Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06571110

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

Led by University of California, Irvine · Updated on 2025-11-12

45

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether traditional acupuncture can improve the pain-relieving effects of opioids in patients with fibromyalgia. This study compares conventional acupuncture with sham acupuncture to understand how acupuncture might enhance opioid response by affecting specific pain receptors. Participants will complete a pain inventory before and after the treatments to measure changes in pain levels. Participants will receive either traditional acupuncture, where thin needles are inserted into specific body points and manually manipulated to create sensations, or sham acupuncture, which involves superficial pricking at non-acupuncture points without skin penetration or stimulation. The study uses a randomized, double-blind design where neither participants nor researchers know who receives which treatment. During the study, participants will undergo an opioid challenge and complete validated pain questionnaires at the start and one week after finishing their acupuncture sessions. Researchers will measure changes in pain scores over time, including the primary outcome of pain intensity following opioid administration. The trial lasts approximately two weeks between the first and last treatment sessions, with ongoing monitoring of pain and function.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Are 18 - 80 years old
  • Have been diagnosed with Fibromyalgia for more than 6 months
  • Are already using chronic, continuous opioid therapy daily
  • Have moderate to excruciating pain at baseline with a score of 5 or greater on the Visual Analogue Scale (VAS)
Not Eligible

You will not qualify if you...

  • Are younger than 18 or older than 80 years old
  • Have been diagnosed with a Substance Use Disorder (SUD)
  • Are pregnant
  • Have an active litigation or worker's compensation case
  • Have an active mental health diagnosis such as bipolar disorder, psychosis, or suicidal ideation
  • Are prescribed and actively using low dose Naltrexone
  • Have tried acupuncture in the last 6 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 weeks

Participants receive either traditional acupuncture or sham acupuncture over a 2-week period to assess the effect on opioid analgesic response.

Multiple acupuncture sessions during the 2 weeks

Follow-up

Duration - 1 week

Participants complete pain assessments one week after the acupuncture treatment is completed to evaluate changes in pain response.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

UCI Health Susan Samueli Integrative Health Institute

Irvine, California, United States, 92617

Actively Recruiting

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Research Team

S

Shima Khanahmadi, MD

H

Hannah Cho, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Greater Somatosensory Afference With Acupuncture Increases Primary Somatosensory Connectivity and Alleviates Fibromyalgia Pain via Insular γ-Aminobutyric Acid: A Randomized Neuroimaging Trial.

Ishtiaq Mawla, Eric Ichesco, Helge J Zöllner...

https://pubmed.ncbi.nlm.nih.gov/33314799

Evoked Pressure Pain Sensitivity Is Associated with Differential Analgesic Response to Verum and Sham Acupuncture in Fibromyalgia.

Noah A Zucker, Alex Tsodikov, Scott D Mist...

https://pubmed.ncbi.nlm.nih.gov/28340147

Treatment of fibromyalgia with formula acupuncture: investigation of needle placement, needle stimulation, and treatment frequency.

Richard E Harris, Xiaoming Tian, David A Williams...

https://pubmed.ncbi.nlm.nih.gov/16131290

Pressure Pain Sensitivity and Insular Combined Glutamate and Glutamine (Glx) Are Associated with Subsequent Clinical Response to Sham But Not Traditional Acupuncture in Patients Who Have Chronic Pain.

Steven E Harte, Daniel J Clauw, Vitaly Napadow...

https://pubmed.ncbi.nlm.nih.gov/24761170