Carpal Arch Space Augmentation (CASA) Clinical Trial

NCT06208709 | Recruiting FDA Device

• 2 other identifiers: 000036711R21AR082111-01A1
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carpal Tunnel Syndrome

Keywords

cts; carpal tunnel syndrome

Outcome Measures

Primary Outcomes (1)

• Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS)

  The BCTQ SSS is a validated, self-reported instrument used in the assessment of pain intensity for patients with carpal tunnel syndrome. Higher numbers are worse outcomes. Possible scores range from 1 ("normal", "no pain", or "without difficulty") to 5 ("very serious", "continued", "more than 5 times") Change = (Baseline score - week 8 score)

  Baseline and up to 8 weeks

Secondary Outcomes (3)

• Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS)

  Baseline and up to 8 weeks

• Michigan Hand Outcomes Questionnaire (MHQ)

  Baseline and up to 8 weeks

• Visual Analog Scales for pain, tingling, and numbness

  Baseline and up to 8 weeks

Study Arms (2)

CASA Arm

EXPERIMENTAL

Arm that will be given the test intervention device.

Device: carpal arch space augmentation (CASA)

SOC Arm

ACTIVE COMPARATOR

Arm that is given a standard brace used for treating Carpal Tunnel Syndrome pain.

Device: standard of care (SOC)

Interventions

carpal arch space augmentation (CASA) DEVICE

A BOA brace with a balloon that is affixed internally. The device applies a small cyclic force of to the wrist. The cycles include a brief period of force applied, followed by a brief period of no force. The device is intended to be worn during hours of sleep.

CASA Arm

standard of care (SOC) DEVICE

A BOA brace that can be adjusted to the arm of the participant.

SOC Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of musculoskeletal or neurological conditions that may confound Carpal Tunnel Syndrome symptoms, including but not limited to:
• Diagnosed or suspected arthritis in the test wrist, hand, or finger joints
• Prior neck trauma, whiplash injury, or any condition suggestive of cervical radiculopathy
• Current or prior treatment from a healthcare provider such as neurologist, physical therapist, physiatrist, rheumatologist, neurosurgeon, orthopedic surgeon or chiropractor for cervical radiculopathy or other musculoskeletal problem involving the neck, shoulder, and or upper extremity
• History of traumatic or chronic symptomatic neuromusculoskeletal disorders involving the upper extremity to be tested.
• The following diseases: uncontrolled diabetes, thyroid disease, rheumatoid arthritis, gout, lupus, renal failure, hemodialysis, sarcoidosis, amyloidosis, additional systemic diseases that may have an effect on the peripheral median nerve.
• Positive diagnosis of cervical disorders affecting the same side of the body as the test hand such as radiculopathy, spondylosis, tumor, and multiple sclerosis
• Symptomatic joint diseases in the test hand (e.g., Osteoarthritis)
• Osteoporosis in the test hand
• History of carpal tunnel release in the test hand
• History of corticosteroid injection treatments for CTS in the test hand within the 3 months preceding study initiation
• Women who are currently pregnant
• Patients who have carpal tunnel release surgery scheduled for the next 12 weeks in their test hand.
• 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

Sponsors & Collaborators

• University of Arizona: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Central Study Contacts

Zong-Ming Li, PhD

CONTACT

520-626-6060; lizongming@arizona.edu

Fernanda Camargo

CONTACT

520-621-2799; fernandac44@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Groups in which participants are randomized into will be unknown to the investigators evaluating the outcome data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Vice Chair of Research, Department of Orthopaedic Surgery

Model Details: Participants will be randomized into one of two treatment arms: Arm 1 - CASA device arm; Arm 2 - Standard of care (SOC) arm In both arms participants are being given a treatment for CTS. Throughout the intervention, participants wear their device daily while they sleep and then record their response within a daily journal. Additionally, participants are contacted weekly to answer weekly questionnaires related to their symptoms and hand function.

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 17, 2024
• Study Start: April 23, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)