Cognitive Functional Therapy for Chronic Shoulder Pain: Pilot and Feasibility Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorFederal University of Paraíba
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Functional Therapy
Other interventionThe intervention focuses on addressing the maladaptive cognitive, physical, and lifestyle behaviors related to the disorder. Cognitive functional therapy will focus on factors considered to contribute to the pain disorder, addressing the following topics: 1. The multidimensional nature of persistent pain, beliefs, emotions, and behaviors (movement and lifestyle) that can reinforce a vicious cycle of pain sensitization and disability. 2. Specific functional training designed to normalize maladaptive and provocative postural and movement behaviors as directed by the individual's presentation. 3. Targeted functional integration into daily activities that are avoided and/or provocative for the patient. 4. Counseling on physical activity and lifestyle, which will include promoting a gradual increase in physical activity based on the individual's preference and availability, advice on sleep hygiene, stress management strategies, and social re-engagement
Exercises
Other interventionIndividuals allocated to this group will perform stretching and strengthening exercises. The self-stretching exercises will target the upper trapezius and posterior shoulder region. Each stretching exercise will be performed for 3 repetitions of 30 seconds, with an interval of 10 seconds between repetitions. The strengthening exercises will be performed using resistance elastic bands. Three sets of 10 repetitions will be performed for each strengthening exercise, with 1 minute of rest between sets. The strengthening exercises will target the lower and middle trapezius, anterior serratus, and the external and internal rotators of the shoulder.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Cognitive Functional TherapyExperimental treatment 1 intervention
Group B: ExercisesActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment rate
Analyze the ability to recruit 12 individuals per group, totaling a sample of 24 individuals with chronic shoulder pain;
Time frame
8 weeks2
Retention rate
This will be evaluated through individual follow-up by the responsible physiotherapist during the 8-week treatment period, during which the physiotherapist will fill out an attendance sheet at each session to also characterize the completion of the intervention by each participant;
Time frame
8 weeks3
Acceptability of the intervention
This will be estimated through adherence to the appointment schedule and mainly through questioning after each intervention session.
Time frame
8 weeksSecondary outcomes
1
Pain intensity
The pain will be measured with 11 point - Numerical Rating Pain Scale with scores ranging from 0 (no pain) to 10 (maximum pain).
Time frame
Pre (baseline), 4 weeks, and post Treatment (8 weeks)2
Shoulder Pain and Disability Index
Shoulder disability will be measured with Shoulder Pain and Disability Index (SPADI), with score ranging from 0 to 100, with higher scores indicating greater shoulder disability.
Time frame
Pre (baseline), 4 weeks, and post Treatment (8 weeks)3
Chronic Pain Self-Efficacy Scale
Self-efficacy will be measured using the Chronic Pain Self-Efficacy Scale (CPSS). The total score ranges from 30 to 300 points, with higher scores indicating greater self-efficacy.
Time frame
Pre (baseline), 4 weeks, and post Treatment (8 weeks)4
Tampa Scale for Kinesiophobia
Kinesiophobia will be measured using the Tampa Scale for Kinesiophobia (TSK). The total score ranges from 17 to 68 points, with higher scores indicating worse beliefs about pain related to movement.
Time frame
Pre (baseline), 4 weeks, and post Treatment (8 weeks)Sponsors and contacts
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Source ClinicalTrials.gov