Recruiting
Early Phase 1

Perineural Hydrodissection

Sponsor:

Leslie Witton

Code:

NCT03616353

Conditions

Carpal Tunnel Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Perineural Hydrodissection

Corticosteroid Injection

Study Details

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.

Conditions

Carpal Tunnel Syndrome

Study ID

NCT03616353

Start date

Oct 15, 2018

Status verified date

Aug, 2019

Completion date

Jun 30, 2020

Anticipated

Primary completion date

Jun 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1: Corticosteroid Injection

Patients in this group will undergo an injection of corticosteroid into the carpal tunnel as per current treatment practices.

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.

Interventions

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.

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.

Primary outcome measure

  • Change in Boston Carpal Tunnel Questionnaire (BCTQ) [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1 year ]

Central Contacts and Locations

Central contacts

Leslie A Witton, MD

905-521-2100leslie.witton@medportal.ca

Meg M Chiavaras, MD

905-521-2100meg.chiavaras@gmail.com

Locations

Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8L 2x2

Contacts

Meg Chiavaras, MD PhD

meg.chiavaras@gmail.com

Leslie Witton, MD

leslie.witton@medportal.ca

More Information

Sponsor

Leslie Witton

Last update posted

Aug 9, 2019

Last verified

Aug, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Leslie Witton on 2019-08-09.