Pelvic PainEmsellaPainNCT04248491
Emsella Chair Versus Sham for the Treatment of Chronic Pelvic Pain
A study testing BTL Emsella chair in people with Pelvic Pain, run by Corewell Health East at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pelvic Pain
- What is being tested?
- BTL Emsella chair
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2020to 13 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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))
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073
About this study
Official title: A Single-Blind, Randomized Study of the BTL Emsella Chair Versus Sham for the Treatment of Chronic Pelvic Pain
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.
Read the 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.
- Conditions
- Pelvic Pain
- Being tested
- BTL Emsella chair
- Keywords
- Chronic Pelvic Pain
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTL Emsella chairDevice
Subjects will sit on the device. The Research Nurse Coordinator (RNC) will turn the device on and increase the setting gradually until the patient reaches their sensory threshold. This is the maximum sensation the patient can tolerate. The treatment threshold should be increased with every treatment until the subject reaches 100%.
| Study group | Role | What they receive |
|---|---|---|
| Emsella Chair Active Treatment | Active comparator | Subjects will be asked to sit on the device and the height will be adjusted until the subject's feet are on the floor. The active treatments are individualized, since some subjects will be more sensitive than others. The Emsella Chair will be turned on and the setting gradually increased to the subject's sensory threshold; the maximum sensation the subject can tolerate. The setting will be decreased slightly and stay unchanged for the remainder of the treatment. The treatment threshold should be increased with every treatment until the subject reaches 100%. Receives: Device: BTL Emsella chair |
| Emsella Sham Treatment | Sham comparator | Sham treatment subjects will be positioned on the device in the same manner. The sham treatment will provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below the therapeutic level (<10% power). Receives: Device: BTL Emsella chair |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in Subject-reported Pain and Discomfort as Measured by the Visual Analog Scale (VAS)
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.
Measured: Baseline and week 8
Secondary outcomes (14)
The Change in Subject-reported Impression of CPP Severity as Measured by the Patient Global Impression of Severity Scale (PGI-S).
Change in subject-reported impression of CPP severity as measured by the Patient Global Impression of Severity scale (PGI-S). The subject will check the box that describes how their condition is now. This is a four point scale, with 1=normal, 2= mild, 3=moderate, and 4= severe. The value at week 12 minus the value at baseline was calculated. A positive change indicates a worsening condition, and a negative value indicated an improvement in condition.
Measured: Baseline and week 12
The Number of Participants Reporting Significant Symptom Improvement as Measured by the Patient Global Impression of Improvement Scale (PGI-I)
Subject-reported impression of CPP improvement as measured by the Patient Global Impression of Improvement scale (PGI-I). The scale has 7 points with a lower number indicating improvement: (1=very much better, 2=much better, 3=a little better, 4=no change, 5=a little worse, 6-=much worse, 7= very much worse) to describe their chronic pelvic pain symptoms now versus prior to study treatment. We will report the number of individuals reporting a score of 1 or 2, very much better or much better (significantly improved).
Measured: 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.
A trained provider will complete a pelvic (women) or rectal (men) exam on subjects. The VAS is a validated questionnaire that assesses pain on a scale from 0 = no pain to 10 = worst possible pain. The subject will provide a pain score from 0 - 10 for each of the 4 quadrants assessed. The average pain score of the 4 quadrants is then calculated. The average pain score ranges from 0 to 10. The value from baseline to secondary endpoint at week 12 is calculated. Positive change indicates improvement of symptoms. A negative change indicates worsening of symptoms.
Measured: Baseline and week 12
The Change in Subject-reported Impression of CPP Severity in Females.
The change in CPP severity as measured by subject-reported sexual function as measured by the Female Sexual Function Index questionnaire (FSFI) for female subjects. The FSFI is a 19 question survey. A lower score is equivalent to a higher degree of sexual dysfunction. Scores range from 0 to 36. The change value is calculated from baseline to week 12. Positive change indicates improvement of symptoms. A negative change indicates worsening of symptoms.
Measured: Baseline and Week 12
The Change in Subject-reported Impression of CPP Severity in Males.
The change in CPP severity as measured by subject-reported sexual function as measured by the Brief Sexual Function Inventory questionnaire (BSFI) for male subjects. The BSFI is a validated questionnaire for male sexual function. Average score ranges from 0 to 44. A lower score indicates a higher degree of dysfunction. Positive change indicates improvement of symptoms. A negative change indicates worsening of symptoms. Calculated from the value at week 12 minus value at baseline
Measured: Baseline and week 12
The Change in Subject-reported Depression Severity as Measured by the Beck Depression Inventory (BDI).
The Beck Depression Inventory is a 21-question multiple-choice self-report inventory. It is composed of items relating to symptoms of depression such as hopelessness, irritability, guilt, fatigue, weight loss, and lack of interest in sex. Subjects that score greater than 30 at any time may be referred for psychological evaluation but may continue study participation. A higher score indicates a greater severity of depression. Scores can range from 0 to 63. The value of change calculated from baseline minus week 12. Positive change indicates improvement of symptoms. A negative change indicates worsening of symptoms.
Measured: 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).
Since both overactive bladder (OAB) and interstitial cystitis/bladder pain syndrome (IC/BPS) share urinary urgency and frequency symptoms, this validated measure will evaluate additional aspects associated with OAB and IC/BPS. The OAB-Q Short Form (SF) consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. Each question is rated on a 6 point scale with 1 = Not at all and 6 = A very great deal. Scores can range from 0 to 100. The change value is calculated from the baseline value minus the value at week 12. Positive change indicates improvement of symptoms. A negative change indicates worsening of symptoms.
Measured: 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).
IC/BPS patients can share urinary urgency and frequency symptoms. The ICSI-PI measures urinary and pain symptoms and assesses how problematic are. A higher score indicates greater severity of symptoms. Scores range from 0-36. The change is calculated by the baseline value minus the value at week 12. Positive change indicates improvement of symptoms. A negative change indicates worsening of symptoms.
Measured: Baseline and week 12
The Change in Subject-reported Anxiety Symptoms as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7).
The GAD-7 questionnaire is a 7-item validated scale to assess generalized anxiety disorder. Patients are grouped by GAD score 0-7 and 8+ which suggests no anxiety disorder and probably anxiety disorder, respectively. Scores can range from 0 to 21. The change is calculated as the value at baseline minus the value at week 12. Positive change indicates improvement of symptoms. A negative change indicates worsening of symptoms.
Measured: Baseline and week 12
The Change in Subject-reported Pain as Measured by the McGill Pain Questionnaire (MPQ).
The McGill Pain Questionnaire can be used to evaluate a person experiencing pain over time to determine the effectiveness of an intervention. The questionnaire consists of 22 questions. Each question is scored 0 (none) to 10 (worst possible). A higher score indicates more severe pain symptoms. Scores range from 0 to 220. The change calculated from the value at baseline minus the value at week 12. Positive change indicates improvement of symptoms. A negative change indicates worsening of symptoms.
Measured: Baseline and week 12
The Change in Subject-reported Rumination, Magnification, and Helplessness Related to Pain as Measured by the Pain Catastrophizing Scale (PCS).
The Pain Catastrophizing Scale (PCS) lists thirteen statements describing different thoughts and feelings that may be associated with pain. Each statement is rated as: 0 =not at all, 1= to a slight degree, 2= to a moderate degree, 3= to a great degree, and 4= all the time. Subjects who report a larger number associated with such thoughts during pain are more likely to rate the pain as more intense. Scores range from 0 to 52. The change is calculated as the value at baseline minus the value at week 12. Positive change indicates improvement of symptoms. A negative change indicates worsening of symptoms.
Measured: 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.
The GRA is a 7-point scale to evaluate the subject's perception of overall improvement in pain. It is scored as follows: 1 = markedly worse, 2 = moderately worse, 3 = mildly worse, 4 = same (unchanged), 5 = slightly improved, 6 = moderately improved, and 7 = markedly improved. The number of participants reporting significant improvement in pain (score of 6 or 7) at week 12 are counted.
Measured: Week 12
Change in Subject-reported Pain and Discomfort as Measured by VAS
Change in subject reported pain and discomfort as measured by the Visual Analog Scale (VAS). The VAS is a validated questionnaire that assesses pain on a scale from 0= no pain to 10= worst possible pain. The change is calculated from the value at baseline minus the value at week 12. Positive change indicates improvement of symptoms. A negative change indicates worsening of symptoms.
Measured: Baseline and week 12
Safety and Tolerability Will be Assessed as the Number of Esmella Chair-related With Adverse Events.
Safety and tolerability of the Emsella chair compared to Sham will be assessed as the number of adverse events reported that were determined to be related to the Emsella chair treatment.
Measured: From baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start13 Jul 2020
- Primary completion18 Jan 2023
- Study completion13 Jul 2023
Why it stopped: Due to low enrollment and lack of efficiency
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth M Peters, MD, Corewell Health East
- Investigators
- Kenneth Peters, MD, Principal investigator, Beaumont Hospital-Royal Oak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248491
- Sponsor's protocol ID
- 2019-348
- Acronym
- EmsellaPain
- Status last verified
- Aug 2023
- First submitted
- 27 Jan 2020
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind, Randomized Study of the BTL Emsella Chair Versus Sham for the Treatment of Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT04248491
- Acronym / sponsor ID
- EmsellaPain / 2019-348
- Conditions
- Pelvic Pain
- Keywords
- Chronic Pelvic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low enrollment and lack of efficiency
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Emsella Chair Active Treatment | Active comparator | Device: BTL Emsella chairSubjects will be asked to sit on the device and the height will be adjusted until the subject's feet are on the floor. The active treatments are individualized, since some subjects will be more sensitive than others. The Emsella Chair will be turned on and the setting gradually increased to the subject's sensory threshold; the maximum sensation the subject can tolerate. The setting will be decreased slightly and stay unchanged for the remainder of the treatment. The treatment threshold should be increased with every treatment until the subject reaches 100%. |
| Emsella Sham Treatment | Sham comparator | Device: BTL Emsella chairSham treatment subjects will be positioned on the device in the same manner. The sham treatment will provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below the therapeutic level (<10% power). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BTL Emsella chairSubjects will sit on the device. The Research Nurse Coordinator (RNC) will turn the device on and increase the setting gradually until the patient reaches their sensory threshold. This is the maximum sensation the patient can tolerate. The treatment threshold should be increased with every treatment until the subject reaches 100%. | Device | Emsella Chair Active Treatment, Emsella Sham Treatment |
Primary outcome
The Change in Subject-reported Pain and Discomfort as Measured by the Visual Analog Scale (VAS)
Time frame: 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.
14 secondary outcomes
The Change in Subject-reported Impression of CPP Severity as Measured by the Patient Global Impression of Severity Scale (PGI-S).
Time frame: Baseline and week 12
The Number of Participants Reporting Significant Symptom Improvement as Measured by the Patient Global Impression of Improvement Scale (PGI-I)
Time frame: 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.
Time frame: Baseline and week 12
The Change in Subject-reported Impression of CPP Severity in Females.
Time frame: Baseline and Week 12
The Change in Subject-reported Impression of CPP Severity in Males.
Time frame: Baseline and week 12
The Change in Subject-reported Depression Severity as Measured by the Beck Depression Inventory (BDI).
Time frame: 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).
Time frame: 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).
Time frame: Baseline and week 12
The Change in Subject-reported Anxiety Symptoms as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7).
Time frame: Baseline and week 12
The Change in Subject-reported Pain as Measured by the McGill Pain Questionnaire (MPQ).
Time frame: Baseline and week 12
The Change in Subject-reported Rumination, Magnification, and Helplessness Related to Pain as Measured by the Pain Catastrophizing Scale (PCS).
Time frame: 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.
Time frame: Week 12
Change in Subject-reported Pain and Discomfort as Measured by VAS
Time frame: Baseline and week 12
Safety and Tolerability Will be Assessed as the Number of Esmella Chair-related With Adverse Events.
Time frame: From baseline to week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Peters, MD principal investigator
Beaumont Hospital-Royal Oak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BTL Emsella chair in people with Pelvic Pain, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change in Subject-reported Pain and Discomfort as Measured by the Visual Analog Scale (VAS) (time frame: Baseline and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.