Carpal Tunnel, Carpal Tunnel Syndrome, CTS
Conditions
Brief summary
Study to compare the safety and effectiveness of carpal tunnel release with ultrasound guidance (CTR-US) vs. mini-open carpal tunnel release (mOCTR) in patients with symptomatic carpal tunnel syndrome (CTS).
Interventions
DEVICECTR with Ultrasound Guidance using the UltraGuideCTR device
Carpal Tunnel Release with Ultrasound Guidance using UltraGuideCTR device
PROCEDUREmOCTR
Mini Open Carpal Tunnel Release
Sponsors
Sonex Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years of age 2. Clinical diagnosis of unilateral or bilateral idiopathic CTS 3. CTS-6 score \>12 in target hand 4. Absence of carpal tunnel symptoms in the contralateral hand that interfere with normal daily activities or work at the time of consent and are not anticipated to interfere with return to activities or return to work within at least 3 months post-operatively 5. Median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region of the target hand measured by diagnostic ultrasound 6. Prior failure of one or more nonsurgical treatment options for the target hand (e.g., physical activity modification, bracing, splinting, corticosteroid injection) 7. Subject agrees to complete follow-up questionnaires over a 12-month period 8. Subject has a valid mobile phone number and email address to receive and answer follow-up questionnaires
Exclusion criteria
1. Prior surgery on the target wrist or hand with the exception of trigger finger that has clinically recovered 2. History of prior surgical CTR procedure in the target hand 3. History of prior surgical CTR in the contralateral hand within 3 months of enrollment or with persistent symptoms that interfere with normal daily activities or work at the time of consent 4. Corticosteroid injection in the target wrist or hand within 6 weeks of study procedure date 5. Presence of additional process in the target wrist or hand requiring additional intervention beyond carpal tunnel release (e.g. neurolysis, mass removal, tenosynovectomy) 6. Clinically significant degenerative arthritis of the upper limb (shoulder to hand) on the target side 7. Clinically significant inflammatory disease (including tenosynovitis) of the upper limb (shoulder to hand) on the target side 8. Clinically significant trauma or deformity of the upper limb (shoulder to hand) on the target side 9. Clinically significant vascular disease (including Raynaud's phenomenon) of the upper limb (shoulder to hand) on the target side 10. Clinically significant neurological disorder (including complex regional pain syndrome) of the upper limb (shoulder to hand) on the target side 11. Planned surgical or interventional procedure on the contralateral wrist or hand 12. Systemic inflammatory disease (e.g., rheumatoid arthritis, lupus) 13. Amyloidosis 14. Chronic renal insufficiency requiring dialysis 15. Diabetes not controlled by a stable dose of medication over the past three months 16. Uncontrolled thyroid disease 17. Pregnant or planning pregnancy in the next 12 months 18. Workers compensation subjects 19. Inability to provide a legally acceptable Informed Consent Form and/or comply with all follow-up requirements 20. Subject has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) Change | 3 Month Follow-Up | 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 scores in BCTQ-SSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased symptom severity and positive change scores indicate increased symptom severity. |
| Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) Change | 3 Month Follow-Up | 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 scores in BCTQ-FSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased functional limitation and positive change scores indicate increased functional limitation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| EuroQol 5-Dimension 5-Level (EQ-5D-5L) Change | 3 Month Follow-Up | 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 scores in the EQ-5D-5L from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased quality of life and positive change scores indicate increased quality of life. |
| Participants With Device or Procedure Related Adverse Events | 3 Month Follow-Up | 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 incidence of device- or procedure-related AEs within 90 days of treatment in each study group will represent an endpoint of the study. |
| Participants Who Returned to Normal Daily Activities Within 3 Days Postoperatively | 3 Month Follow-Up | The 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. |
| Time to Return to Work Among Employed Subjects | 3 Month Follow-Up | The 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. |
| Numeric Pain Scale Change | 3 Month Follow-Up | 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 to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased pain severity and positive change scores indicate increased pain severity. |
Countries
United States
Participant flow
Recruitment details
Enrollment in the TUTOR study began on August 8, 2022, and 122 subjects were enrolled. Enrollment was completed on February 2, 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 (CTR) via their assigned treatment method.
Pre-assignment details
No pre-assignments for this study
Participants by arm
| Arm | Count |
|---|---|
| Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device Participants who were randomized to and treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the TUTOR Study. | 94 |
| Mini Open Carpal Tunnel Release (mOCTR) Participants who were randomized to and treated using the Mini Open Carpal Tunnel Release (mOCTR) procedure in the TUTOR Study. | 28 |
| Total | 122 |
Baseline characteristics
| Characteristic | Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device | Mini Open Carpal Tunnel Release (mOCTR) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 34 Participants | 9 Participants | 43 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 19 Participants | 79 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 14 | 57 years STANDARD_DEVIATION 14 | 57 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 1 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants | 27 Participants | 111 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 86 Participants | 25 Participants | 111 Participants |
| Sex: Female, Male Female | 60 Participants | 21 Participants | 81 Participants |
| Sex: Female, Male Male | 34 Participants | 7 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 94 | 0 / 28 |
| other Total, other adverse events | 1 / 94 | 1 / 28 |
| serious Total, serious adverse events | 1 / 94 | 0 / 28 |
Outcome results
Primary
Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) Change
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 scores in BCTQ-FSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased functional limitation and positive change scores indicate increased functional limitation.
Time frame: 3 Month Follow-Up
Population: Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) change at 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device | Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) Change | -0.8 units on a scale |
| Mini Open Carpal Tunnel Release (mOCTR) | Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) Change | -0.8 units on a scale |
p-value: 0.9295% CI: [-0.2, 0.23]Mixed Models Analysis
Primary
Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) Change
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 scores in BCTQ-SSS from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased symptom severity and positive change scores indicate increased symptom severity.
Time frame: 3 Month Follow-Up
Population: Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) change at 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device | Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) Change | -1.5 units on a scale |
| Mini Open Carpal Tunnel Release (mOCTR) | Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) Change | -1.5 units on a scale |
p-value: 0.4695% CI: [-0.13, 0.29]Mixed Models Analysis
Other Pre-specified
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Change
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 scores in the EQ-5D-5L from baseline to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased quality of life and positive change scores indicate increased quality of life.
Time frame: 3 Month Follow-Up
Population: EuroQol 5-Dimension 5-Level (EQ-5D-5L) change at 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device | EuroQol 5-Dimension 5-Level (EQ-5D-5L) Change | 0.11 units on a scale |
| Mini Open Carpal Tunnel Release (mOCTR) | EuroQol 5-Dimension 5-Level (EQ-5D-5L) Change | 0.12 units on a scale |
p-value: 0.995% CI: [-0.06, 0.05]Mixed Models Analysis
Other Pre-specified
Numeric Pain Scale Change
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 to the 3-month follow-up are reported for each study group. Negative change scores indicate decreased pain severity and positive change scores indicate increased pain severity.
Time frame: 3 Month Follow-Up
Population: Numeric Pain Scale change at 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device | Numeric Pain Scale Change | -3.2 Unit |
| Mini Open Carpal Tunnel Release (mOCTR) | Numeric Pain Scale Change | -3.8 Unit |
p-value: 0.0995% CI: [-0.08, 1.3]Mixed Models Analysis
Other Pre-specified
Participants Who Returned to Normal Daily Activities Within 3 Days Postoperatively
The 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.
Time frame: 3 Month Follow-Up
Population: Participants who returned to normal daily activities within 3 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device | Participants Who Returned to Normal Daily Activities Within 3 Days Postoperatively | 55 Participants |
| Mini Open Carpal Tunnel Release (mOCTR) | Participants Who Returned to Normal Daily Activities Within 3 Days Postoperatively | 20 Participants |
Other Pre-specified
Participants With Device or Procedure Related 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 incidence of device- or procedure-related AEs within 90 days of treatment in each study group will represent an endpoint of the study.
Time frame: 3 Month Follow-Up
Population: Participants with Procedure and/or Device-Related Adjudicated Adverse Events
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device | Participants With Device or Procedure Related Adverse Events | 2 Participants |
| Mini Open Carpal Tunnel Release (mOCTR) | Participants With Device or Procedure Related Adverse Events | 1 Participants |
Other Pre-specified
Time to Return to Work Among Employed Subjects
The 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.
Time frame: 3 Month Follow-Up
Population: Time to return to work in days among employed subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carpal Tunnel Release With Ultrasound Guidance Using the UltraGuideCTR Device | Time to Return to Work Among Employed Subjects | 3.0 Days |
| Mini Open Carpal Tunnel Release (mOCTR) | Time to Return to Work Among Employed Subjects | 4.0 Days |