Carpal Arch Space Augmentation (CASA) Clinical Trial (CASA)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Device: carpal arch space augmentation (CASA); Device: standard of care (SOC)

Detailed Description

Carpal tunnel syndrome is a commonly diagnosed disorder of the hand that affects 3.7% of the population. Carpal tunnel release surgery can provide some symptomatic relief to patients but surgical transection of the transverse carpal ligament can disrupt essential anatomical, biomechanical, and physiological functions of the carpal tunnel. This clinical trial seeks to determine the effectiveness of the CASA device in alleviating CTS pain by augmenting the carpal arch space. During an early investigation of the transverse carpal ligament, investigators discovered the biomechanical mechanism of carpal arch space augmentation (CASA) for median nerve decompression. The CASA approach is supported extensively through research findings utilizing geometric modeling, finite element analysis, in vitro cadaveric experiments, and in vivo human studies.

In this proposed pilot clinical trial, investigators will compare the device's performance with a widely accepted standard of care (SOC) brace intervention (Thermoformable Exos# Wrist Brace, DJO, Vista, CA). Incorporating the CASA intervention as part of a brace is an innovative intervention study design offering a unique opportunity to identify the additive benefit of CASA and for patients to benefit from the combined effects of both CASA and a SOC.

This study is designed to be a randomized, single-blinded, two-arm trial. A sufficient number of patients will be recruited such that a total of 76 subjects will successfully complete the baseline run-in period and be randomized, with consideration of a 20% attrition rate among randomized patients, to yield 60 participants with complete data. The CASA group will be required to undergo wrist compression during the evening. The wrist compression is achieved by automated inflation of the balloon for a saturated pressure of 140 mmHg, which is calibrated to impart the targeted therapeutic compression force on the patient's wrist of 10 N. The intervention period will last for four weeks for the CASA group. For the SOC group, there is no compression force, as it is measuring a brace-alone condition, and will similarly last for a period of four weeks.

Patients will self-administer their assigned intervention of either CASA or sham device, and will have off-site access to study materials and questionnaire journals, thus reducing participant burden and eliminating travel expense. Data forms are designed to capture all data elements with the structure to facilitate completeness, quality, and statistical analysis. Furthermore, exploratory endpoints will be evaluated such as (a) number of participants that began to take analgesics during the study intervention phase, (b) the number of participants who opted for surgery during the intervention and post-intervention follow-up phases, (c) per-protocol comparisons of treatment arms, and (d) the impact of sex on response to treatment.

The trial will consist of 3 phases for participants; run-in, intervention, follow-up. During the run-in phase, subjects will be randomized and undergo compliance testing, along with a brief duration of device wearing, to ensure they conform with protocol instructions.

Once participants successfully complete the run-in, they will move into the intervention phase. During the intervention phase, subjects will wear their arm's respective device/brace nightly. Participants will report their adherence each day before falling asleep and once again upon waking. Participants will receive weekly phone calls in which they will report the outcome measures for the week to a member of the study team who will record the data.

After the intervention phase, participants will proceed to the follow-up phase which will last for four weeks. In this phase, participants will continue to receive weekly phone calls.

Regardless what the participant's compliance to protocol requirements for abstaining from analgesics or wearing the device 8 hours per day, the participant will be asked to complete their journals per protocol for the primary intent to treat outcome. The data gained from these patients will be used in an exploratory statistical analysis to determine if any significant differences exist between patients who were compliant to the study and those who were not. If adherence standards are not consistently met within either treatment group, a sensitivity analysis using a per-protocol cohort will be performed. A significance level of 0.05 will be assumed for tests of the primary outcome. Analyses of secondary outcomes will be interpreted cautiously due to multiple comparisons.

It is predicted that an intervention period of wearing the CASA device will significantly improve patient reported outcomes of the primary endpoint, BCTQ SSS, and some of the secondary endpoints. Furthermore, it is expected that the positive effects of the CASA device intervention will continue after the treatment period has concluded. In both long-term wear and combined CASA-brace effect, it is anticipated that the CASA device group will outperform the SOC group in alleviating patient symptoms.

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zong-Ming Li, PhD; Phone Number: 520-626-6060; Email: lizongming@arizona.edu
• Study Contact Backup: Name: Jeremy Makar, BA; Phone Number: 520-626-4916; Email: jmakar@arizona.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 within 2 weeks prior to initiation of the study.
• Will not participate in other CTS treatment or therapies during this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CASA Arm; Arm that will be given the test intervention device.	Device: carpal arch space augmentation (CASA); 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.
Active Comparator: SOC Arm; Arm that is given a standard brace used for treating Carpal Tunnel Syndrome pain.	Device: standard of care (SOC); A BOA brace that can be adjusted to the arm of the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS)	The BCTQ FSS is a validated, self-reported instrument used in the assessment of hand function for patients with carpal tunnel syndrome. Higher numbers are worse outcomes. Possible scores range from 1 (no difficulty) to 5 (cannot perform activity at all due to symptoms) Change = (Baseline score - week 8 score)	Baseline and up to 8 weeks
Michigan Hand Outcomes Questionnaire (MHQ)	The MHQ is a valid and reliable instrument for the outcomes in comparing pain and task completion between right and left hands. For scales in sections I and II of the MHQ, higher numbers are worse outcomes. Possible scores range from 1 ("very good", "not at all difficult") to 5 ("very poor", very difficult") For scales in sections III and IV of the MHQ, higher numbers are better outcomes. Possible scores range from 1 (always) to 5 (never). For scales in sections V and VI of the MHQ, higher numbers are worse outcomes. Possible scores range from 1 (strongly agree) to 5 (strongly disagree) Change = (Baseline score - week 8 score)	Baseline and up to 8 weeks
Visual Analog Scales for pain, tingling, and numbness	Scales used to report pain, tingling, numbness intensity by the participant. Higher numbers are worse outcomes. Possible scores range from 0 (no pain) to 10 (worst pain). Change = (Baseline score - week 8 score)	Baseline and up to 8 weeks

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Estimated): January 17, 2024

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: carpal tunnel syndrome; cts
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: 00003671; 1R21AR082111-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No current plan exists. If data is shared in the future, it will only be deidentified data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No