Ear Acupuncture for Neuropathic Pain

NCT ID: NCT05052645

Last Updated: 2022-12-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2023-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of Care Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Acupuncture Treatment Group

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

Group Type: EXPERIMENTAL

Auricular acupuncture

Intervention Type: PROCEDURE

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

Interventions

Auricular acupuncture

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Tony Y. Chon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tony Chon, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

20-010454

Identifier Type: -

Identifier Source: org_study_id