Emsella Chair Versus Sham for the Treatment of Chronic 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

Summary

This trial is testing the Emsella Chair, which uses electromagnetic waves to strengthen pelvic muscles, on patients with chronic pelvic pain. These patients often have severe pain that doesn't respond well to usual treatments. The chair helps by making the pelvic muscles work out and get stronger. Electromagnetic fields (EMFs) provide a non-invasive, safe, and easy method to treat pain with respect to musculoskeletal diseases.

Eligible Conditions

Pelvic Pain
Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The Change in Subject-reported Pain and Discomfort as Measured by the Visual Analog Scale (VAS)

Secondary study objectives

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 more

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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