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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Battlefield Acupuncture to Treat Pain in Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT04218422
- Acronym / sponsor ID
- IRB-19-12-1642
- Conditions
- Hidradenitis Suppurativa
- Keywords
- acupuncture, pain, battlefield acupuncture, hidradenitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 23 Dec 2030 (estimated)
- Study completion
- 20 Feb 2031 (estimated)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Blinded, randomized trial
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: Battlefield Acupuncture2 treatments of battlefield acupuncture to the bilateral ears spaced one week apart |
| Control | Sham comparator | Procedure: Sham Acupuncture2 treatments with sham acupuncture to the bilateral ears at acupuncture points not associated with pain relief (2 liver and 1 stomach) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Battlefield AcupunctureAcupuncture at 5 points on the ears | Procedure or surgery | Treatment |
| Sham AcupunctureSham acupuncture in 2 points for liver and 1 point for stomach | Procedure or surgery | Control |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Background: PubMed 26470616Horvath 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.
- Individual participant dataSharing planned: No. There is no plan to share data
Related trials for Hidradenitis Suppurativa
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Battlefield Acupuncture in people with Hidradenitis Suppurativa, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Numerical Rating Score (time frame: Average Score from scores Recorded daily for 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04218422, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.