Analgesic Response to Opioids in Patients With Fibromyalgia After Conventional Acupuncture Versus Sham Acupuncture

Part of paid clinical trials in Irvine, California.

Sponsor
University of California, Irvine
Study ID
NCT06571110
Status
Recruiting
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Conditions

  • Fibromyalgia

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Traditional Acupuncture — PROCEDURE
    Acupuncture is a type of treatment where thin needles are gently inserted into specific parts of your body. It's often used to help with things like pain, headaches, stress, and anxiety.
  • Sham Acupuncture — PROCEDURE
    Sham acupuncture in this trial involves the insertion superficially to mimic the procedure of true acupuncture without providing any therapeutic effect. The needles will be similar to those used in the true acupuncture group but will not be stimulated, ensuring blinding and controlling for placebo effects.

Study Details

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.

Key Dates

Start date
Mar 15, 2025
Status verified
Nov 2025
Primary completion
Apr 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Change in the pain VAS versus time following opioid challenge for pre-post TA vs. pre-post SA [ Time Frame: Change in pain score after opioid administration comparing the first and last study treatment session (2 weeks separation in time). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCI Health Susan Samueli Integrative Health InstituteIrvineCalifornia92617
Richard Harris, Phd
[email protected]
Jonathan Brand, LAc
[email protected]

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UCI Health Susan Samueli Integrative Health Institute· Irvine, CA

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