IMpact of Perineural Hydrodissection Over Alternative Therapies in Patients With Carpal Tunnel Syndrome
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Carpal Tunnel Syndrome
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: RandomizedIntervention Model: Single Group AssignmentMasking: 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
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT03616353
- Collaborators
- Not Provided
- Investigators
- Not Provided