Auriculotherapy for Surgical Pain

Study Overview
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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.

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.

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

Conditions
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Surgery, Acute Pain, Shoulder Pain

Intervention / Treatment
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* Device: Auriculotherapy cryopuncture device without nitrogen gas
* Device: Auriculotherapy cryopuncture device with nitrogen gas


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Auriculotherapy without nitrogen gas<br>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. | Device: Auriculotherapy cryopuncture device without nitrogen gas<br>* 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<br>|
| Active Comparator: Auriculotherapy with nitrogen gas<br>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. | Device: Auriculotherapy cryopuncture device with nitrogen gas<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioids, auriculotherapy, acute pain, shoulder surgery