CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
Acupuncture +1 moredevice
Likely dose
9 acupuncture treatments over 4 weeksAI-extracted
Key inclusion· 6
  • Diagnosed with fibromyalgia by American College of Rheumatology 1990 criteria for at least 1 year
  • Chronic pain present more than 50% of days
  • Willing to avoid starting any new fibromyalgia medications or treatments during the study
  • Able to attend study visits up to three times per week
Key exclusion· 10
  • Prior acupuncture treatment (would compromise blinding)
  • Known coagulation abnormality, thrombocytopenia, or bleeding disorder that may preclude safe acupuncture use
  • Other autoimmune or inflammatory diseases causing pain (e.g., rheumatoid arthritis, lupus, inflammatory bowel disease)
  • Daily use of narcotic pain relievers

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00142597
NCT00142597Phase 2Completed

Mechanisms of Acupuncture Analgesia

University of Michigan·interventional·Posted Sep 2, 2005·Updated Apr 13, 2015

In Brief

A Phase 2 clinical trial evaluating Acupuncture and Sham treatment for Fibromyalgia. Completed, enrolled 46 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2, 2005
Enrollment StartMay 1, 2005
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 20.8 years ago

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.

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.