The primary objective is to determine the efficacy of Lidocaine Patch 1.8% in reducing the severity of symptoms in participants with moderate-to-severe pain from Carpal Tunnel Syndrome.
This is a prospective, randomized, double-blind, cross-over study. Following informed consent, participants fulfilling entry criteria will be randomly assigned into one of two treatment cohorts. Cohort 1 will be treated with active lidocaine study patch for 1 week following FDA approved dosing recommendations, i.e. 12 hours during each 24-hour daily cycle. Following a 1-week washout period, provided participants continue to meet criteria to proceed, they will then be treated with a placebo topical patch for 1 week. A final visit after another 1-week washout period will complete the study. Participants assigned to the Cohort 2 will be evaluated in the same way except they will enter the placebo arm first and then, after 1-week washout, they will enter the active treatment arm, provided to continue to meet criteria to proceed. For all measures, participants will serve as their own matched control. Comparisons will be made between significant improvements on active versus placebo treatment arms. The first two-week treatment period is Arm 1; the second two-week period is considered the cross-over arm. Participants failing treatment will be offered standard of care treatment of steroid injection. All participants will wear a brace for the duration of the study per standard clinical practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
45
Topical Patch
Matching Placebo Patch
Michigan Orthopaedic & Spine Surgeons
Rochester Hills, Michigan, United States
Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ): minimally clinically important difference
The minimum score is 11 indicating low symptom severity and the maximum score is 55 which would indicate high symptom severity.
Time frame: After 1 Week of Treatment
Functional Status Score (FSS) of the Boston Carpal Tunnel Questionnaire (BCTQ):minimally clinically important difference
The minimum score is 8 indicating low symptom severity and the maximum score is 40 which would indicate high symptom severity.
Time frame: After 1 Week of Treatment
Sensory examination
Clinical sensory neurological examination will assess for response to light touch, pinprick, and vibration.
Time frame: After 1 Week of Treatment
Pain Detect Questionnaire
The Pain DETECT questionnaire screens for components of neuropathic pain: intensity, pattern and quality.
Time frame: After 1 Week of Treatment
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