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NCT Number: NCT06571110

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCI Health Susan Samueli Integrative Health Institute

Irvine, California, 92617, United States

Location status: Recruiting

Location contact

Jonathan Brand, LAc

CONTACT

[email protected]

Richard Harris, Phd

CONTACT

[email protected]

About this study

The investigator hypothesizes that traditional acupuncture (TA) enhances binding of the MOR receptor which will then enhance the pain-reducing effects of opioids compared to sham acupuncture (SA). The investigator will test the hypothesis by giving participants a validated Brief Pain Inventory to complete during the pre-therapy opioid challenge and one week after TA or SA therapy is completed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

    We hypothesize that patients randomized to TA treatment will have a statistically greater change in pain after the final opioid challenge compared to the initial opioid challenge, as compared to patients randomized to SA treatment(p-value set at 0.05).

Secondary outcomes

  1. Change in FIQ

    Time frame: Change in pain score after opioid administration comparing the first and last study treatment session (2 weeks separation in time).

    patients' response to pain interference over the past 7 days as assessed by the Fibromyalgia Impact Questionnaire in both patient groups to ensure a similar response to TA and SA as reflected in prior studies. The minimum value is: 0 and the maximum value is: 100. A Higher score on the FIQ indicates a worse outcome, meaning greater impact of fibromyalgia on the individual's daily life and overall functioning.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Cho, MD

CONTACT

[email protected]

Shima Khanahmadi, MD

CONTACT

[email protected]

6262550574

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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