Digital Versus Conventional Physical Therapy for Chronic Shoulder Tendinopathy
NCT04636528 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2025-01-29
Summary
This is a single-center, prospective, randomised, controlled study, with two parallel groups, designed to assess the clinical impact of a digital exercise program against conventional rehabilitation for shoulder tendonitis. The hypothesis is that all the clinical outcomes measured will significantly improve after the program, and patients using this novel system will attain at least the same outcomes than the ones attained by the conventional PT group.
Conditions
- Musculoskeletal Pain
- Chronic Shoulder Pain
- Shoulder Tendinopathy
Interventions
- DEVICE
-
Digital rehabilitation
Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health. Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist.
- DEVICE
-
Conventional rehabilitation
Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant. In addition to the face-to-face sessions, physical therapists will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week).
Sponsors & Collaborators
-
University of California, San Francisco
collaborator OTHER -
Sword Health, SA
lead INDUSTRY
Principal Investigators
-
Sam Pak, PT · University of California, San Francisco
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-04
- Primary Completion
- 2022-12-16
- Completion
- 2022-12-23
- FDA Device
- Yes
Countries
- United States
Study Locations
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