An Early Phase 1 interventional study of Perineural Hydrodissection and Corticosteroid Injection in Carpal Tunnel Syndrome, sponsored by Leslie Witton. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-09.
Sponsored by Leslie Witton · Early Phase 1, Interventional, and Treatment
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.
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.
605 studies on the registry are indexed under Carpal Tunnel Syndrome; 138 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 457 interventional studies indexed under Carpal Tunnel Syndrome.
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Exclusion Criteria:
Patients in this group will undergo an injection of corticosteroid into the carpal tunnel as per current treatment practices.
Procedure: Corticosteroid Injection
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.
Also known as: PNH
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.
Also known as: Steroid
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.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year
Plan to share: No
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