NCT00932061

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

2.5 years

First QC Date

June 25, 2009

Last Update Submit

July 29, 2020

Conditions

Fibromyalgia

Keywords

FibromyalgiaHealthy controlsAcupunctureSham AcupuncturefMRIBiological marker

Outcome Measures

Primary Outcomes (6)

  • fMRI signal

    pre treatment - week 1

  • PET signal

    pre treatment - week 1

  • H-MRS Glutamate

    pre treatment - week 1

  • fMRI signal

    post treatment - week 5

  • PET signal

    post treatment - week 5

  • H-MRS - Glutamate

    post treatment - week 5

Secondary Outcomes (2)

  • Pain

    pre treatment - week 1

  • Pain

    post treatment - week 5

Study Arms (2)

Traditional Acupuncture

ACTIVE COMPARATOR

Acupuncture sites will be used for active intervention.

Other: Traditional Acupuncture

Sham Treatment

SHAM COMPARATOR

Sham acupuncture is used.

Other: Sham Treatment

Interventions

Traditional AcupunctureOTHER

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.

Traditional Acupuncture
Sham TreatmentOTHER

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.

Sham Treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan, Chronic Pain and Fatigue Research Center

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (5)

  • Harris RE, Zubieta JK, Scott DJ, Napadow V, Gracely RH, Clauw DJ. Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on mu-opioid receptors (MORs). Neuroimage. 2009 Sep;47(3):1077-85. doi: 10.1016/j.neuroimage.2009.05.083. Epub 2009 Jun 6.

    PMID: 19501658RESULT

  • Harris RE, Sundgren PC, Pang Y, Hsu M, Petrou M, Kim SH, McLean SA, Gracely RH, Clauw DJ. Dynamic levels of glutamate within the insula are associated with improvements in multiple pain domains in fibromyalgia. Arthritis Rheum. 2008 Mar;58(3):903-7. doi: 10.1002/art.23223.

    PMID: 18311814RESULT

  • Harris RE, Clauw DJ, Scott DJ, McLean SA, Gracely RH, Zubieta JK. Decreased central mu-opioid receptor availability in fibromyalgia. J Neurosci. 2007 Sep 12;27(37):10000-6. doi: 10.1523/JNEUROSCI.2849-07.2007.

    PMID: 17855614RESULT

  • Harris RE, Sundgren PC, Craig AD, Kirshenbaum E, Sen A, Napadow V, Clauw DJ. Elevated insular glutamate in fibromyalgia is associated with experimental pain. Arthritis Rheum. 2009 Oct;60(10):3146-52. doi: 10.1002/art.24849.

    PMID: 19790053RESULT

  • Napadow V, LaCount L, Park K, As-Sanie S, Clauw DJ, Harris RE. Intrinsic brain connectivity in fibromyalgia is associated with chronic pain intensity. Arthritis Rheum. 2010 Aug;62(8):2545-55. doi: 10.1002/art.27497.

    PMID: 20506181RESULT

Related Links

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Richard Harris, Ph.D.

    Univeristy of Michigan, Chronic Pain & Fatigue Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 25, 2009

First Posted

July 2, 2009

Study Start

June 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

July 30, 2020

Record last verified: 2020-07

Locations

US(1)