Analgesic Response to Opioids in Patients With Fibromyalgia After Conventional Acupuncture Versus Sham Acupuncture
- Conditions
- Fibromyalgia
- Interventions
- Procedure: Traditional/Sham Acupuncture
- Registration Number
- NCT06571110
- Lead Sponsor
- University of California, Irvine
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Traditional acupuncture Traditional/Sham 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 acupuncture Traditional/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.
- Primary Outcome Measures
Name Time Method Change in the pain VAS versus time following opioid challenge for pre-post TA vs. pre-post SA 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 Outcome Measures
Name Time Method Change in FIQ Change in pain score after opioid administration comparing the first and last study treatment session (2 weeks separation in time). 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.
Trial Locations
- Locations (1)
UCI Health Susan Samueli Integrative Health Institute
🇺🇸Irvine, California, United States