

Cognitive functional therapy versus therapeutic exercises for the treatment of individuals with chronic shoulder pain: A protocol for a randomized controlled trial.

Vander Gava, Jessica Mayara da Silva Eugenio, Ney Meziat-Filho...

https://pubmed.ncbi.nlm.nih.gov/40258003