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Ear Acupuncture for Neuropathic Pain

Primary Purpose

Neuropathic Pain

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auricular acupuncture
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neuropathic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care Group

Acupuncture Treatment Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 13, 2021
Last Updated
December 6, 2022
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05052645
Brief Title
Ear Acupuncture for Neuropathic Pain
Official Title
Auricular Acupuncture in the Treatment of Neuropathic Pain: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
investigators have limited availability
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care Group
Arm Type
No Intervention
Arm Description
Subjects will receive standard of care neuropathic pain treatment without acupuncture.
Arm Title
Acupuncture Treatment Group
Arm Type
Experimental
Arm Description
Subjects will receive acupuncture treatment in addition to to the standard of care neuropathic pain treatment.
Intervention Type
Procedure
Intervention Name(s)
Auricular acupuncture
Intervention Description
Placement of acupuncture needles in specific points on the ear in two consecutive treatments spaced 7 days apart.
Primary Outcome Measure Information:
Title
Change in self-reported neuropathic pain scores
Description
Measured on the numeric rating scale for pain (NRS Pain) for pain intensity using a scale of 0=no pain, 10=worst imaginable
Time Frame
Daily during inpatient stay, approximately 7-10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony Chon, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Ear Acupuncture for Neuropathic Pain

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