Chronic PainNCT03716830
Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation
A study testing verum acupuncture and real tDCS in people with Chronic Pain, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- verum acupuncture and real tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2020to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Charlestown, Massachusetts, 02129-2020
About this study
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
- Being tested
- verum acupuncture, sham acupuncture, real tDCS, sham tDCS
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
verum acupunctureDevice
Participants will receive real acupuncture treatment.
sham acupunctureDevice
Participants will receive sham acupuncture treatment.
real tDCSDevice
Participants will receive real transcranial direct current stimulation.
sham tDCSDevice
Participants will receive sham transcranial direct current stimulation.
| Study group | Role | What they receive |
|---|---|---|
| verum acupuncture + real tDCS | Experimental | Not described Receives: Device: verum acupuncture; Device: real tDCS |
| sham acupuncture + real tDCS | Experimental | Not described Receives: Device: sham acupuncture; Device: real tDCS |
| verum acupuncture + sham tDCS | Experimental | Not described Receives: Device: verum acupuncture; Device: sham tDCS |
| sham acupuncture + sham tDCS | Sham comparator | Not described Receives: Device: sham acupuncture; Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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)
Measured: Day 1 (pre-intervention); post-intervention at Week 4
Quantitative Sensory Testing (QST) Differences
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.
Measured: 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
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
Measured: Day 1 (pre-intervention); post-intervention at Week 4 (pre-intervention - post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start7 Nov 2020
- Primary completion31 Jan 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Kong, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716830
- Sponsor's protocol ID
- 2018P001970
- Status last verified
- Oct 2025
- First submitted
- 18 Oct 2018
- Last updated
- 5 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation
- ClinicalTrials.gov ID
- NCT03716830
- Acronym / sponsor ID
- 2018P001970
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 7 Nov 2020 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Posted 5 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| verum acupunctureParticipants will receive real acupuncture treatment. | Device | verum acupuncture + real tDCS, verum acupuncture + sham tDCS |
| sham acupunctureParticipants will receive sham acupuncture treatment. | Device | sham acupuncture + real tDCS, sham acupuncture + sham tDCS |
| real tDCSParticipants will receive real transcranial direct current stimulation. | Device | sham acupuncture + real tDCS, verum acupuncture + real tDCS |
| sham tDCSParticipants will receive sham transcranial direct current stimulation. | Device | sham acupuncture + sham tDCS, verum acupuncture + sham tDCS |
Primary outcome
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.
4 secondary outcomes
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)
Cerebral Blood Flow (CBF) Differences Before and After Treatments
Time frame: Day 1 (pre-intervention); post-intervention at Week 4
Quantitative Sensory Testing (QST) Differences
Time frame: 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
Time frame: Day 1 (pre-intervention); post-intervention at Week 4 (pre-intervention - post-intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing verum acupuncture and real tDCS in people with Chronic Pain, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.