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Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain

NCT02064296 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2022-09-22

Study results available
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Summary

The aim of this study is to evaluate the impact of electro-acupuncture in pain processing on patients with fibromyalgia (FM). The investigators hypothesize that electro-acupuncture is effective for FM because it functions as a desensitization therapy, which when applied repeatedly over multiple treatment sessions, gradually habituates the nervous system to continuing pain and sensory signaling.

Conditions

  • Fibromyalgia

Interventions

DEVICE

Needle acupuncture (Traditional Acupuncture)

This group will receive needle acupuncture at 3 pairs of sites. The needles will be stimulated with low intensity, low frequency electric current using a constant-current electro-acupuncture device (AS Super 4 digital needle stimulator).

DEVICE

Laser acupuncture (Non-traditional Acupuncture)

For non-traditional acupuncture, a laser acupuncture device (Vita Laser 650, Lhasa OMS) will be positioned over all of the same acupoints used in EA. There will be no palpation prior to positioning these devices, and there will be no physical contact between device and skin.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Massachusetts General Hospital

    collaborator OTHER

  • University of Michigan

    lead OTHER

Principal Investigators

  • Richard E Harris, PhD · University of Michigan

  • Viataly Napadow, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2019-11-22
Completion
2019-11-22

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02064296 on ClinicalTrials.gov