Cognitive Functional Therapy for Treating Individuals With Chronic Shoulder Pain

Federal University of Paraíba

Status: Enrolling

Conditions: Psychosocial Rehabilitation; Exercise Therapy; Chronic Shoulder Pain

Treatments: Behavioral: Cognitive Functional Therapy (CFT); Other: Therapeutic exercises group

Study type: Interventional

Funder types: Other

Identifiers

NCT06661681

409730/2023-8

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Cognitive Functional Therapy

Experimental group

Description:

Cognitive Functional Therapy (CFT) will be conducted weekly in sessions lasting approximately 60 minutes over 8 weeks.

Treatment:

Behavioral: Cognitive Functional Therapy (CFT)

Therapeutic exercises group

Active Comparator group

Description:

Individuals assigned to this group will be treated twice a week for eight weeks, wich each session will last approximately 40 to 60 minutes.

Treatment:

Other: Therapeutic exercises group