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Battlefield Acupuncture for Pain in Hidradenitis Suppurativa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04218422
Recruitment Status : Recruiting
First Posted : January 6, 2020
Last Update Posted : May 4, 2022
Information provided by (Responsible Party):
Steven D Daveluy, Wayne State University

Brief Summary:
The investigators will investigate battlefield acupuncture as a treatment for the pain of hidradenitis suppurativa.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Procedure: Battlefield Acupuncture Procedure: Sham Acupuncture Not Applicable

Detailed Description:
Participants will report their pain level daily for 4 weeks. At week 2 and 3, they will get acupuncture in the ears.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Blinded, randomized trial
Masking: Single (Participant)
Masking Description: Participants will not know whether they got battlefield acupuncture or sham acupuncture
Primary Purpose: Treatment
Official Title: Battlefield Acupuncture to Treat Pain in Hidradenitis Suppurativa
Actual Study Start Date : January 22, 2020
Estimated Primary Completion Date : December 23, 2022
Estimated Study Completion Date : February 20, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment
2 treatments of battlefield acupuncture to the bilateral ears spaced one week apart
Procedure: Battlefield Acupuncture
Acupuncture at 5 points on the ears

Sham Comparator: Control
2 treatments with sham acupuncture to the bilateral ears at acupuncture points not associated with pain relief (2 liver and 1 stomach)
Procedure: Sham Acupuncture
Sham acupuncture in 2 points for liver and 1 point for stomach

Primary Outcome Measures :
  1. Change in Pain Numerical Rating Score [ Time Frame: Average Score from scores Recorded daily for 4 weeks ]
    Difference in Average Patient self-reported Pain Numerical Rating Score from 0-10, comparing average from 2 weeks prior to treatment with average from 2 weeks after treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • age 18 years or older
  • dermatologist-confirmed diagnosis of hidradenitis suppurativa
  • significant pain from hidradenitis at least twice weekly
  • stable treatment regimen for hidradenitis during study period

Exclusion Criteria:

  • disease or disfigurement of the ear that prevents battlefield acupuncture of the ears
  • other chronic pain that will interfere with the ability to rate hidradenitis pain

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 identifier (NCT number): NCT04218422

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United States, Michigan
WSUPG Dermatology Recruiting
Dearborn, Michigan, United States, 48124
Contact: Steven D Daveluy    313-429-7854   
Sponsors and Collaborators
Wayne State University
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Responsible Party: Steven D Daveluy, Associate Professor, Wayne State University Identifier: NCT04218422    
Other Study ID Numbers: IRB-19-12-1642
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: May 4, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Steven D Daveluy, Wayne State University:
battlefield acupuncture
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Bacterial Infections and Mycoses
Skin Diseases, Infectious