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Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation

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Conditions

Chronic Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation

Quick Facts

Study Start:2020-11-07
Study Completion:2025-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT03716830

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * volunteers 18-60 years of age
  2. * meet the classification criteria of chronic low back pain (having low back pain for more than 6 months), as determined by the referring physician
  3. * at least 4/10 clinical pain on the 11-point Low Back Pain Numeric Rating Scale (LBP NRS)
  4. * 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
  1. * history of epilepsy or loss consciousness (LOC)
  2. * specific causes of back pain (e.g. cancer, fractures, spinal stenosis, infections)
  3. * complicated back problems (e.g. prior back surgery, medicolegal issues)
  4. * the intent to undergo surgery during the time of involvement in the study
  5. * 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
  6. * 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
  7. * history of medical or psychiatric illness as determined by the investigator
  8. * history of substance abuse or dependence

Contacts and Locations

Study Locations (Sites)

Massachusetts General Hospital
Charlestown, Massachusetts, 02129-2020
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-07
Study Completion Date2025-03-31

Study Record Updates

Study Start Date2020-11-07
Study Completion Date2025-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Pain