Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation

Chronic Pain Clinical Trial

Official title:

Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03716830
• Other study ID #: 2018P001970
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: February 2023
• Source: Massachusetts General Hospital
• Contact: Jian Kong
• Phone: 617-726-7893
• Email: jkong2[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, investigators will examine the brain mechanism behind the synergistic effects of combining acupuncture and transcranial direct current stimulation (tDCS) treatments. Specifically, chronic low back pain (cLBP) patients will be recruited and randomized to one of four groups (30 per group, one month of treatment): 1) verum acupuncture + real tDCS, 2) sham acupuncture + real tDCS, 3) verum acupuncture + sham tDCS, and 4) sham acupuncture + sham tDCS. Investigators will study 1) the longitudinal (one-month) effects of different treatments as indicated by changes in resting state functional connectivity (rsFC), cerebral blood flow (CBF), clinical outcomes of low back pain, and quantitative sensory test (QST) and 2) the association between these changes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• volunteers 18-60 years of age
• meet the classification criteria of chronic low back pain (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 Low Back Pain Numeric Rating Scale (LBP NRS)
• 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:

• history of epilepsy or loss consciousness (LOC)
• 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 outcomes. For example: asthma or claustrophobia
• presence of any contraindications to magnetic resonance imaging (MRI) scanning. For example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, inability to remain still in MRI scanner
• history of medical or psychiatric illness as determined by the investigator
• history of substance abuse or dependence

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• verum acupuncture
Participants will receive real acupuncture treatment.
• sham acupuncture
Participants will receive sham acupuncture treatment.
• real tDCS
Participants will receive real transcranial direct current stimulation.
• sham tDCS
Participants will receive sham transcranial direct current stimulation.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	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	Periaqueductal Gray (PAG) Resting State Functional Connectivity (rsFC) Changes	Investigators will explore whether tDCS and acupuncture treatments evoke PAG rsFC connectivity changes. This outcome will be assessed by comparing participants' pre-treatment MRI scans to their post-treatment scans.	Day 1 (pre-intervention); post-intervention at Week 4
Secondary	Clinical Outcomes as Measured by LBP Intensity Scores	The Low Back Pain Numeric Rating Scale (LBP NRS) will be used to assess clinical outcomes. Participants will be required to rate their pain on this scale prior to the first treatment and after all treatments.	Day 1 (pre-intervention); post-intervention at Week 4
Secondary	Cerebral Blood Flow (CBF) Differences Before and After Treatments	Investigators will examine CBF changes before and after treatment in several pain-related brain areas. CBF data will be collected during arterial spin labeling (ASL) scans that will take place before the first treatment and after the last treatment. Images from these scans will be aggregated to an average CBF-weighted image to be used for analysis.	Day 1 (pre-intervention); post-intervention at Week 4
Secondary	Quantitative Sensory Testing (QST) Differences	Participants' QST ratings will be analyzed before and after all treatments.	Day 1 (pre-intervention); post-intervention at Week 4
Secondary	Differences in rsFC of M1 and Other Networks	Similar to the CBF measure, rSFC will be analyzed from ASL data (obtained during MRI scanning). rSFC from pre- to post-treatment will be compared.	Day 1 (pre-intervention); post-intervention at Week 4