Lidocaine Patch 1.8% for Moderate to Severe Pain From Carpal Tunnel Syndrome (CTS)

A Prospective, Randomized, Double-Blind, Cross-over Study of Lidocaine Patch 1.8% in Patients With Moderate to Severe Pain From Carpal Tunnel Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Drug: Lidocaine 1.8%; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Rochester Hills, Michigan, United States, 48307
      • Michigan Orthopaedic & Spine Surgeons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 exclusion criteria will not be enrolled into the study

• Participants must NOT have had prior steroid injection for CTS, CTS surgery, or other intervention/injury to the wrist that might interfere with assessments in the previous 30 days;
• Participants must not have pain at other sites that interfere with their ability to report site-specific pain related to the study (bilateral CT is an exclusion);
• Participants must NOT have cognitive or psychological impairment that interferes with the ability to complete study related assessments;
• Participants with mild (NRS less than 4) or no pain (only numbness) at baseline prior to randomization;
• Opioid tolerance (receiving at least 1 week of oral morphine 60 mg/day OR transdermal fentanyl 25 mcg/hour OR oral oxycodone 30 mg/day OR oral hydromorphone 8 mg/day OR an equianalgesic dose of any other opioid);
• History of sensitivity or allergy to lidocaine or ZTLIDO;
• Irritated, abraded, or otherwise non-intact skin over the affected wrist;
• Concurrently taking tocainide, mexiletine, or local anesthetics;
• Participants with history of or at significant risk for methemoglobinemia;
• Participation in another study of investigational drugs or devices within 30 days before screening, or previous participation in a Lidocaine Patch study;
• Known to or suspected of not being able to comply with the study protocol;
• Any clinically significant condition that would, in the investigator's opinion, preclude study participation for instance alcohol, medication or drug dependency, neurotic personality, psychiatric illness, epilepsy or suicide risk;
• Pregnancy or nursing mother;
• Woman in childbearing age without satisfactory contraception;
• Presence of possible other cause/s for hand pain (i.e., radicular pain, arthritis, injury, surgery) that could confound assessment or self-evaluation of the pain due to Carpal Tunnel Syndrome;
• Participants using topically applied analgesic compounds on the affected area;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; Lidocaine Patch 1.8% applied to affected hand at night for 2 weeks following FDA approved dosing recommendations, i.e. 12 hours during each 24-hour daily cycle.	Drug: Lidocaine 1.8%; Topical Patch
Placebo Comparator: Placebo; Placebo Patch applied to affected hand at night for 2 weeks for 12 hours during each 24-hour daily cycle.	Drug: Placebo; Matching Placebo Patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After 1 Week of Treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After 1 Week of Treatment
Sensory examination	Clinical sensory neurological examination will assess for response to light touch, pinprick, and vibration.	After 1 Week of Treatment
Pain Detect Questionnaire	The Pain DETECT questionnaire screens for components of neuropathic pain: intensity, pattern and quality.	After 1 Week of Treatment

Collaborators and Investigators

• Sponsor: John Papakonstantinou, MD
• Collaborators: Scilex Ltd.
• Investigators: Principal Investigator: John Papakonstantinou, MD, Michigan Orthopaedic & Spine Surgeons

Publications and helpful links

General Publications

• Chung SY, Kwak JM, Kang S, Son SH, Kim JD, Yoon JS. Predictive Variables for Sonographically Guided Corticosteroid Injection in Mild-to-Moderate Carpal Tunnel Syndrome. Ann Rehabil Med. 2018 Apr;42(2):213-221. doi: 10.5535/arm.2018.42.2.213. Epub 2018 Apr 30.
• Chesterton LS, Blagojevic-Bucknall M, Burton C, Dziedzic KS, Davenport G, Jowett SM, Myers HL, Oppong R, Rathod-Mistry T, van der Windt DA, Hay EM, Roddy E. The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial. Lancet. 2018 Oct 20;392(10156):1423-1433. doi: 10.1016/S0140-6736(18)31572-1.
• Moghtaderi AR, Jazayeri SM, Azizi S. EMLA cream for carpal tunnel syndrome: how it compares with steroid injection. Electromyogr Clin Neurophysiol. 2009 Sep-Oct;49(6-7):287-9.
• Leppert W, Malec-Milewska M, Zajaczkowska R, Wordliczek J. Transdermal and Topical Drug Administration in the Treatment of Pain. Molecules. 2018 Mar 17;23(3):681. doi: 10.3390/molecules23030681.
• Sears ED, Meerwijk EL, Schmidt EM, Kerr EA, Chung KC, Kamal RN, Harris AHS. Variation in Nonsurgical Services for Carpal Tunnel Syndrome Across a Large Integrated Health Care System. J Hand Surg Am. 2019 Feb;44(2):85-92.e1. doi: 10.1016/j.jhsa.2018.11.002. Epub 2018 Dec 20.
• Okamura A, Guidetti BC, Caselli R, Borracini JA, Moraes VY, Belloti JC. HOW DO BOARD-CERTIFIED HAND SURGEONS MANAGE CARPAL TUNNEL SYNDROME? A NATIONAL SURVEY. Acta Ortop Bras. 2018 Jan-Feb;26(1):48-53. doi: 10.1590/1413-785220182601181880.
• Graham B. The value added by electrodiagnostic testing in the diagnosis of carpal tunnel syndrome. J Bone Joint Surg Am. 2008 Dec;90(12):2587-93. doi: 10.2106/JBJS.G.01362.
• Aroori S, Spence RA. Carpal tunnel syndrome. Ulster Med J. 2008 Jan;77(1):6-17.

Helpful Links

• FULL PRESCRIBING INFORMATION of ZTLIDO (lidocaine topical system) 1.8%

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2020
• Primary Completion (Actual): May 7, 2023
• Study Completion (Actual): May 7, 2023

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: CTS2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No