Auriculotherapy for Surgical Pain
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Chronic Pain, Orthopedic |
| Therapuetic Areas: | Musculoskeletal, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/3/2019 |
| Start Date: | February 2019 |
| End Date: | April 2020 |
| Contact: | Amy Monroe |
| Email: | Monroeal@upmc.edu |
| Phone: | 412-623-6382 |
The Effect of Auriculotherapy Combined With an Interscalene Block for Post- Operative Pain Management Following Rotator Cuff Surgery: A Randomized, Placebo-Controlled Trial
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.
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.
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).
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).
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
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