NCT00142597

Brief Summary

This study will determine the effectiveness of acupuncture versus a placebo in altering brain activity and relieving pain due to fibromyalgia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2005

Longer than P75 for phase_1

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

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

April 13, 2015

Completed
Last Updated

April 13, 2015

Status Verified

December 1, 2014

Enrollment Period

5.8 years

First QC Date

September 1, 2005

Results QC Date

December 4, 2014

Last Update Submit

April 9, 2015

Conditions

Fibromyalgia

Keywords

acupunctureanalgesiapainfibromyalgiafMRIPET

Outcome Measures

Primary Outcomes (1)

  • Change in Mu-opioid Receptor Occupancy

    Here we report the change (post - pre) in mu-opioid receptor binding potential (BP) for the perigenual anterior cingulate. BP is a unitless measure and reflects the total maximum binding of receptors divided by the dissociation constant. BP = Bmax/Kd.

    measured from baseline to week 5

Study Arms (2)

Traditional Acupuncture

ACTIVE COMPARATOR

Acupuncture sites will be used for active intervention.

Device: Acupuncture

Sham Treatment

SHAM COMPARATOR

Sham acupuncture is used.

Other: Sham treatment

Interventions

AcupunctureDEVICE

Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body. Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks. All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional.

Traditional Acupuncture
Sham treatmentOTHER

Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks. All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional.

Sham Treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
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
  • Must be within driving distance of Ann Arbor, MI
  • Willing to refrain from alcohol intake for 48 hours prior to PET studies

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
  • Current major depression
  • Condition that may make exposure to PET medically inadvisable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • 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: 18311814DERIVED

MeSH Terms

Conditions

FibromyalgiaAgnosiaPain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Results Point of Contact

Title
Richard E. Harris
Organization
University of Michigan
reharris@med.umich.edu
734-998-6996

Study Officials

  • Richard E. Harris, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

May 1, 2005

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

April 13, 2015

Results First Posted

April 13, 2015

Record last verified: 2014-12

Locations

US(1)