About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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
Parallel
Treatments tested in this trial
Cognitive Functional Therapy (CFT)
BehavioralCognitive Functional Therapy (CFT) is underpinned by a strong therapeutic alliance, active listening, and motivational interviewing style, covering the following domains: i) Making sense of pain involves discussing the multidimensional nature of persistent pain, as well as the beliefs, emotions, and behaviors that can perpetuate the vicious cycle of pain and disability. ii) Exposure with control involves a functional training designed to normalize maladaptive and provocative postural and movement behaviors, where individuals will learn strategies to improve their body awareness and control and modify postures and tasks commonly associated with pain. iii) Lifestyle change aims to help patients embrace a healthy lifestyle, which will include promoting a gradual increase in physical activity, sleep hygiene counseling, stress management strategies, and social re-engagement.
Therapeutic exercises group
Other interventionEach session will include stretching exercises targeting the following muscles i) Upper trapezius; ii) Pectoralis minor; iii) Posterior shoulder region, and strengthening exercises targeting the following muscles i) Lower trapezius, ii) Middle trapezius, iii) Serratus punch exercise, iv) Shoulder external rotators, and v) Shoulder internal rotators.
Treatment groups
Trial outcomes
Primary outcomes
Pain intensity: Numerical Pain Rating Scale (NPRS)
The pain intensity will be measured with 11 point - Numerical Rating Pain Scale (NPRS) with scores ranging from 0 (no pain) to 10 (maximum pain). Higher scores indicate greater pain intensity.
Disability: Shoulder Pain and Disability Index (SPADI)
Disability will be assessed with Shoulder Pain and Disability Index (SPADI). which is composed of 13 questions related to two domains: disability (eight items) and pain (five items). The final score ranges from 0 to 100, with higher scores indicating greater shoulder disability
Secondary outcomes
Shoulder function: Patient Specific Functional Scale
Shoulder functional ability will be measured with Patient Specific Functional Scale. The individuals will select three to five important activities that are challenging to perform due to shoulder pain. For each reported activity, the individual will score on an 11-point scale, where 0 is (unable to perform the activity) and 10 is (able to perform the activity at the level prior to the injury). Score ranges from 0 (unable to perform) to 10 (able to perform at preinjury level). Higher score means better function.
Self-efficacy: Pain Self-Efficacy Questionnaire (PSEQ)
Self-efficacy will be assessed with Pain Self-Efficacy Questionnaire (PSEQ) will be used to assess, which is composed of of 10 items. The total score ranges from 0 to 60 points, with the higher score indicating greater self-efficacy.
Sleep quality: Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be assessed with Pittsburgh Sleep Quality Index (PSQI), which is composed of 19 items, resulting in a total score ranging from 0 to 21, and covering 7 domains: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbance, (6) medication use and (7) dysfunction during the day. The total score ranges from 0 to 21, with higher scores indicating worse sleep quality.
Biopsychosocial Aspects: Brief Screening Questions for Biopsychosocial Aspects
Biopsychosocial Aspects will be assessed with the Brief Screening Questions for Biopsychosocial, which is composed of six questions covering five domains: anxiety, kinesiophobia, stress, catastrophizing, and depression. The scores for each question range from 0 to 10, with higher scores indicating worse symptoms.
Sponsors and contacts
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