Hidradenitis SuppurativaNCT04218422
Battlefield Acupuncture for Pain in Hidradenitis Suppurativa
A study testing Battlefield Acupuncture in people with Hidradenitis Suppurativa, run by Wayne State University at 1 site in United States.
Trial summary
The investigators will investigate battlefield acupuncture as a treatment for the pain of hidradenitis suppurativa. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Battlefield Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2020to 20 Feb 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
WSUPG Dermatology
Dearborn, Michigan, 48124
Steven D Daveluy, 313-429-7854, sdaveluy@med.wayne.edu
About this study
Official title: Battlefield Acupuncture to Treat Pain in Hidradenitis Suppurativa
The investigators will investigate battlefield acupuncture as a treatment for the pain of hidradenitis suppurativa.
Read the detailed description
Participants will report their pain level daily for 4 weeks. At week 2 and 3, they will get acupuncture in the ears.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Battlefield Acupuncture, Sham Acupuncture
- Keywords
- acupuncture, pain, battlefield acupuncture, hidradenitis
- Medical subject headings
- Hidradenitis Suppurativa, Pain, Hidradenitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Battlefield AcupunctureProcedure or surgery
Acupuncture at 5 points on the ears
Sham AcupunctureProcedure or surgery
Sham acupuncture in 2 points for liver and 1 point for stomach
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 2 treatments of battlefield acupuncture to the bilateral ears spaced one week apart Receives: Procedure: Battlefield Acupuncture |
| Control | Sham comparator | 2 treatments with sham acupuncture to the bilateral ears at acupuncture points not associated with pain relief (2 liver and 1 stomach) Receives: Procedure: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Average Score from scores Recorded daily for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start22 Jan 2020
- Primary completion23 Dec 2030 (estimated)
- Study completion20 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blinded, randomized trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven D Daveluy, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218422
- Sponsor's protocol ID
- IRB-19-12-1642
- Status last verified
- May 2023
- First submitted
- 27 Dec 2019
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share data
Publications
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.
PubMed 26470616