NCT04218422

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
58mo left

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Jan 2020Feb 2031

First Submitted

Initial submission to the registry

December 27, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

January 22, 2020

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2030

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2031

Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

10.9 years

First QC Date

December 27, 2019

Last Update Submit

May 12, 2023

Conditions

Hidradenitis Suppurativa

Keywords

acupuncturepainbattlefield acupuncturehidradenitis

Outcome Measures

Primary Outcomes (1)

  • 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

    Average Score from scores Recorded daily for 4 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

2 treatments of battlefield acupuncture to the bilateral ears spaced one week apart

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)

Procedure: Sham Acupuncture

Interventions

Battlefield AcupuncturePROCEDURE

Acupuncture at 5 points on the ears

Treatment
Sham AcupuncturePROCEDURE

Sham acupuncture in 2 points for liver and 1 point for stomach

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WSUPG Dermatology

Dearborn, Michigan, 48124, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26470616BACKGROUND

MeSH Terms

Conditions

Hidradenitis SuppurativaPainHidradenitis

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesSweat Gland DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not know whether they got battlefield acupuncture or sham acupuncture
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Blinded, randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 27, 2019

First Posted

January 6, 2020

Study Start

January 22, 2020

Primary Completion (Estimated)

December 23, 2030

Study Completion (Estimated)

February 20, 2031

Last Updated

May 16, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

There is no plan to share data

Locations

US(1)