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Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

45 Participants Needed

Acupuncture for Fibromyalgia

Overseen ByShima Khanahmadi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Must be taking: Opioids

Must not be taking: Naltrexone

Disqualifiers: Substance use disorder, Pregnancy, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires participants to continue using their current opioid medications, as it aims to see if acupuncture enhances their effects. There is no mention of stopping other medications, so the protocol does not specify.

What data supports the effectiveness of acupuncture as a treatment for fibromyalgia?

Research shows that acupuncture can improve symptoms of fibromyalgia, such as reducing pain and improving quality of life, when compared to sham (fake) acupuncture or usual treatment.¹ ² ³ ⁴ ⁵

Is acupuncture safe for treating fibromyalgia?

Research on acupuncture for fibromyalgia often focuses on its effectiveness, but some studies also report on safety. Generally, acupuncture is considered safe when performed by trained professionals, with few side effects like minor bruising or soreness at the needle sites.¹ ² ³ ⁴ ⁶

How does acupuncture treatment differ from other treatments for fibromyalgia?

Acupuncture for fibromyalgia is unique because it involves stimulating specific points on the body to potentially modulate the nervous system, which may help relieve pain. Unlike medications, acupuncture does not involve taking drugs and instead uses thin needles to target pain pathways, offering an alternative for those seeking non-drug therapies.¹ ⁷ ⁸ ⁹ ¹⁰

Research Team

Ariana Nelson, MD

Principal Investigator

University of California, Irvine

Eligibility Criteria

This trial is for individuals with fibromyalgia or myofascial pain syndrome. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions and agree to the study's procedures.

Inclusion Criteria

I am on daily opioid pain medication like Norco or Percocet.

My pain level is moderate to severe, scoring 5 or more on a pain scale.

I have been diagnosed with Fibromyalgia for over 6 months.

Exclusion Criteria

I am currently taking low dose Naltrexone.

Have been diagnosed with a Substance Use Disorder (SUD)

Pregnant

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either traditional acupuncture or sham acupuncture over a 2-week period, with opioid challenges conducted before and after the treatment

2 weeks

Follow-up

Participants are monitored for changes in pain and fibromyalgia impact after treatment

4 weeks

Treatment Details

Interventions

Traditional/Sham Acupuncture

Trial OverviewThe study is testing if traditional acupuncture can improve the effectiveness of opioids in managing pain for fibromyalgia patients compared to sham (fake) acupuncture.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Traditional acupunctureActive Control1 Intervention

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.

Group II: Sham acupuncturePlacebo Group1 Intervention

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.