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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional acupuncture | Active Comparator | 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. |
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| Sham acupuncture | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Acupuncture | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the pain VAS versus time following opioid challenge for pre-post TA vs. pre-post SA | 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). | Change in pain score after opioid administration comparing the first and last study treatment session (2 weeks separation in time). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FIQ | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shima Khanahmadi, MD | Contact | 6262550574 | skhanahm@hs.uci.edu | |
| Hannah Cho, MD | Contact | hecho2@hs.uci.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ariana Nelson, MD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCI Health Susan Samueli Integrative Health Institute | Recruiting | Irvine | California | 92617 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33314799 | Background | 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. | |
| 28340147 |
| Label | URL |
|---|---|
| Greater Somatosensory Afference With Acupuncture Increases Primary Somatosensory Connectivity and Alleviates Fibromyalgia Pain via Insular γ-Aminobutyric Acid: A Randomized Neuroimaging Trial | View source |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Sham Acupuncture | Procedure | 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. |
|
| Change in pain score after opioid administration comparing the first and last study treatment session (2 weeks separation in time). |
| Background |
| 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. |
| 17855614 | Background | 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. |
| 38986891 | Background | 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. |
| 16131290 | Background | 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. |
| 27420606 | Background | 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. |
| 24761170 | Background | 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. |
| Evoked Pressure Pain Sensitivity Is Associated with Differential Analgesic Response to Verum and Sham Acupuncture in Fibromyalgia | View source |
| Decreased central mu-opioid receptor availability in fibromyalgia | View source |
| Temporal Summation but Not Expectations of Pain Relief Predict Response to Acupuncture Treatment in Fibromyalgia | View source |
| Endogenous opioidergic dysregulation of pain in fibromyalgia: a PET and fMRI study | View source |
| 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 | View source |
| D009422 |
| Nervous System Diseases |