IMpact of Perineural Hydrodissection Over Alternative Therapies in Patients With Carpal Tunnel Syndrome
IMPACTS
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2017
CompletedFirst Posted
Study publicly available on registry
August 6, 2018
CompletedStudy Start
First participant enrolled
October 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedAugust 9, 2019
August 1, 2019
1.7 years
July 31, 2017
August 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Boston Carpal Tunnel Questionnaire (BCTQ)
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.
Baseline, 6 weeks, 3 months, 6 months, 1 year
Secondary Outcomes (6)
Change in Ultrasonographic Measurement
Baseline, 6 weeks, 6 months, 1 year
Change in Electromyographic Measurement- Amplitude
Baseline, 6 months, 1 year
Change in Electromyographic Measurement- Motor Conduction Velocity
Baseline, 6 months, 1 year
Change in Electromyographic Measurement- Sensory Conduction Velocity
Baseline, 6 months, 1 year
Change in Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Baseline, 6 weeks, 3 months, 6 months, 1 year
- +1 more secondary outcomes
Study Arms (2)
Group 1: Corticosteroid Injection
EXPERIMENTALPatients in this group will undergo an injection of corticosteroid into the carpal tunnel as per current treatment practices.
Group 2: Perineural Hydrodissection
EXPERIMENTALPatients in this group will undergo a perineural hydrodissection plus an injection of corticosteroid into the carpal tunnel, as a novel technique.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Adult men or women aged 18 years or greater.
- Clinical and electromyographic diagnosis of Carpal Tunnel Syndrome.
- Persistent symptoms from Carpal Tunnel Syndrome after at least three months of appropriate splinting.
- Ability to consent for study.
You may not qualify if:
- Acute symptom onset (less than 3 months).
- Bifid median nerve
- Anticoagulation with International Normalized Ratio (INR) \> 1.4, or platelets \<150.
- Anomalous muscles (eg. inverted palmaris longus).
- Patients requiring anti-platelet medication for the treatment of heart attack, stroke, or other medical condition.
- Previous surgery for Carpal Tunnel Syndrome.
- Previous local injections, including steroids within the past 6 months.
- Allergy to any of the injection agents.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Leslie Wittonlead
Study Sites (1)
Hamilton Health Sciences
Hamilton, Ontario, L8L 2x2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Neurology Resident
Study Record Dates
First Submitted
July 31, 2017
First Posted
August 6, 2018
Study Start
October 15, 2018
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
August 9, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share