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Behavioural Intervention

Acupuncture for Fibromyalgia

N/A

Waitlist Available

Led By Ariana Nelson, MD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Are prescribed and actively using low dose Naltrexone

Are younger than 18 or older than 80 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in pain score after opioid administration comparing the first and last study treatment session (2 weeks separation in time).

Summary

This trial aims to see if acupuncture can help patients with fibromyalgia by providing them with acupuncture treatment and observing if acupuncture can improve the effects of an opioid medication.

Who is the study for?

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.

What is being tested?

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

What are the potential side effects?

Possible side effects may include discomfort at needle insertion points, minor bleeding or bruising from acupuncture, and typical opioid-related side effects like drowsiness, nausea, constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Fibromyalgia for over 6 months.

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

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I am between 18 and 80 years old.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking low dose Naltrexone.

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I am between 18 and 80 years old.

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I have tried acupuncture in the past 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in pain score after opioid administration comparing the first and last study treatment session (2 weeks separation in time).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in pain score after opioid administration comparing the first and last study treatment session (2 weeks separation in time).

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in pain score after opioid administration comparing the first and last study treatment session (2 weeks separation in time). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the pain VAS versus time following opioid challenge for pre-post TA vs. pre-post SA

Secondary study objectives

Change in FIQ

Trial Design

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.

0 / 7Eligibility criteria met