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Brain Mechanisms of Psychosocial Aspects of Acupuncture Therapy

NCT02908022 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-10-16

No results posted yet for this study

Summary

The overall aim of the present proposal is to investigate how patients' and clinicians' (Licensed acupuncturists, LAc) neural and autonomic processes during treatment interaction correlate to patient outcomes. Male and female healthy clinicians and fibromyalgia patients will be recruited for the study.

Conditions

  • Physician-patient Relationship
  • Fibromyalgia
  • Acupuncture Therapy

Interventions

DEVICE

Electroacupuncture Analgesia

For the MRI sessions, acupuncture needles will be inserted next to the cuff placed on the left leg and will be connected to electrodes. Low-amplitude electrical current will be activated when a button is pressed via a handheld device, controlled by the acupuncturist, in order to reduce pain, acting as an analgesic. Additionally, electroacupuncture-induced analgesia will be used for the treatments. During the treatment sessions the acupuncturist will insert needles in several locations aimed to reduce the patient's fibromyalgia pain. Low-amplitude electrical current will be activated by the acupuncturist using the same electroacupuncture device as in the MRI machine.

DEVICE

Hokanson Rapid Cuff Inflator

The Hokanson Rapid Cuff Inflator will be placed on the lower right leg of the subject and utilized for pain testing purposes according to the protocol. Ascending pressures will be administered using the cuff to elicit different pain intensities.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Vitaly Napadow, PhD, LicAc · Spaulding Rehabilitation Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • United States

Study Locations

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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 NCT02908022 on ClinicalTrials.gov