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Completed

NCT Number: NCT04322864

Telerehabilitation Intervention for Individuals With Shoulder Pain

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%.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de São Carlos

São Carlos, São Paulo, 13565-905, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

therapeutic exercises

Other

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

Primary outcomes

  1. Change in baseline Shoulder Pain and Disability to 12 weeks

    Time frame: Pre (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 outcomes

  1. Change in baseline Pain to 12 weeks

    Time frame: Pre (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).

  2. Change in baseline Function to 12 weeks

    Time frame: Pre (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)

  3. Change in baseline Self-efficacy to 12 weeks

    Time frame: Pre (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)

  4. Change in baseline Kinesiophobia to 12 weeks

    Time frame: Pre (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)

  5. Patients' expectation with the treatment at baseline

    Time frame: Pre (baseline) treatment

    Patients' expectation with the treatment will be measured with a 7-point Likert scale ranging from 1 (worse than ever) to 7 (totally recovered).

  6. Patients' Self-perception of improvement with the treatment at 12 weeks

    Time frame: Post 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).

Sponsors and collaborators

Lead sponsor

Universidade Federal de Sao Carlos

Other

Registry information

Official study title

Telerehabilitation Intervention for Individuals With Shoulder Pain: Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 26, 2020
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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