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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06571110
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of California, Irvine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ariana Nelson, MD
Principal Investigator Affiliation	University of California, Irvine
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Fibromyalgia
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Traditional acupuncture

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.

Sham Comparator: Sham acupuncture

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.

Interventions

Procedure: - Traditional Acupuncture

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.

Procedure: - Sham Acupuncture

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Irvine, California

Status

Recruiting

Address

UCI Health Susan Samueli Integrative Health Institute

Irvine, California, 92617

Site Contact

Richard Harris, Phd

[email protected]

6262550574

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