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Electromagnetic Therapy
Emsella Chair Active Treatment for Pelvic Pain (EmsellaPain Trial)
N/A
Waitlist Available
Led By Kenneth Peters, MD
Research Sponsored by William Beaumont Hospitals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
EmsellaPain Trial Summary
This trial will compare the Emsella Chair therapy to a Sham treatment to see if electromagnetic technology is effective in treating chronic pelvic pain. Subjects will receive 2 treatments per week for 4 weeks.
EmsellaPain Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Change in Subject-reported Pain and Discomfort as Measured by the Visual Analog Scale (VAS)
Secondary outcome measures
Change in Subject-reported Pain and Discomfort as Measured by VAS
Safety and Tolerability Will be Assessed as the Number of Esmella Chair-related With Adverse Events.
The Change in Subject-reported Anxiety Symptoms as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7).
+11 moreEmsellaPain Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Emsella Chair Active TreatmentActive Control1 Intervention
Subjects will be asked to sit on the device and the height will be adjusted until the subject's feet are on the floor. The active treatments are individualized, since some subjects will be more sensitive than others. The Emsella Chair will be turned on and the setting gradually increased to the subject's sensory threshold; the maximum sensation the subject can tolerate. The setting will be decreased slightly and stay unchanged for the remainder of the treatment. The treatment threshold should be increased with every treatment until the subject reaches 100%.
Group II: Emsella Sham TreatmentPlacebo Group1 Intervention
Sham treatment subjects will be positioned on the device in the same manner. The sham treatment will provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below the therapeutic level (<10% power).
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Who is running the clinical trial?
William Beaumont HospitalsLead Sponsor
149 Previous Clinical Trials
112,518 Total Patients Enrolled
10 Trials studying Pelvic Pain
4,603 Patients Enrolled for Pelvic Pain
Kenneth Peters, MDPrincipal InvestigatorBeaumont Hospital-Royal Oak
26 Previous Clinical Trials
2,015 Total Patients Enrolled
5 Trials studying Pelvic Pain
850 Patients Enrolled for Pelvic Pain
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You weigh more than 330 pounds.You have used the BTL EMSELLA device before.You have chronic pelvic pain that lasts for at least 6 months and doesn't go away with other treatments.You have trouble breathing and get tired easily, especially during physical activity. You may also experience a fast or irregular heartbeat, swelling in your legs or feet, dizziness or fainting, and bluish color on your nails or lips.You have received physical therapy for your pelvic floor muscles within the last 30 days.You are currently undergoing treatment for cancer that would make it difficult for you to take part in the study.You have a condition that makes you unable to feel normal sensations in your lower body, including your pelvis, buttocks, and legs.You have had injections or procedures in your pelvic area within the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Emsella Chair Active Treatment
- Group 2: Emsella Sham Treatment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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