Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation

NCT ID: NCT03716830

Last Updated: 2025-11-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-07

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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verum acupuncture + real tDCS

Group Type EXPERIMENTAL

verum acupuncture

Intervention Type DEVICE

Participants will receive real acupuncture treatment.

real tDCS

Intervention Type DEVICE

Participants will receive real transcranial direct current stimulation.

sham acupuncture + real tDCS

Group Type EXPERIMENTAL

sham acupuncture

Intervention Type DEVICE

Participants will receive sham acupuncture treatment.

real tDCS

Intervention Type DEVICE

Participants will receive real transcranial direct current stimulation.

verum acupuncture + sham tDCS

Group Type EXPERIMENTAL

verum acupuncture

Intervention Type DEVICE

Participants will receive real acupuncture treatment.

sham tDCS

Intervention Type DEVICE

Participants will receive sham transcranial direct current stimulation.

sham acupuncture + sham tDCS

Group Type SHAM_COMPARATOR

sham acupuncture

Intervention Type DEVICE

Participants will receive sham acupuncture treatment.

sham tDCS

Intervention Type DEVICE

Participants will receive sham transcranial direct current stimulation.

Interventions

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verum acupuncture

Participants will receive real acupuncture treatment.

Intervention Type DEVICE

sham acupuncture

Participants will receive sham acupuncture treatment.

Intervention Type DEVICE

real tDCS

Participants will receive real transcranial direct current stimulation.

Intervention Type DEVICE

sham tDCS

Participants will receive sham transcranial direct current stimulation.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jian Kong

Associate Professor, Associate Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Charlestown, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2018P001970

Identifier Type: -

Identifier Source: org_study_id

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