Clinical trial NCT06661681: Cognitive Functional Therapy for Treating Individuals With Chronic Shoulder Pain
Official title: Cognitive Functional Therapy Versus Therapeutic Exercises for the Treatment of Individuals With Chronic Shoulder Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: 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: 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.

Detailed description: This will be a randomized controlled trial, single-blinded with two parallel groups. Seventy-two individuals with chronic shoulder pain will be randomly assigned to one of two groups: CFT or Therapeutic exercises. The interventions will last eight weeks, with the CFT group receiving therapy once a week and the therapeutic exercise group receiving sessions twice weekly. The primary outcomes will be pain intensity and disability, while the secondary outcomes will include function, self-efficacy, sleep quality, biopsychosocial factors, perception of improvement/deterioration, and central pain processing.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain intensity: Numerical Pain Rating Scale (NPRS)
timeFrame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
measure: Disability: Shoulder Pain and Disability Index (SPADI)
timeFrame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Secondary outcomes:
measure: Shoulder function: Patient Specific Functional Scale
timeFrame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
measure: Self-efficacy: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
measure: Sleep quality: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
measure: Biopsychosocial Aspects: Brief Screening Questions for Biopsychosocial Aspects
timeFrame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
measure: Perception of improvement/deterioration over time: Global Rating of Change Scale
timeFrame: 4-week, at the end of treatment (8-week), and 12-week follow-up
measure: Central pain processing: Pressure Pain Threshold (PPT)
timeFrame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
measure: Central pain processing: Temporal summation
timeFrame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
measure: Central pain processing: Conditioned Pain Modulation
timeFrame: Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Federal University of Paraíba
state: Paraíba
Study officials:
affiliation: Universidade Federal da Paraíba
name: Danilo H Kamonseki, PhD
role: PRINCIPAL_INVESTIGATOR
References: