Clinical trial NCT06571110: Analgesic Response to Opioids in Patients With Fibromyalgia After Conventional Acupuncture Versus Sham Acupuncture
Official title: Analgesic Response to Opioids in Patients With Fibromyalgia After Conventional Acupuncture Versus Sham Acupuncture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: Acupunture
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)
* 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

Primary outcomes:
measure: Change in the pain VAS versus time following opioid challenge for pre-post TA vs. pre-post SA
timeFrame: Change in pain score after opioid administration comparing the first and last study treatment session (2 weeks separation in time).
Secondary outcomes:
measure: Change in FIQ
timeFrame: Change in pain score after opioid administration comparing the first and last study treatment session (2 weeks separation in time).
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UCI Health Susan Samueli Integrative Health Institute
state: California
Study officials:
affiliation: University of California, Irvine
name: Ariana Nelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mawla I, Ichesco E, Zollner HJ, Edden RAE, Chenevert T, Buchtel H, Bretz MD, Sloan H, Kaplan CM, Harte SE, Mashour GA, Clauw DJ, Napadow V, Harris RE. Greater Somatosensory Afference With Acupuncture Increases Primary Somatosensory Connectivity and Alleviates Fibromyalgia Pain via Insular gamma-Aminobutyric Acid: A Randomized Neuroimaging Trial. Arthritis Rheumatol. 2021 Jul;73(7):1318-1328. doi: 10.1002/art.41620. Epub 2021 May 31.
citation: Zucker NA, Tsodikov A, Mist SD, Cina S, Napadow V, Harris RE. Evoked Pressure Pain Sensitivity Is Associated with Differential Analgesic Response to Verum and Sham Acupuncture in Fibromyalgia. Pain Med. 2017 Aug 1;18(8):1582-1592. doi: 10.1093/pm/pnx001.
citation: Harris RE, Clauw DJ, Scott DJ, McLean SA, Gracely RH, Zubieta JK. Decreased central mu-opioid receptor availability in fibromyalgia. J Neurosci. 2007 Sep 12;27(37):10000-6. doi: 10.1523/JNEUROSCI.2849-07.2007.
citation: Murphy AE, Buchtel H, Mawla I, Ichesco E, Larkin T, Harte SE, Zhan E, Napadow V, Harris RE. Temporal Summation but Not Expectations of Pain Relief Predict Response to Acupuncture Treatment in Fibromyalgia. J Pain. 2024 Oct;25(10):104622. doi: 10.1016/j.jpain.2024.104622. Epub 2024 Jul 8.
citation: Harris RE, Tian X, Williams DA, Tian TX, Cupps TR, Petzke F, Groner KH, Biswas P, Gracely RH, Clauw DJ. Treatment of fibromyalgia with formula acupuncture: investigation of needle placement, needle stimulation, and treatment frequency. J Altern Complement Med. 2005 Aug;11(4):663-71. doi: 10.1089/acm.2005.11.663.
citation: Schrepf A, Harper DE, Harte SE, Wang H, Ichesco E, Hampson JP, Zubieta JK, Clauw DJ, Harris RE. Endogenous opioidergic dysregulation of pain in fibromyalgia: a PET and fMRI study. Pain. 2016 Oct;157(10):2217-2225. doi: 10.1097/j.pain.0000000000000633.
citation: Harte SE, Clauw DJ, Napadow V, Harris RE. Pressure Pain Sensitivity and Insular Combined Glutamate and Glutamine (Glx) Are Associated with Subsequent Clinical Response to Sham But Not Traditional Acupuncture in Patients Who Have Chronic Pain. Med Acupunct. 2013 Apr;25(2):154-160. doi: 10.1089/acu.2013.0965.