Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Device: verum acupuncture; Device: real tDCS; Device: sham acupuncture; Device: sham tDCS

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian Kong; Phone Number: 617-726-7893; Email: jkong2@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129-2020
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Maya Eshel; Email: meshel@mgh.harvard.edu
      • Contact: Rachel Dao; Email: rdao@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: verum acupuncture + real tDCS	Device: verum acupuncture; Participants will receive real acupuncture treatment.; Device: real tDCS; Participants will receive real transcranial direct current stimulation.
Experimental: sham acupuncture + real tDCS	Device: real tDCS; Participants will receive real transcranial direct current stimulation.; Device: sham acupuncture; Participants will receive sham acupuncture treatment.
Experimental: verum acupuncture + sham tDCS	Device: verum acupuncture; Participants will receive real acupuncture treatment.; Device: sham tDCS; Participants will receive sham transcranial direct current stimulation.
Sham Comparator: sham acupuncture + sham tDCS	Device: sham acupuncture; Participants will receive sham acupuncture treatment.; Device: sham tDCS; Participants will receive sham transcranial direct current stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: October 18, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2018P001970

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No