Analgesic Response to Opioids in Patients With Fibromyalgia After Conventional Acupuncture Versus Sham Acupuncture
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study aims to see whether acupuncture can help fibromyalgia patients by giving them acupuncture treatment and seeing whether acupuncture helps enhance the effects of an opioid.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Are 18 - 80 years old
• have been diagnosed with Fibromyalgia for more than 6 months
• Are already using chronic, continuous opioid therapy, including but not limited to the use of Hydrocodone (Norco), Oxycodone (Percocet), morphine, methadone or Tylenol #3 daily
• Have moderate to excruciating pain at baseline, determined by a 5 or greater score on the Visual Analogue Scale (VAS)
Locations
United States
California
UCI Health Susan Samueli Integrative Health Institute
RECRUITING
Irvine
Contact Information
Primary
Shima Khanahmadi, MD
skhanahm@hs.uci.edu
6262550574
Backup
Hannah Cho, MD
hecho2@hs.uci.edu
Time Frame
Start Date: 2025-03-15
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 45
Treatments
Active_comparator: Traditional acupuncture
During TA, 9 acupuncture needles (Seirin 0.25 · 50 mm) are inserted at GV20,earShenmen,LI4,LI11,SP6,LR3,GB34,and bilateral ST 36. Needle insertion depth is approximately 2 cm for all TA points except for DU 20 and ear Shenmen, which have shallower insertion depths. All needles below the neck level are manually manipulated to elicit De Qi sensations.
Sham_comparator: Sham acupuncture
SA participants experience a non-skin penetrating pricking sensation at 9 non-acupuncture point locations, sham intervention did not penetrate the skin and was designed to not elicit De Qi. somatosensory component generated by this procedure would be likely to be less than the skin penetrating-TA protocol that elicited De Qi. The sham locations were within similar body locations as the TA points; however, the SA location is not on known acupuncture points or meridians.
Related Therapeutic Areas
Sponsors
Leads: University of California, Irvine