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Auriculotherapy for Surgical Pain

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ClinicalTrials.gov Identifier: NCT03860259
Recruitment Status : Not yet recruiting
First Posted : March 1, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Jacques E. Chelly, University of Pittsburgh

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.


Condition or disease Intervention/treatment Phase
Acute Pain Surgery Shoulder Pain Device: Auriculotherapy cryopuncture device without nitrogen gas Device: Auriculotherapy cryopuncture device with nitrogen gas Not Applicable

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. (This individual will likely be contacted through the University of Pittsburgh's CSTI group...correspondence currently ongoing). CTSI will hold master randomization list and will provide treatment allocation confidentially to the unblinded PI.

Study coordinators, Co-Is and subjects will be blinded. PI will be the only individual who is unblinded as he is completing the treatment. Once patient is randomized to a treatment group by research staff, Auriculotherapy will be performed by Dr. Jacques Chelly using a cryopuncture device in the pre-operative setting, either with nitrogen gas (intervention group), or an empty cryopunture with no gas (control group). Dr. Chelly is formally certified in auriculotherapy.

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 an 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, and then once a month for three months (post op days 30, 60 and 90). 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 3 post-operatively, and then on post-operative days 30, 60 and 90 to remind subject about diary completion for that evening and to assess any adverse events. On the post-operative Day 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 IV morphine equivalent doses of analgesics used to provide pain relief). Secondary outcome measures will include time to readiness for discharge from PACU, time to hospital discharge, readmission to the hospital, percentage of patients readmitted because of pain related issues, 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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: The only person unblinded to treatment allocation will be the Principal investigator -- the individual performing cryopuncture
Primary Purpose: Treatment
Official Title: The Effect of Auriculotherapy Combined With an Interscalene Block for Post- Operative Pain Management Following Rotator Cuff Surgery: A Randomized, Placebo-Controlled Trial
Estimated Study Start Date : June 20, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
Auriculotherapy will be performed by PI using a cryopuncture device in the pre-operative setting 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
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

Active Comparator: Intervention
Auriculotherapy will be performed by PI using a cryopuncture device in the pre-operative setting 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
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




Primary Outcome Measures :
  1. Opioid consumption following rotator cuff surgery [ Time Frame: Day of surgery through three months ]
    Demonstrate how auriculotherapy using the cryopuncture changes total narcotic consumption following rotator cuff surgery


Secondary Outcome Measures :
  1. Incidence of post-operative complications [ Time Frame: Day of surgery through three months ]
    Investigate the incidence of post-operative complications in subjects who received the standard protocol versus subjects who received the standard protocol + Auriculotherapy

  2. Change in post-operative opioid consumption in opioid naïve subjects undergoing rotator cuff surgery [ Time Frame: Day of surgery through three months ]
    Investigate the change in post-operative opioid consumption in opioid naïve subjects undergoing rotator cuff surgery

  3. Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12) [ Time Frame: Day of surgery through three months ]
    The SF-12® Health Survey includes 12 questions from the SF-36® Health Survey (Version 1). These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health (psychological distress and psychological well-being). Total score will be reported and can range from 12 to 53.

  4. Time to readiness for discharge from PACU [ Time Frame: Perioperative ]
    Evaluate time to readiness for discharge from PACU

  5. Time to hospital discharge [ Time Frame: Day of surgery up to 12 weeks ]
    Evaluate time to hospital discharge

  6. Number of patients readmitted to the hospital [ Time Frame: Day of surgery through three months ]
    Determine the number of patients readmitted to the hospital

  7. Percentage of patients readmitted because of pain related issues [ Time Frame: Day of surgery through three months ]
    Evaluate percentage of subjects readmitted because of pain related issues

  8. Overall patient satisfaction [ Time Frame: Day of surgery through three months ]
    The subject will be asked to assess their overall patient satisfaction at the Day 90 call, on a scale of 0 (least satisfaction) to 6 (most satisfaction)

  9. Patient satisfaction relating to pain management [ Time Frame: Day of surgery through three months ]
    The subject will be asked to assess their overall patient satisfaction at the Day 90 call, on a scale of 0 (least satisfaction) to 10 (most satisfaction)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860259


Contacts
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Contact: Amy Monroe 412-623-6382 Monroeal@upmc.edu

Locations
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United States, Pennsylvania
UPMC Shadyside Hospital Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Jacques E Chelly, MD    412-623-6904    ChelJE@anes.upmc.edu   
Contact: Amy Monroe    412-623-6382    Monroeal@upmc.edu   
Sponsors and Collaborators
Jacques E. Chelly
Investigators
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Principal Investigator: Jacques E Chelly, MD University of Pittsburgh

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.
Wendt, M. (2007). Auricular acupuncture for pain relief after ambulatory knee surgery: A randomized trial. Canadian Medical Association Journal, 176(2), 179-183. doi:10.1503/cmaj.060875Veerasak Narongpunt, Stefan Datcu, Laurent Ibos, Frederic Adnet, Bernard Fontas, Yves Candau, Alimi D. Monitoring acupressure effects by infrared thermography. Quantitative Infra-Red Thermography Journal 2004; 1: 185-204.

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Responsible Party: Jacques E. Chelly, Professor of Anesthesiology (with Tenure) and Orthopedic Surgery, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03860259     History of Changes
Other Study ID Numbers: PRO18050099
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Acute Pain
Shoulder Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Arthralgia
Joint Diseases
Musculoskeletal Diseases