Chronic Shoulder Pain
Conditions
Keywords
shoulder pain, Psychosocial Rehabilitation, exercise therapy
Brief summary
The objective of this clinical trial is to determine whether cognitive functional therapy is superior to therapeutic exercises for the treatment of chronic shoulder pain. The main questions it aims to answer are: Is cognitive functional therapy superior to therapeutic exercises for pain and disability in individuals with chronic shoulder pain? Is cognitive functional therapy superior to therapeutic exercises for functionality and psychosocial factors? Participants will: Receive 4 to 8 sessions of cognitive functional therapy once a week for four to eight weeks. Follow a therapeutic exercise protocol for eight weeks with a frequency of twice per week.
Detailed description
This will be a randomized controlled trial, single-blind, with two parallel groups. 148 individuals with chronic shoulder pain will be randomly assigned to one of two groups: Cognitive functional therapy (CFT) or therapeutic exercises. The interventions will last between four and eight weeks, with the CFT group receiving therapy once a week and the therapeutic exercise group receiving sessions twice a week for eight weeks. The primary outcomes will be pain intensity and disability, while the secondary outcomes will include specific function, kinesiophobia, self-efficacy, sleep quality, treatment expectations, perception of change, treatment satisfaction and exercise adherence.
Interventions
BEHAVIORALCognitive functional therapy
The intervention consists of a Cognitive-Functional Therapy (CFT) program for individuals with shoulder pain, conducted by trained physiotherapists (106 hours of training) under the supervision of an expert with over 8 years of experience. CFT adopts a biopsychosocial approach and is structured into three main components: Making Sense of Pain - A cognitive component aimed at reinterpreting dysfunctional beliefs about pain through a reflective process based on the patient's life history, promoting understanding and self-efficacy. Graded Exposure with Control - Gradual exposure to functional activities, aiming to modify maladaptive associations between movement and pain, fostering the development of movement confidence. Lifestyle Change - Discussion and implementation of strategies to promote a healthy lifestyle, including physical activity, sleep habits, and stress management. All three components are integrated from the first session, with initial focus on building the therapeutic all.
OTHERTherapeutic exercise
Participants in the Therapeutic Exercises Group will engage in individualized exercises targeting the scapulothoracic musculature and rotator cuff. The exercises, performed bilaterally, include lateral arm rotation, T, W, wall hand slide, and diagonal arm movement upwards. Each participant will be guided by one of two physiotherapists, randomly assigned. The exercises will follow a protocol consisting of 3 sets of 12 repetitions, with 1-minute rest between sets, using progressively resistant Thera-Bands®. Resistance will increase when pain is ≤2 on the Numerical Rating Scale and perceived exertion is \<3 on the Borg Scale. The protocol was designed based on scientific literature and shoulder pain treatment guidelines to address muscle activation deficits and rotator cuff and scapulothoracic imbalances.
Sponsors
Universidade Federal de Sao Carlos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Evaluators will be blinded to the treatment group
Intervention model description
This is a superiority randomized controlled trial, single-blinded, with two parallel groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Individuals of both sexes, aged between 18 and 65 years, will be included if they have had shoulder pain for at least 3 months and report a pain intensity of at least 3 points on the Numeric Pain Rating Scale (NPRS) at rest or during arm movement. Additionally, they must have a minimum score of 20 points on the Shoulder Pain and Disability Index (SPADI).
Exclusion criteria
Individuals will not be included if they have adhesive capsulitis, defined as a loss of more than 50% of passive shoulder range of motion in external rotation; previous shoulder surgery; a history of shoulder fracture; systemic musculoskeletal diseases (e.g., rheumatoid arthritis, fibromyalgia); shoulder pain reproduced by active or passive cervical spine movement; signs of glenohumeral instability identified by a positive sulcus test or a positive apprehension test indicating laxity in the glenohumeral joint; self-reported systemic disease; a positive drop arm test; pregnancy; active cancer treatment; neurological diseases; cognitive impairments; corticosteroid injection within three months prior to the intervention; or physical therapy in the three months preceding the study. Participants will be discontinued from the study if they experience fractures, surgeries, musculoskeletal or neural injuries that prevent access to treatment, or receive corticosteroid injections during the treatment or follow-up period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up | The intensity of shoulder pain will be assessed during arm movement in which the patient reports, pain using the Numeric pain rating scale (NPRS). The scale consists of an 11-point ordinal system, ranging from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. |
| Shoulder disability | Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up | Disability will be assessed using the Shoulder Pain and Disability Index (SPADI). The instrument is self-administered and consists of 13 items divided into 2 subscales (5 items for pain; 8 items for disability) and each item is scored from 0 to 10 points. The final score ranges from 0 to 100, with higher scores indicating greater shoulder disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Specific Function | Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up | The Patient Specific Functional Scale (PSFS) will be used to assess the patient's specific functionality. Patients will be asked to identify up to three important activities that they are having difficulty with or are unable to perform due to their condition. Furthermore, patients must classify, on a scale of 11 points (ranging from 0 unable to perform activity to 10 able to perform activity. |
| Kinesiophobia | Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up | Kinesiophobia will be assessed by the Tampa Kinesiophobia Scale 11 (TSK-11). The TSK is an instrument used to measure fear of movement. It is a self-administered questionnaire and presents 11 questions related to pain and intensity of symptoms. The score ranges from 11 to 44 points, in which higher scores indicate higher levels of kinesiophobia. |
| Pain Self-Efficacy | Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up | Self-efficacy will be assessed using the Pain Self-Efficacy Questionnaire (PSEQ). This is a 10-item self-report questionnaire that measures the degree of self-confidence in performing certain activities. Each item is rated on a 7-point Likert scale (0 = not at all confident; 6 = completely confident), with higher scores reflecting greater self-confidence. |
| Sleep Quality | Baseline, 4-week, at the end of treatment (8-week), and 12-week follow-up | Sleep quality will be assessed using the Insomnia Severity Index (ISI). This is a scale that assesses the nature, intensity, and impact of insomnia experienced in the last month. The self-report instrument consists of 7 questions, answered using a Likert scale ranging from 0 (no severity) to 4 (high severity). The total score ranges from 0 to 28, classified as follows: no insomnia (0-7), mild insomnia (8-14), moderate insomnia (15-21), and severe insomnia (22-28). |
| Expectations with Treatment | Baseline | The patient's expectations regarding the treatment will be assessed by asking the question How much do you expect your shoulder to improve at the end of the treatment?. The score will be measured on a 7-point Likert scale, with 1 being worst possible and 7 being completely recovered. The assessment will be made before the intervention begins. |
| Perception of Change | 4-week, at the end of treatment (8-week), and 12-week follow-up | The individual's perception of changes in health status over time will be measured using the Global Change Assessment Scale. The score varies from 15 points, with -7 being a very significant worsening, 0 indicating no change and +7 a very significant improvement |
| Satisfaction with treatment | At the end of treatment (8-week), and 12-week follow-up | The individual's satisfaction with the treatment will be measured using the Global Rating of Change Scale. The score varies from 15 points, with -7 being the worst possible satisfaction, 0 indicating no change and +7 the best possible satisfaction. |
| Exercise adherence | 4-week, at the end of treatment (8-week), and 12-week follow-up | To assess exercise adherence, sections B and C of the Brazilian version of the Exercise Adherence Rating Scale (EARS-Br) will be used. Section B consists of 6 items rated on a 5-point Likert scale ranging from 0 (strongly agree) to 4 (strongly disagree). This section aims to measure the participant's level of adherence to the recommended exercises. The total score ranges from 0 to 24 points, with scores equal to or greater than 17 indicating good adherence to the home exercise program. Section C consists of 9 items, also organized on a 5-point Likert scale (0 = strongly agree; 4 = strongly disagree). This section explores factors that influence exercise adherence, divided into barriers (items 1, 2, 3, 8, and 9) and facilitators (items 4, 5, 6, and 7). |
Countries
Brazil
Contacts
Primary ContactMatheus Dias Gregorio
Outcome results
None listed