Ear Acupuncture for Neuropathic Pain

Not Applicable

Withdrawn

• Conditions: Neuropathic Pain
• Interventions: Procedure: Auricular acupuncture

• Registration Number: NCT05052645
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-22
• Study Start: 2022-09
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-08
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture Treatment Group	Auricular acupuncture	Subjects will receive acupuncture treatment in addition to to the standard of care neuropathic pain treatment.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States