Back to resultsClinical Outcomes of USCTR vs. mOCTR
Primary Purpose
Carpal Tunnel
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
USCTR
mOCTR
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel focused on measuring Median Nerve Neuropathy Treatments, Ultrasound Guided Carpal Tunnel Release (USCTR), Military, Minimally Invasive Carpal Tunnel Release
Eligibility Criteria
Inclusion Criteria:
- Adults age ≥18 years
- DEERS Eligible
- Fluent in speaking, reading, and understanding English
- Clinical diagnosis of Carpal Tunnel Syndrome (CTS)
- Candidate for surgical CTR based on severe and/or refractory symptoms
- Confirmatory electrodiagnostic test indicating median neuropathy at the wrist (abnormal findings)
- Ultrasound findings consistent with median nerve enlargement in the carpal tunnel
Exclusion Criteria:
- Previous carpal tunnel release or previous wrist surgery on the ipsilateral side
- Carpal tunnel injection with corticosteroid within 6 weeks prior to anticipated study procedure
- Previous traumatic injury to the median nerve or any of its branches on the ipsilateral side
- History of medical condition that would preclude safe participation in study procedures (e. g. complex regional pain syndrome (CRPS), upper limb vascular disease (including thoracic outlet syndrome), Raynaud's phenomenon, etc.)
- Inability to stop anticoagulation medications (Plavix, Coumadin/Warfarin, Xarelto), or unable to be bridged with Lovenox
- Unable to understand and provide written informed consent
- Contraindication to proceeding with USCTR based on diagnostic ultrasound (i.e. identification of anomalous anatomic structures such as bifid median nerve or space occupying lesions within the carpal tunnel)
- Electrodiagnostic evaluation of the carpal tunnel which indicates normal findings
Sites / Locations
- Walter Reed National Military Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
USCTR Procedure
mOCTR Procedure
Arm Description
Participants will undergo the USCTR procedure with SX-One MicroKnife®
Participants will undergo the traditional mOCTR procedure.
Outcomes
Primary Outcome Measures
Measure the effect of USCTR vs mOCTR on the longitudinal change in QuickDASH.
QuickDash is a region-specific PROM consisting of 11 items measuring the difficulty in performing physical activities relevant to shoulder, arm or hand function. Each item is scored on a scale of 1-5 and a final score of 0 to 100 is calculated, with higher scores representing greater degrees of upper extremity disability (0 points indicate no disability and 100 points indicates maximum disability).
Measure the effect of USCTR vs mOCTR on the longitudinal change in BCTQ-S.
The BCTQ is a PROM for CTS and is the most commonly used outcome measure for CTS. Each item on the 11-item symptom severity scale (BCTQ-S) is graded from 1 (mildest) to 5 (most severe). Outcomes are typically recorded as a mean score.
Measure the effect of USCTR vs mOCTR on the longitudinal change in hand pinch and grip strength.
Manually tested using a dynamometer.
Measure the impact of USCTR vs mOCTR on participant perception of change in overall physical condition
Participant self reported change in physical condition. Participant will select one response from the following descriptions to rate overall condition from the time they began treatment to the designated time-point: A very great deal worse; About the same; A very great deal better; A great deal worse; A great deal better; Quite a bit worse; Quite a bit better; Moderately worse; Moderately better; Somewhat worse; Somewhat better; A little bit worse; A little bit better; A tiny bit worse(almost the same); A tiny bit better (almost the same)
Change in military work status as assessed using single-item self-report assessment
Participants will complete a questionnaire to depict when normal work or daily activities commenced.
Surgical time during procedure (minutes)
On the day the participant receives their study assigned procedure (USCTR vs. mOCTR), clinical team will record surgical time to perform the procedure in minutes
Change in self-reported satisfaction as assessed using a satisfaction rating scale
Participants will rate satisfaction with the following: completely dissatisfied, mostly dissatisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat satisfied, mostly satisfied, or completely satisfied.
Completely dissatisfied with represent the lowest score, and completely satisfied will represent the highest score.
Change in self-reported pain as assessed using the 11-item Pain Numeric Rating Scale (NRS) participant pain levels over 1 month following the CTR procedure.
The 11-item NRS scale is a unidimensional measure of pain intensity. It is a segmented numeric version of the visual analog scale in which participants will select a whole number (0-10 integers) that best reflects the intensity of their pain. The scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. worst possible pain).
Change in pain medication usage as assessed using single-item self-report assessment
Participant self-reported pain medication usage. Participant will respond with responses ranging from "less than once a week', "once a week", "several times a week", "daily", "multiple times per day", "or did not use". "Did not use" will represent the minimum value, and "multiple times per day" will represent the maximum value.
Incision length in cm
On the day the participant receives their study assigned procedure (USCTR vs. mOCTR), clinical team will record incision length in cm
Change in self-reported pain as assessed using the 11-item Pain Numeric Rating Scale (NRS)
Using the 11-item Pain Numeric Rating Scale (NRS), compare the distributions of participant self-reported pain at both pre- and immediately -post CTR procedure between the USCTR and mOCTR groups.
The 11-item NRS scale is a unidimensional measure of pain intensity. It is a segmented numeric version of the visual analog scale in which participants will select a whole number (0-10 integers) that best reflects the intensity of their pain. The scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. worst possible pain).
Change in self-reported pain as assessed using the 4-item CTS Palmar Pain Scale over 1 month following CTR procedure
The 4-item Carpal Tunnel Syndrome Palmer and Incision Pain questionnaire inquiries about severity of pain. Each item has five-six possible response options which range from 1 (no pain) to 5/6 (very severe). The symptom score is the mean of all answered items; higher scores indicate worse symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT04504019
First Posted
June 22, 2020
Last Updated
May 18, 2021
Sponsor
Walter Reed National Military Medical Center
Collaborators
Uniformed Services University of the Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04504019
Brief Title
Clinical Outcomes of USCTR vs. mOCTR
Official Title
Clinical Outcomes of Carpal Tunnel Release With and Without Ultrasound Guidance
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Walter Reed National Military Medical Center
Collaborators
Uniformed Services University of the Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy and affects 3-6% of adults in the United States. In patients with severe or refractory symptoms, carpal tunnel release (CTR) represents the definitive management option, and over 550,000 CTRs are performed annually in the United States with over 90% of patients reporting clinical improvement. Currently available CTR techniques include mini-open CTR via a single, 1-3 cm palmar incision (mOCTR), endoscopic CTR via one (wrist) or two (wrist and palm) 1-2 cm incisions (ECTR), and ultrasound guided CTR via a single < 1 cm wrist or palmar incision (USCTR). The primary objective is to assess the impact of USCTR vs mOCTR in a military population. This study is a multi-site prospective randomized comparative trial.
Participants with CTS will be randomized to a study arm and receive treatment with ultrasound guided carpal tunnel release (USCTR) vs. traditional mini-open carpal tunnel release (mOCTR). All patients will be followed for a period of 24 months with respect to standard clinical data, military relevant data, and validated patient related outcome measures (PROMs). Data will be collected at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, and 12 months, and 24 months post-CTR procedure.
Investigators hypothesize that USCTR using the SX-One MicroKnife® will safely and more-effectively improve symptoms of carpal tunnel syndrome compared to traditional mOCTR, with less loss of military duty days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel
Keywords
Median Nerve Neuropathy Treatments, Ultrasound Guided Carpal Tunnel Release (USCTR), Military, Minimally Invasive Carpal Tunnel Release
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
510 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
USCTR Procedure
Arm Type
Experimental
Arm Description
Participants will undergo the USCTR procedure with SX-One MicroKnife®
Arm Title
mOCTR Procedure
Arm Type
Active Comparator
Arm Description
Participants will undergo the traditional mOCTR procedure.
Intervention Type
Device
Intervention Name(s)
USCTR
Intervention Description
Ultrasound guided CTR via a single < 1 cm wrist or palmar incision. The procedure will be performed using the SX-One MicroKnife®
Intervention Type
Procedure
Intervention Name(s)
mOCTR
Intervention Description
Mini-open CTR via a single 1-3cm palmar incision
Primary Outcome Measure Information:
Title
Measure the effect of USCTR vs mOCTR on the longitudinal change in QuickDASH.
Description
QuickDash is a region-specific PROM consisting of 11 items measuring the difficulty in performing physical activities relevant to shoulder, arm or hand function. Each item is scored on a scale of 1-5 and a final score of 0 to 100 is calculated, with higher scores representing greater degrees of upper extremity disability (0 points indicate no disability and 100 points indicates maximum disability).
Time Frame
Change from baseline to 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
Title
Measure the effect of USCTR vs mOCTR on the longitudinal change in BCTQ-S.
Description
The BCTQ is a PROM for CTS and is the most commonly used outcome measure for CTS. Each item on the 11-item symptom severity scale (BCTQ-S) is graded from 1 (mildest) to 5 (most severe). Outcomes are typically recorded as a mean score.
Time Frame
Change from baseline to 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
Title
Measure the effect of USCTR vs mOCTR on the longitudinal change in hand pinch and grip strength.
Description
Manually tested using a dynamometer.
Time Frame
Change from baseline to 3 months, and 12 months post CTR procedure
Title
Measure the impact of USCTR vs mOCTR on participant perception of change in overall physical condition
Description
Participant self reported change in physical condition. Participant will select one response from the following descriptions to rate overall condition from the time they began treatment to the designated time-point: A very great deal worse; About the same; A very great deal better; A great deal worse; A great deal better; Quite a bit worse; Quite a bit better; Moderately worse; Moderately better; Somewhat worse; Somewhat better; A little bit worse; A little bit better; A tiny bit worse(almost the same); A tiny bit better (almost the same)
Time Frame
Change from 1 week to 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
Title
Change in military work status as assessed using single-item self-report assessment
Description
Participants will complete a questionnaire to depict when normal work or daily activities commenced.
Time Frame
Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
Title
Surgical time during procedure (minutes)
Description
On the day the participant receives their study assigned procedure (USCTR vs. mOCTR), clinical team will record surgical time to perform the procedure in minutes
Time Frame
At time of procedure, measured as day 0
Title
Change in self-reported satisfaction as assessed using a satisfaction rating scale
Description
Participants will rate satisfaction with the following: completely dissatisfied, mostly dissatisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat satisfied, mostly satisfied, or completely satisfied.
Completely dissatisfied with represent the lowest score, and completely satisfied will represent the highest score.
Time Frame
Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
Title
Change in self-reported pain as assessed using the 11-item Pain Numeric Rating Scale (NRS) participant pain levels over 1 month following the CTR procedure.
Description
The 11-item NRS scale is a unidimensional measure of pain intensity. It is a segmented numeric version of the visual analog scale in which participants will select a whole number (0-10 integers) that best reflects the intensity of their pain. The scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. worst possible pain).
Time Frame
Captured at 1 week, 2 weeks, 3 weeks, and 1 month post CTR procedure
Title
Change in pain medication usage as assessed using single-item self-report assessment
Description
Participant self-reported pain medication usage. Participant will respond with responses ranging from "less than once a week', "once a week", "several times a week", "daily", "multiple times per day", "or did not use". "Did not use" will represent the minimum value, and "multiple times per day" will represent the maximum value.
Time Frame
Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
Title
Incision length in cm
Description
On the day the participant receives their study assigned procedure (USCTR vs. mOCTR), clinical team will record incision length in cm
Time Frame
At time of procedure, measured as day 0
Title
Change in self-reported pain as assessed using the 11-item Pain Numeric Rating Scale (NRS)
Description
Using the 11-item Pain Numeric Rating Scale (NRS), compare the distributions of participant self-reported pain at both pre- and immediately -post CTR procedure between the USCTR and mOCTR groups.
The 11-item NRS scale is a unidimensional measure of pain intensity. It is a segmented numeric version of the visual analog scale in which participants will select a whole number (0-10 integers) that best reflects the intensity of their pain. The scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. worst possible pain).
Time Frame
At time of procedure, measured as day 0
Title
Change in self-reported pain as assessed using the 4-item CTS Palmar Pain Scale over 1 month following CTR procedure
Description
The 4-item Carpal Tunnel Syndrome Palmer and Incision Pain questionnaire inquiries about severity of pain. Each item has five-six possible response options which range from 1 (no pain) to 5/6 (very severe). The symptom score is the mean of all answered items; higher scores indicate worse symptoms
Time Frame
Captured at 1 week, 2 weeks, 3 weeks, and 1 month post CTR procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults age ≥18 years
DEERS Eligible
Fluent in speaking, reading, and understanding English
Clinical diagnosis of Carpal Tunnel Syndrome (CTS)
Candidate for surgical CTR based on severe and/or refractory symptoms
Confirmatory electrodiagnostic test indicating median neuropathy at the wrist (abnormal findings)
Ultrasound findings consistent with median nerve enlargement in the carpal tunnel
Exclusion Criteria:
Previous carpal tunnel release or previous wrist surgery on the ipsilateral side
Carpal tunnel injection with corticosteroid within 6 weeks prior to anticipated study procedure
Previous traumatic injury to the median nerve or any of its branches on the ipsilateral side
History of medical condition that would preclude safe participation in study procedures (e. g. complex regional pain syndrome (CRPS), upper limb vascular disease (including thoracic outlet syndrome), Raynaud's phenomenon, etc.)
Inability to stop anticoagulation medications (Plavix, Coumadin/Warfarin, Xarelto), or unable to be bridged with Lovenox
Unable to understand and provide written informed consent
Contraindication to proceeding with USCTR based on diagnostic ultrasound (i.e. identification of anomalous anatomic structures such as bifid median nerve or space occupying lesions within the carpal tunnel)
Electrodiagnostic evaluation of the carpal tunnel which indicates normal findings
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Miller, MD
Phone
301-295-7752
Email
matthew.e.miller78.mil@mail.mil
First Name & Middle Initial & Last Name or Official Title & Degree
Whitley Lucio
Email
whitley.lucio.ctr@usuhs.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Miller, MD
Organizational Affiliation
Walter Reed National Military Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Miller
Email
matthew.e.miller78.mil@mail.mil
First Name & Middle Initial & Last Name & Degree
Matthew Miller, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Outcomes of USCTR vs. mOCTR
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