Battlefield Acupuncture for Pain in Hidradenitis Suppurativa

May 12, 2023 updated by: Steven D Daveluy, Wayne State University

Battlefield Acupuncture to Treat Pain in Hidradenitis Suppurativa

The investigators will investigate battlefield acupuncture as a treatment for the pain of hidradenitis suppurativa.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Dearborn, Michigan, United States, 48124
        • Recruiting
        • WSUPG Dermatology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Average Score from scores Recorded daily for 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2020

Primary Completion (Anticipated)

December 23, 2030

Study Completion (Anticipated)

February 20, 2031

Study Registration Dates

First Submitted

December 27, 2019

First Submitted That Met QC Criteria

January 2, 2020

First Posted (Actual)

January 6, 2020

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-19-12-1642

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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