Acupuncture for Fibromyalgia

Overseen By Shima 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether acupuncture can enhance the pain-relief effects of opioids for people with fibromyalgia. Participants will receive either traditional acupuncture or a sham version (a fake treatment that doesn't use real acupuncture points) to determine any difference in pain relief. It suits those diagnosed with fibromyalgia for over six months, experiencing moderate to severe pain, and already using opioids regularly. As an unphased trial, this study provides an opportunity to explore alternative pain management strategies for fibromyalgia.

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 prior data suggests that acupuncture is safe for fibromyalgia patients?

Research shows that acupuncture is generally safe. Studies have found that acupuncture treatments for fibromyalgia can reduce pain, improve sleep, and enhance overall quality of life. Importantly, these studies have not reported any serious side effects from acupuncture.

Traditional acupuncture uses small needles to target specific points on the body. Many trials have tested this method, and serious side effects are rare. Most people handle the treatment well. Some might feel slight discomfort or a tingling sensation where the needle is inserted, but this is usually mild.

Overall, acupuncture appears to be a well-tolerated treatment option with a low risk of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about acupuncture for fibromyalgia because it offers a unique approach compared to traditional treatments like medications and physical therapy. Traditional acupuncture involves inserting needles at specific points to stimulate De Qi sensations, which is different from simply managing symptoms with drugs. Sham acupuncture, on the other hand, uses a non-penetrating technique at non-acupuncture points, providing a valuable comparison to understand acupuncture's true effects. This trial could reveal if acupuncture provides a natural, drug-free alternative that effectively reduces fibromyalgia symptoms by tapping into the body's own healing processes.

What evidence suggests that acupuncture is effective for fibromyalgia?

This trial will compare traditional acupuncture with sham acupuncture for fibromyalgia. Research has shown that acupuncture might help people with fibromyalgia. Studies have found that acupuncture can lessen pain and improve the quality of life for these patients. One study reported significant pain relief after acupuncture treatment. Another study observed that acupuncture can quickly reduce pain with a noticeable impact. Overall, acupuncture appears promising for managing fibromyalgia symptoms. ^{1 2 4 5 6}

Who Is on the Research Team?

Ariana Nelson, MD

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

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

Have been diagnosed with a Substance Use Disorder (SUD)

Pregnant

Have an active litigation or worker's compensation case

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Traditional/Sham Acupuncture

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

How Is the Trial Designed?

Group I: Traditional acupuncture Active Control 1 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 acupuncture Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8567806/

Efficacy of acupuncture in the treatment of fibromyalgia - PMC Clinical trials studying acupuncture in fibromyalgia have shown improvement in pain, quality of sleep, and quality of life, though the quality of evidence is ...

2. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2023.1097475/full

Effectiveness of non-pharmacological traditional Chinese ... Ba-Duan-Jin alleviates pain and fibromyalgia-related symptoms in patients with fibromyalgia: results of a randomised controlled trial.

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04317-y

Acupuncture for primary fibromyalgia: Study protocol of a ... This clinical trial will use advanced research methods to evaluate the efficacy and safety of acupuncture on fibromyalgia.

4. cms.gov cms.gov/medicare-coverage-database/view/technology-assessments.aspx?taid=18

TA - Acupuncture for Fibromyalgia This study of 70 patients found statistically significant benefits for acupuncture using several outcome measures such as pain relief. This study used ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2255502114001473

Acupuncture in fibromyalgia: a randomized, controlled ... Acupuncture has proven effective in the immediate pain reduction in patients with fibromyalgia, with a quite significant effect size.

6. tandfonline.com tandfonline.com/doi/full/10.2147/JPR.S351320

Full article: Effect of Acupuncture on Pain, Fatigue, Sleep ... Studies on the efficacy of acupuncture on FM have shown mixed results. The earliest systematic review concluded that acupuncture is effective ...