Recruiting

Acupuncture vs. Sham Acupuncture

Sponsor:

UCLA

Code:

NCT06571110

Conditions

Fibromyalgia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Traditional Acupuncture

Sham Acupuncture

Study Details

Brief 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.

Conditions

Fibromyalgia

Study ID

NCT06571110

Start date

Mar 15, 2025

Status verified date

Jun, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Are younger than 18 or older than 80 years old
  • Have been diagnosed with a Substance Use Disorder (SUD)
  • 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

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Traditional acupuncture

During TA, 9 acupuncture needles (Seirin 0.25 ยท 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.

Interventions

Traditional Acupuncture

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

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.

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 and Locations

Central contacts

Shima Khanahmadi, MD

6262550574skhanahm@hs.uci.edu

Hannah Cho, MD

hecho2@hs.uci.edu

Locations

UCI Health Susan Samueli Integrative Health Institute

Recruiting

Irvine, California, United States, 92617

Contacts

Richard Harris, Phd

richareh@uci.edu

Jonathan Brand, LAc

jmbrand@hs.uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • Acupunture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-06-15.