Trial Outcomes & Findings for Multicenter Prospective Trial of Office-based Carpal Tunnel Release With Ultrasound Guidance (ROBUST) (NCT NCT05675046)
NCT ID: NCT05675046
Last Updated: 2026-01-06
Results Overview
The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) is a Carpal Tunnel Syndrome specific questionnaire that has been shown to be highly reproducible, internally consistent, valid, and responsive to clinical change in Carpal Tunnel Syndrome (CTS) and subject status post-carpal tunnel release (CTR). The BCTQ consists of 11 symptom severity questions (BCTQ-SSS). Scoring for the BCTQ- SSS ranges from 1 to 5, with higher scores indicating more severe symptoms, and is calculated as the mean of each response. The mean change score in BCTQ-SSS from baseline and 3-month follow-up are reported. Negative change scores indicate decreased symptom severity and positive change scores indicate increased symptom severity. Bilateral patients with both hands treated are reported based on their averaged score.
COMPLETED
NA
149 participants
Baseline and 3 Months
2026-01-06
Participant Flow
Enrollment in the ROBUST study began on February 16, 2023, and 149 subjects were enrolled. Enrollment was completed on June 30, 2023. Per the protocol, a subject was considered enrolled once they had signed the informed consent form, met all inclusion and exclusion criteria, and completed carpal tunnel release with Ultrasound guidance (CTR-US) using the UltraGuideCTR device.
Subjects could choose between having both hands treated (bilateral) at the same time if both hands met study criteria, or having one hand treated (unilateral) in the study. Bilateral patients with both hands treated are reported based on their averaged score, where applicable.
Participant milestones
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
Participants who were treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the ROBUST Study.
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|---|---|
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Overall Study
STARTED
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149
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Overall Study
COMPLETED
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149
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multicenter Prospective Trial of Office-based Carpal Tunnel Release With Ultrasound Guidance (ROBUST)
Baseline characteristics by cohort
| Measure |
CTR-US
n=149 Participants
Participants who underwent Carpal Tunnel Release with Ultrasound Guidance (CTR-US) using the UltraGuideCTR device in the ROBUST Study.
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Age, Continuous
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58.4 years
STANDARD_DEVIATION 12.9 • n=37 Participants
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Sex: Female, Male
Female
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77 Participants
n=37 Participants
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Sex: Female, Male
Male
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72 Participants
n=37 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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8 Participants
n=37 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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131 Participants
n=37 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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10 Participants
n=37 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=37 Participants
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Race (NIH/OMB)
Asian
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2 Participants
n=37 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=37 Participants
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Race (NIH/OMB)
Black or African American
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6 Participants
n=37 Participants
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Race (NIH/OMB)
White
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132 Participants
n=37 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=37 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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8 Participants
n=37 Participants
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PRIMARY outcome
Timeframe: Baseline and 3 MonthsPopulation: Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) change at 3 months
The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) is a Carpal Tunnel Syndrome specific questionnaire that has been shown to be highly reproducible, internally consistent, valid, and responsive to clinical change in Carpal Tunnel Syndrome (CTS) and subject status post-carpal tunnel release (CTR). The BCTQ consists of 11 symptom severity questions (BCTQ-SSS). Scoring for the BCTQ- SSS ranges from 1 to 5, with higher scores indicating more severe symptoms, and is calculated as the mean of each response. The mean change score in BCTQ-SSS from baseline and 3-month follow-up are reported. Negative change scores indicate decreased symptom severity and positive change scores indicate increased symptom severity. Bilateral patients with both hands treated are reported based on their averaged score.
Outcome measures
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
n=146 Participants
Participants who were treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the ROBUST Study. 146 out of 149 eligible participants completed the BCTQ-SSS at the 3-month visit and were analyzed for this endpoint. 3 participants did not complete the assessment.
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|---|---|
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Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)
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-1.543 units on a scale
Interval -1.617 to -1.469
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SECONDARY outcome
Timeframe: 3 MonthsPopulation: Time to return to normal daily activities
Time to return to normal daily activities will be defined as the number of days between treatment and the time the subject reports returning to normal daily activities, irrespective of work status.
Outcome measures
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
n=149 Participants
Participants who were treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the ROBUST Study. 146 out of 149 eligible participants completed the BCTQ-SSS at the 3-month visit and were analyzed for this endpoint. 3 participants did not complete the assessment.
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Time to Return To Normal Daily Activities (RTA)
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3.8 Days
Standard Deviation 6.66
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SECONDARY outcome
Timeframe: 3 MonthsPopulation: Time to return to work in days among employed subjects. 102/149 subjects were analyzed as only employed subjects were asked for return to work data.
Time to return to work will be defined as the number of days between treatment and the time the subject reports returning to work in any capacity.
Outcome measures
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
n=102 Participants
Participants who were treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the ROBUST Study. 146 out of 149 eligible participants completed the BCTQ-SSS at the 3-month visit and were analyzed for this endpoint. 3 participants did not complete the assessment.
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Time to Return To Work Among Employed Subjects (RTW)
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7.0 Days
Standard Deviation 17.94
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SECONDARY outcome
Timeframe: Baseline and 3 MonthsPopulation: Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) change at 3 months. 146 out of 149 eligible participants completed the BCTQ-FSS at the 3-month visit and were analyzed for this endpoint. 3 participants did not complete the assessment.
The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) additionally consists of 8 functional status questions. Scoring for the BCTQ-FSS ranges from 1 to 5, with higher scores indicating more functional limitation, and is calculated as the mean of each response. The mean change score in BCTQ-FSS from baseline to the 3-month follow-up are reported. Negative change scores indicate decreased functional limitation and positive change scores indicate increased functional limitation.
Outcome measures
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
n=146 Participants
Participants who were treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the ROBUST Study. 146 out of 149 eligible participants completed the BCTQ-SSS at the 3-month visit and were analyzed for this endpoint. 3 participants did not complete the assessment.
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|---|---|
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Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)
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-0.969 units on a scale
Interval -1.055 to -0.882
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SECONDARY outcome
Timeframe: Baseline and 3 MonthsPopulation: Michigan Hand Questionnaire (MHQ) change at 3 months. 145 out of 149 eligible participants completed the MHQ at the 3-month visit and were analyzed for this endpoint. 4 participants did not complete the assessment.
Michigan Hand Questionnaire (MHQ) is a validated, hand-specific questionnaire consisting of 37 questions in 6 domains: * Overall hand function * Activities of daily living * Work performance * Pain * Aesthetics * Satisfaction The total score ranges from 0 to 100. Higher scores indicate better hand performance; lower scores indicate lower hand performance. Mean change in the total MHQ score at the 3-month follow-up relative to baseline is reported.
Outcome measures
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
n=145 Participants
Participants who were treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the ROBUST Study. 146 out of 149 eligible participants completed the BCTQ-SSS at the 3-month visit and were analyzed for this endpoint. 3 participants did not complete the assessment.
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Michigan Hand Questionnaire (MHQ)
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29.486 units on a scale
Interval 27.443 to 31.528
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SECONDARY outcome
Timeframe: Baseline and 3 MonthsPopulation: Numeric Pain Scale change at 3 months
The Numeric Pain Scale measures pain severity. Scoring for the Numeric Pain Scale ranges from 0 (indicating no pain) to 10 (indicating worst pain possible). The mean change scores in the Numeric Pain Scale from baseline and 3-month follow-up are reported. Negative change scores indicate decreased pain severity and positive change scores indicate increased pain severity. Bilateral patients with both hands treated are reported based on their averaged score.
Outcome measures
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
n=145 Participants
Participants who were treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the ROBUST Study. 146 out of 149 eligible participants completed the BCTQ-SSS at the 3-month visit and were analyzed for this endpoint. 3 participants did not complete the assessment.
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|---|---|
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Numeric Pain Scale
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-3.472 units on a scale
Interval -3.706 to -3.237
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SECONDARY outcome
Timeframe: Baseline and 3 MonthsPopulation: EuroQol 5-Dimension 5-Level (EQ-5D-5L) change at 3 months
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) is a generic preference-based questionnaire developed by the EuroQol Group to measure health-related quality of life. The EQ-5D-5L measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking consisting of: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. Scoring for the EQ-5D-5L ranges from -0.57 (indicating lowest quality of life) to 1.00 (indicating highest quality of life). The mean change score in the EQ-5D-5L from baseline to the 3-month follow-up are reported. Negative change scores indicate decreased quality of life and positive change scores indicate increased quality of life.
Outcome measures
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
n=145 Participants
Participants who were treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the ROBUST Study. 146 out of 149 eligible participants completed the BCTQ-SSS at the 3-month visit and were analyzed for this endpoint. 3 participants did not complete the assessment.
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EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
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0.138 units on a scale
Interval 0.116 to 0.16
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SECONDARY outcome
Timeframe: 3 MonthsPopulation: Participants with Procedure and/or Device-Related Adjudicated Adverse Events
Participants with adverse events (AEs) occurring within 90 days of treatment and that are adjudicated as definitely related or probably related to the device or definitely related or probably related to the procedure will be included in this endpoint. The number of device- or procedure-related AEs within 90 days of treatment will represent an endpoint of the study.
Outcome measures
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
n=149 Participants
Participants who were treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the ROBUST Study. 146 out of 149 eligible participants completed the BCTQ-SSS at the 3-month visit and were analyzed for this endpoint. 3 participants did not complete the assessment.
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|---|---|
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Number of Participants With Device and/or Procedure Related Adverse Events
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1 Participants
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SECONDARY outcome
Timeframe: 3 MonthsPopulation: Global satisfaction score at 3 months
Subjects were asked to rate their satisfaction with the carpal tunnel release procedure. The global satisfaction scale ranges from 1 to 5, with 1 = Very Dissatisfied, 2 = Dissatisfied, 3 = Neither Satisfied nor Dissatisfied, 4 = Satisfied and 5 = Very Satisfied. The mean satisfaction score at the 3-month follow-up is reported. Bilateral patients with both hands treated are reported based on their averaged score. Higher scores indicate higher satisfaction; lower scores indicate lower satisfaction.
Outcome measures
| Measure |
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device
n=148 Participants
Participants who were treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the ROBUST Study. 146 out of 149 eligible participants completed the BCTQ-SSS at the 3-month visit and were analyzed for this endpoint. 3 participants did not complete the assessment.
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|---|---|
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Global Satisfaction
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4.4 units on a scale
Standard Deviation 0.78
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Adverse Events
CTR-US
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CTR-US
n=149 participants at risk
Participants who underwent Carpal Tunnel Release with Ultrasound Guidance (CTR-US) using the UltraGuideCTR device in the ROBUST Study.
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|---|---|
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Musculoskeletal and connective tissue disorders
Nerve Injury Median (non-digital)
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0.67%
1/149 • Number of events 1 • Adverse events were collected out to 1 year.
AE could be reported 2 ways. 1) Documented by the site during the study procedure. 2) Subject reported an AE directly to the investigative site. If the site is notified of a potential AE by the subject, confirmation of the AE will occur by phone call with the subject or by asking the subject to return for a follow-up clinical evaluation.
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Additional Information
Amy Stegner, Vice President Clinical Affairs
Sonex Health, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place