Skip to main content
OpenTrials
Completed

NCT Number: NCT00932061

Developing Biomarkers for Fibromyalgia

The hypothesis of this study is that biological markers are present in the body that are good indicators of chronic pain. Eligible participants will be assessed at baseline and after receiving a series of acupuncture or "sham" acupuncture (something that resembles, but is not, active acupuncture) sessions. If the subject qualifies for the investigators' research and are subsequently enrolled in this study, they will be randomly assigned (like the flip of a coin) to one of these two groups. Acupuncture, as previously shown by this group, leads to improvements in both clinical and evoked pain associated with fibromyalgia. The study involves two magnetic resonance imaging (MRI) brain scans, one at the beginning and one at the end of the study. Another optional portion of the study would involve 2 PET (positron emission tomography) scans of the subject's brain, one at the beginning and one at the end of the study; this type of scan allows us to get more specific information about the subject's brain function during an acupuncture session.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Chronic Pain and Fatigue Research Center

Ann Arbor, Michigan, 48106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

for Fibromyalgia Volunteers:

  • Has met American College of Rheumatology (1990) criteria for the diagnosis of fibromyalgia for at least 1 year
  • Chronic pain more than 50% of days
  • Willing to limit introduction of any new medications or treatments for fibromyalgia during the study
  • Able to attend study visits up to three times weekly
  • Right-handed
  • Be capable of giving written informed consent

Inclusion criteria

for Healthy Volunteers:

  • Willing to refrain from alcohol intake for 48 hours prior to brain scans
  • Be right handed
  • Be capable of giving written informed consent

PET Inclusion Criteria:

  • Willing to refrain from alcohol intake 48 hours prior to brain scans
  • Capable of giving written consent

Exclusion criteria

Exclusion criteria

for Fibromyalgia Volunteers:

  • Knowledge that could prevent "blinding" of the participant to the study interventions (including previous acupuncture treatment)
  • Presence of a known coagulation abnormality, thrombocytopenia, or bleeding diathesis that may preclude the safe use of acupuncture
  • Autoimmune or inflammatory disease (in addition to fibromyalgia) that causes pain (e.g., rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease)
  • Daily use of narcotic pain-relievers
  • History of substance abuse
  • Simultaneous participation in other therapeutic trials
  • Pregnant or breastfeeding
  • Current severe psychiatric illness (e.g., schizophrenia, major depression with suicidal ideation)
  • Condition that may make exposure to fMRI medically inadvisable
  • Any condition that may prevent satisfactory completion of the study protocol

Exclusion for Healthy Volunteers:

  • Autoimmune or inflammatory disease (in addition to fibromyalgia) that causes pain (e.g., rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease)
  • Having met the ACR criteria for FM
  • Simultaneous participation in other therapeutic trials
  • Pregnant or breastfeeding
  • Current severe psychiatric illness (e.g., schizophrenia, major depression with suicidal ideation)
  • Condition that may make exposure to fMRI medically inadvisable
  • Any condition that may prevent satisfactory completion of the study protocol

PET Exclusion Criteria:

  • Meets any of the fMRI exclusion criteria
  • Current major depression
  • Condition that may make exposure to PET medically inadvisable

Treatment and study plan

Traditional Acupuncture

Other

Fibromyalgia subjects will be randomized to receive 9 acupuncture treatments over the course of four weeks.

Subjects enrolled in the study may have 1) only fMRI or 2) fMRI scans and PET scans, depending on their eligibility criteria.

Sham Treatment

Other

Fibromyalgia subjects will be randomized to receive 9 sham treatments over the course of four weeks.

Subjects enrolled in the study may have 1) only fMRI or 2) fMRI scans and PET scans, depending on their eligibility criteria.

Primary outcomes

  1. fMRI signal

    Time frame: pre treatment - week 1

  2. PET signal

    Time frame: pre treatment - week 1

  3. H-MRS Glutamate

    Time frame: pre treatment - week 1

  4. fMRI signal

    Time frame: post treatment - week 5

  5. PET signal

    Time frame: post treatment - week 5

  6. H-MRS - Glutamate

    Time frame: post treatment - week 5

Secondary outcomes

  1. Pain

    Time frame: pre treatment - week 1

  2. Pain

    Time frame: post treatment - week 5

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • The Dana Foundation
  • United States Department of Defense

Registry information

Acronym: Biomarkers

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 2, 2009
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.