CASA Pilot Clinical Trial

This research proposes to evaluate the effectiveness of a novel device designed for the non-surgical treatment of carpal tunnel syndrome. The device applies a small cyclic force to the wrist. The cycles include a small time period in which force is applied, followed by a brief period of no force. The device is intended to be worn during hours of sleep. Treatment efficacy will be evaluated based on comparisons to patient reported outcomes for a standard of care treatment.

Study phase: II

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

Inclusion Criteria:

  • 18 and older
  • Diagnosed with right-handed or bilateral CTS. Participants will be treated only in the right hand.

Exclusion Criteria:

  • History of traumatic or chronic neuromusculoskeletal disorders involving the right upper extremity.
  • Systemic diseases (e.g. diabetes, thyroid disease, rheumatoid arthritis, gout, renal failure, hemodialysis, sarcoidosis, amyloidosis)
  • Positive diagnosis of cervical disorders such as radiculopathy, spondylosis, tumor, and multiple sclerosis
  • Degenerative joint diseases in the right hand (e.g., Osteoarthritis)
  • Osteoporosis in the right hand
  • History of carpal tunnel release in the right hand
  • History of conservative CTS treatments in the right hand within the 3 months preceding study initiation (e.g. splinting, corticosteroid injections, oral anti-inflammatory medication, physical therapy)
  • Body mass index greater than 35
  • Women who are currently pregnant
  • Patients who have carpal tunnel release surgery scheduled for the next 12 weeks.
  • Patients who have taken pain medication, including over-the-counter products, within 2 weeks prior to initiation of the study.
  • Will not participate in other CTS treatment or therapies during this study.

Primary disease category: Orthopaedics, Muscle & Bone

Secondary disease categories: Brain, Spinal Cord & Nervous System, Parkinson's Disease, Neuromuscular Disorders & Other Movement Disorders, Stroke, Aneurysms & Vascular Lesions

Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases

Protocol number: STUDY00003761

Projected enrollment dates: February 2024 to August 2025

Official study title: Biomechanical Treatment of CTS Via Carpal Arch Space Augmentation: A Pilot Clinical Trial

ClinicalTrials.gov page:
http://www.clinicaltrials.gov/show/NCT06208709