Back to results

Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation

Primary Purpose

Chronic Pain

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

verum acupuncture

sham acupuncture

real tDCS

sham tDCS

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Arm Label

verum acupuncture + real tDCS

sham acupuncture + real tDCS

verum acupuncture + sham tDCS

sham acupuncture + sham tDCS

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Quantitative Sensory Testing (QST) Differences

Participants' QST ratings will be analyzed before and after all treatments.

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.

Full Information

NCT ID

NCT03716830

First Posted

October 18, 2018

Last Updated

February 28, 2023

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03716830

Brief Title

Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation

Official Title

Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 7, 2020 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

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

ParticipantInvestigator

Masking Description

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.

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

verum acupuncture + real tDCS

Arm Type

Experimental

Arm Title

sham acupuncture + real tDCS

Arm Type

Experimental

Arm Title

verum acupuncture + sham tDCS

Arm Type

Experimental

Arm Title

sham acupuncture + sham tDCS

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

verum acupuncture

Intervention Description

Participants will receive real acupuncture treatment.

Intervention Type

Device

Intervention Name(s)

sham acupuncture

Intervention Description

Participants will receive sham acupuncture treatment.

Intervention Type

Device

Intervention Name(s)

real tDCS

Intervention Description

Participants will receive real transcranial direct current stimulation.

Intervention Type

Device

Intervention Name(s)

sham tDCS

Intervention Description

Participants will receive sham transcranial direct current stimulation.

Primary Outcome Measure Information:

Title

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

Description

Time Frame