Auriculotherapy for Surgical Pain

Surgery Clinical Trial

Official title:

The Effect of Auriculotherapy for Post-Operative Pain Management Following Rotator Cuff Surgery: A Randomized, Placebo-Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860259
• Other study ID #: PRO18050099
• Status: Completed
• Phase: N/A
• Start date: January 24, 2020
• Est. completion date: September 29, 2021

Study information

• Verified date: March 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 29, 2021
• Est. primary completion date: July 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Acute Pain
• Shoulder Pain
• Surgery

Intervention

Device:
• 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
• 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

Locations

Country	Name	City	State
United States	UPMC Shadyside Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Jacques E. Chelly

Country where clinical trial is conducted

United States, 

References & Publications (36)

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Alimi, D. L'Auriculotherapie Medicale: Bases Scientifiques, Principles, Indications et Strategies Therapeutiques. Chapitre 10. Neurophysiologie des perceptions. Elsevier Masson

Alimi, D. L'Auriculotherapie Medicale: Bases Scientifiques. Principles, Indications et Strategies Therapeutiques. Elsevier Masson SAS, 2017. pp 87-99. French

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Karst M, Winterhalter M, Münte 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. — View Citation

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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. — View Citation

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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. — View Citation

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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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

Usichenko 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. — View Citation

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Wan LS, Li WS, Li WY, Li GC. [Observation on the anesthesia effect of general anesthesia assisted by auricular-plaster therapy in gynecological surgery]. Zhongguo Zhen Jiu. 2013 Mar;33(3):237-40. Chinese. — View Citation

Warrender 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. Review. — View Citation

Wetzel 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. — View Citation

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative
Secondary	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.	24 hrs through 90-days post-operative
Secondary	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.	Time of discharge through 90-days post-operative
Secondary	Non-narcotic Analgesic Consumption	Investigate the efficacy of auriculotherapy in reducing total perioperative consumption of non-narcotic analgesics.	Day of surgery through 5-days post-operative
Secondary	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.	Day of surgery through 90 days post-operative
Secondary	Length of Recovery Room Stay	Evaluate time to readiness for discharge from post-anesthesia care unit (PACU) from out of OR time in minutes	Day of surgery through recovery room discharge, up to 142 min post-operative
Secondary	Length of Hospital Stay	Evaluate time to hospital discharge from out of OR time in minutes	Day of surgery through time of discharge, up to 270 min post-operative
Secondary	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.	Day of surgery through 90-days post-operative
Secondary	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	Day of surgery through 90-days post-operative
Secondary	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.	Day of surgery through time of discharge, up to 270 min post-operative
Secondary	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.	Day of surgery through 90-days post-operative
Secondary	Subjects Requiring Hospital Readmission	Evaluate the number of subjects readmitted to the hospital for post-operative complications other than pain-related issues.	Day of surgery through 90-days post-operative