Ear Acupuncture for Neuropathic Pain

NCT05052645 | Withdrawn

• 1 other identifier: 20-010454
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard of Care Group

NO INTERVENTION

Subjects will receive standard of care neuropathic pain treatment without acupuncture.

Acupuncture Treatment Group

EXPERIMENTAL

Subjects will receive acupuncture treatment in addition to to the standard of care neuropathic pain treatment.

Procedure: Auricular acupuncture

Interventions

Auricular acupuncture PROCEDURE

Placement of acupuncture needles in specific points on the ear in two consecutive treatments spaced 7 days apart.

Acupuncture Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Neuralgia

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Officials

• Tony Chon, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 22, 2021
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 8, 2022

Record last verified: 2022-12

Locations

US (1)