Digital Versus Conventional Physical Therapy for Chronic Shoulder Tendinopathy

NCT04636528 | Completed Results DMC FDA Device

• 1 other identifier: SH-RCT-CS-US-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in the Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH)

  Shoulder physical function and symptoms will be measured using the shortened Disabilities of the Arm, Shoulder and Hand questionnaire QuickDASH, ranging from 0 (zero;non-disability) to 100 (maximum disability)

  8 weeks after initiation of rehabilitation program

Secondary Outcomes (12)

• Change in Shoulder Pain - Worst Pain Level

  8 weeks after initiation of rehabilitation program

• Surgery Intent

  8 weeks after initiation of rehabilitation program

• Anxiety

  8 weeks after initiation of rehabilitation program

• Patient Satisfaction With Intervention

  8 weeks after initiation of rehabilitation program

• Change in Shoulder Pain - Least Pain Level

  8 weeks after initiation of rehabilitation program

Study Arms (2)

Digital Rehabilitation

EXPERIMENTAL

Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist

Device: Digital rehabilitation

Conventional Rehabilitation

ACTIVE COMPARATOR

Outpatient clinic-based 8 week rehabilitation program with face-to-face physical therapy sessions

Device: Conventional rehabilitation

Interventions

Digital rehabilitation DEVICE

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.

Digital Rehabilitation

Conventional rehabilitation DEVICE

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).

Conventional Rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged between 18 and 80 years of age at enrolment
• Reporting intermittent or persistent shoulder pain for at least 12 weeks, and/or present at least 50% of the time in the past 6 months
• Lack of visual/audio or cognitive impairment interfering with the ability to understand or comply with the program

You may not qualify if:

• Non-English speaking
• Residing outside greater SF area
• Known pregnancy
• Submitted to spinal surgery less than 3 months ago
• Symptoms and/or signs indicative of possible infectious disorder
• Referred pain from spine and/or thoracic outlet syndrome
• Active cancer diagnosis or undergoing treatment for cancer
• Cardiac, respiratory or other known disorder incompatible with at least 20 minutes of light to moderate physical activity
• Concomitant neurological disorder (e.g. stroke, multiple sclerosis, Parkinson's disease)
• Dementia or psychiatric disorders precluding patient from complying with a home-based exercise program
• Illiteracy and/or serious visual or auditory impairment interfering with communication or compliance

Sponsors & Collaborators

• Sword Health, SA: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Physical Medicine and Rehabilitation Clinic

San Francisco, California, 94158, United States

Location

Related Publications (1)

• Pak SS, Janela D, Freitas N, Costa F, Moulder R, Molinos M, Areias AC, Bento V, Cohen SP, Yanamadala V, Souza RB, Correia FD. Comparing Digital to Conventional Physical Therapy for Chronic Shoulder Pain: Randomized Controlled Trial. J Med Internet Res. 2023 Aug 18;25:e49236. doi: 10.2196/49236.

  PMID: 37490337 DERIVED

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was conducted during the COVID-19 pandemic which may have influenced compliance with physical therapy programs. The cohort included may limit generalizability. Cognitive behavioural therapy (CBT) and educational components differed between groups despite conceptual similarity. Investigators and participants were unblinded to group allocation. Absence of follow-up restricts conclusions on long-term benefits and cost-effectiveness.

Results Point of Contact

• Title: Fernando Dias Correia
• Organization: Sword Health Inc

fcorreia@swordhealth.com

+1 (646) 379-6751

Study Officials

• Sam Pak, PT

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding of investigators and patients regarding allocation arm will not be possible, given the nature of the intervention. Analysis of study results will be performed by an independent statistician at UCSF.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single-center, prospective, randomised, controlled study, with two parallel groups

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 19, 2020
• Study Start: August 4, 2021
• Primary Completion: December 16, 2022
• Study Completion: December 23, 2022
• Last Updated: January 29, 2025
• Results First Posted: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon study publication, for at least five years.
• Access Criteria: Study protocol will be made available in clinicaltrials.gov and the excel file with the aggregate results will be made available upon study publication, for at least 5 years.

Locations

US (1)