Cognitive Functional Therapy for Chronic Shoulder Pain: Pilot and Feasibility Study
NCT Number: NCT06542666
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Shoulder Pain|Exercise Therapy|Psychosocial Rehabilitation
Interventions: OTHER: Cognitive Functional Therapy|OTHER: Exercises
Sponsor: Federal University of Paraíba
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2025-09-01
Locations: Federal University of Paraíba, João Pessoa, Paraíba, 58051-970, Brazil

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?

Primary Outcome Measures: Recruitment rate, Analyze the ability to recruit 12 individuals per group, totaling a sample of 24 individuals with chronic shoulder pain;, 8 weeks|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;, 8 weeks|Acceptability of the intervention, This will be estimated through adherence to the appointment schedule and mainly through questioning after each intervention session., 8 weeks
Secondary Outcome Measures: 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)., Pre (baseline), 4 weeks, and post Treatment (8 weeks)|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., Pre (baseline), 4 weeks, and post Treatment (8 weeks)|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., Pre (baseline), 4 weeks, and post Treatment (8 weeks)|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., Pre (baseline), 4 weeks, and post Treatment (8 weeks)|Pain Catastrophizing Scale, Pain catastrophizing will be measured using the Pain Catastrophizing Scale (PCS). The total score ranges from 0 to 52 points, with higher scores indicating greater pain catastrophizing., Pre (baseline), 4 weeks, and post Treatment (8 weeks)|Pittsburgh Sleep Quality Index, Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21 points. A score greater than 5 indicates poor sleep quality, with significant difficulty in at least two components of the questionnaire or moderate difficulty in three components., Pre (baseline), 4 weeks, and post Treatment (8 weeks)|Biopsychosocial aspects, Biopsychosocial aspects will be measured with short screening questions on biopsychosocial aspects of chronic pain., Pre (baseline), 4 weeks, and post Treatment (8 weeks)|Patients' expectations of the treatment., For the assessment of patients' expectations regarding their treatment, participants will respond to the question, "How much do you expect your shoulder problem to change as a result of treatment?" Their responses will be measured on a 7-point Likert scale, where 1 corresponds to "worse" and 7 corresponds to "completely recovered.", Baseline|Patient-Specific Functional Scale, The Patient-Specific Functional Scale (PSFS) will be used to assess functional status. Individuals will score on an 11-point scale, indicating how difficult it is to perform 3 to 5 activities that are important to them. A score of 0 on the 11-point scale indicates "unable to perform the activity," while a score of 10 indicates "able to perform the activity at the pre-injury level., Pre (baseline), 4 weeks, and post Treatment (8 weeks)