Ear Acupuncture for Neuropathic Pain

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Neuropathic Pain
• Intervention / Treatment: Procedure: Auricular acupuncture

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Tony Chon, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: 20-010454

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No