Emsella Chair Versus Sham for the Treatment of Chronic Pelvic Pain
TerminatedNot applicableNCT04248491
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Single-Blind, Randomized Study of the BTL Emsella Chair Versus Sham for the Treatment of Chronic Pelvic Pain
- Conditions
- Interventions
- Device: BTL Emsella chair
- Sponsor
- Corewell Health East
- Start date
- 2020-07-13
- Primary completion
- 2023-01-18
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. 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. 2. Females and males, 18 to 80 years of age, at screening 3. Self-reported CPP defined as pelvic pain that is non-cyclical and of at least 6 months duration and refractory to other treatments 4. Subject agrees not to start any new treatment for CPP (medication or otherwise) during the treatment and follow-up periods. 5. Subject agrees to maintain a stable dose all current medications throughout the treatment and follow-up period For Females Only: 6. 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)) Exclusion Criteria: 1. Pelvic floor physical therapy, including muscle training and/or electrostimulation, in a clinical setting within 30 days prior to screening. 2. Pelvic floor trigger point injections, pudendal nerve block, or bladder hydrodistention within 30 days prior to screening 3. Subject weighs more than 330 pounds 4. 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. 5. 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) 6. Subject is currently receiving treatment for a malignant tumor that would interfere with study participation. 7. Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and lower extremities 8. History of Hunner's lesion in the medical record 9. 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 investiā¦
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04248491