Neck PainNCT04378959
Lidocaine Patch for Neck Pain
A study testing Lidocaine patch in people with Neck Pain and Neck Pain, Posterior, run by Johns Hopkins University at 2 sites in United States.
Trial summary
In this randomized, double-blind, placebo-controlled crossover study, up to 84 patients with non-radicular neck pain will be allocated in a 1:1 ratio to receive up to 3 topical lidocaine or placebo patches, to be applied 12 hours per day. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neck Pain, Neck Pain, Posterior
- What is being tested?
- Lidocaine patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2021to 2 Jun 2023
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 90 years
- Tenderness to palpation over affected areas (using average 4 kg force for 70 kg person)
- Average pain score >/= 4 over the week prior to enrollment
- On stable doses of analgesics for 2 weeks prior to enrollment
- Chronic mechanical neck pain > 3 months in duration
- Boundaries are upper trapezius, mastoid processes, shoulders
Who cannot join
- Radicular pain as determined by clinical presentation
- Opioid dose in oral morphine equivalents/day > 30
- Moderate or severe hepatic disease (will obtain blood work and exclude individuals with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the normal range.
- Previous neck surgery
- Known structural defect presumed to be the primary pain generator (e.g. severe degenerative disc or facet joint disease)
- Serious medical (e.g. unstable angina) or psychiatric (e.g. poorly controlled depression, active substance abuse) that could interfere with treatment or pain response
Show all 13Show fewer
- Secondary gain
- Pregnancy or breastfeeding
- painDETECT score > 18
- Known allergy to lidocaine
- Diffuse pain phenotype (e.g. fibromyalgia)
- Cervical pain greater in area than 3 patches (10 x 14 cm/patch)
- Skin defects (e.g. burns, active infection) in area(s) of application that could result in significant systemic absorption
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Blaustein Pain Treatment Center
Baltimore, Maryland, 21205
DC VA Medical Center
Washington D.C., District of Columbia, 20422
About this study
Official title: Randomized, Placebo-controlled Crossover Trial Evaluating Topical Lidocaine Patch(es) for Mechanical Neck Pain.
In this randomized, double-blind, placebo-controlled crossover study, up to 84 patients with non-radicular neck pain will be allocated in a 1:1 ratio to receive up to 3 topical lidocaine or placebo patches, to be applied 12 hours per day. At the end of 4 weeks, patients will return for patients' post-phase I treatment evaluation. Patients will crossover to receive up to 3 identical-looking topical patches of the treatment patients did not receive, to be applied in the same fashion for the same 4-week period. The primary outcome measure will be average neck pain over the past week, 4 weeks post-treatment. A positive categorical outcome (i.e. responder) will be defined as a 2-point or greater decrease in average neck pain coupled with a patient global impression of change score >/= 5/7.
Read the detailed description
84 patients will be allocated to receive lidocaine patch or an identical placebo patch for phase I of this crossover study. Depending on the area of pain, up to 3 patches can be applied. Patches will be applied for 12 hours on and 12 hours off (e.g. from 8 PM to 8 AM or 8 AM to 8PM) depending on whether a person's pain is worse in the day or night.
At the end of 4 weeks of treatment, patients will return to clinic for the post-phase I treatment evaluation, at which time outcome measures will be collected. Patients will then enter a 1-week washout period, after which patients will return between 1 and 3 weeks (depending on patients' availability) to receive the treatment patch patients did not receive in phase I (i.e. lidocaine for group II patients and placebo for group I patients). The short washout period is justifiable based on the short half-life of lidocaine (90-120 minutes) and is consistent with previous topical lidocaine crossover studies. The crossover patch will be applied in the same fashion as in the 1st phase, again for a 4-week duration.
In order to reduce confounding variables, subjects in both groups must agree to not seek any additional pain management treatment as long as patients remain in the study. However, some treatments, such as physical therapy or exercise that are widely recommended can continue, so patients will be told to advise patients' pain clinic physician of any new treatments patients wish to seek during this time period. Subjects will be also be advised that patients can be prescribed rescue medications in the form of a non-steroidal anti-inflammatory drug or acetaminophen, or tramadol (up to 100 mg/d) for those who have already failed a non-steroidal anti-inflammatory drug and acetaminophen, or cannot take the drugs for medical reasons (e.g. renal disease, high cardiovascular risk).
The primary outcome measure will be average neck pain over the past week, 4 weeks post-treatment. A positive categorical outcome (i.e. responder) will be defined as a 2-point or greater decrease in average neck pain coupled with a patient global impression of change score </= 3/7.
- Conditions
- Neck Pain, Neck Pain, Posterior
- Being tested
- Lidocaine patch, Placebo patch
- Keywords
- Cervicalgia, Neck pain, Lidocaine, Topical
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine patchDrug
Up to 3 patches will be applied for 12 hours on (e.g. from 8 AM to 8 PM for those whose pain is worse during the day, or from 8 PM to 8 AM for those whose pain is worse at night) and 12 hours off x 4 weeks.
Placebo patchDrug
Up to 3 patches will be applied for 12 hours on (e.g. from 8 AM to 8 PM for those whose pain is worse during the day, or from 8 PM to 8 AM for those whose pain is worse at night) and 12 hours off x 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine patch first | Experimental | This group will receive up to 3 lidocaine patches for 4 weeks, followed by placebo patches after a 1-3 week washout period. Receives: Drug: Lidocaine patch; Drug: Placebo patch |
| Placebo patch first | Placebo comparator | This group will receive up to 3 placebo patches for 4 weeks, followed by lidocaine patches after a 1-3 week washout period. Receives: Drug: Lidocaine patch; Drug: Placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean reduction in average neck pain score on 0-10 numerical rating scale
Mean reduction in average neck pain score over the past week at week 4 compared to baseline on 0-10 numerical rating scale (higher pain scores represent greater pain)
Measured: 4 weeks
Secondary outcomes (10)
Average neck pain score on 0-10 numerical rating scale
Average neck pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain)
Measured: 4 weeks
Mean reduction in worst neck pain score on 0-10 numerical rating scale
Mean reduction in worst neck pain score over the past week at week 4 compared to baseline on 0-10 numerical rating scale (higher pain scores represent greater pain)
Measured: 4 weeks
Worst neck pain score on 0-10 numerical rating scale
Worst neck pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain)
Measured: 4 weeks
Neck disability index score
Neck disability index score on 0 to 100 percent scale (higher scores represent greater disability)
Measured: 4 weeks
Mean reduction in neck disability index score
Mean reduction in neck disability index score over the past week at week 4 compared to baseline (higher scores represent greater disability)
Measured: 4 weeks
Number of participants with a positive outcome
Positive outcome is defined as a greater than or equal to 2-point decrease in average neck pain on 0-10 NRS scale coupled with a score of greater than or equal to 5 on a 7-point patient global impression of change scale.
Measured: 4 weeks
Patient global impression of change (PGIC) score
1-7 scale evaluating, with higher scores indicating greater improvement.
Measured: 4 weeks
Athens Insomnia Scale score
Scale measuring sleep dysfunction on an 8-question 0-24 scale, with higher numbers indicating greater dysfunction.
Measured: 4 weeks
Hospital Anxiety and Depression Scale score
14-question scale measuring anxiety and depression, with each question scored as 0-3 (higher numbers represent greater anxiety or depression).
Measured: 4 weeks
Pain pressure threshold
Pain pressure threshold, measured via algometry 3 times over the most tender area (mean of 3 measurements)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start1 Feb 2021
- Primary completion2 Jun 2023
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 4 week treatment periods, separated by a 1 to 3 week washout period
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Washington D.C. Veterans Affairs Medical Center, Pain Management Institute Bethesda-Washington-Maryland, Walter Reed National Military Medical Center, Scilex Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Steven Cohen, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378959
- Sponsor's protocol ID
- IRB00233514
- Status last verified
- Aug 2023
- First submitted
- 4 May 2020
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The protocol, and de-identified data may be shared with other researchers, pending approval (if relevant) from the Dept. of Defense (Walter Reed) and VA (DC VA Hospital)
Publications
Predel HG, Giannetti B, Pabst H, Schaefer A, Hug AM, Burnett I. Efficacy and safety of diclofenac diethylamine 1.16% gel in acute neck pain: a randomized, double-blind, placebo-controlled study. BMC Musculoskelet Disord. 2013 Aug 21;14:250. doi: 10.1186/1471-2474-14-250.
PubMed 23964752Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.
PubMed 28807894Hashmi JA, Baliki MN, Huang L, Parks EL, Chanda ML, Schnitzer T, Apkarian AV. Lidocaine patch (5%) is no more potent than placebo in treating chronic back pain when tested in a randomised double blind placebo controlled brain imaging study. Mol Pain. 2012 Apr 24;8:29. doi: 10.1186/1744-8069-8-29.
PubMed 22531485Lin YC, Kuan TS, Hsieh PC, Yen WJ, Chang WC, Chen SM. Therapeutic effects of lidocaine patch on myofascial pain syndrome of the upper trapezius: a randomized, double-blind, placebo-controlled study. Am J Phys Med Rehabil. 2012 Oct;91(10):871-82. doi: 10.1097/PHM.0b013e3182645d30.
PubMed 22854911Hsieh LF, Hong CZ, Chern SH, Chen CC. Efficacy and side effects of diclofenac patch in treatment of patients with myofascial pain syndrome of the upper trapezius. J Pain Symptom Manage. 2010 Jan;39(1):116-25. doi: 10.1016/j.jpainsymman.2009.05.016. Epub 2009 Oct 12.
PubMed 19822404
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled Crossover Trial Evaluating Topical Lidocaine Patch(es) for Mechanical Neck Pain.
- ClinicalTrials.gov ID
- NCT04378959
- Acronym / sponsor ID
- IRB00233514
- Conditions
- Neck Pain, Neck Pain, Posterior
- Keywords
- Cervicalgia, Neck pain, Lidocaine, Topical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Washington D.C. Veterans Affairs Medical Center, Pain Management Institute Bethesda-Washington-Maryland, Walter Reed National Military Medical Center, Scilex Pharmaceuticals, Inc.
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 7 May 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.
In this randomized, double-blind, placebo-controlled crossover study, up to 84 patients with non-radicular neck pain will be allocated in a 1:1 ratio to receive up to 3 topical lidocaine or placebo patches, to be applied 12 hours per day. At the end of 4 weeks, patients will return for patients' post-phase I treatment evaluation. Patients will crossover to receive up to 3 identical-looking topical patches of the treatment patients did not receive, to be applied in the same fashion for the same 4-week period. The primary outcome measure will be average neck pain over the past week, 4 weeks post-treatment. A positive categorical outcome (i.e. responder) will be defined as a 2-point or greater decrease in average neck pain coupled with a patient global impression of change score >/= 5/7.
Detailed description
84 patients will be allocated to receive lidocaine patch or an identical placebo patch for phase I of this crossover study. Depending on the area of pain, up to 3 patches can be applied. Patches will be applied for 12 hours on and 12 hours off (e.g. from 8 PM to 8 AM or 8 AM to 8PM) depending on whether a person's pain is worse in the day or night.
At the end of 4 weeks of treatment, patients will return to clinic for the post-phase I treatment evaluation, at which time outcome measures will be collected. Patients will then enter a 1-week washout period, after which patients will return between 1 and 3 weeks (depending on patients' availability) to receive the treatment patch patients did not receive in phase I (i.e. lidocaine for group II patients and placebo for group I patients). The short washout period is justifiable based on the short half-life of lidocaine (90-120 minutes) and is consistent with previous topical lidocaine crossover studies. The crossover patch will be applied in the same fashion as in the 1st phase, again for a 4-week duration.
In order to reduce confounding variables, subjects in both groups must agree to not seek any additional pain management treatment as long as patients remain in the study. However, some treatments, such as physical therapy or exercise that are widely recommended can continue, so patients will be told to advise patients' pain clinic physician of any new treatments patients wish to seek during this time period. Subjects will be also be advised that patients can be prescribed rescue medications in the form of a non-steroidal anti-inflammatory drug or acetaminophen, or tramadol (up to 100 mg/d) for those who have already failed a non-steroidal anti-inflammatory drug and acetaminophen, or cannot take the drugs for medical reasons (e.g. renal disease, high cardiovascular risk).
The primary outcome measure will be average neck pain over the past week, 4 weeks post-treatment. A positive categorical outcome (i.e. responder) will be defined as a 2-point or greater decrease in average neck pain coupled with a patient global impression of change score </= 3/7.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 4 week treatment periods, separated by a 1 to 3 week washout period
| Arm | Type | Receives |
|---|---|---|
| Lidocaine patch first | Experimental | Drug: Lidocaine patch, Drug: Placebo patchThis group will receive up to 3 lidocaine patches for 4 weeks, followed by placebo patches after a 1-3 week washout period. |
| Placebo patch first | Placebo comparator | Drug: Lidocaine patch, Drug: Placebo patchThis group will receive up to 3 placebo patches for 4 weeks, followed by lidocaine patches after a 1-3 week washout period. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 90 years
- Tenderness to palpation over affected areas (using average 4 kg force for 70 kg person)
- Average pain score >/= 4 over the week prior to enrollment
- On stable doses of analgesics for 2 weeks prior to enrollment
- Chronic mechanical neck pain > 3 months in duration
Key exclusion criteria (13 listed)
- Radicular pain as determined by clinical presentation
- Opioid dose in oral morphine equivalents/day > 30
- Moderate or severe hepatic disease (will obtain blood work and exclude individuals with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the normal range.
- Previous neck surgery
- Known structural defect presumed to be the primary pain generator (e.g. severe degenerative disc or facet joint disease)
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 patchUp to 3 patches will be applied for 12 hours on (e.g. from 8 AM to 8 PM for those whose pain is worse during the day, or from 8 PM to 8 AM for those whose pain is worse at night) and 12 hours off x 4 weeks. | Drug | Lidocaine patch first, Placebo patch first |
| Placebo patchUp to 3 patches will be applied for 12 hours on (e.g. from 8 AM to 8 PM for those whose pain is worse during the day, or from 8 PM to 8 AM for those whose pain is worse at night) and 12 hours off x 4 weeks. | Drug | Lidocaine patch first, Placebo patch first |
Primary outcome
Mean reduction in average neck pain score on 0-10 numerical rating scale
Time frame: 4 weeks
Mean reduction in average neck pain score over the past week at week 4 compared to baseline on 0-10 numerical rating scale (higher pain scores represent greater pain)
10 secondary outcomes
Average neck pain score on 0-10 numerical rating scale
Time frame: 4 weeks
Mean reduction in worst neck pain score on 0-10 numerical rating scale
Time frame: 4 weeks
Worst neck pain score on 0-10 numerical rating scale
Time frame: 4 weeks
Neck disability index score
Time frame: 4 weeks
Mean reduction in neck disability index score
Time frame: 4 weeks
Number of participants with a positive outcome
Time frame: 4 weeks
Patient global impression of change (PGIC) score
Time frame: 4 weeks
Athens Insomnia Scale score
Time frame: 4 weeks
Hospital Anxiety and Depression Scale score
Time frame: 4 weeks
Pain pressure threshold
Time frame: 4 weeks
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 Aug 2023.
- Background: PubMed 23964752Predel HG, Giannetti B, Pabst H, Schaefer A, Hug AM, Burnett I. Efficacy and safety of diclofenac diethylamine 1.16% gel in acute neck pain: a randomized, double-blind, placebo-controlled study. BMC Musculoskelet Disord. 2013 Aug 21;14:250. doi: 10.1186/1471-2474-14-250.
- Results publication: PubMed 28807894Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.
- Results publication: PubMed 22531485Hashmi JA, Baliki MN, Huang L, Parks EL, Chanda ML, Schnitzer T, Apkarian AV. Lidocaine patch (5%) is no more potent than placebo in treating chronic back pain when tested in a randomised double blind placebo controlled brain imaging study. Mol Pain. 2012 Apr 24;8:29. doi: 10.1186/1744-8069-8-29.
- Results publication: PubMed 22854911Lin YC, Kuan TS, Hsieh PC, Yen WJ, Chang WC, Chen SM. Therapeutic effects of lidocaine patch on myofascial pain syndrome of the upper trapezius: a randomized, double-blind, placebo-controlled study. Am J Phys Med Rehabil. 2012 Oct;91(10):871-82. doi: 10.1097/PHM.0b013e3182645d30.
- Results publication: PubMed 19822404Hsieh LF, Hong CZ, Chern SH, Chen CC. Efficacy and side effects of diclofenac patch in treatment of patients with myofascial pain syndrome of the upper trapezius. J Pain Symptom Manage. 2010 Jan;39(1):116-25. doi: 10.1016/j.jpainsymman.2009.05.016. Epub 2009 Oct 12.
- Individual participant dataSharing planned: Yes. The protocol, and de-identified data may be shared with other researchers, pending approval (if relevant) from the Dept. of Defense (Walter Reed) and VA (DC VA Hospital)
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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.
Steven Cohen, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine patch in people with Neck Pain and Neck Pain, Posterior, run by Johns Hopkins University at 2 sites 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 6 inclusion and 13 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 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Mean reduction in average neck pain score on 0-10 numerical rating scale (time frame: 4 weeks). 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 NCT04378959, which also lists 5 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 Aug 2023.