Acute PainNCT03860259
Auriculotherapy for Surgical Pain
A study testing Auriculotherapy cryopuncture device without nitrogen gas and Auriculotherapy cryopuncture device with nitrogen gas in people with Acute Pain and Surgery, run by Jacques E. Chelly at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Pain, Surgery, Shoulder Pain
- What is being tested?
- Auriculotherapy cryopuncture device without nitrogen gas and Auriculotherapy cryopuncture device with nitrogen gas
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2020to 29 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is greater than 18 years of age
- Subject is willing and able to provide informed consent
- Subject is scheduled to undergo elective rotator cuff surgery
- Subject has consented to an interscalene block
Who cannot join
- Opioid dependence
- Any subject diagnosed with a chronic pain condition which daily opioid use is needed
- Anatomical malformation, which in the investigator's opinion may interfere with the placement of the nerve block
- Raynaud's disease diagnosis
- Vasculopathy
- Patient refusal
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
About this study
Official title: The Effect of Auriculotherapy for Post-Operative Pain Management Following Rotator Cuff Surgery: A Randomized, Placebo-Controlled Study
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.
Read the detailed description
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.
- Conditions
- Acute Pain, Surgery, Shoulder Pain
- Being tested
- Auriculotherapy cryopuncture device without nitrogen gas, Auriculotherapy cryopuncture device with nitrogen gas
- Keywords
- opioids, auriculotherapy, acute pain, shoulder surgery
- Medical subject headings
- Acute Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auriculotherapy cryopuncture device without nitrogen gasDevice
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 cryopuncture device with nitrogen gasDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Auriculotherapy without nitrogen gas | Placebo comparator | 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. Receives: Device: Auriculotherapy cryopuncture device without nitrogen gas |
| Auriculotherapy with nitrogen gas | Active comparator | 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. Receives: Device: Auriculotherapy cryopuncture device with nitrogen gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption Following Rotator Cuff Surgery
Investigate the efficacy of auriculotherapy in reducing perioperative opioid consumption in opioid-naïve patients undergoing elective rotator cuff surgery. This is reported in consumption of oral morphine mg equivalents (OME) at 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative as well as the total sum of these intervals
Measured: 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative
Secondary outcomes (11)
Post-Operative Pain With Movement
Numerical Rating Scale (NRS) Pain with movement on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome.
Measured: 24 hrs through 90-days post-operative
Post-Operative Pain at Rest
Numerical Rating Scale (NRS) pain at rest on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome.
Measured: Time of discharge through 90-days post-operative
Non-narcotic Analgesic Consumption
Investigate the efficacy of auriculotherapy in reducing total perioperative consumption of non-narcotic analgesics.
Measured: Day of surgery through 5-days post-operative
Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12)
Functional recovery will be measured by the assessment of the participant's answers to the Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12). The SF-12 Health Survey includes questions from the SF-36 Health Survey (Version 1). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average. The highest possible PCS-12 score is 56.57706 and the lowest possible score is 23.99938. The highest possible MCS-12 score is 67.37178 and the lowest possible score is 17.57825. Higher scores for both represent better functioning.
Measured: Day of surgery through 90 days post-operative
Length of Recovery Room Stay
Evaluate time to readiness for discharge from post-anesthesia care unit (PACU) from out of OR time in minutes
Measured: Day of surgery through recovery room discharge, up to 142 min post-operative
Length of Hospital Stay
Evaluate time to hospital discharge from out of OR time in minutes
Measured: Day of surgery through time of discharge, up to 270 min post-operative
Number of Participants Who Experienced Post-operative Complications
The number of participants who experienced complications and received the standard protocol versus subjects who received the standard protocol + Auriculotherapy. Post-operative complications can be defined as unexpected problems that arise following surgery including increased bleeding, infection, recurrent rotator cuff tear, and displacement of suture anchor.
Measured: Day of surgery through 90-days post-operative
Subjects Requiring Readmission Due to Pain
Evaluate the number of subjects readmitted because of pain or pain-related issues during the 90 day study duration
Measured: Day of surgery through 90-days post-operative
Overall Patient Satisfaction
Participants are asked to assess their overall satisfaction with care upon discharge on a 10-point satisfaction scale of 0 (least satisfaction) to 10 (highest satisfaction). The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a better outcome.
Measured: Day of surgery through time of discharge, up to 270 min post-operative
Satisfaction With Pain Management
Participants are asked to assess their satisfaction with pain management at discharge, 24 hrs, 48 hrs, 72 hrs, 96, hours, 120 hrs and 14 days, 30 days, 60 days and 90 days post-operative on a 10-point satisfaction scale of 0 (least satisfaction) to 10 (highest satisfaction). The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a better outcome.
Measured: Day of surgery through 90-days post-operative
Subjects Requiring Hospital Readmission
Evaluate the number of subjects readmitted to the hospital for post-operative complications other than pain-related issues.
Measured: Day of surgery through 90-days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start24 Jan 2020
- Primary completion6 Jul 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacques E. Chelly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jacques E. Chelly, University of Pittsburgh
- Investigators
- Jacques E Chelly, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860259
- Sponsor's protocol ID
- PRO18050099
- Status last verified
- Mar 2022
- First submitted
- 22 Jan 2019
- Last updated
- 17 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Alimi D., Geissmann A., Gardeur D., Bahr F. Study in fMRI of the stimulation of the auricular areas of the knee as the French -German and Chinese localizations. The Journal of Radiology. Photon 2014; 125, 133-14.
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.
PubMed 14615440Cho ZH, Oleson TD, Alimi D, Niemtzow RC. Acupuncture: the search for biologic evidence with functional magnetic resonance imaging and positron emission tomography techniques. J Altern Complement Med. 2002 Aug;8(4):399-401. doi: 10.1089/107555302760253577. No abstract available.
PubMed 12230898Usichenko 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.
PubMed 15777857Usichenko TI, Kuchling S, Witstruck T, Pavlovic D, Zach M, Hofer A, Merk H, Lehmann C, Wendt M. Auricular acupuncture for pain relief after ambulatory knee surgery: a randomized trial. CMAJ. 2007 Jan 16;176(2):179-83. doi: 10.1503/cmaj.060875.
PubMed 17224599Wetzel B, Pavlovic D, Kuse R, Gibb A, Merk H, Lehmann C, Wendt M, Usichenko TI. The effect of auricular acupuncture on fentanyl requirement during hip arthroplasty: a randomized controlled trial. Clin J Pain. 2011 Mar-Apr;27(3):262-7. doi: 10.1097/AJP.0b013e3181fd516c.
PubMed 21346689Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
PubMed 28403427Kukreja 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.
PubMed 32572357Crockett 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.
PubMed 30340754Farmer AD, Drewes AM, Chiarioni G, De Giorgio R, O'Brien T, Morlion B, Tack J. Pathophysiology and management of opioid-induced constipation: European expert consensus statement. United European Gastroenterol J. 2019 Feb;7(1):7-20. doi: 10.1177/2050640618818305. Epub 2018 Dec 14.
PubMed 30788113Kozub E, Uttermark A, Skoog R, Dickey W. Preventing Postoperative Opioid-Induced Respiratory Depression Through Implementation of an Enhanced Monitoring Program. J Healthc Qual. 2022 Jan-Feb 01;44(1):e7-e14. doi: 10.1097/JHQ.0000000000000322.
PubMed 34469926Warrender WJ, Syed UAM, Hammoud S, Emper W, Ciccotti MG, Abboud JA, Freedman KB. Pain Management After Outpatient Shoulder Arthroscopy: A Systematic Review of Randomized Controlled Trials. Am J Sports Med. 2017 Jun;45(7):1676-1686. doi: 10.1177/0363546516667906. Epub 2016 Oct 13.
PubMed 27729319Karst 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.
PubMed 17242083Lux 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.
PubMed 28315017Li 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.
PubMed 24032205
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Auriculotherapy for Post-Operative Pain Management Following Rotator Cuff Surgery: A Randomized, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT03860259
- Acronym / sponsor ID
- PRO18050099
- Conditions
- Acute Pain, Surgery, Shoulder Pain
- Keywords
- opioids, auriculotherapy, acute pain, shoulder surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jacques E. ChellyUniversity, hospital or other
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 6 Jul 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Posted 13 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auriculotherapy without nitrogen gas | Placebo comparator | Device: Auriculotherapy cryopuncture device without nitrogen gasAuriculotherapy 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. |
| Auriculotherapy with nitrogen gas | Active comparator | Device: Auriculotherapy cryopuncture device with nitrogen gasAuriculotherapy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is greater than 18 years of age
- Subject is willing and able to provide informed consent
- Subject is scheduled to undergo elective rotator cuff surgery
- Subject has consented to an interscalene block
Key exclusion criteria (6 listed)
- Opioid dependence
- Any subject diagnosed with a chronic pain condition which daily opioid use is needed
- Anatomical malformation, which in the investigator's opinion may interfere with the placement of the nerve block
- Raynaud's disease diagnosis
- Vasculopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auriculotherapy cryopuncture device without nitrogen gasAuriculotherapy 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 | Device | Auriculotherapy without nitrogen gas |
| Auriculotherapy cryopuncture device with nitrogen gasAuriculotherapy 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 | Device | Auriculotherapy with nitrogen gas |
Primary outcome
Opioid Consumption Following Rotator Cuff Surgery
Time frame: 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative
Investigate the efficacy of auriculotherapy in reducing perioperative opioid consumption in opioid-naïve patients undergoing elective rotator cuff surgery. This is reported in consumption of oral morphine mg equivalents (OME) at 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative as well as the total sum of these intervals
11 secondary outcomes
Post-Operative Pain With Movement
Time frame: 24 hrs through 90-days post-operative
Post-Operative Pain at Rest
Time frame: Time of discharge through 90-days post-operative
Non-narcotic Analgesic Consumption
Time frame: Day of surgery through 5-days post-operative
Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12)
Time frame: Day of surgery through 90 days post-operative
Length of Recovery Room Stay
Time frame: Day of surgery through recovery room discharge, up to 142 min post-operative
Length of Hospital Stay
Time frame: Day of surgery through time of discharge, up to 270 min post-operative
Number of Participants Who Experienced Post-operative Complications
Time frame: Day of surgery through 90-days post-operative
Subjects Requiring Readmission Due to Pain
Time frame: Day of surgery through 90-days post-operative
Overall Patient Satisfaction
Time frame: Day of surgery through time of discharge, up to 270 min post-operative
Satisfaction With Pain Management
Time frame: Day of surgery through 90-days post-operative
Subjects Requiring Hospital Readmission
Time frame: Day of surgery through 90-days post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundAlimi D., Geissmann A., Gardeur D., Bahr F. Study in fMRI of the stimulation of the auricular areas of the knee as the French -German and Chinese localizations. The Journal of Radiology. Photon 2014; 125, 133-14.
- Background: PubMed 14615440Alimi 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.
- Background: PubMed 12230898Cho ZH, Oleson TD, Alimi D, Niemtzow RC. Acupuncture: the search for biologic evidence with functional magnetic resonance imaging and positron emission tomography techniques. J Altern Complement Med. 2002 Aug;8(4):399-401. doi: 10.1089/107555302760253577. No abstract available.
- Background: PubMed 15777857Usichenko 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.
- Background: PubMed 17224599Usichenko TI, Kuchling S, Witstruck T, Pavlovic D, Zach M, Hofer A, Merk H, Lehmann C, Wendt M. Auricular acupuncture for pain relief after ambulatory knee surgery: a randomized trial. CMAJ. 2007 Jan 16;176(2):179-83. doi: 10.1503/cmaj.060875.
- Background: PubMed 21346689Wetzel B, Pavlovic D, Kuse R, Gibb A, Merk H, Lehmann C, Wendt M, Usichenko TI. The effect of auricular acupuncture on fentanyl requirement during hip arthroplasty: a randomized controlled trial. Clin J Pain. 2011 Mar-Apr;27(3):262-7. doi: 10.1097/AJP.0b013e3181fd516c.
- Background: PubMed 28403427Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
- Background: PubMed 32572357Kukreja 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.
- Background: PubMed 30340754Crockett 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.
- Background: PubMed 30788113Farmer AD, Drewes AM, Chiarioni G, De Giorgio R, O'Brien T, Morlion B, Tack J. Pathophysiology and management of opioid-induced constipation: European expert consensus statement. United European Gastroenterol J. 2019 Feb;7(1):7-20. doi: 10.1177/2050640618818305. Epub 2018 Dec 14.
- Background: PubMed 34469926Kozub E, Uttermark A, Skoog R, Dickey W. Preventing Postoperative Opioid-Induced Respiratory Depression Through Implementation of an Enhanced Monitoring Program. J Healthc Qual. 2022 Jan-Feb 01;44(1):e7-e14. doi: 10.1097/JHQ.0000000000000322.
- Background: PubMed 27729319Warrender WJ, Syed UAM, Hammoud S, Emper W, Ciccotti MG, Abboud JA, Freedman KB. Pain Management After Outpatient Shoulder Arthroscopy: A Systematic Review of Randomized Controlled Trials. Am J Sports Med. 2017 Jun;45(7):1676-1686. doi: 10.1177/0363546516667906. Epub 2016 Oct 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques E Chelly, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auriculotherapy cryopuncture device without nitrogen gas and Auriculotherapy cryopuncture device with nitrogen gas in people with Acute Pain and Surgery, run by Jacques E. Chelly at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Consumption Following Rotator Cuff Surgery (time frame: 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03860259, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.