Neuromodulation of Lidocaine Cream Effect on Chronic Pain Patients

Chronic Low Back Pain Clinical Trial

Official title:

Neuromodulation of Lidocaine Cream Effect on Chronic Pain Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03046017
• Other study ID #: 2015P001440
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2017
• Est. completion date: May 2023

Study information

• Verified date: December 2022
• Source: Massachusetts General Hospital
• Contact: Georgia Wilson, BA
• Phone: 617-726-5004
• Email: gjwilson[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Low Back Pain
• Chronic Pain
• Low Back Pain

Intervention

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).
• Control cream
A neutral cream will be applied as a control.

Locations

Country	Name	City	State
United States	Martinos Center for Biomedical Imagin	Charlestown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRI signal changes		2 days; Sessions 5 and 7
Primary	Gracely Scale pain rating changes		2 days; Sessions 2 and 7
Primary	resting state functional connectivity changes		2 days; Sessions 5 and 7