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IMpact of Perineural Hydrodissection Over Alternative Therapies in Patients With Carpal Tunnel Syndrome (IMPACTS)

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ClinicalTrials.gov Identifier: NCT03616353
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Leslie Witton, Hamilton Health Sciences Corporation

Tracking Information
First Submitted Date  ICMJE July 31, 2017
First Posted Date  ICMJE August 6, 2018
Last Update Posted Date August 9, 2019
Actual Study Start Date  ICMJE October 15, 2018
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2018)
Change in Boston Carpal Tunnel Questionnaire (BCTQ) [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1 year ]
The BCTQ is a five-point rating scale with 19 items. The overall score is the average score across all items. The score will be recorded for each visit and change in score will be plotted over time.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03616353 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2018)
  • Change in Ultrasonographic Measurement [ Time Frame: Baseline, 6 weeks, 6 months, 1 year ]
    Cross-sectional index (CSI) of the median nerve as measured by ultrasound. The CSI will be recorded for each visit and change will be plotted over time.
  • Change in Electromyographic Measurement- Amplitude [ Time Frame: Baseline, 6 months, 1 year ]
    Amplitudes will be recorded for each visit and change in these values will be plotted over time.
  • Change in Electromyographic Measurement- Motor Conduction Velocity [ Time Frame: Baseline, 6 months, 1 year ]
    Motor conduction velocities will be recordedfor each visit and change in these values will be plotted over time.
  • Change in Electromyographic Measurement- Sensory Conduction Velocity [ Time Frame: Baseline, 6 months, 1 year ]
    Sensory conduction velocities will be recordedfor each visit and change in these values will be plotted over time.
  • Change in Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1 year ]
    The DASH is a 30-item measure using five-point Likert scales assessing aspects of physical functioning and symptoms, intended specifically to measure disability. Its overall score is between 0 and 100. The score will be recorded for each visit and change in score will be plotted over time.
  • Change in Visual Analog Scale (VAS) for Pain [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1 year ]
    The VAS is a commonly used, subjective scale in which the patient rates their pain on a scale ranging from 0 to 10 (0, no pain; 10, maximum pain possible). The score will be recorded for each visit and change will be plotted over time.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IMpact of Perineural Hydrodissection Over Alternative Therapies in Patients With Carpal Tunnel Syndrome
Official Title  ICMJE IMpact of Perineural Hydrodissection Over Alternative Therapies in Patients With Carpal Tunnel Syndrome (IMPACTS): A Single-Centre, Randomized Trial Comparing Perineural Hydrodissection of the Median Nerve Versus Steroid Injection in Patients With Carpal Tunnel Syndrome
Brief Summary This is a multidisciplinary, single-blinded, three-arm randomized controlled trial, comparing perineural hydrodissection and steroid injection for the treatment of CTS. Patients are screened based on pre-established eligibility criteria and randomized to one of the three study groups. Patients are followed at 6-week, 3-month, 6-month, and 12-month time points to assess the primary and secondary outcomes of the study, which include both patient-reported outcome measures and objective clinical assessments.
Detailed Description

This study aims to examine the effect of perineural hydrodissection (PNH), a novel treatment for CTS. PNH is a minimally invasive, ultrasound-guided, percutaneous technique in which the median nerve is released by injecting fluid (local anesthetic and corticosteroid) circumferentially, using larger fluid volumes and higher pressure to target areas of adhesion between the median nerve and its surrounding structures. In chronic CTS, a rind of perineural fibrosis develops, tethering the median nerve to the overlying flexor retinaculum and to the adjacent flexor tendons. Theoretically, the removal of tethering to adjacent structures, via perineural hydrodissection, should allow circumferential bathing of the median nerve with the local anesthetic and corticosteroid, thus reducing inflammation and prolonging symptom relief.

The primary outcome is pain as measured by the Boston Carpal Tunnel Questionnaire (BCTQ). Secondary outcomes include health-related quality of life measures using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire and the Visual Analog Scale (VAS) for pain.

The selected questionnaires have been shown to correlate well with domains of the International Classification of Functioning, Disability, and Health (ICF) (3). Other secondary measures include the ultrasound appearance (cross-sectional index) of the median nerve, and electromyography (EMG) measurements (including sensory and motor conduction velocities, and amplitudes), before and after the injection.

The study hypothesis is that PNH will show greater benefits in terms of pain, function, and patient quality of life when compared to corticosteroid injection in patients with CTS. The null hypothesis is that there is no difference. The study is powered to address the primary outcome and will also be powered to identify minimally important differences in functional, sonographic, and electromyographic outcomes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Care provider is performing a specific type of injection and therefore cannot be blinded. Those investigators responsible for collecting, managing, and analyzing data will be blinded to treatment randomization.
Primary Purpose: Treatment
Condition  ICMJE Carpal Tunnel Syndrome
Intervention  ICMJE
  • Procedure: Perineural Hydrodissection
    The subcutaneous tissues of the ulnar aspect of the wrist at the level of the carpal tunnel will be infiltrated with 2 ml of lidocaine 1% for local anesthetic. Using ultrasound guidance and aseptic technique, the needle will then be angled deep to the median nerve within the carpal tunnel, and 5 ml of a 50%/50% mixture of lidocaine 1% and sensorcaine 0.5% will be injected under pressure. While continuing to use ultrasound guidance and aseptic technique, the needle will then be angled superficial to the median nerve within the carpal tunnel, and 5 ml of a 50%/50% mixture of lidocaine 1% and sensorcaine 0.5% will be injected under pressure. The needle will be returned to its original angle deep to the median nerve, and the syringe will be changed to inject 40 mg Depo-Medrol in 1ml of saline.
    Other Name: PNH
  • Procedure: Corticosteroid Injection
    The subcutaneous soft tissues of the ulnar aspect of the wrist at the level of the carpal tunnel will be infiltrated with 2 ml of lidocaine 1% for local anesthetic. Using ultrasound guidance and aseptic technique, the needle will then be angled deep to the median nerve within the carpal tunnel, and 40 mg Depo-Medrol in 1ml of saline will be injected into the area deep to the median nerve.
    Other Name: Steroid
Study Arms  ICMJE
  • Experimental: Group 1: Corticosteroid Injection
    Patients in this group will undergo an injection of corticosteroid into the carpal tunnel as per current treatment practices.
    Intervention: Procedure: Corticosteroid Injection
  • Experimental: Group 2: Perineural Hydrodissection
    Patients in this group will undergo a perineural hydrodissection plus an injection of corticosteroid into the carpal tunnel, as a novel technique.
    Intervention: Procedure: Perineural Hydrodissection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 31, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adult men or women aged 18 years or greater.
  2. Clinical and electromyographic diagnosis of Carpal Tunnel Syndrome.
  3. Persistent symptoms from Carpal Tunnel Syndrome after at least three months of appropriate splinting.
  4. Ability to consent for study.

Exclusion Criteria:

  1. Acute symptom onset (less than 3 months).
  2. Bifid median nerve
  3. Anticoagulation with International Normalized Ratio (INR) > 1.4, or platelets <150.
  4. Anomalous muscles (eg. inverted palmaris longus).
  5. Patients requiring anti-platelet medication for the treatment of heart attack, stroke, or other medical condition.
  6. Previous surgery for Carpal Tunnel Syndrome.
  7. Previous local injections, including steroids within the past 6 months.
  8. Allergy to any of the injection agents.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Leslie A Witton, MD 905-521-2100 ext 4750 leslie.witton@medportal.ca
Contact: Meg M Chiavaras, MD 905-521-2100 ext 46521 meg.chiavaras@gmail.com
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03616353
Other Study ID Numbers  ICMJE 1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Leslie Witton, Hamilton Health Sciences Corporation
Study Sponsor  ICMJE Leslie Witton
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hamilton Health Sciences Corporation
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP