Clinical trial NCT06854809: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Shoulder Pain
Keywords: shoulder pain
Psychosocial Rehabilitation
exercise therapy
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a superiority randomized controlled trial, single-blinded, with two parallel groups.
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Pain intensity
timeFrame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
measure: Shoulder disability
timeFrame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Secondary outcomes:
measure: Patient Specific Function
timeFrame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
measure: Kinesiophobia
timeFrame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
measure: Pain Self-Efficacy
timeFrame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
measure: Sleep Quality
timeFrame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
measure: Expectations with Treatment
timeFrame: Baseline
measure: Perception of Change
timeFrame: 4-week, at the end of treatment (8-week), and 12-week follow-up
measure: Satisfaction with treatment
timeFrame: At the end of treatment (8-week), and 12-week follow-up
measure: Exercise adherence
timeFrame: 4-week, at the end of treatment (8-week), and 12-week follow-up
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Universidade Federal de Sao Carlos
state: SP
Study officials:
References: