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Electromagnetic Therapy

Emsella Chair Active Treatment for Pelvic Pain (EmsellaPain Trial)

Q: Is enrollment still available for this study?

Indeed, information accessible on clinicaltrials.gov confirms that this medical trial is still recruiting patients; it was initially posted on July 13th 2020 and last updated October 1st 2022. There is a need to recruit 60 individuals from one particular clinic.

Q: Is participation in this research endeavor open to individuals aged 55 or older?

Participants must have surpassed the age of consent and not yet reached their eightieth birthday in order to be considered for this medical trial.

Q: How many participants are being recruited for this clinical trial?

Affirmative. The information posted on clinicaltrials.gov states that this research endeavour is actively enrolling participants, with the trial having first been made public on July 13th 2020 and last updated in October 1st 2022. It is seeking sixty volunteers from one location for participation.

Q: Do I meet the criteria to participate in this research endeavor?

This medical trial seeks 60 volunteers, aged 18-80, that are suffering from non-cyclical pelvic <a href="https://www.withpower.com/clinical-trials/pain">pain</a>. Eligible participants must be able to read and understand the study's informed consent form; provide written and dated confirmation of their understanding; comply with <a href="https://www.withpower.com/clinical-trials/all">all</a> protocol requirements (including completion of associated questionnaires); refrain from starting any new treatments for CPP during the treatment period; maintain a steady dosage for current medications throughout the course of the trial; and if applicable, practice approved <a href="https://www.withpower.com/clinical-trials/birth-control">birth control</a> methods such as oral contraceptives or surgically sterilized partners.

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

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

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 more

EmsellaPain 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

112,847 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

Media Library

BTL Emsella Chair (Electromagnetic Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04248491 — N/A

Pelvic Pain Research Study Groups: Emsella Chair Active Treatment, Emsella Sham Treatment

Pelvic Pain Clinical Trial 2023: BTL Emsella Chair Highlights & Side Effects. Trial Name: NCT04248491 — N/A

BTL Emsella Chair (Electromagnetic Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04248491 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still available for this study?

"Indeed, information accessible on clinicaltrials.gov confirms that this medical trial is still recruiting patients; it was initially posted on July 13th 2020 and last updated October 1st 2022. There is a need to recruit 60 individuals from one particular clinic."

Answered by AI

Is participation in this research endeavor open to individuals aged 55 or older?

"Participants must have surpassed the age of consent and not yet reached their eightieth birthday in order to be considered for this medical trial."

Answered by AI

How many participants are being recruited for this clinical trial?

"Affirmative. The information posted on clinicaltrials.gov states that this research endeavour is actively enrolling participants, with the trial having first been made public on July 13th 2020 and last updated in October 1st 2022. It is seeking sixty volunteers from one location for participation."

Answered by AI

Do I meet the criteria to participate in this research endeavor?

"This medical trial seeks 60 volunteers, aged 18-80, that are suffering from non-cyclical pelvic pain. Eligible participants must be able to read and understand the study's informed consent form; provide written and dated confirmation of their understanding; comply with all protocol requirements (including completion of associated questionnaires); refrain from starting any new treatments for CPP during the treatment period; maintain a steady dosage for current medications throughout the course of the trial; and if applicable, practice approved birth control methods such as oral contraceptives or surgically sterilized partners."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Emsella Chair Versus Sham for the Treatment of Chronic Pelvic Pain

Kenneth M Peters, MD 2020. "Emsella Chair Versus Sham for the Treatment of Chronic Pelvic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04248491.