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Procedure

Acupuncture + tDCS for Chronic Pain

N/A
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Volunteers 18-60 years of age
At least 4/10 clinical pain on the 11-point Low Back Pain Numeric Rating Scale (LBP NRS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (pre-intervention); post-intervention at week 4
Awards & highlights

Study Summary

This trial is testing whether combining acupuncture and transcranial direct current stimulation (tDCS) is more effective than either treatment alone for chronic low back pain (cLBP). Patients will be randomized to one of four groups: 1) verum acupuncture + real tDCS, 2) sham acupuncture + real tDCS, 3) verum acupuncture + sham tDCS, or 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

Who is the study for?
This trial is for adults aged 18-60 with chronic low back pain lasting over 6 months, experiencing a pain level of at least 4/10. Participants must understand English well enough to comprehend assessment questions. Excluded are those planning surgery soon, with substance abuse history, epilepsy, specific or complicated back issues, certain diseases like asthma or claustrophobia, MRI contraindications (like pacemakers), and significant medical or psychiatric conditions.Check my eligibility
What is being tested?
The study tests if combining acupuncture with tDCS enhances treatment for chronic low back pain. It randomly assigns patients into four groups: real acupuncture plus real tDCS; fake acupuncture plus real tDCS; real acupuncture plus fake tDCS; and fake acupuncture plus fake tDCS. The effects on brain function and clinical outcomes will be monitored over one month.See study design
What are the potential side effects?
Potential side effects from the treatments could include mild skin irritation or discomfort at the site of the acupuncture or tDCS application. There may also be temporary headaches or dizziness post-treatment. Serious adverse events are rare but will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 60 years old.
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My back pain scores at least 4 out of 10 on a pain scale.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (pre-intervention); post-intervention at week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (pre-intervention); post-intervention at week 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Periaqueductal Gray (PAG) Resting State Functional Connectivity (rsFC) Changes
Secondary outcome measures
Cerebral Blood Flow (CBF) Differences Before and After Treatments
Clinical Outcomes as Measured by LBP Intensity Scores
Differences in rsFC of M1 and Other Networks
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: verum acupuncture + sham tDCSExperimental Treatment2 Interventions
Group II: verum acupuncture + real tDCSExperimental Treatment2 Interventions
Group III: sham acupuncture + real tDCSExperimental Treatment2 Interventions
Group IV: sham acupuncture + sham tDCSPlacebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
sham tDCS
2018
Completed Phase 2
~760
verum acupuncture
2008
N/A
~70
real tDCS
2015
N/A
~160
sham acupuncture
2011
Completed Phase 4
~1540

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,235 Total Patients Enrolled
30 Trials studying Chronic Pain
4,893 Patients Enrolled for Chronic Pain

Media Library

Real tDCS (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03716830 — N/A
Chronic Pain Research Study Groups: verum acupuncture + real tDCS, sham acupuncture + real tDCS, verum acupuncture + sham tDCS, sham acupuncture + sham tDCS
Chronic Pain Clinical Trial 2023: Real tDCS Highlights & Side Effects. Trial Name: NCT03716830 — N/A
Real tDCS (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03716830 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who qualifies to participate in this experiment?

"This clinical trial is accepting applications from people aged between 18 and 60 who suffer from chronic pain; 120 participants are required in total."

Answered by AI

Are there any openings in this research endeavor for participants?

"Affirmative. According to clinicaltrials.gov, the updated trial posted on November 7th 2020 is currently enrolling individuals. The last update occurred in March 2021 and it requires 120 subjects from a single site."

Answered by AI

What is the quota of participants for this clinical experiment?

"Affirmative. The information available on clinicaltrials.gov indicates that the trial, which was launched November 7th 2020, is currently recruiting participants from a single centre with an enrolment goal of 120 patients."

Answered by AI

Is participation in this experiment limited to individuals who are within a certain age bracket?

"This trial is only open to those aged 18-60. However, there are 33 studies available for minors and 362 clinical trials that cater specifically to seniors."

Answered by AI

Who else is applying?

What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation
Jian Kong 2020. "Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03716830.
~27 spots leftby Apr 2025
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