An interventional study of Cognitive Functional Therapy and Exercises in Chronic Shoulder Pain, Exercise Therapy and Psychosocial Rehabilitation, sponsored by Federal University of Paraíba. Completed at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Federal University of Paraíba · Not applicable, Interventional, and Other
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:
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.
735 studies on the registry are indexed under Shoulder Pain; 167 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 587 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →Federal University of Paraíba is the lead sponsor of 73 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cognitive Functional Therapy will be conducted once a week, in individual and in-person sessions lasting approximately 40 minutes, over eight weeks.
Other: Cognitive Functional Therapy
Twelve participants will be allocated to this group. They will perform strengthening and stretching exercises twice a week for eight weeks, with each session lasting approximately 30 to 40 minutes.
Other: Exercises
The 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
Individuals 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.
Recruitment rate
Analyze the ability to recruit 12 individuals per group, totaling a sample of 24 individuals with chronic shoulder pain;
Time frame: 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;
Time frame: 8 weeks
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 weeks
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)
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)
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)
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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."
Time frame: 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.
Time frame: Pre (baseline), 4 weeks, and post Treatment (8 weeks)
Plan to share: Yes — The individual participant data will be shared under request.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Federal University of Paraíba