Carpal Tunnel Syndrome
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGLidocaine 1.8%
Topical Patch
DRUGPlacebo
Matching Placebo Patch
Sponsors
Scilex Ltd.
John Papakonstantinou, MD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Double-Blind
Intervention model description
Participants will serve as their own control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants must meet all of the following inclusion criteria to be eligible for enrollment into the study: * Male and female participants, 18 years or older at Screening; * Participants with Carpal Tunnel Syndrome, confirmed by CT6; * Pain score of at least 4, based on an 11-point numeric rating scale (NRS) (scale of 0-10), at the screening (baseline) visit; * Able and willing to provide a written informed consent; * Able and willing to follow study instructions; * Able and willing to return to clinic for follow-up visits; * Able and willing to complete a daily diary; * Intact skin over the affected wrist; * Woman of childbearing age agreeing to use 2 forms of contraception.
Exclusion criteria
Participants presenting with any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ): minimally clinically important difference | After 1 Week of Treatment | The minimum score is 11 indicating low symptom severity and the maximum score is 55 which would indicate high symptom severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Status Score (FSS) of the Boston Carpal Tunnel Questionnaire (BCTQ):minimally clinically important difference | After 1 Week of Treatment | The minimum score is 8 indicating low symptom severity and the maximum score is 40 which would indicate high symptom severity. |
| Sensory examination | After 1 Week of Treatment | Clinical sensory neurological examination will assess for response to light touch, pinprick, and vibration. |
| Pain Detect Questionnaire | After 1 Week of Treatment | The Pain DETECT questionnaire screens for components of neuropathic pain: intensity, pattern and quality. |
Countries
United States
Outcome results
None listed