Chronic Low Back PainNCT03046017
Neuromodulation of Lidocaine Cream Effect on Chronic Pain Patients
A study testing tDCS and Lidocaine cream in people with Chronic Low Back Pain, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Chronic low back pain patients aged 21 to 60 needed for a research study of the effects of transcranial direct current stimulation (tDCS) on the analgesic effects of lidocaine cream as measured by functional Magnetic Resonance Imaging (fMRI). Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- tDCS and Lidocaine cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2017to May 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Volunteers 21-60 years of age.
- Meets the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by the referring physician.
- At least 4/10 clinical pain on the 11-point LBP VAS (criteria recommended by Dworkin et al.)
- At least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures.
Who cannot join
- Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections).
- Complicated back problems (e.g., prior back surgery, medicolegal issues).
- The intent to undergo surgery during the time of involvement in the study.
- History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma, claustrophobia, epilepsy or acute eczema under the electrodes.
- Presence of any contraindications to MRI scanning. For example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in an fMRI scanner.
- History of medical or psychiatric illness.
- History of substance / alcohol abuse or dependence.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Martinos Center for Biomedical Imagin
Charlestown, Massachusetts, 02129
About this study
Chronic low back pain patients aged 21 to 60 needed for a research study of the effects of transcranial direct current stimulation (tDCS) on the analgesic effects of lidocaine cream as measured by functional Magnetic Resonance Imaging (fMRI). Study will be conducted on nine separate days not requiring an overnight stay in the hospital.
- Conditions
- Chronic Low Back Pain
- Being tested
- tDCS, Lidocaine cream, Control cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Electrical stimulation will be applied on the head to temporarily influence brain activity in specific regions.
Lidocaine creamOther
Lidocaine cream will be applied to reduce pain sensitivity (analgesia).
Control creamOther
A neutral cream will be applied as a control.
| Study group | Role | What they receive |
|---|---|---|
| real tDCS | Active comparator | In this group, the tDCS stimulates areas of the brain being examined in this study to increase their activity. Receives: Device: tDCS; Other: Lidocaine cream; Other: Control cream |
| sham tDCS | Sham comparator | In this group, sham tDCS does not provide real stimulation though participants will not know this until the debriefing at the end of the study. Sham will be used to determine if the results of this study are due to the tDCS or other reasons. Receives: Device: tDCS; Other: Lidocaine cream; Other: Control cream |
| control group | Other | In this group, participants will receive tDCS but will only receive a cream on their lower back. Receives: Device: tDCS; Other: Lidocaine cream; Other: Control cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI signal changes
Measured: 2 days; Sessions 5 and 7
Gracely Scale pain rating changes
Measured: 2 days; Sessions 2 and 7
resting state functional connectivity changes
Measured: 2 days; Sessions 5 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start30 Aug 2017
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Kong, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046017
- Sponsor's protocol ID
- 2015P001440
- Status last verified
- Dec 2022
- First submitted
- 27 Jan 2017
- Last updated
- 3 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation of Lidocaine Cream Effect on Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT03046017
- Acronym / sponsor ID
- 2015P001440
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 8 Feb 2017 (estimated)
- 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.
Chronic low back pain patients aged 21 to 60 needed for a research study of the effects of transcranial direct current stimulation (tDCS) on the analgesic effects of lidocaine cream as measured by functional Magnetic Resonance Imaging (fMRI). Study will be conducted on nine separate days not requiring an overnight stay in the hospital.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| real tDCS | Active comparator | Device: tDCS, Other: Lidocaine cream, Other: Control creamIn this group, the tDCS stimulates areas of the brain being examined in this study to increase their activity. |
| sham tDCS | Sham comparator | Device: tDCS, Other: Lidocaine cream, Other: Control creamIn this group, sham tDCS does not provide real stimulation though participants will not know this until the debriefing at the end of the study. Sham will be used to determine if the results of this study are due to the tDCS or other reasons. |
| control group | Other | Device: tDCS, Other: Lidocaine cream, Other: Control creamIn this group, participants will receive tDCS but will only receive a cream on their lower back. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Volunteers 21-60 years of age.
- Meets the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by the referring physician.
- At least 4/10 clinical pain on the 11-point LBP VAS (criteria recommended by Dworkin et al.)
- At least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures.
Key exclusion criteria (7 listed)
- Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections).
- Complicated back problems (e.g., prior back surgery, medicolegal issues).
- The intent to undergo surgery during the time of involvement in the study.
- History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma, claustrophobia, epilepsy or acute eczema under the electrodes.
- Presence of any contraindications to MRI scanning. For example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in an fMRI scanner.
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 |
|---|---|---|
| tDCSElectrical stimulation will be applied on the head to temporarily influence brain activity in specific regions. | Device | control group, real tDCS, sham tDCS |
| Lidocaine creamLidocaine cream will be applied to reduce pain sensitivity (analgesia). | Other | control group, real tDCS, sham tDCS |
| Control creamA neutral cream will be applied as a control. | Other | control group, real tDCS, sham tDCS |
Primary outcome
fMRI signal changes
Time frame: 2 days; Sessions 5 and 7
Gracely Scale pain rating changes
Time frame: 2 days; Sessions 2 and 7
resting state functional connectivity changes
Time frame: 2 days; Sessions 5 and 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and Lidocaine cream in people with Chronic Low Back Pain, run by Massachusetts General Hospital 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Jan 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgia Wilson, BA (617-726-5004, gjwilson@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI signal changes (time frame: 2 days; Sessions 5 and 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2023.