Recruiting

Lidocaine Cream

Sponsor:

Massachusetts General Hospital

Code:

NCT03046017

Conditions

Chronic Low Back Pain

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Not accepted

Interventions

tDCS

Lidocaine cream

Control cream

Study Details

Brief 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). Study will be conducted on nine separate days not requiring an overnight stay in the hospital.

Conditions

Chronic Low Back Pain

Study ID

NCT03046017

Start date

Aug 30, 2017

Status verified date

Dec, 2022

Completion date

May, 2023

Anticipated

Primary completion date

May, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: real tDCS

In this group, the tDCS stimulates areas of the brain being examined in this study to increase their activity.

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.

other: control group

In this group, participants will receive tDCS but will only receive a cream on their lower back.

Interventions

tDCS

Electrical stimulation will be applied on the head to temporarily influence brain activity in specific regions.

Lidocaine cream

Lidocaine cream will be applied to reduce pain sensitivity (analgesia).

Control cream

A neutral cream will be applied as a control.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Georgia Wilson, BA

617-726-5004gjwilson@mgh.harvard.edu

Locations

Martinos Center for Biomedical Imagin

Recruiting

Charlestown, Massachusetts, United States, 02129

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jan 3, 2023

Last verified

Dec, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2023-01-03.