Ear Acupuncture for Neuropathic Pain

Study Overview
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Brief Summary
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The purpose of this study is to gather information on the effectiveness of auricular acupuncture (i.e., the placement of acupuncture needles in specific points on the ear) in reducing pain and improving quality of life among patients experiencing neuropathic pain in the acute inpatient rehabilitation setting.

Official Title
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Auricular Acupuncture in the Treatment of Neuropathic Pain: A Randomized Controlled Trial

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Procedure: Auricular acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have acute or chronic neuropathic pain of any etiology (traumatic, non-traumatic, central, peripheral, and mixed cases). Ability to provide informed consent. Ability to speak English and complete all aspects of this trial. At least 18 years of age. Patients will have stable neuropathic pain medication dosing for 3 days prior to enrollment to include gabapentin, pre-gabalin, TCAs, duloxetine, carbamazepine, oxcarbazepine, and venlafaxine). Exclusion Criteria: Patients with platelet count <50,000 or known bleeding disorder. Patients in a severe immunocompromised state. Pregnant women. All patients who meet the criteria will have their medical records reviewed to ensure they are not pregnant. Allergy to gold. Use of non-FDA approved herbal supplements. Their effect on enhancing or blunting effect of acupuncture is not known. Patients using medical marijuana with an approved prescription from a state issuing such prescriptions will not be excluded. Current infection of the skin or cartilage of the ear. Patients already using adjuvant modalities such as chiropractic, massage, yoga, tai chi, massage will not be excluded, but those who add in these modalities during the course of the intervention and observation period will be excluded. Patients not anticipated to stay for a minimum of 7 days after enrollment. Patient without mental capacity to participate in the consent process and the questionnaire responses. Fear of needles or no interest in acupuncture.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care Group<br>Subjects will receive standard of care neuropathic pain treatment without acupuncture. | |
| Experimental: Acupuncture Treatment Group<br>Subjects will receive acupuncture treatment in addition to to the standard of care neuropathic pain treatment. | Procedure: Auricular acupuncture<br>* Placement of acupuncture needles in specific points on the ear in two consecutive treatments spaced 7 days apart.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported neuropathic pain scores | Measured on the numeric rating scale for pain (NRS Pain) for pain intensity using a scale of 0=no pain, 10=worst imaginable | Daily during inpatient stay, approximately 7-10 days |