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Carpal Arch Space Augmentation (CASA) Clinical Trial

ConditionCarpal Tunnel Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Arizona

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 and older

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • standard of care (SOC)

    Device

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

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: CASA ArmExperimental treatment 1 intervention
Group B: SOC ArmActive comparator 1 intervention

Trial outcomes

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)

Time frame
Baseline and up to 8 weeks

Secondary outcomes

1

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)

Time frame
Baseline and up to 8 weeks
2

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)

Time frame
Baseline and up to 8 weeks
3

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)

Time frame
Baseline and up to 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Arizona

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Source ClinicalTrials.gov
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