Clinical trial NCT06542666: Cognitive Functional Therapy for Chronic Shoulder Pain: Pilot and Feasibility Study
Official title: Cognitive Functional Therapy Versus Therapeutic Exercises for Treating Individuals With Chronic Shoulder Pain: A Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Shoulder Pain
Exercise Therapy
Psychosocial Rehabilitation
Keywords: Shoulder pain
Subacromial pain
Rotator cuff related pain
Shoulder Impingement
Chronic pain
Psychosocial
Rehabilitation
Biopsychosocial
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This pilot randomized controlled clinical trial (RCT) will assess the feasibility and identify the key components necessary for conducting the main RCT, which will involve the comparison of Cognitive Functional Therapy with Therapeutic Exercises in individuals with chronic shoulder pain. The main questions it aims to answer are:

* What barriers to the participation of the included individuals might arise?
* Will the assessment procedures and outcome measures be feasible and suitable?
* What time will be necessary to conduct the assessments?
* Will participants be willing to be randomized to the proposed treatment groups?
* What barriers to the clinical delivery of Cognitive Functional Therapy in the healthcare system might exist?
* Will the treatment(s) be acceptable to patients?
* Will participants adhere to the treatment?
* What will the recruitment rates be per week/month?
* Will there be any selection bias?
* Will participant retention be high among the allocation groups?
* Will the data be complete?
* What will the data variability be?
* Will the treatment effects/outcomes be consistent with expectations and previous literature?

Detailed description: Shoulder pain is a potentially debilitating musculoskeletal condition, with functional, physical, and psychological impact. Its chronicity has been mainly correlated with affective-emotional and cognitive dimensions of pain. In this scenario, interventions for individuals with chronic shoulder pain should be seen within the biopsychosocial model. In this context, Cognitive Functional Therapy (CFT) emerges as a psychologically informed physiotherapeutic approach directed towards the biopsychosocial and multidimensional nature of pain, which is divided into three approaches to reduce pain and disability: (1) understanding pain, (2) controlled exposure, and (3) lifestyle change. The present study aims to verify the feasibility and viability of a randomized clinical trial to compare the effects of Cognitive Functional Therapy with therapeutic exercises in individuals with chronic shoulder pain.

Eligibility criteria: Inclusion Criteria:

* Men and 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 during the past week.
* 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.

Primary outcomes:
measure: Recruitment rate
timeFrame: 8 weeks
measure: Retention rate
timeFrame: 8 weeks
measure: Acceptability of the intervention
timeFrame: 8 weeks
Secondary outcomes:
measure: Pain intensity
timeFrame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
measure: Shoulder Pain and Disability Index
timeFrame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
measure: Chronic Pain Self-Efficacy Scale
timeFrame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
measure: Tampa Scale for Kinesiophobia
timeFrame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
measure: Pain Catastrophizing Scale
timeFrame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
measure: Pittsburgh Sleep Quality Index
timeFrame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
measure: Biopsychosocial aspects
timeFrame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
measure: Patients' expectations of the treatment.
timeFrame: Baseline
measure: Patient-Specific Functional Scale
timeFrame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Federal University of Paraíba
state: Paraíba
Study officials:
affiliation: Universidade Federal da Paraíba
name: VALÉRIA MA OLIVEIRA, PhD
role: PRINCIPAL_INVESTIGATOR
References: