NCT05675046: ROBUST

Multicenter Prospective Trial of Office-based Carpal Tunnel Release With Ultrasound Guidance (ROBUST)

Completed NA Results posted Last updated 6 January 2026

What this trial tests

NA trial testing Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device in Carpal Tunnel Syndrome in 149 participants. Completed in 6 August 2025.

Timeline

16 February 2023

Primary endpoint
24 September 2023

6 August 2025

Quick facts

Lead sponsor	Sonex Health, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	149
Start date	16 February 2023
Primary completion	24 September 2023
Estimated completion	6 August 2025
Sites	7 locations across United States

Drugs / interventions tested

• Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device

Conditions studied

• Carpal Tunnel Syndrome — all drugs for Carpal Tunnel Syndrome →
• CTS — all drugs for CTS →

Sponsor

Sonex Health, Inc.

Who can join

18 and older, any sex, with Carpal Tunnel Syndrome or CTS. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS) Primary · Baseline and 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 a

Group	Value	95% CI
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device	-1.543	-1.617 – -1.469

Time to Return To Normal Daily Activities (RTA) Secondary · 3 Months

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.

Group	Value	95% CI
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device	3.8	± 6.66

Time to Return To Work Among Employed Subjects (RTW) Secondary · 3 Months

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.

Group	Value	95% CI
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device	7.0	± 17.94

Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS) Secondary · Baseline and 3 Months

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.

Group	Value	95% CI
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device	-0.969	-1.055 – -0.882

Michigan Hand Questionnaire (MHQ) Secondary · Baseline and 3 Months

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.

Group	Value	95% CI
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device	29.486	27.443 – 31.528

Numeric Pain Scale Secondary · Baseline and 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.

Group	Value	95% CI
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device	-3.472	-3.706 – -3.237

EuroQoL 5-Dimension 5-Level (EQ-5D-5L) Secondary · Baseline and 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 chang

Group	Value	95% CI
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device	0.138	0.116 – 0.160

Number of Participants With Device and/or Procedure Related Adverse Events Secondary · 3 Months

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.

Group	Value	95% CI
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device	1

Global Satisfaction Secondary · 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.

Group	Value	95% CI
Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device	4.4	± 0.78

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected out to 1 year.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CTR-US

Serious: 0/149 (0%)

Deaths: 0/149

Other adverse events (1 terms — click to expand)

Reaction	System	CTR-US
Nerve Injury Median (non-digital)	Musculoskeletal and connective tissue disorders	—

Data from ClinicalTrials.gov NCT05675046 adverse events section.

Sponsor's own description

Multicenter prospective single-arm trial of subjects with symptomatic Carpal Tunnel Syndrome treated with Ultrasound Guided Carpal Tunnel Release (CTR-US) in an office-based setting.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Office-Based Carpal Tunnel Release With Ultrasound Guidance: 6-month Outcomes From the Multicenter ROBUST Trial.
   Pistorio AL, Marwin VM, Paterson PD, Alexander RD, et al · · 2024 · cited 3× · PMID 38817765 · DOI 10.1016/j.jhsg.2023.12.005
2. Protocol of a Multicenter Prospective Trial of Office-Based Carpal Tunnel Release With Ultrasound Guidance (ROBUST).
   Pistorio AL, Chung KC, Miller LE, Adams JE, et al · · 2023 · cited 1× · PMID 37056220 · DOI 10.7759/cureus.37479