Health TrialsbyHealthPanel

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

ConditionFibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of California, Irvine

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Traditional Acupuncture

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: Traditional acupunctureActive comparator 1 intervention
Group B: Sham acupunctureSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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).

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

Secondary outcomes

1

Change in FIQ

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Irvine

Lead sponsor

Source ClinicalTrials.gov
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