Analgesic Response to Opioids in Patients With Fibromyalgia After Conventional Acupuncture Versus Sham Acupuncture
NCT ID: NCT06571110
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2025-03-15
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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University of California, Irvine
OTHER
Responsible Party
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Ariana M. Nelson
MD, Associate Clinical Professor
Principal Investigators
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Ariana Nelson, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Irvine
Locations
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UCI Health Susan Samueli Integrative Health Institute
Irvine, California, United States
Countries
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Central Contacts
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Facility Contacts
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Richard Harris, Phd
Role: primary
Jonathan Brand, LAc
Role: backup
References
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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.
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.
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.
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.
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.
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.
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.
Related Links
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Greater Somatosensory Afference With Acupuncture Increases Primary Somatosensory Connectivity and Alleviates Fibromyalgia Pain via Insular γ-Aminobutyric Acid: A Randomized Neuroimaging Trial
Evoked Pressure Pain Sensitivity Is Associated with Differential Analgesic Response to Verum and Sham Acupuncture in Fibromyalgia
Decreased central mu-opioid receptor availability in fibromyalgia
Temporal Summation but Not Expectations of Pain Relief Predict Response to Acupuncture Treatment in Fibromyalgia
Endogenous opioidergic dysregulation of pain in fibromyalgia: a PET and fMRI study
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
Other Identifiers
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4736
Identifier Type: -
Identifier Source: org_study_id