A Single-Blind, Randomized Study of the BTL Emsella Chair Versus Sham for the Treatment of Chronic Pelvic Pain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- The Change in Subject-reported Pain and Discomfort as Measured by the Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The sham Emsella treatment will provide sensation without active HIFEM technology. The sham treatment amplitude setting will be limited to below the therapeutic level.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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))
排除标准
- •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.
结局指标
主要结局
The Change in Subject-reported Pain and Discomfort as Measured by the Visual Analog Scale (VAS)
时间窗: Baseline and week 8
Mean change in Pain VAS from baseline to end of treatment will be compared between the Emsella Chair group and the sham group. VAS is scored from 0-10, where 0 = no pain and 10 = worst possible pain. Value at week 8 minus the value at baseline was used to calculate change. Negative numbers indicate an improvement in pain, and positive numbers indicate a worsening pain.
次要结局
- The Change in Subject-reported Impression of CPP Severity in Males.(Baseline and week 12)
- 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).(Baseline and week 12)
- The Change in Subject-reported Pain as Measured by the McGill Pain Questionnaire (MPQ).(Baseline and week 12)
- The Number of Participants Reporting Significant Symptom Improvement as Measured by the Patient Global Impression of Improvement Scale (PGI-I)(at 12 weeks)
- 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.(Baseline and week 12)
- The Change in Subject-reported Impression of CPP Severity in Females.(Baseline and Week 12)
- The Change in Subject-reported Impression of CPP Severity as Measured by the Patient Global Impression of Severity Scale (PGI-S).(Baseline and week 12)
- The Change in Subject-reported Bother Related to Overactive Bladder Symptoms as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-Q).(Baseline and week 12)
- The Subject-reported Perception of Overall Improvement in Pain as Measured by Global Response Assessments (GRA) for Pain and Quality of Life.(Week 12)
- The Change in Subject-reported Depression Severity as Measured by the Beck Depression Inventory (BDI).(Baseline and week 12)
- Safety and Tolerability Will be Assessed as the Number of Esmella Chair-related With Adverse Events.(From baseline to week 12)
- The Change in Subject-reported Anxiety Symptoms as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7).(Baseline and week 12)
- The Change in Subject-reported Rumination, Magnification, and Helplessness Related to Pain as Measured by the Pain Catastrophizing Scale (PCS).(Baseline and week 12)
- Change in Subject-reported Pain and Discomfort as Measured by VAS(Baseline and week 12)
研究者
Kenneth M Peters, MD
Director and Chair of the Department of Urology
William Beaumont Hospitals