NCT03046017

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

August 30, 2017

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

January 3, 2023

Status Verified

December 1, 2022

Enrollment Period

5.7 years

First QC Date

January 27, 2017

Last Update Submit

December 29, 2022

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (3)

  • fMRI signal changes

    2 days; Sessions 5 and 7

  • Gracely Scale pain rating changes

    2 days; Sessions 2 and 7

  • resting state functional connectivity changes

    2 days; Sessions 5 and 7

Study Arms (3)

real tDCS

ACTIVE COMPARATOR

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

Device: tDCSOther: Lidocaine creamOther: 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.

Device: tDCSOther: Lidocaine creamOther: Control cream

control group

OTHER

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

Device: tDCSOther: Lidocaine creamOther: Control cream

Interventions

tDCSDEVICE

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

control groupreal tDCSsham tDCS
Lidocaine creamOTHER

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

control groupreal tDCSsham tDCS
Control creamOTHER

A neutral cream will be applied as a control.

control groupreal tDCSsham tDCS

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Martinos Center for Biomedical Imagin

Charlestown, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Central Study Contacts

Georgia Wilson, BA

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 27, 2017

First Posted

February 8, 2017

Study Start

August 30, 2017

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

January 3, 2023

Record last verified: 2022-12

Locations

US(1)