Study Results
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
50 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-01-24
Study Completion Date
2021-09-29
Brief Summary
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The current opioid epidemic has led to a renewed interest in exploring non-pharmacological techniques to treat post-operative pain. An increasing number of patients are suffering from the adverse effects of opioid use following surgery, including post-operative nausea and vomiting, respiratory depression, immunosuppression, constipation, and most recently, addiction. In the United States, over $600 billion is spent every year on opioid addiction, including $79 billion related to opioid addiction following surgery. Despite many initiatives to decrease the use of opiates in the preoperative setting, opioids continue to be regularly prescribed before, during and after surgery. Although the risk of opioid addiction following surgery is recognized, the percentage of patients becoming addicted to opioids following surgery is not well understood.
To date, there has been virtually no agreement regarding the duration and dosage that qualify for opioid dependence following surgery, nor that a clear estimation of the factors such as biological, psychosocial and socioeconomic that increase the risk of using opioids for extended periods of time after surgery. The interscalene block is the gold standard for postoperative pain management following shoulder surgery. However, the duration of the block does not cover rehabilitation, and in most cases, patients are discharged from the hospital with an opioid prescription. Therefore, there is a growing need to investigate complementary pain-management methods that offer a non-pharmacological solution to managing post-operative pain. Auriculotherapy is such a technique that has been shown in previous studies to provide significant analgesia without the adverse effects of opioids or other pain-relieving medications. Auriculotherapy has been shown to reduce the need for opioid immediately after surgery. However, everyone agrees that more research is needed, especially due to the concern of the placebo effect when using a needle and electro-stimulation. This study is purposely based on the use of a cryopuntor device, which has been shown to produce the same effect as needles. This is a novel complementary approach to reducing the persistence of opioid prescription following rotator cuff surgery, which is considered a model of severe functional pain. Data obtained from this study will support a future NIDA proposal to expand the use of auriculotherapy for perioperative management of pain and functional recovery associated with surgery. The use of an auriculotherapy approach has the potential of providing effective non-opioid analgesia to patients not only undergoing rotator cuff surgery, but also other surgical models.
To date, there has been virtually no agreement regarding the duration and dosage that qualify for opioid dependence following surgery, nor that a clear estimation of the factors such as biological, psychosocial and socioeconomic that increase the risk of using opioids for extended periods of time after surgery. The interscalene block is the gold standard for postoperative pain management following shoulder surgery. However, the duration of the block does not cover rehabilitation, and in most cases, patients are discharged from the hospital with an opioid prescription. Therefore, there is a growing need to investigate complementary pain-management methods that offer a non-pharmacological solution to managing post-operative pain. Auriculotherapy is such a technique that has been shown in previous studies to provide significant analgesia without the adverse effects of opioids or other pain-relieving medications. Auriculotherapy has been shown to reduce the need for opioid immediately after surgery. However, everyone agrees that more research is needed, especially due to the concern of the placebo effect when using a needle and electro-stimulation. This study is purposely based on the use of a cryopuntor device, which has been shown to produce the same effect as needles. This is a novel complementary approach to reducing the persistence of opioid prescription following rotator cuff surgery, which is considered a model of severe functional pain. Data obtained from this study will support a future NIDA proposal to expand the use of auriculotherapy for perioperative management of pain and functional recovery associated with surgery. The use of an auriculotherapy approach has the potential of providing effective non-opioid analgesia to patients not only undergoing rotator cuff surgery, but also other surgical models.
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Detailed Description
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Once patient has signed the Informed Consent to participate in this trial, demographic information and medical history will be collected from each participant on the day of surgery. Research staff will record this information from the medical chart. The Medical Outcomes Study Questionnaire 12-Item Short Form Health Survey (SF-12) will also be administered at this time to obtain baseline value. Randomization will occur by assigning the participant a subject ID number, and this ID number will correspond to a treatment allocation based on a pre-designed randomization schema. This treatment allocation (intervention/control) will be contained in a sealed, opaque, envelope with the subject ID number that is designated on envelope. The master randomization list will be created and held by an independent data monitor who will both create and hold the master randomization list.
Study coordinators, Co-Is and subjects will be blinded. Only the research staff completing the treatment will be unblinded. Once the patient is randomized to a treatment group by research staff, Auriculotherapy will be performed by certified research staff using a cryoauriculopuncture in the post-anesthesia recovery room, either with nitrogen gas (intervention group), or an empty cryoauriculopunture with no gas (control group).
After proper disinfection of the designated ear, the treatment consists of the stimulation of 9 ear points on the ipsilateral ear. These points include:-Ω2 (the master point for the mesoderm), the shoulder point, 6 points involved with the pain pathway (the stellar ganglion, the sensory and motor C7 branches, the sensory master point (MSP), the reticular master point (RMP) and the point corresponding to the Thalamus). Finally, the stimulation of the ACTH point completes the treatment. The total time required to complete auriulotherapy treatment is approximately 10 minutes. The enrolled subject will also receive a pre-operative interscalene block as per standard of care. The patient will receive standard of care treatment for surgery, post-operative pain management, and physical therapy. After surgery, the subject will be assessed at time of hospital discharge to review how to complete the subject diary, administer pain satisfaction questionnaire (0-6) and obtain NRS pain at rest and with movement scores (0-10). When the patient is discharged from the hospital, the subject will be asked to take home and complete a subject diary where they will record their total narcotic/pain medication consumption, pain satisfaction score (0-6), and NRS pain score (0-10), and adverse events daily for first 5 days post-discharge. The subject will be instructed to complete the diary just before bedtime on these post-op days. The patient will be contacted via telephone on Day 5 post-operatively as a reminder to return pain diary. On post-operative Day 14, 30, 60 and 90 telephone calls, functional recovery will be measured using the Medical Outcomes Study Questionnaire 12-Item Short Form Health Survey (SF-12). The subject will also be asked to assess their overall patient satisfaction at the Day 90 call, on a scale of 0 (least satisfaction) to 10 (most satisfaction). Analgesic efficacy in both groups will also be evaluated by the amount of total narcotic consumption (measured with oral morphine equivalent doses of analgesics used to provide pain relief). Secondary outcome measures will include pain at rest and with movement, total non-narcotic pain medication consumption for the first 5-days post-discharge, time to readiness for discharge from PACU, time to hospital discharge, readmission to the hospital because of pain related issues, incidence of postoperative complications, overall patient satisfaction, patient satisfaction relating to pain management and functional recovery. Functional recovery will be measured using the Medical Outcomes Study Questionnaire 12-Item Short Form Health Survey (SF-12).
Since, starting the study, the secondary outcome measure of "Change in post-operative opioid consumption in opioid naïve subjects undergoing rotator cuff surgery" has been removed as this is repetitive of the data collected as part of the primary outcome measure and its analysis. Additionally the outcome of "Pain scores following rotator cuff surgery" was further specified to Post-operative pain at rest and Post-operative pain with movement for clarification and analysis of each individually. This was also altered from a primary to secondary outcome to match the current IRB approved protocol for this study in which pain scores were a secondary outcome.
Study coordinators, Co-Is and subjects will be blinded. Only the research staff completing the treatment will be unblinded. Once the patient is randomized to a treatment group by research staff, Auriculotherapy will be performed by certified research staff using a cryoauriculopuncture in the post-anesthesia recovery room, either with nitrogen gas (intervention group), or an empty cryoauriculopunture with no gas (control group).
After proper disinfection of the designated ear, the treatment consists of the stimulation of 9 ear points on the ipsilateral ear. These points include:-Ω2 (the master point for the mesoderm), the shoulder point, 6 points involved with the pain pathway (the stellar ganglion, the sensory and motor C7 branches, the sensory master point (MSP), the reticular master point (RMP) and the point corresponding to the Thalamus). Finally, the stimulation of the ACTH point completes the treatment. The total time required to complete auriulotherapy treatment is approximately 10 minutes. The enrolled subject will also receive a pre-operative interscalene block as per standard of care. The patient will receive standard of care treatment for surgery, post-operative pain management, and physical therapy. After surgery, the subject will be assessed at time of hospital discharge to review how to complete the subject diary, administer pain satisfaction questionnaire (0-6) and obtain NRS pain at rest and with movement scores (0-10). When the patient is discharged from the hospital, the subject will be asked to take home and complete a subject diary where they will record their total narcotic/pain medication consumption, pain satisfaction score (0-6), and NRS pain score (0-10), and adverse events daily for first 5 days post-discharge. The subject will be instructed to complete the diary just before bedtime on these post-op days. The patient will be contacted via telephone on Day 5 post-operatively as a reminder to return pain diary. On post-operative Day 14, 30, 60 and 90 telephone calls, functional recovery will be measured using the Medical Outcomes Study Questionnaire 12-Item Short Form Health Survey (SF-12). The subject will also be asked to assess their overall patient satisfaction at the Day 90 call, on a scale of 0 (least satisfaction) to 10 (most satisfaction). Analgesic efficacy in both groups will also be evaluated by the amount of total narcotic consumption (measured with oral morphine equivalent doses of analgesics used to provide pain relief). Secondary outcome measures will include pain at rest and with movement, total non-narcotic pain medication consumption for the first 5-days post-discharge, time to readiness for discharge from PACU, time to hospital discharge, readmission to the hospital because of pain related issues, incidence of postoperative complications, overall patient satisfaction, patient satisfaction relating to pain management and functional recovery. Functional recovery will be measured using the Medical Outcomes Study Questionnaire 12-Item Short Form Health Survey (SF-12).
Since, starting the study, the secondary outcome measure of "Change in post-operative opioid consumption in opioid naïve subjects undergoing rotator cuff surgery" has been removed as this is repetitive of the data collected as part of the primary outcome measure and its analysis. Additionally the outcome of "Pain scores following rotator cuff surgery" was further specified to Post-operative pain at rest and Post-operative pain with movement for clarification and analysis of each individually. This was also altered from a primary to secondary outcome to match the current IRB approved protocol for this study in which pain scores were a secondary outcome.
Conditions
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Acute Pain
Surgery
Shoulder Pain
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Outcome Assessors
The only person unblinded to treatment allocation will be the Principal investigator or designee -- the individual performing cryopuncture
Study Groups
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Auriculotherapy without nitrogen gas
Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.
Group Type
PLACEBO_COMPARATOR
Auriculotherapy cryopuncture device without nitrogen gas
Intervention Type
DEVICE
Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
Auriculotherapy with nitrogen gas
Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy.
Group Type
ACTIVE_COMPARATOR
Auriculotherapy cryopuncture device with nitrogen gas
Intervention Type
DEVICE
Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
Interventions
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Auriculotherapy cryopuncture device without nitrogen gas
Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
Intervention Type
DEVICE
Auriculotherapy cryopuncture device with nitrogen gas
Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
1. Subject is greater than 18 years of age
2. Subject is willing and able to provide informed consent
3. Subject is scheduled to undergo elective rotator cuff surgery
4. Subject has consented to an interscalene block
2. Subject is willing and able to provide informed consent
3. Subject is scheduled to undergo elective rotator cuff surgery
4. Subject has consented to an interscalene block
Exclusion Criteria
1. Opioid dependence
2. Any subject diagnosed with a chronic pain condition which daily opioid use is needed
3. Anatomical malformation, which in the investigator's opinion may interfere with the placement of the nerve block
4. Raynaud's disease diagnosis
5. Vasculopathy
6. Patient refusal
2. Any subject diagnosed with a chronic pain condition which daily opioid use is needed
3. Anatomical malformation, which in the investigator's opinion may interfere with the placement of the nerve block
4. Raynaud's disease diagnosis
5. Vasculopathy
6. Patient refusal
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Jacques E. Chelly
OTHER
Sponsor Role
lead
Responsible Party
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Jacques E. Chelly
Professor of Anesthesiology (with Tenure) and Orthopedic Surgery
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Jacques E Chelly, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, United States
Site Status
Countries
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United States
References
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Alimi D, Rubino C, Pichard-Leandri E, Fermand-Brule S, Dubreuil-Lemaire ML, Hill C. Analgesic effect of auricular acupuncture for cancer pain: a randomized, blinded, controlled trial. J Clin Oncol. 2003 Nov 15;21(22):4120-6. doi: 10.1200/JCO.2003.09.011.
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Usichenko TI, Dinse M, Hermsen M, Witstruck T, Pavlovic D, Lehmann C. Auricular acupuncture for pain relief after total hip arthroplasty - a randomized controlled study. Pain. 2005 Apr;114(3):320-327. doi: 10.1016/j.pain.2004.08.021.
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BACKGROUND
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Kukreja P, Avila A, Northern T, Dangle J, Kolli S, Kalagara H. A Retrospective Case Series of Pericapsular Nerve Group (PENG) Block for Primary Versus Revision Total Hip Arthroplasty Analgesia. Cureus. 2020 May 19;12(5):e8200. doi: 10.7759/cureus.8200.
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Crockett SD, Greer KB, Heidelbaugh JJ, Falck-Ytter Y, Hanson BJ, Sultan S; American Gastroenterological Association Institute Clinical Guidelines Committee. American Gastroenterological Association Institute Guideline on the Medical Management of Opioid-Induced Constipation. Gastroenterology. 2019 Jan;156(1):218-226. doi: 10.1053/j.gastro.2018.07.016. Epub 2018 Oct 16. No abstract available.
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Karst M, Winterhalter M, Munte S, Francki B, Hondronikos A, Eckardt A, Hoy L, Buhck H, Bernateck M, Fink M. Auricular acupuncture for dental anxiety: a randomized controlled trial. Anesth Analg. 2007 Feb;104(2):295-300. doi: 10.1213/01.ane.0000242531.12722.fd.
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BACKGROUND
Lux EA, Wahl G, Erlenwein J, Wiese C, Wirz S. [Is supplemental ear acupuncture for surgical tooth removal with local anesthesia effective? : A pilot study]. Schmerz. 2017 Oct;31(5):489-498. doi: 10.1007/s00482-017-0212-3. German.
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BACKGROUND
Li WS, Wan LS, Liu XJ, Li WY, Xiao JB, Zhao WX. [Effect of assisted anesthesia of auricular point magnetic sticking on postoperative recovery of gynecological surgery]. Zhongguo Zhen Jiu. 2013 Jul;33(7):648-52. Chinese.
Reference Type
BACKGROUND
Zhang LH, Cao CL, Li JZ, Chen ML, Wang MS, Dai CY. [Influence of auricular point sticking on incidence of nausea and vomiting and analgesia effect after gynecological laparoscopy]. Zhongguo Zhen Jiu. 2013 Apr;33(4):339-41. Chinese.
Reference Type
BACKGROUND
Zhang WF, Sun M, Da LM. [Electroacupuncture at auricular points for 43 cases of postpartum depression]. Zhongguo Zhen Jiu. 2012 Dec;32(12):1075-6. No abstract available. Chinese.
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BACKGROUND
Usichenko T, Hacker H, Lotze M. Transcutaneous auricular vagal nerve stimulation (taVNS) might be a mechanism behind the analgesic effects of auricular acupuncture. Brain Stimul. 2017 Nov-Dec;10(6):1042-1044. doi: 10.1016/j.brs.2017.07.013. Epub 2017 Aug 2.
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BACKGROUND
Vieira A, Reis AM, Matos LC, Machado J, Moreira A. Does auriculotherapy have therapeutic effectiveness? An overview of systematic reviews. Complement Ther Clin Pract. 2018 Nov;33:61-70. doi: 10.1016/j.ctcp.2018.08.005. Epub 2018 Aug 23.
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BACKGROUND
Baker TE, Chang G. The use of auricular acupuncture in opioid use disorder: A systematic literature review. Am J Addict. 2016 Dec;25(8):592-602. doi: 10.1111/ajad.12453. Epub 2016 Nov 2.
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BACKGROUND
Asher GN, Jonas DE, Coeytaux RR, Reilly AC, Loh YL, Motsinger-Reif AA, Winham SJ. Auriculotherapy for pain management: a systematic review and meta-analysis of randomized controlled trials. J Altern Complement Med. 2010 Oct;16(10):1097-108. doi: 10.1089/acm.2009.0451.
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BACKGROUND
Contim CLV, Santo FHDE, Moretto IG. Applicability of auriculotherapy in cancer patients: an integrative literature review. Rev Esc Enferm USP. 2020 Sep 7;54:e03609. doi: 10.1590/S1980-220X2019001503609. English, Portuguese.
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BACKGROUND
Plunkett A, McCoart A, Howard RS, Dennison E, Bartoszek M. A randomized, single-blind, prospective trial of auricular 'battlefield' acupuncture for the reduction of postoperative tonsillectomy pain in adults. Pain Manag. 2018 Jul 1;8(4):287-295. doi: 10.2217/pmt-2018-0007. Epub 2018 Jun 14.
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BACKGROUND
Michalek-Sauberer A, Heinzl H, Sator-Katzenschlager SM, Monov G, Knolle E, Kress HG. Perioperative auricular electroacupuncture has no effect on pain and analgesic consumption after third molar tooth extraction. Anesth Analg. 2007 Mar;104(3):542-7. doi: 10.1213/01.ane.0000253233.51490.dd.
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BACKGROUND
Alimi D, Chelly JE. New Universal Nomenclature in Auriculotherapy. J Altern Complement Med. 2018 Jan;24(1):7-14. doi: 10.1089/acm.2016.0351. Epub 2017 Aug 23.
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BACKGROUND
Alimi D, Geisdsmann A, Gardeur D. Auricular acupuncture stimulation measured on functional magnetic Imaging. Med Acup 2002;13:18-21
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Romoli M, Allais G, Airola G, Benedetto C, Mana O, Giacobbe M, Pugliese AM, Battistella G, Fornari E. Ear acupuncture and fMRI: a pilot study for assessing the specificity of auricular points. Neurol Sci. 2014 May;35 Suppl 1:189-93. doi: 10.1007/s10072-014-1768-7.
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Alimi, D. L'Auriculotherapie Medicale: Bases Scientifiques. Principles, Indications et Strategies Therapeutiques. Elsevier Masson SAS, 2017. pp 87-99. French
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Wirz-Ridolfi A. The History of Ear Acupuncture and Ear Cartography: Why Precise Mapping of Auricular Points Is Important. Med Acupunct. 2019 Jun 1;31(3):145-156. doi: 10.1089/acu.2019.1349. Epub 2019 Jun 17.
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BACKGROUND
Alimi, D. L'Auriculotherapie Medicale: Bases Scientifiques, Principles, Indications et Strategies Therapeutiques. Chapitre 10. Neurophysiologie des perceptions. Elsevier Masson
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Felten DL, Shetty AN. Second edition of the Netter's Atlas of Neuroscience Chapter 9. Peripheral nervous system. Publisher Saunders, Elsevier;2010. pp 135-172
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Peuker ET, Filler TJ. The nerve supply of the human auricle. Clin Anat. 2002 Jan;15(1):35-7. doi: 10.1002/ca.1089.
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Anthwal N, Thompson H. The development of the mammalian outer and middle ear. J Anat. 2016 Feb;228(2):217-32. doi: 10.1111/joa.12344. Epub 2015 Jul 30.
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Rouwette T, Vanelderen P, Roubos EW, Kozicz T, Vissers K. The amygdala, a relay station for switching on and off pain. Eur J Pain. 2012 Jul;16(6):782-92. doi: 10.1002/j.1532-2149.2011.00071.x. Epub 2011 Dec 19.
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Babygirija R, Sood M, Kannampalli P, Sengupta JN, Miranda A. Percutaneous electrical nerve field stimulation modulates central pain pathways and attenuates post-inflammatory visceral and somatic hyperalgesia in rats. Neuroscience. 2017 Jul 25;356:11-21. doi: 10.1016/j.neuroscience.2017.05.012. Epub 2017 May 17.
Reference Type
BACKGROUND
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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PRO18050099
Identifier Type: -
Identifier Source: org_study_id
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