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Completed

NCT Number: NCT03716830

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Charlestown, Massachusetts, 02129-2020, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Verum acupuncture

Device

Participants will receive real acupuncture treatment.

Sham acupuncture

Device

Participants will receive sham acupuncture treatment.

real tDCS

Device

Participants will receive real transcranial direct current stimulation.

Sham tDCS

Device

Participants will receive sham transcranial direct current stimulation.

Primary outcomes

  1. Periaqueductal Gray (PAG) Resting State Functional Connectivity (rsFC) Changes

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

    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.

Secondary outcomes

  1. Clinical Outcomes as Measured by LBP Intensity Scores

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

    The Low Back Pain Numeric Rating Scale (LBP NRS) is a standardized adaptation of the Pain Numeric Rating Scale for assessing pain intensity specifically related to the lower back. It uses an 11-point scale from 0 ("no low back pain") to 10 ("worst low back pain imaginable"), allowing patients to rate their pain over the past week.

  2. Cerebral Blood Flow (CBF) Differences Before and After Treatments

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

    Investigators will examine Cerebral blood flow (CBF) changes before and after treatment in several pain-related brain areas. Cerebral blood flow represents the volume of blood delivered to brain tissue per unit time, 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. In this report, we focused on bilateral postcentral Gyrus (MNI coordinate: +/-18, -34, 56, 2 mm sphere)

  3. Quantitative Sensory Testing (QST) Differences

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

    Participants' quantitative sensory testing (QST) ratings were analyzed before and after all treatments. Here, we report the heat pain threshold measured around the affected lower back area.

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

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

    We investigated whether tDCS and acupuncture treatments modulate resting-state functional connectivity (rsFC) of the M1. 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), using a seed defined by the rACC peak MNI coordinate (0, 34, 20) 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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 23, 2018
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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