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

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

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.

Study Overview

• Status: Unknown
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Procedure: Corticosteroid Injection; Procedure: Perineural Hydrodissection

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: Interventional
• Enrollment (Anticipated): 60
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Leslie A Witton, MD; Phone Number: 4750 905-521-2100; Email: leslie.witton@medportal.ca
• Study Contact Backup: Name: Meg M Chiavaras, MD; Phone Number: 46521 905-521-2100; Email: meg.chiavaras@gmail.com

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Recruiting
      • Hamilton Health Sciences
      • Contact: Meg Chiavaras, MD PhD; Email: meg.chiavaras@gmail.com
      • Contact: Leslie Witton, MD; Email: leslie.witton@medportal.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Corticosteroid Injection; Patients in this group will undergo an injection of corticosteroid into the carpal tunnel as per current treatment practices.	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 Names: Steroid
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.	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 Names: PNH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ultrasonographic Measurement	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.	Baseline, 6 weeks, 6 months, 1 year
Change in Electromyographic Measurement- Amplitude	Amplitudes will be recorded for each visit and change in these values will be plotted over time.	Baseline, 6 months, 1 year
Change in Electromyographic Measurement- Motor Conduction Velocity	Motor conduction velocities will be recordedfor each visit and change in these values will be plotted over time.	Baseline, 6 months, 1 year
Change in Electromyographic Measurement- Sensory Conduction Velocity	Sensory conduction velocities will be recordedfor each visit and change in these values will be plotted over time.	Baseline, 6 months, 1 year
Change in Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire	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.	Baseline, 6 weeks, 3 months, 6 months, 1 year
Change in Visual Analog Scale (VAS) for Pain	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.	Baseline, 6 weeks, 3 months, 6 months, 1 year

Collaborators and Investigators

• Sponsor: Leslie Witton

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 7, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No