Clinical trial NCT04248491: Emsella Chair Versus Sham for the Treatment of Chronic Pelvic Pain
Official title: A Single-Blind, Randomized Study of the BTL Emsella Chair Versus Sham for the Treatment of Chronic Pelvic Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pelvic Pain
Keywords: Chronic Pelvic Pain
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who meet all the eligibility criteria will be enrolled in the study and randomized (1:1) to receive Emsella chair or sham treatments. The subject and biostatistician will be blinded to the group allocation throughout the study. The initial analysis of data, performed by the biostatistician will not include group assignment.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Chronic pelvic pain (CPP) is a common and often debilitating in both men and women. It occurs below the umbilicus and is severe enough to cause functional impairment or require treatment. The health care burden of CPP is substantial. First line treatments involve a multidisciplinary approach and include general relaxation and stress management, patient education, self-care and behavioral modification, and pain management. Second-line agents include physical therapy (avoiding kegel exercises), and oral and intravesical agents. More invasive options including neuromodulation.

The Emsella chair is currently approved as a treatment for stress urinary incontinence. Chronic pelvic pain patients may benefit from treatment. The Emsella chair generates electromagnetic stimulation which is able to penetrate deep into the pelvic floor muscles inducing stimulation and providing rehabilitation for weak pelvic floor muscles. The Emsella chair is a novel high-intensity focused electromagnetic (HIFEM) technology for the treatment of stress urinary incontinence (SUI), in addition to other pelvic floor related disorders. HIFEM technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes.

Eligibility criteria: 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 investigator for inclusion in the study.
10. Subject has a piercing between the waist and knees and is not willing to remove it before each treatment
11. Subject has used the BTL EMSELLA device previously
12. 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
13. 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:
14. 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.

Primary outcomes:
measure: The Change in Subject-reported Pain and Discomfort as Measured by the Visual Analog Scale (VAS)
timeFrame: Baseline and week 8
Secondary outcomes:
measure: The Change in Subject-reported Impression of CPP Severity as Measured by the Patient Global Impression of Severity Scale (PGI-S).
timeFrame: Baseline and week 12
measure: The Number of Participants Reporting Significant Symptom Improvement as Measured by the Patient Global Impression of Improvement Scale (PGI-I)
timeFrame: at 12 weeks
measure: 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.
timeFrame: Baseline and week 12
measure: The Change in Subject-reported Impression of CPP Severity in Females.
timeFrame: Baseline and Week 12
measure: The Change in Subject-reported Impression of CPP Severity in Males.
timeFrame: Baseline and week 12
measure: The Change in Subject-reported Depression Severity as Measured by the Beck Depression Inventory (BDI).
timeFrame: Baseline and week 12
measure: The Change in Subject-reported Bother Related to Overactive Bladder Symptoms as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-Q).
timeFrame: Baseline and week 12
measure: 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).
timeFrame: Baseline and week 12
measure: The Change in Subject-reported Anxiety Symptoms as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7).
timeFrame: Baseline and week 12
measure: The Change in Subject-reported Pain as Measured by the McGill Pain Questionnaire (MPQ).
timeFrame: Baseline and week 12
measure: The Change in Subject-reported Rumination, Magnification, and Helplessness Related to Pain as Measured by the Pain Catastrophizing Scale (PCS).
timeFrame: Baseline and week 12
measure: The Subject-reported Perception of Overall Improvement in Pain as Measured by Global Response Assessments (GRA) for Pain and Quality of Life.
timeFrame: Week 12
measure: Change in Subject-reported Pain and Discomfort as Measured by VAS
timeFrame: Baseline and week 12
measure: Safety and Tolerability Will be Assessed as the Number of Esmella Chair-related With Adverse Events.
timeFrame: From baseline to week 12
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Hospital-Royal Oak
state: Michigan
Study officials:
affiliation: Beaumont Hospital-Royal Oak
name: Kenneth Peters, MD
role: PRINCIPAL_INVESTIGATOR
References: