search
Back to results

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

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lidocaine 1.8%
Placebo
Sponsored by
John Papakonstantinou, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 Electromyography (EMG);
  • 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 6 months;
  • 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;
  • Participants with bilateral CTS.

Sites / Locations

  • Michigan Orthopaedic & Spine Surgeons

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

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.

Placebo Patch applied to affected hand at night for 2 weeks for 12 hours during each 24-hour daily cycle.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Sensory examination
Clinical sensory neurological examination will assess for response to light touch, pinprick, and vibration.
Pain Detect Questionnaire
The Pain DETECT questionnaire screens for components of neuropathic pain: intensity, pattern and quality.

Full Information

First Posted
January 22, 2020
Last Updated
June 7, 2023
Sponsor
John Papakonstantinou, MD
Collaborators
Scilex Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04245371
Brief Title
Lidocaine Patch 1.8% for Moderate to Severe Pain From Carpal Tunnel Syndrome
Acronym
CTS
Official Title
A Prospective, Randomized, Double-Blind, Cross-over Study of Lidocaine Patch 1.8% in Patients With Moderate to Severe Pain From Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
May 7, 2023 (Actual)
Study Completion Date
May 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
John Papakonstantinou, MD
Collaborators
Scilex Ltd.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
Participants will serve as their own control
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double-Blind
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Patch applied to affected hand at night for 2 weeks for 12 hours during each 24-hour daily cycle.
Intervention Type
Drug
Intervention Name(s)
Lidocaine 1.8%
Intervention Description
Topical Patch
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo Patch
Primary Outcome Measure Information:
Title
Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ): minimally clinically important difference
Description
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
Secondary Outcome Measure Information:
Title
Functional Status Score (FSS) of the Boston Carpal Tunnel Questionnaire (BCTQ):minimally clinically important difference
Description
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
Title
Sensory examination
Description
Clinical sensory neurological examination will assess for response to light touch, pinprick, and vibration.
Time Frame
After 1 Week of Treatment
Title
Pain Detect Questionnaire
Description
The Pain DETECT questionnaire screens for components of neuropathic pain: intensity, pattern and quality.
Time Frame
After 1 Week of Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Papakonstantinou, MD
Organizational Affiliation
Michigan Orthopaedic & Spine Surgeons
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan Orthopaedic & Spine Surgeons
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29765874
Citation
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.
Results Reference
background
PubMed Identifier
30343858
Citation
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.
Results Reference
background
PubMed Identifier
19845100
Citation
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.
Results Reference
background
PubMed Identifier
29562618
Citation
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.
Results Reference
background
PubMed Identifier
30579690
Citation
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.
Results Reference
background
PubMed Identifier
29977145
Citation
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.
Results Reference
background
PubMed Identifier
19047703
Citation
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.
Results Reference
background
PubMed Identifier
18269111
Citation
Aroori S, Spence RA. Carpal tunnel syndrome. Ulster Med J. 2008 Jan;77(1):6-17.
Results Reference
background
Links:
URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207962s000lbl.pdf
Description
FULL PRESCRIBING INFORMATION of ZTLIDO (lidocaine topical system) 1.8%

Learn more about this trial

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

We'll reach out to this number within 24 hrs