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Ear Acupuncture for Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT05052645
Recruitment Status : Not yet recruiting
First Posted : September 22, 2021
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
Tony Y. Chon, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Procedure: Auricular acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Auricular Acupuncture in the Treatment of Neuropathic Pain: A Randomized Controlled Trial
Estimated Study Start Date : November 2021
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
No Intervention: Standard of Care Group
Subjects will receive standard of care neuropathic pain treatment without acupuncture.
Experimental: Acupuncture Treatment Group
Subjects will receive acupuncture treatment in addition to to the standard of care neuropathic pain treatment.
Procedure: Auricular acupuncture
Placement of acupuncture needles in specific points on the ear in two consecutive treatments spaced 7 days apart.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05052645


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Tony Chon, MD Mayo Clinic
Additional Information:
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Responsible Party: Tony Y. Chon, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT05052645    
Other Study ID Numbers: 20-010454
First Posted: September 22, 2021    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations