Carpal Tunnel Syndrome Clinical Trial
Official title:
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.
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.
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