Clinical trial NCT04636528: Digital Versus Conventional Physical Therapy for Chronic Shoulder Tendinopathy
Official title: Digital Care Program for Chronic Shoulder Tendinopathy Versus Conventional Physical Therapy: a Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Chronic Shoulder Pain
Shoulder Tendinopathy
Lead sponsor: Sword Health, SA
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2020-11-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-center, prospective, randomised, controlled study, with two parallel groups
Primary purpose: TREATMENT

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.

Detailed description: Shoulder pain is highly prevalent, being the third main complaint in primary care settings.There is a wide range of reported incidence and prevalence rates, with a median of 24.8% of adults reporting shoulder pain every month. In developed countries, 1% of adults annually consult a primary care provider due to shoulder pain.

Around 65 to 70% of shoulder pain complaints involve problems in the rotator cuff (RTC) tendons, with incidence rising higher after the 4th decade of life.Abundant data from across the world is available on the prevalence of RTC pathologies.

RTC dysfunction represent a huge burden for healthcare systems, insurance companies and employers alike. Shoulder problems account for 2.4% of all general practitioner consultations in the UK, and 4.5 million visits to physicians annually in the USA. One study in the UK20 estimated that nearly £310 million is spent on medical appointments in the first 6 months of shoulder pain onset, and additional costs of surgical procedures are estimated at approximately £30 million/year, with up to 50% of these costs related to sick leave from paid employment. More than 300,000 surgical repairs for RTC pathologies are performed annually in the USA, and the annual financial burden of RTC management was also estimated at $3 billion.

A myriad of international clinical practice guidelines have been put forth over the years, outlining the management of pain-causing shoulder disorders. Most causes of mild-to-moderate and gradual onset shoulder pain are treated initially with conservative care. Indeed, many recent studies and systematic reviews, as well as the American Academy of Orthopaedic Surgeons guidelines, support that firstly the patient should be directed to a physical therapy (PT) program and not surgery. For some specific conditions (e.g., symptomatic small to medium full-thickness RTC tears), strong evidence further supports that both PT and operative treatment attain significant improvements in patient-reported outcomes. Of note, another systematic review on treatment options for shoulder pain suggests that passive modalities, such as manual therapy, electrotherapy and taping should be avoided as mono-therapy but that they could, in specific cases, provide additional benefit when utilized in conjunction with therapeutic exercise programs. This suggests that the exercise component of PT is fundamental in the treatment of painful shoulder disorders.

Regarding rehabilitation setting, some studies show that home-based therapy, based on exercise, could be as effective as conventional PT interventions. This is in line with the recent trends in healthcare delivery, moving away from inpatient care and towards home-based care with the intent of improving cost-effectiveness. Furthermore, the need for home-based digital solutions is now felt more acutely than ever, in the face of the current pandemic. In this context, solutions enabling home-based rehabilitation without requiring real-time human supervision can be key to improving effectiveness and lowering costs, while keeping all stakeholders safe. Indeed, there are studies demonstrating the potential and cost-effectiveness of shoulder postoperative care and rehabilitation through telehealth solutions.

However, while evidence is growing that digital therapeutics (DTx) can improve outcomes, personalize care and decrease costs, there is still much ground to be explored in the field of digital therapy following RCR. Several studies can be found on the validation/development of systems/algorithms for monitoring shoulder motion to assist clinicians on patient evaluation but these do not meet the aforementioned needs and cannot be considered digital therapeutics.

There have been some advances on new technologies for shoulder rehabilitation, namely using wearable sensors and augmented reality. Of note, some of these studies focus on systems based on inertial motion trackers that can be used by the patient at home, under remote monitoring from the physical therapist. However, these are either in very preliminary stages of development or validation, with no clinical validation studies performed, or are directed at rehabilitation after stroke.

SWORD Health has developed a novel motion tracking-based digital biofeedback system for home-based physical rehabilitation - SWORD Phoenix - which is an FDA-listed class II medical device. The company has previously conducted two pilot studies (NCT03047252; NCT03045549) comparing a digital therapy program using this device against conventional face-to-face physical therapy. These studies have proven the feasibility, safety and effectiveness of this digital therapeutic on rehabilitation after total knee and hip arthroplasty.

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:

1. Subjects aged between 18 and 80 years of age at enrolment
2. 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
3. Lack of visual/audio or cognitive impairment interfering with the ability to understand or comply with the program

Exclusion Criteria:

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

Primary outcomes:
measure: Change in the Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH)
timeFrame: 8 weeks after initiation of rehabilitation program
Secondary outcomes:
measure: Change in Shoulder Pain - Worst Pain Level
timeFrame: 8 weeks after initiation of rehabilitation program
measure: Surgery Intent
timeFrame: 8 weeks after initiation of rehabilitation program
measure: Anxiety
timeFrame: 8 weeks after initiation of rehabilitation program
measure: Patient Satisfaction With Intervention
timeFrame: 8 weeks after initiation of rehabilitation program
measure: Change in Shoulder Pain - Least Pain Level
timeFrame: 8 weeks after initiation of rehabilitation program
measure: Change in Shoulder Pain - Average Pain Level
timeFrame: 8 weeks after initiation of rehabilitation program
measure: Depression
timeFrame: 8 weeks after initiation of rehabilitation program
measure: Dropout Rate
timeFrame: Program-end
measure: Total Sessions
timeFrame: 8 weeks
measure: Treatment Intensity
timeFrame: Between baseline and 8 weeks.
measure: Frequency of Sessions Per Week
timeFrame: 8 weeks
measure: Retention Rate
timeFrame: Between baseline and 8 weeks.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Physical Medicine and Rehabilitation Clinic
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sam Pak, PT
role: PRINCIPAL_INVESTIGATOR
References: