Ear Acupuncture for Neuropathic Pain

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05052645
• Other study ID #: 20-010454
• Status: Withdrawn
• Phase: N/A
• Start date: September 2022
• Est. completion date: September 2023

Study information

• Verified date: December 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Mayo Clinic Clinical Trials