Clinical trial NCT03860259: Auriculotherapy for Surgical Pain
Official title: The Effect of Auriculotherapy for Post-Operative Pain Management Following Rotator Cuff Surgery: A Randomized, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Surgery
Shoulder Pain
Keywords: opioids
auriculotherapy
acute pain
shoulder surgery
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Opioid Consumption Following Rotator Cuff Surgery
timeFrame: 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative
Secondary outcomes:
measure: Post-Operative Pain With Movement
timeFrame: 24 hrs through 90-days post-operative
measure: Post-Operative Pain at Rest
timeFrame: Time of discharge through 90-days post-operative
measure: Non-narcotic Analgesic Consumption
timeFrame: Day of surgery through 5-days post-operative
measure: Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12)
timeFrame: Day of surgery through 90 days post-operative
measure: Length of Recovery Room Stay
timeFrame: Day of surgery through recovery room discharge, up to 142 min post-operative
measure: Length of Hospital Stay
timeFrame: Day of surgery through time of discharge, up to 270 min post-operative
measure: Number of Participants Who Experienced Post-operative Complications
timeFrame: Day of surgery through 90-days post-operative
measure: Subjects Requiring Readmission Due to Pain
timeFrame: Day of surgery through 90-days post-operative
measure: Overall Patient Satisfaction
timeFrame: Day of surgery through time of discharge, up to 270 min post-operative
measure: Satisfaction With Pain Management
timeFrame: Day of surgery through 90-days post-operative
measure: Subjects Requiring Hospital Readmission
timeFrame: Day of surgery through 90-days post-operative
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Shadyside Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jacques E Chelly, MD
role: PRINCIPAL_INVESTIGATOR
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