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

NCT ID: NCT03616353

Last Updated: 2019-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-15
• Study Completion Date: 2020-06-30

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1: Corticosteroid Injection

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

Group Type: EXPERIMENTAL

Corticosteroid Injection

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

Perineural Hydrodissection

Intervention Type: PROCEDURE

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.

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

PNH; Steroid

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leslie Witton

OTHER

Sponsor Role: lead

Responsible Party

Leslie Witton

Neurology Resident

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Leslie A Witton, MD

Role: CONTACT

leslie.witton@medportal.ca

905-521-2100 ext. 4750

Meg M Chiavaras, MD

Role: CONTACT

meg.chiavaras@gmail.com

905-521-2100 ext. 46521

Facility Contacts

Meg Chiavaras, MD PhD

Role: primary

meg.chiavaras@gmail.com

Leslie Witton, MD

Role: backup

leslie.witton@medportal.ca

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id