Phase 2
N=46
Effectiveness of Acupuncture in Relieving Pain Due to Fibromyalgia
Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT00142597 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Change in Mu-opioid Receptor Occupancy — 0.2352; .0015 Unitless: binding potential is Bmax/Kd
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Acupuncture (Device); Sham treatment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Michigan
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mu-opioid Receptor Occupancy |
0.2352; .0015 | — |
Summary
This study will determine the effectiveness of acupuncture versus a placebo in altering brain activity and relieving pain due to fibromyalgia.
Eligibility Criteria
Inclusion Criteria
fMRI Inclusion Criteria:
- 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
PET Inclusion Criteria:
- Meets fMRI inclusion criteria
- Willing to refrain from alcohol intake for 48 hours prior to PET studies
Exclusion Criteria
fMRI Exclusion Criteria:
- 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
PET Exclusion Criteria:
- Meets any of the fMRI exclusion criteria
- Current major depression
- Condition that may make exposure to PET medically inadvisable
Data sourced from ClinicalTrials.gov (NCT00142597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.