Neuromodulation of Lidocaine Cream Effect on Chronic Pain Patients

Mass General Brigham

Status: Enrolling

Conditions: Chronic Low Back Pain

Treatments: Other: Lidocaine cream; Device: tDCS; Other: Control cream

Study type: Interventional

Funder types: Other

Identifiers

NCT03046017

2015P001440

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

real tDCS

Active Comparator group

Description:

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

Treatment:

Other: Control cream

Other: Lidocaine cream

Device: tDCS

sham tDCS

Sham Comparator group

Description:

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.

Treatment:

Other: Control cream

Other: Lidocaine cream

Device: tDCS

control group

Other group

Description:

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

Treatment:

Other: Control cream

Other: Lidocaine cream

Device: tDCS