Emsella Chair Active Treatment for Pelvic Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Beaumont Hospital-Royal Oak, Royal Oak, MIPelvic PainBTL Emsella chair - Device
Eligibility
18 - 80
All Sexes
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Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
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2
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Study Objectives

1 Primary · 14 Secondary · Reporting Duration: Treatment durability will be assessed 4 weeks after the primary endpoint; week 12 of the study

Week 8
Compare the efficacy of Emsella Chair to sham by evaluating the change in subject-reported pain and discomfort as measured by the Visual Analog Scale (VAS)
Week 12
Compare the efficacy of Emsella Chair versus sham by evaluating the change in subject-reported impression of CPP severity as measured by subject-reported pelvic floor tenderness to palpation during 4 quadrant pelvic examination as measured by VAS.
Compare the efficacy of Emsella Chair versus sham by evaluating the change in subject-reported impression of CPP severity as measured by the Patient Global Impression of Improvement scale (PGI-I)
Compare the efficacy of Emsella Chair versus sham by evaluating the change in subject-reported impression of CPP severity as measured by the Patient Global Impression of Severity scale (PGI-S).
Compare the efficacy of Emsella Chair versus sham by evaluating the change in subject-reported impression of CPP severity in females.
Week 12
Compare the efficacy of Emsella Chair versus sham by evaluating the change in subject-reported anxiety symptoms as measured by the Generalized Anxiety Disorder Questionnaire (GAD-7).
Pain
Compare the efficacy of Emsella Chair versus sham by evaluating the change in subject-reported urinary and pain symptoms, as well as bother, as measured by the Interstitial Cystitis Symptom Index and Problem Index (ICSI-PI).
Week 4
Compare the efficacy of Emsella Chair versus sham by evaluating the change in subject-reported depression severity as measured by the Beck Depression Inventory (BDI).
Week 12
Compare the efficacy of Emsella Chair versus sham by evaluating the change in subject-reported bother related to overactive bladder symptoms as measured by the Overactive Bladder Questionnaire-Short Form (OAB-Q).
Compare the efficacy of Emsella Chair versus sham by evaluating the change in subject-reported impression of CPP severity in males
Week 12
Compare the efficacy of Emsella Chair versus sham by evaluating the change in subject-reported perception of overall improvement in symptoms as measured by Global Response Assessments (GRA) for Pain and Quality of Life.
Compare the efficacy of Emsella Chair versus sham by evaluating the change in subject-reported rumination, magnification, and helplessness related to pain as measured by the Pain Catastrophizing Scale (PCS).
Week 12
The secondary safety objectives of this study are to determine the safety and tolerability of Emsella Chair compared to sham. Safety and tolerability will be assessed in relation to the incidence of adverse events.
Week 12
The secondary durability objective for this study is to determine whether subjects in the Emsella Chair group continue to have decrease in pain, as measured by VAS, compared to the Sham group 4 weeks after the primary efficacy endpoint.

Trial Safety

Safety Progress

1 of 3

Similar Trials

2
Pelvic Floor Physical Therapy
3
Behavioral therapy
2
BHV3000

Trial Design

2 Treatment Groups

Emsella Chair Active Treatment
1 of 2
Emsella Sham Treatment
1 of 2

Active Control

Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Emsella Chair Active Treatment · Has Placebo Group · N/A

Emsella Chair Active Treatment
Device
ActiveComparator Group · 1 Intervention: BTL Emsella chair · Intervention Types: Device
Emsella Sham Treatment
Device
ShamComparator Group · 1 Intervention: BTL Emsella chair · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: treatment durability will be assessed 4 weeks after the primary endpoint; week 12 of the study

Who is running the clinical trial?

William Beaumont HospitalsLead Sponsor
143 Previous Clinical Trials
114,362 Total Patients Enrolled
9 Trials studying Pelvic Pain
4,578 Patients Enrolled for Pelvic Pain
Kenneth Peters, MDPrincipal InvestigatorBeaumont Hospital-Royal Oak
24 Previous Clinical Trials
2,231 Total Patients Enrolled
4 Trials studying Pelvic Pain
825 Patients Enrolled for Pelvic Pain

Eligibility Criteria

Age 18 - 80 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be between 18 and 80 years old at the time of screening, regardless of gender.
You must keep taking your current medications at the same dose during the study period.
If you are a woman of child-bearing age, you must agree to use an approved method of birth control during the study. These methods include oral contraceptives, condoms, injections, diaphragms or cervical caps, vaginal contraceptive rings, intrauterine devices (IUDs), implantable contraceptives, surgical sterilization (bilateral tubal ligation), or having a partner who has undergone vasectomy.
You are able to read and understand information about the study, and can provide written consent. You are also able to follow the study protocol, complete questionnaires, and inform study personnel about any important information related to your health.
You have experienced pelvic pain for at least 6 months, which is not related to your menstrual cycle and has not improved with other treatments.
You agree not to start any new treatments for your CPP (chronic pelvic pain) during the study and follow-up periods.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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