Carpal Tunnel SyndromePhase 4CTSNCT04245371
Lidocaine Patch 1.8% for Moderate to Severe Pain From Carpal Tunnel Syndrome
A Phase 4 study testing Lidocaine 1.8% in people with Carpal Tunnel Syndrome, run by John Papakonstantinou, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Lidocaine 1.8%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2020to 7 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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);
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- 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;
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Orthopaedic & Spine Surgeons
Rochester Hills, Michigan, 48307
About this study
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
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.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Lidocaine 1.8%, Placebo
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 1.8%Drug
Topical Patch
PlaceboDrug
Matching Placebo Patch
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | 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. Receives: Drug: Lidocaine 1.8% |
| Placebo | Placebo comparator | Placebo Patch applied to affected hand at night for 2 weeks for 12 hours during each 24-hour daily cycle. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 1 Week of Treatment
Secondary outcomes (3)
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.
Measured: After 1 Week of Treatment
Sensory examination
Clinical sensory neurological examination will assess for response to light touch, pinprick, and vibration.
Measured: After 1 Week of Treatment
Pain Detect Questionnaire
The Pain DETECT questionnaire screens for components of neuropathic pain: intensity, pattern and quality.
Measured: After 1 Week of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start24 Feb 2020
- Primary completion7 May 2023
- Study completion7 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will serve as their own control
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Papakonstantinou, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Scilex Ltd.
- Responsible party
- Sponsor-investigator, John Papakonstantinou, MD, Michigan Orthopaedic & Spine Surgeons
- Investigators
- John Papakonstantinou, MD, Principal investigator, Michigan Orthopaedic & Spine Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245371
- Sponsor's protocol ID
- CTS2020
- Acronym
- CTS
- Status last verified
- Jun 2023
- First submitted
- 22 Jan 2020
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29765874Chesterton 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.
PubMed 30343858Moghtaderi 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.
PubMed 19845100Leppert 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.
PubMed 29562618Sears 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.
PubMed 30579690Okamura 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.
PubMed 29977145Graham 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.
PubMed 19047703Aroori S, Spence RA. Carpal tunnel syndrome. Ulster Med J. 2008 Jan;77(1):6-17.
PubMed 18269111
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04245371
- Acronym / sponsor ID
- CTS / CTS2020
- Conditions
- Carpal Tunnel Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- John Papakonstantinou, MDUniversity, hospital or other
- Collaborators
- Scilex Ltd.
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 7 May 2023 (actual)
- Study completion
- 7 May 2023 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will serve as their own control
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: Lidocaine 1.8%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 | Placebo comparator | Drug: PlaceboPlacebo Patch applied to affected hand at night for 2 weeks for 12 hours during each 24-hour daily cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine 1.8%Topical Patch | Drug | Active |
| PlaceboMatching Placebo Patch | Drug | Placebo |
Primary outcome
Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ): minimally clinically important difference
Time frame: 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.
3 secondary outcomes
Functional Status Score (FSS) of the Boston Carpal Tunnel Questionnaire (BCTQ):minimally clinically important difference
Time frame: After 1 Week of Treatment
Sensory examination
Time frame: After 1 Week of Treatment
Pain Detect Questionnaire
Time frame: After 1 Week of Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Background: PubMed 29765874Chung 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.
- Background: PubMed 30343858Chesterton 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.
- Background: PubMed 19845100Moghtaderi 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.
- Background: PubMed 29562618Leppert 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.
- Background: PubMed 30579690Sears 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.
- Background: PubMed 29977145Okamura 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.
- Background: PubMed 19047703Graham 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.
- Background: PubMed 18269111Aroori S, Spence RA. Carpal tunnel syndrome. Ulster Med J. 2008 Jan;77(1):6-17.
- FULL PRESCRIBING INFORMATION of ZTLIDO (lidocaine topical system) 1.8%Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Papakonstantinou, MD principal investigator
Michigan Orthopaedic & Spine Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine 1.8% in people with Carpal Tunnel Syndrome, run by John Papakonstantinou, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ): minimally clinically important difference (time frame: After 1 Week of Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04245371, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.