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Telerehabilitation Intervention for Individuals With Shoulder Pain

Telerehabilitation Intervention for Individuals With Shoulder Pain: Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04322864
Enrollment
184
Registered
2020-03-26
Start date
2021-10-01
Completion date
2024-10-01
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal Diseases, Shoulder Pain

Brief summary

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 telerehabiliation intervention to increase access to physiotherapy for shoulder pain patients. Objective: To assess the effectiveness of telerehabilitation when compared to in-person physiotherapy on pain and disability in individuals with persistent rotator cuff related shoulder pain. Methods: This study is a controlled, randomized, blinded clinical trial. A total of 184 individuals with shoulder pain were randomly assigned to two groups. One group received a telerehabiliation intervention and the other group received the in-person intervention. The intervention consisted of strengthening exercises with emphasis on the lateral rotator and scapulothoracic muscles. The primary outcome was pain and disability (SPADI, Shoulder Pain and Disability Index), and the secondary outcomes were pain intensity (NPRS, Numerical Pain Rating Scale), 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 self-perceived improvement (Global Change Assessment Scale). All outcomes were measured before and after 12 weeks of treatment (2x/week). Normality of data was verified by Kolmogorov Smirnov's test. Differences between groups were assessed using the mixed linear models including the group × time interaction. The effect size was calculated for the variables between the groups. The significance level was set at 5%.

Interventions

OTHERTherapeutic exercises

Patients will perform strengthening exercises focusing on scapulothoracic muscles and shoulder lateral rotators.

Sponsors

Universidade Federal de Sao Carlos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Age 18-60; * Self-reported pain of intensity equal to or greater than 3 points on the numerical pain scale (NDT) at rest or arm movement in the anterolateral region of the shoulder; * Duration of at least 3 months of shoulder pain;

Exclusion criteria

* History of trauma related to the onset of symptoms; * History of clavicle, scapula or humerus fracture; * History of surgical stabilization or rotator cuff repair; * History of shoulder dislocation; * Pain related to the cervical spine; * Adhesive capsulitis; * Systemic disease involving the joints and cognitive alteration that makes it impossible to carry out questionnaires or use the mobile application.

Design outcomes

Primary

MeasureTime frameDescription
Change in baseline Shoulder Pain and Disability to 12 weeksPre (baseline) treatment, post treatment (12 weeks)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)

Secondary

MeasureTime frameDescription
Change in baseline Pain to 12 weeksPre (baseline) treatment, post treatment (12 weeks)Pain will be measured with 11 point - Numerical Rating Pain Scale with scores ranging from 0 (no pain) to 10 (maximum pain).
Change in baseline Function to 12 weeksPre (baseline) treatment, post treatment (12 weeks)Function will be measured with Disabilities of the Arm, Shoulder and Hand with scores ranging from 0 to 100 (higher score reflects higher disability)
Change in baseline Self-efficacy to 12 weeksPre (baseline) treatment, post treatment (12 weeks)Self-efficacy will be measured with Chronic Pain Self-Efficacy Scale with scores ranging from 30 to 300 (higher score reflects greater self-efficacy)
Change in baseline Kinesiophobia to 12 weeksPre (baseline) treatment, post treatment (12 weeks)Kinesiophobia will be measured with Tampa Scale of Kinesiophobia with scores ranging from 17 to 68 (higher score reflects higher kinesiophobia)
Patients' expectation with the treatment at baselinePre (baseline) treatmentPatients' expectation with the treatment will be measured with a 7-point Likert scale ranging from 1 (worse than ever) to 7 (totally recovered).
Patients' Self-perception of improvement with the treatment at 12 weeksPost treatment (12 weeks)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).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026