Back to resultsBattlefield Acupuncture for Pain in Hidradenitis Suppurativa
Primary Purpose
Hidradenitis Suppurativa
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Battlefield Acupuncture
Sham Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring acupuncture, pain, battlefield acupuncture, hidradenitis
Eligibility 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
Sites / Locations
- WSUPG DermatologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Treatment
Control
Arm Description
2 treatments of battlefield acupuncture to the bilateral ears spaced one week apart
2 treatments with sham acupuncture to the bilateral ears at acupuncture points not associated with pain relief (2 liver and 1 stomach)
Outcomes
Primary Outcome Measures
Change in Pain Numerical Rating Score
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04218422
Brief Title
Battlefield Acupuncture for Pain in Hidradenitis Suppurativa
Official Title
Battlefield Acupuncture to Treat Pain in Hidradenitis Suppurativa
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
December 23, 2030 (Anticipated)
Study Completion Date
February 20, 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
acupuncture, pain, battlefield acupuncture, hidradenitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Blinded, randomized trial
Masking
Participant
Masking Description
Participants will not know whether they got battlefield acupuncture or sham acupuncture
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
2 treatments of battlefield acupuncture to the bilateral ears spaced one week apart
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
2 treatments with sham acupuncture to the bilateral ears at acupuncture points not associated with pain relief (2 liver and 1 stomach)
Intervention Type
Procedure
Intervention Name(s)
Battlefield Acupuncture
Intervention Description
Acupuncture at 5 points on the ears
Intervention Type
Procedure
Intervention Name(s)
Sham Acupuncture
Intervention Description
Sham acupuncture in 2 points for liver and 1 point for stomach
Primary Outcome Measure Information:
Title
Change in Pain Numerical Rating Score
Description
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
Time Frame
Average Score from scores Recorded daily for 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
WSUPG Dermatology
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven D Daveluy
Phone
313-429-7854
Email
sdaveluy@med.wayne.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share data
Citations:
PubMed Identifier
26470616
Citation
Horvath 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.
Results Reference
background
Learn more about this trial
Battlefield Acupuncture for Pain in Hidradenitis Suppurativa
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