Fibromyalgia
Conditions
Keywords
Acupunture
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 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.
Interventions
PROCEDURETraditional 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.
PROCEDURESham 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.
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactShima Khanahmadi, MD
Backup ContactHannah Cho, MD
Outcome results
None listed