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Battlefield Acupuncture for Pain in Hidradenitis Suppurativa

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ClinicalTrials.gov Identifier: NCT04218422
Recruitment Status : Recruiting
First Posted : January 6, 2020
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Steven D Daveluy, Wayne State University

Study Description
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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.
Study Design
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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, 2020
Estimated Study Completion Date : February 20, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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): NCT04218422


Locations
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United States, Michigan
WSUPG Dermatology Recruiting
Dearborn, Michigan, United States, 48124
Contact: Steven D Daveluy    313-429-7854    sdaveluy@med.wayne.edu   
Sponsors and Collaborators
Wayne State University
More Information
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Publications:

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Responsible Party: Steven D Daveluy, Associate Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT04218422    
Other Study ID Numbers: IRB-19-12-1642
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
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:
acupuncture
pain
battlefield acupuncture
hidradenitis
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
 Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration