Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation

NCT03716830 | Completed Results DMC

• 1 other identifier: 2018P001970
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Periaqueductal Gray (PAG) Resting State Functional Connectivity (rsFC) Changes

  We investigated whether tDCS and acupuncture treatments modulate resting-state functional connectivity (rsFC) of the periaqueductal gray (PAG). This was evaluated by comparing pre- and post-treatment MRI scans. In this report, we focused on the rsFC between the PAG and the rostral anterior cingulate cortex (rACC, peak MNI coordinate (2, 38, 12) with a 2-mm radius sphere). Functional connectivity values were computed as Pearson's correlation coefficients between the mean time series of predefined regions of interest (ROIs). To improve normality and enable parametric statistical analysis, these correlation coefficients (r) were converted to Fisher z values using the transformation z = 0.5 × ln\[(1 + r) / (1 - r)\]. Higher Fisher z values indicate stronger positive connectivity, whereas lower values indicate weaker or negative connectivity. Changes in Fisher z values from baseline to post-intervention reflect the degree and direction of connectivity modulation.

  difference between Day 1 (pre-intervention); post-intervention at Week 4 (pre-intervention - Post-intervention)

Secondary Outcomes (4)

• Clinical Outcomes as Measured by LBP Intensity Scores

  Difference between the Day 1 (pre-intervention) and post-intervention at Week 4 (post-intervention - pre-intervention)

• Cerebral Blood Flow (CBF) Differences Before and After Treatments

  Day 1 (pre-intervention); post-intervention at Week 4

• Quantitative Sensory Testing (QST) Differences

  Day 1 (pre-intervention); post-intervention at Week 4 (pre-intervention - post-intervention)

• Primary Motor Cortex (M1) rsFC Changes Before and After 4-week Treatments

  Day 1 (pre-intervention); post-intervention at Week 4 (pre-intervention - post-intervention)

Study Arms (4)

verum acupuncture + real tDCS

EXPERIMENTAL

Device: verum acupuncture; Device: real tDCS

sham acupuncture + real tDCS

EXPERIMENTAL

Device: sham acupuncture; Device: real tDCS

verum acupuncture + sham tDCS

EXPERIMENTAL

Device: verum acupuncture; Device: sham tDCS

sham acupuncture + sham tDCS

SHAM COMPARATOR

Device: sham acupuncture; Device: sham tDCS

Interventions

verum acupuncture DEVICE

Participants will receive real acupuncture treatment.

verum acupuncture + real tDCS; verum acupuncture + sham tDCS

sham acupuncture DEVICE

Participants will receive sham acupuncture treatment.

sham acupuncture + real tDCS; sham acupuncture + sham tDCS

real tDCS DEVICE

Participants will receive real transcranial direct current stimulation.

sham acupuncture + real tDCS; verum acupuncture + real tDCS

sham tDCS DEVICE

Participants will receive sham transcranial direct current stimulation.

sham acupuncture + sham tDCS; verum acupuncture + sham tDCS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129-2020, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jian Kong, PI of the clinical trial
• Organization: Massachusetts General Hospital

kongj@nmr.mgh.harvard.edu

6177267893

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both participants and study staff will be blinded to the treatment group of participants. Only the licensed acupuncturist will be aware of the type of acupuncture the participant will be receiving.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Associate Researcher

Model Details: Participants will be randomized to one of four groups: 1) verum acupuncture + real tDCS, 2) sham acupuncture + real tDCS, 3) verum acupuncture + sham tDCS, and 4) sham acupuncture + sham tDCS.

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 23, 2018
• Study Start: November 7, 2020
• Primary Completion: January 31, 2025
• Study Completion: March 31, 2025
• Last Updated: November 5, 2025
• Results First Posted: November 5, 2025

Record last verified: 2025-10

Locations

US (1)