Emsella Chair Versus Sham for the Treatment of Chronic Pelvic Pain

Stopped early · Not applicable · Has a placebo group

Conditions studied: Pelvic Pain

In brief

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.

Key facts

Study ID

NCT04248491

Run by

Corewell Health East

People needed

11

Starts

2020-07-13

Expected to finish

2023-07-13

Last updated by the study team

2023-09-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to read, understand, and provide written, dated, informed consent prior to screening, and be likely to comply with study protocol, including independently complete study questionnaires and communicate with study personnel about adverse events (AEs) and other clinically important information.
• Females and males, 18 to 80 years of age, at screening
• Self-reported CPP defined as pelvic pain that is non-cyclical and of at least 6 months duration and refractory to other treatments
• Subject agrees not to start any new treatment for CPP (medication or otherwise) during the treatment and follow-up periods.
• Subject agrees to maintain a stable dose all current medications throughout the treatment and follow-up period
• For Females Only:
• If of child-bearing age and female, agree to practice approved birth-control methods (oral contraceptives, condom barrier, injection, diaphragm or cervical cap, vaginal contraceptive ring, Intrauterine device (IUD), implantable contraceptive, surgical sterilization (bilateral tubal ligation), vasectomized partner(s))

You may not qualify if…

• Pelvic floor physical therapy, including muscle training and/or electrostimulation, in a clinical setting within 30 days prior to screening.
• Pelvic floor trigger point injections, pudendal nerve block, or bladder hydrodistention within 30 days prior to screening
• Subject weighs more than 330 pounds
• Current urinary tract infection (UTI). If a subject has a confirmed symptomatic UTI at screening, per the investigator's clinical judgment, they will be deferred from screening until treatment is completed, and may resume once symptoms have resolved.
• Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; heartbeat (palpitations); swelling of the legs or feet; dizziness or fainting; and/or bluish discoloration of the nails and/or lips (cyanosis)
• Subject is currently receiving treatment for a malignant tumor that would interfere with study participation.
• Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and lower extremities
• History of Hunner's lesion in the medical record
• Major metal implants such as: metal plates, screws, joint replacements, implanted cardiac pacemakers, drug pumps, neurostimulators, electronic implants, copper intrauterine devices, defibrillators, and metal implants in the pelvic area. Patients with other metal implants will be evaluated by the investigator for inclusion in the study.
• Subject has a piercing between the waist and knees and is not willing to remove it before each treatment
• Subject has used the BTL EMSELLA device previously
• Currently participating in an investigational study that may impact study results or previously received an investigational drug or treatment within 30 days of the Screening Visit
• Current or history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation
• For Females Only:
• Pregnant, or planning to become pregnant, at screening or anytime throughout the study period
• Note: For the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.

Where it is running

• Beaumont Hospital-Royal Oak — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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