Analgesic Response to Opioids in Patients With Fibromyalgia After Conventional Acupuncture Versus Sham Acupuncture
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- University of California, Irvine
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Change in the pain VAS versus time following opioid challenge for pre-post TA vs. pre-post SA
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
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.
Detailed Description
The team 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). We will test our hypothesis by giving patients a validated Brief Pain Inventory to complete during the pre-therapy opioid challenge and one week after TA or SA therapy is completed.
Investigators
Ariana M. Nelson
MD, Associate Clinical Professor
University of California, Irvine
Eligibility 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)
- •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
Outcomes
Primary Outcomes
Change in the pain VAS versus time following opioid challenge for pre-post TA vs. pre-post SA
Time Frame: Change in pain score after opioid administration comparing the first and last study treatment session (2 weeks separation in time).
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).
Secondary Outcomes
- Change in FIQ(Change in pain score after opioid administration comparing the first and last study treatment session (2 weeks separation in time).)