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Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation

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ClinicalTrials.gov Identifier: NCT03716830
Recruitment Status : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Jian Kong, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Device: verum acupuncture Device: sham acupuncture Device: real tDCS Device: sham tDCS Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention 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 (Participant, Investigator)
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.
Primary Purpose: Treatment
Official Title: Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: verum acupuncture + real tDCS Device: verum acupuncture
Participants will receive real acupuncture treatment.

Device: real tDCS
Participants will receive real transcranial direct current stimulation.

Experimental: sham acupuncture + real tDCS Device: sham acupuncture
Participants will receive acupuncture treatment with retractable needles (sham).

Device: real tDCS
Participants will receive real transcranial direct current stimulation.

Experimental: verum acupuncture + sham tDCS Device: verum acupuncture
Participants will receive real acupuncture treatment.

Device: sham tDCS
Participants will receive sham transcranial direct current stimulation.

Sham Comparator: sham acupuncture + sham tDCS Device: sham acupuncture
Participants will receive acupuncture treatment with retractable needles (sham).

Device: sham tDCS
Participants will receive sham transcranial direct current stimulation.




Primary Outcome Measures :
  1. Periaqueductal Gray (PAG) Resting State Functional Connectivity (rsFC) Changes [ Time Frame: Day 1 (pre-intervention); post-intervention at Week 4 ]
    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 :
  1. Clinical Outcomes as Measured by LBP Intensity Scores [ Time Frame: Day 1 (pre-intervention); post-intervention at Week 4 ]
    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.

  2. Cerebral Blood Flow (CBF) Differences Before and After Treatments [ Time Frame: Day 1 (pre-intervention); post-intervention at Week 4 ]
    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.

  3. Quantitative Sensory Testing (QST) Differences [ Time Frame: Day 1 (pre-intervention); post-intervention at Week 4 ]
    Participants' QST ratings will be analyzed before and after all treatments.

  4. Differences in rsFC of M1 and Other Networks [ Time Frame: Day 1 (pre-intervention); post-intervention at Week 4 ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716830


Contacts
Contact: Jian Kong, MD, MS, MPH 617-726-7893 jkong2@mgh.harvard.edu

Sponsors and Collaborators
Massachusetts General Hospital

Responsible Party: Jian Kong, Associate Professor, Associate Researcher, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03716830     History of Changes
Other Study ID Numbers: 2018P001970
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms