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Electrical Stimulation

Usual Care for Myofascial Pelvic Pain

Q: Does the age limitation of this experiment exceed 25 years?

To be eligible for this research, patients must between 18 and 65 years old. Separate trials exist to provide services to those outside of these parameters; two studies are available for individuals younger than eighteen while twenty-one can cater specifically toward seniors over the age of 65.

Q: How many participants is this trial expecting to recruit?

Affirmative. According to the information published on clinicaltrials.gov, this medical trial is accepting participants and was initially advertised on October 1st 2022. 60 individuals are expected to enrol across a single study site with the last update being made on September 27th 2022.

Q: Is this clinical research currently accepting participants?

Clinicaltrials.gov confirms that this medical study, beginning on October 1st 2022, is actively searching for participants. The data was last modified on September 27th of the same year.

Q: How can I participate in this clinical trial?

Successful applicants to this trial must have pelvic <a href="https://www.withpower.com/clinical-trials/pain">pain</a> and be aged between 18-65 years old. The study will admit a maximum of 60 individuals in total.

Q: What are the essential goals of this clinical research?

This 8-week medical trial's primary objective is to assess changes in myofascial pelvic <a href="https://www.withpower.com/clinical-trials/pain">pain</a> symptoms. As secondary objectives, this study will explore the effect of treatment on bothersome visceral bladder symptoms (using ICIQ - FLUTS), bothersome sexual functioning (via FSFI) and genital symptomology (VuAS and VAS). The outcome measures are score ranges that denote improvements or deteriorations in patient wellbeing.

N/A

Recruiting

Led By A. Lenore Ackerman, MD, PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial will test the effectiveness of a new, high-frequency transvaginal electrical stimulation (HF-TES) treatment for myofascial pelvic pain (MPP) in comparison to the standard, first-line treatment of education, stretching, and low-impact exercise.

Who is the study for?

This trial is for women aged 18-65 with chronic pelvic pain lasting over 6 months and a daily pain score of at least 4. Participants should have palpable trigger points in their pelvic floor muscles but no other major health issues or causes for their pain, such as interstitial cystitis or recent surgeries. They must not be pregnant, planning pregnancy, or have had childbirth within the last year.Check my eligibility

What is being tested?

The study tests transvaginal electrical stimulation using a device called Urostym against standard care (education, stretching, low-impact exercise) to treat Myofascial Pelvic Pain. It's a three-arm randomized study where nursing staff will administer the treatment and compare it to specialist-provided care over a period of three months.See study design

What are the potential side effects?

While specific side effects are not listed here, transvaginal electrical stimulation may cause discomfort during application, potential muscle soreness afterwards similar to post-exercise feelings, and possible irritation at the site of use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Benefit of therapy

Change of myofascial pelvic pain symptoms

Patient perception of treatment delivery by an LVN in comparison to specialist MD

+1 more

Secondary outcome measures

Change in bothersome visceral bladder symptoms

Change in bothersome visceral bowel symptoms

Change in bothersome visceral genital symptoms

+3 more

Other outcome measures

Short-term durability of symptomatic improvements

Trial Design

3Treatment groups

Active Control

Group I: Usual CareActive Control1 Intervention

The current standard, first line treatment for MPP is a program of education, home exercises, and stretching. At enrollment, subjects will be counseled about the origins of myofascial pain in a one-on-one setting with the aid of informational handouts. They will be counseled about specific practices, such as Kegel exercises, volitional holding of urine or stool, and intensive exercise, that aggravate pelvic floor hypertonicity. They will be counseled about appropriate hydration and maintaining an adequate bowel regimen to avoid constipation. A stretching regimen aimed at abdominal and pelvic muscle release with elements of self-massage should be performed three times daily. Lastly, subjects will be prescribed 20 minutes of walking daily. Subjects will be recommended to continue this long-term, self-care program indefinitely.

Group II: HF-TES by LVNActive Control1 Intervention

In-office pulsed HF-TES will be delivered by licensed vocational nurse using the Urostym® clinic-based Pelvic Floor Rehabilitation System. An LVN will undergo didactic and practical training, which will include a detailed orientation to the device. Sessions of electric muscle stimulation will be performed at a frequency of 200 Hz (to induce a passive pelvic floor muscle contraction) for 20 min weekly using a pulse duration of 1 ms of stimulation and an interpulse interval of 4.1 ms. Stimulation intensity (current) will be adjusted manually to palpable, but not painful, stimulation. Vaginal and surface abdominal electromyographic monitoring (EMG) will be conducted throughout the treatment session, recording the average pre- and post-treatment values for each session. In subjects whose pelvic floor EMG does not normalize to <4 millielectronvolts (mV) in a 20-minute session, the subsequent session will be increased to 30 minutes.

Group III: HF-TES by PhysicianActive Control1 Intervention

A urogynecologic specialist will deliver HF-TES in office using Urostym® pelvic floor rehabilitation system. A physician will undergo didactic and practical training, which will include a detailed orientation to the device. Sessions of electric muscle stimulation will be performed at a frequency of 200 Hz (to induce a passive pelvic floor muscle contraction) for 20 min weekly using a pulse duration of 1 ms of stimulation and an interpulse interval of 4.1 ms. Stimulation intensity (current) will be adjusted manually to palpable, but not painful, stimulation. Vaginal and surface abdominal electromyographic monitoring (EMG) will be conducted throughout the treatment session, recording the average pre- and post-treatment values for each session. In subjects whose pelvic floor EMG does not normalize to <4 millielectronvolts (mV) in a 20-minute session, the subsequent session will be increased to 30 minutes.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,530 Previous Clinical Trials

10,278,142 Total Patients Enrolled

A. Lenore Ackerman, MD, PhDPrincipal InvestigatorUniversity of California, Los Angeles

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age limitation of this experiment exceed 25 years?

"To be eligible for this research, patients must between 18 and 65 years old. Separate trials exist to provide services to those outside of these parameters; two studies are available for individuals younger than eighteen while twenty-one can cater specifically toward seniors over the age of 65."

Answered by AI

How many participants is this trial expecting to recruit?

"Affirmative. According to the information published on clinicaltrials.gov, this medical trial is accepting participants and was initially advertised on October 1st 2022. 60 individuals are expected to enrol across a single study site with the last update being made on September 27th 2022."

Answered by AI

Is this clinical research currently accepting participants?

"Clinicaltrials.gov confirms that this medical study, beginning on October 1st 2022, is actively searching for participants. The data was last modified on September 27th of the same year."

Answered by AI

How can I participate in this clinical trial?

"Successful applicants to this trial must have pelvic pain and be aged between 18-65 years old. The study will admit a maximum of 60 individuals in total."

Answered by AI

What are the essential goals of this clinical research?

"This 8-week medical trial's primary objective is to assess changes in myofascial pelvic pain symptoms. As secondary objectives, this study will explore the effect of treatment on bothersome visceral bladder symptoms (using ICIQ - FLUTS), bothersome sexual functioning (via FSFI) and genital symptomology (VuAS and VAS). The outcome measures are score ranges that denote improvements or deteriorations in patient wellbeing."

Answered by AI

Recent research and studies

Physical TherapyJournal

Use of High Voltage Pulsed Galvanic Stimulation for Patients with Levator Ani Syndrome

Morris, Lydia, and Roberta A. Newton. 1987. “Use of High Voltage Pulsed Galvanic Stimulation for Patients with Levator Ani Syndrome”. Physical Therapy. Oxford University Press (OUP). doi:10.1093/ptj/67.10.1522.

Diseases of the Colon & RectumJournal

Levator Syndrome

Nicosia, Jon F., and Herand Abcarian. 1985. “Levator Syndrome”. Diseases of the Colon & Rectum. Ovid Technologies (Wolters Kluwer Health). doi:10.1007/bf02560224.

The American Journal of SurgeryJournal

The Levator Syndrome and Its Treatment with High-voltage Electrogalvanic Stimulation

Sohn, Norman, Michael A. Weinstein, and Richard D. Robbins. 1982. “The Levator Syndrome and Its Treatment with High-voltage Electrogalvanic Stimulation”. The American Journal of Surgery. Elsevier BV. doi:10.1016/0002-9610(82)90586-4.

Diseases of the Colon & RectumJournal