Cognitive Functional Therapy Versus Exercises for Chronic Shoulder Pain

Official title

Effects of Cognitive Functional Therapy Versus Therapeutic Exercises in Individuals With Chronic Shoulder Pain: A Randomized Controlled Trial

Overview

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.

Detailed description

This will be a randomized controlled trial, single-blind, with two parallel groups. 148 individuals with chronic shoulder pain will be randomly assigned to one of two groups: Cognitive functional therapy (CFT) or therapeutic exercises. The interventions will last between four and eight weeks, with the CFT group receiving therapy once a week and the therapeutic exercise group receiving sessions twice a week for eight weeks. The primary outcomes will be pain intensity and disability, while the secondary outcomes will include specific function, kinesiophobia, self-efficacy, sleep quality, treatment expectations, perception of change, treatment satisfaction and exercise adherence.

Interventions

• Behavioral Cognitive functional therapy
  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, promoti
• Other Therapeutic exercise
  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 The

Primary outcome measures

• Pain intensity [Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up]
• Shoulder disability [Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up]

Secondary outcome measures (8)

• Patient Specific Function [Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up]
• Kinesiophobia [Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up]
• Pain Self-Efficacy [Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up]
• Sleep Quality [Time frame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up]
• Expectations with Treatment [Time frame: Baseline]
• Perception of Change [Time frame: 4-week, at the end of treatment (8-week), and 12-week follow-up]
• Satisfaction with treatment [Time frame: At the end of treatment (8-week), and 12-week follow-up]
• Exercise adherence [Time frame: 4-week, at the end of treatment (8-week), and 12-week follow-up]

Eligibility criteria

Inclusion criteria

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).

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Universidade Federal de Sao Carlos — São Carlos

Identifiers

NCT: NCT06854809 · CFTandShoulderPain

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗