MedTrace Logo

Emsella Chair Versus Sham for the Treatment of Chronic Pelvic Pain

NCT04248491 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-09-21

Study results available
· View outcomes & findings →

Summary

The purpose of this clinical trial is to compare the Emsella Chair therapy to Sham and to determine whether electromagnetic technology is effective in the treatment of chronic pelvic pain. Currently there are no other studies utilizing the Emsella Chair for the treatment of chronic pelvic pain. Eligible subjects will receive 2 treatments per week for a total of 4 weeks.

Conditions

  • Pelvic Pain

Interventions

DEVICE

BTL Emsella chair

Subjects will sit on the device. The Research Nurse Coordinator (RNC) will turn the device on and increase the setting gradually until the patient reaches their sensory threshold. This is the maximum sensation the patient can tolerate. The treatment threshold should be increased with every treatment until the subject reaches 100%.

Sponsors & Collaborators

  • William Beaumont Hospitals

    lead OTHER

Principal Investigators

  • Kenneth Peters, MD · Beaumont Hospital-Royal Oak

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2023-01-18
Completion
2023-07-13
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04248491 on ClinicalTrials.gov