Neuromodulation of Lidocaine Cream Effect on Chronic Pain Patients

December 29, 2022 updated by: Jian Kong, Massachusetts General Hospital
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Charlestown, Massachusetts, United States, 02129
        • Recruiting
        • Martinos Center for Biomedical Imagin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: real tDCS
In this group, the tDCS stimulates areas of the brain being examined in this study to increase their activity.
Device: tDCS
Electrical stimulation will be applied on the head to temporarily influence brain activity in specific regions.
Other: Lidocaine cream
Lidocaine cream will be applied to reduce pain sensitivity (analgesia).
Other: Control cream
A neutral cream will be applied as a control.
Sham Comparator: sham tDCS
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.
Device: tDCS
Electrical stimulation will be applied on the head to temporarily influence brain activity in specific regions.
Other: Lidocaine cream
Lidocaine cream will be applied to reduce pain sensitivity (analgesia).
Other: Control cream
A neutral cream will be applied as a control.
Other: control group
In this group, participants will receive tDCS but will only receive a cream on their lower back.
Device: tDCS
Electrical stimulation will be applied on the head to temporarily influence brain activity in specific regions.
Other: Lidocaine cream
Lidocaine cream will be applied to reduce pain sensitivity (analgesia).
Other: Control cream
A neutral cream will be applied as a control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fMRI signal changes
Time Frame: 2 days; Sessions 5 and 7
2 days; Sessions 5 and 7
Gracely Scale pain rating changes
Time Frame: 2 days; Sessions 2 and 7
2 days; Sessions 2 and 7
resting state functional connectivity changes
Time Frame: 2 days; Sessions 5 and 7
2 days; Sessions 5 and 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2017

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

January 27, 2017

First Submitted That Met QC Criteria

February 7, 2017

First Posted (Estimate)

February 8, 2017

Study Record Updates

Last Update Posted (Actual)

January 3, 2023

Last Update Submitted That Met QC Criteria

December 29, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015P001440

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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