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Clinical Trials/NCT05052645
NCT05052645
Withdrawn
Not Applicable

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

Mayo Clinic1 site in 1 countrySeptember 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neuropathic Pain
Sponsor
Mayo Clinic
Locations
1
Primary Endpoint
Change in self-reported neuropathic pain scores
Status
Withdrawn
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2022
End Date
September 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tony Y. Chon

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in self-reported neuropathic pain scores

Time Frame: 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

Study Sites (1)

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