N/A
N=90
Digital Versus Conventional Physical Therapy for Chronic Shoulder Tendinopathy
Musculoskeletal Pain · Chronic Shoulder Pain · Shoulder Tendinopathy
Bottom Line
View on ClinicalTrials.gov: NCT04636528 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Change in the Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) — 15.5; 13.1 units on a scale — p=0.75
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Digital rehabilitation (Device); Conventional rehabilitation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sword Health, SA
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) |
15.5; 13.1 | 0.75 |
| SECONDARY Change in Shoulder Pain - Worst Pain Level |
2.6; 1.5 | 0.12 |
| SECONDARY Surgery Intent |
6.3; 7.2 | 0.89 |
| SECONDARY Anxiety |
2.8; 2.2 | 0.51 |
| SECONDARY Patient Satisfaction With Intervention |
8; 10 | <0.001 sig |
| SECONDARY Change in Shoulder Pain - Least Pain Level |
0.7; 0.7 | <.001 sig |
| SECONDARY Change in Shoulder Pain - Average Pain Level |
2.1; 1.5 | <.001 sig |
| SECONDARY Depression |
2.7; 1.6 | .27 |
| SECONDARY Dropout Rate |
4; 9 | 0.14 |
| SECONDARY Total Sessions |
26.1; 13.4 | <0.001 sig |
| SECONDARY Treatment Intensity |
461.6; 393.9 | 0.36 |
| SECONDARY Frequency of Sessions Per Week |
3.3; 1.68 | <0.001 sig |
| SECONDARY Retention Rate |
39; 35 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04636528). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.