Web-based Instrument Intervention for Individuals With Shoulder Pain

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

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%.

Study Overview

• Status: Recruiting
• Conditions: Musculoskeletal Diseases; Shoulder Pain
• Intervention / Treatment: Other: Therapeutic exercises

• Study Type: Interventional
• Enrollment (Estimated): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • São Carlos, São Paulo, Brazil, 13565-905
      • Recruiting
      • Universidade Federal de Sao Carlos
      • Contact: Vander Gava, PT; Phone Number: 55 16 3306 6695; Email: vandergava@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: In-person supervised intervention	Other: Therapeutic exercises; Patients will perform strengthening exercises focusing on scapulothoracic muscles and shoulder lateral rotators.
Experimental: Web-based instrument intervention	Other: Therapeutic exercises; Patients will perform strengthening exercises focusing on scapulothoracic muscles and shoulder lateral rotators.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Universidade Federal de Sao Carlos

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Arthralgia; Shoulder Pain; Musculoskeletal Diseases
• Other Study ID Numbers: eHealthRCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No