Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04636528 |
Other study ID # |
SH-RCT-CS-US-01 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 4, 2021 |
Est. completion date |
December 23, 2022 |
Study information
Verified date |
January 2023 |
Source |
Sword Health, SA |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.