Web-based Instrument Intervention for Individuals With Shoulder Pain

Shoulder Pain Clinical Trial

Official title:

Web-based Instrument Intervention for Individuals With Shoulder Pain: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04322864
• Other study ID #: eHealthRCT
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: May 31, 2026

Study information

• Verified date: June 2024
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: May 31, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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;

• Have a mobile phone with Android 4.1 or higher.

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.

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Shoulder Pain

Intervention

Other:
• Therapeutic exercises
Patients will perform strengthening exercises focusing on scapulothoracic muscles and shoulder lateral rotators.

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Carlos	São Carlos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)