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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

Tracking Information
First Submitted Date  ICMJE December 27, 2019
First Posted Date  ICMJE January 6, 2020
Last Update Posted Date May 28, 2020
Actual Study Start Date  ICMJE January 22, 2020
Estimated Primary Completion Date December 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Battlefield Acupuncture for Pain in Hidradenitis Suppurativa
Official Title  ICMJE Battlefield Acupuncture to Treat Pain in Hidradenitis Suppurativa
Brief Summary The investigators will investigate battlefield acupuncture as a treatment for the pain of hidradenitis suppurativa.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Hidradenitis Suppurativa
Intervention  ICMJE
  • Procedure: Battlefield Acupuncture
    Acupuncture at 5 points on the ears
  • Procedure: Sham Acupuncture
    Sham acupuncture in 2 points for liver and 1 point for stomach
Study Arms  ICMJE
  • Experimental: Treatment
    2 treatments of battlefield acupuncture to the bilateral ears spaced one week apart
    Intervention: Procedure: Battlefield Acupuncture
  • 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)
    Intervention: Procedure: Sham Acupuncture
Publications * Horváth B, Janse IC, Sibbald GR. Pain management in patients with hidradenitis suppurativa. J Am Acad Dermatol. 2015 Nov;73(5 Suppl 1):S47-51. doi: 10.1016/j.jaad.2015.07.046. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 2, 2020)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 20, 2021
Estimated Primary Completion Date December 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04218422
Other Study ID Numbers  ICMJE IRB-19-12-1642
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share data
Responsible Party Steven D Daveluy, Wayne State University
Study Sponsor  ICMJE Wayne State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Wayne State University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP