Digital Versus Conventional Physical Therapy for Chronic Shoulder Tendinopathy
Condition: Musculoskeletal Pain; Chronic Shoulder Pain; Shoulder Tendinopathy
MeSH terms: Shoulder Pain; Tendinopathy; Musculoskeletal Pain
Study type: Interventional

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.
    

Intervention name(s): Digital rehabilitation; Conventional rehabilitation
Intervention type(s): Device; Device
Intervention description(s): 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.; Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face PT 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, PTs 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-center, prospective, randomised, controlled study, with two parallel groups
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment