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Introduction: Shoulder pain is a condition of high prevalence in the general population. Studies indicate that physiotherapeutic treatment with exercise is effective in reducing pain and restoring function in patients with shoulder pain. Patients may have difficulty accessing the physiotherapy service due to the cost of treatment, transportation to the service, and long waiting lines. A possible solution is the use of a web-based exercise prescription instrument to increase access to physiotherapy for shoulder pain patients. Objective: To verify the effects of an intervention with a web-based instrument compared to a in person and supervised intervention. Methods: This study is a controlled, randomized, blinded clinical trial. There will be 184 individuals with shoulder pain who will be randomly assigned to two groups. One group will receive a web-based instrument intervention and the other group will receive the in person and supervised intervention. The intervention will consist of strengthening exercises with emphasis on the lateral rotator and scapulothoracic muscles. The primary outcome will be pain and disability (SPADI, Shoulder Pain and Disability Index), and the secondary outcomes will be function (DASH questionnaire, Disabilities of the Arm, Shoulder and Hand), self-efficacy (CPSS, Chronic Pain Self-Efficacy Scale), kinesiophobia (Cover Scale), patient expectation of treatment (7-point Likert Scale), and patient satisfaction (Global Change Assessment Scale). All outcomes will be measured before and after 12 weeks of treatment (2x/week), after 6 months and 12 months from the end of treatment. Normality of data will be verified by Kolmogorov Smirnov's test. Differences between groups will be verified using the mixed linear models with the interaction terms versus time. The effect size will be calculated for the variables between the groups. The significance level will be set at 5%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-person supervised intervention | Active Comparator |
| |
| Web-based instrument intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic exercises | Other | Patients will perform strengthening exercises focusing on scapulothoracic muscles and shoulder lateral rotators. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline Shoulder Pain and Disability to 12 weeks, 6 months (follow-up 1) and 12 months (follow-up 2) | Shoulder Pain and Disability will be measured with Shoulder Pain and Disability Index with scores ranging from 0 to 100 (higher score reflects higher pain and disability) | Pre (baseline) treatment, post treatment (12 weeks), after 6 months (follow-up 1) and 12 months (follow-up 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline Pain to 12 weeks, 6 months (follow-up 1) and 12 months (follow-up 2) | Pain will be measured with 11 point - Numerical Rating Pain Scale with scores ranging from 0 (no pain) to 10 (maximum pain). | Pre (baseline) treatment, post treatment (12 weeks), after 6 months (follow-up 1) and 12 months (follow-up 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de São Carlos | São Carlos | São Paulo | 13565-905 | Brazil |
At the end of the clinical trial will be published the Study Protocol and Statistical Analysis Plan (SAP), if any researcher wants more information can request. The Informed Consent Form (ICF) can also be available.
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Change in baseline Function to 12 weeks, 6 months (follow-up 1) and 12 months (follow-up 2) |
Function will be measured with Disabilities of the Arm, Shoulder and Hand with scores ranging from 0 to 100 (higher score reflects higher disability) |
| Pre (baseline) treatment, post treatment (12 weeks), after 6 months (follow-up 1) and 12 months (follow-up 2) |
| Change in baseline Self-efficacy to 12 weeks, 6 months (follow-up 1) and 12 months (follow-up 2) | Self-efficacy will be measured with Chronic Pain Self-Efficacy Scale with scores ranging from 30 to 300 (higher score reflects greater self-efficacy) | Pre (baseline) treatment, post treatment (12 weeks), after 6 months (follow-up 1) and 12 months (follow-up 2) |
| Change in baseline Kinesiophobia to 12 weeks, 6 months (follow-up 1) and 12 months (follow-up 2) | Kinesiophobia will be measured with Tampa Scale of Kinesiophobia with scores ranging from 17 to 68 (higher score reflects higher kinesiophobia) | Pre (baseline) treatment, post treatment (12 weeks), after 6 months (follow-up 1) and 12 months (follow-up 2) |
| Patients' expectation with the treatment at baseline | Patients' expectation with the treatment will be measured with a 7-point Likert scale ranging from 1 (worse than ever) to 7 (totally recovered). | Pre (baseline) treatment |
| Patients' Self-perception of improvement with the treatment at 12 weeks, 6 months (follow-up 1) and 12 months (follow-up 2) | Self-perception of improvement will be measured with the Global Rating of Change Scale with scores ranging from -7 to +7 (A higher score indicates higher recovery from the condition). | Post treatment (12 weeks), after 6 months (follow-up 1) and 12 months (follow-up 2) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |