[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06571110":3,"trial-entities:NCT06571110":142,"trial-summary:NCT06571110":145},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":45,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":67,"locations":70,"central_contacts":88,"overall_officials":96,"references":100,"see_also_links":123},"NCT06571110","4736","Analgesic Response to Opioids in Patients With Fibromyalgia After Conventional Acupuncture Versus Sham Acupuncture","RECRUITING","2027-12-01","2026-06","2026-06-15","2025-03-15","University of California, Irvine","OTHER",true,"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.",[18],"Fibromyalgia",[20],"Acupunture","INTERVENTIONAL","SUPPORTIVE_CARE",[24],"NA",{"count":26,"type":27},45,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"PROCEDURE","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.",[34],"Traditional acupuncture",{"type":30,"name":36,"description":37,"armGroupLabels":38},"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.",[39],"Sham acupuncture",[41],{"measure":42,"description":43,"timeFrame":44},"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).",[46],{"measure":47,"description":48,"timeFrame":44},"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.","ALL","18 Years","80 Years",false,{"inclusion":54,"exclusion":59,"raw_text":66},[55,56,57,58],"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)",[60,61,62,63,64,65],"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","Inclusion Criteria:\n\n* Are 18 - 80 years old\n* have been diagnosed with Fibromyalgia for more than 6 months\n* 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\n* Have moderate to excruciating pain at baseline, determined by a 5 or greater score on the Visual Analogue Scale (VAS)\n\nExclusion Criteria:\n\n* Are younger than 18 or older than 80 years old\n* Have been diagnosed with a Substance Use Disorder (SUD)\n* Pregnant\n* Have an active litigation or worker's compensation case\n* Have an active mental health diagnosis, such as bipolar disorder, psychosis, or suicidal ideation\n* Are prescribed and actively using low dose Naltrexone . Have tried acupuncture in the last 6 months",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":72,"status":7,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":85},"UCI Health Susan Samueli Integrative Health Institute","Irvine","California","92617","United States",[78,82],{"name":79,"role":80,"email":81},"Richard Harris, Phd","CONTACT","richareh@uci.edu",{"name":83,"role":80,"email":84},"Jonathan Brand, LAc","jmbrand@hs.uci.edu",{"lat":86,"lon":87},33.66946,-117.82311,[89,93],{"name":90,"role":80,"phone":91,"email":92},"Shima Khanahmadi, MD","6262550574","skhanahm@hs.uci.edu",{"name":94,"role":80,"email":95},"Hannah Cho, MD","hecho2@hs.uci.edu",[97],{"name":98,"affiliation":12,"role":99},"Ariana Nelson, MD","PRINCIPAL_INVESTIGATOR",[101,105,108,111,114,117,120],{"pmid":102,"type":103,"citation":104},"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\u002Fart.41620. Epub 2021 May 31.",{"pmid":106,"type":103,"citation":107},"28340147","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\u002Fpm\u002Fpnx001.",{"pmid":109,"type":103,"citation":110},"17855614","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\u002FJNEUROSCI.2849-07.2007.",{"pmid":112,"type":103,"citation":113},"38986891","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\u002Fj.jpain.2024.104622. Epub 2024 Jul 8.",{"pmid":115,"type":103,"citation":116},"16131290","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\u002Facm.2005.11.663.",{"pmid":118,"type":103,"citation":119},"27420606","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\u002Fj.pain.0000000000000633.",{"pmid":121,"type":103,"citation":122},"24761170","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\u002Facu.2013.0965.",[124,127,130,133,136,139],{"label":125,"url":126},"Greater Somatosensory Afference With Acupuncture Increases Primary Somatosensory Connectivity and Alleviates Fibromyalgia Pain via Insular γ-Aminobutyric Acid: A Randomized Neuroimaging Trial","https:\u002F\u002Fwww.ncbi.nlm.nih.gov\u002Fpmc\u002Farticles\u002Fpmid\u002F33314799\u002F",{"label":128,"url":129},"Evoked Pressure Pain Sensitivity Is Associated with Differential Analgesic Response to Verum and Sham Acupuncture in Fibromyalgia","https:\u002F\u002Fwww.ncbi.nlm.nih.gov\u002Fpmc\u002Farticles\u002Fpmid\u002F28340147\u002F",{"label":131,"url":132},"Decreased central mu-opioid receptor availability in fibromyalgia","https:\u002F\u002Fwww.ncbi.nlm.nih.gov\u002Fpmc\u002Farticles\u002Fpmid\u002F17855614\u002F",{"label":134,"url":135},"Temporal Summation but Not Expectations of Pain Relief Predict Response to Acupuncture Treatment in Fibromyalgia","https:\u002F\u002Flinkinghub.elsevier.com\u002Fretrieve\u002Fpii\u002FS1526-5900(24)00563-7",{"label":137,"url":138},"Endogenous opioidergic dysregulation of pain in fibromyalgia: a PET and fMRI study","https:\u002F\u002Fwww.ncbi.nlm.nih.gov\u002Fpmc\u002Farticles\u002Fpmid\u002F27420606\u002F",{"label":140,"url":141},"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","https:\u002F\u002Fwww.ncbi.nlm.nih.gov\u002Fpmc\u002Farticles\u002Fpmid\u002F24761170\u002F",{"nct_id":4,"conditions":143,"biomarkers":144},[18],[],{"nct_id":4,"found":14,"summary":146,"prompt_version":156},{"design":147,"status":148,"heading":149,"summary":150,"follow_up":151,"word_count":152,"commitments":153,"compensation":154,"drugs_mentioned":155},"This interventional study will involve 45 participants. It compares traditional acupuncture to sham acupuncture to see their effects.","completed","Acupuncture and Opioid Response in Fibromyalgia","This study is looking at whether traditional acupuncture can help people with fibromyalgia who are already taking opioid pain medications. Researchers want to see if acupuncture can make the pain-reducing effects of opioids stronger compared to a sham (fake) acupuncture treatment. You might be able to join if you are 18-80 years old, have had fibromyalgia for over 6 months, are currently taking opioid pain medication like Hydrocodone or Oxycodone daily, and have moderate to excruciating pain. The main goal is to measure how much your pain changes after taking an opioid, comparing results before and after receiving either traditional or sham acupuncture. The study plans to enroll 45 participants, but its current recruitment status is unclear.","The primary endpoint is measured after the first and last study treatment session, which are 2 weeks apart.",117,"Participants will complete a pain inventory during an opioid challenge before therapy and one week after acupuncture therapy is completed.","Not stated in the trial record.",[31,36],"v2"]