Comparison of the Effectiveness of EMG-Biofeedback and Rebound Therapy in Patients With Endometriosis

April 20, 2026 updated by: Çağla ÖZGÖREN, Medipol University
The aim of our study is to investigate the effects of pelvic floor muscle strengthening exercises with EMG-Biofeedback and pelvic floor muscle strengthening exercises with Rebound therapy on pelvic floor muscle strength, pain level, NGF level, perceived stress level, quality of life and sleep in women diagnosed with endometriosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Endometriosis is a chronic, systematic, inflammatory, estrogen-dependent public health problem characterized by the growth of endometrial-like tissue outside the uterine cavity, including the pelvic peritoneum, rectovaginal septum and ovaries, and is particularly seen in women of reproductive age and significantly affects quality of life. The aim of our study is to investigate the effects of pelvic floor muscle strengthening exercises with EMG-Biofeedback and pelvic floor muscle strengthening exercises with Rebound therapy on pelvic floor muscle strength, pain level, NGF level, perceived stress level, quality of life and sleep in women diagnosed with endometriosis. The study will consist of 3 groups. Group 1: EMG-Biofeedback group, Group 2: Rebound Therapy Group and Group 3: Home Exercises Group. Participants will be included in the study for 8 weeks. During the evaluation, pelvic floor muscle strength will be assessed with EMG, pain level with Visual Analog Scale (VAS), perceived stress level with Perceived Stress Scale, quality of life with Endometriosis Health Profile Questionnaire (EHP-30), and sleep quality with Pittsburgh Sleep Quality Index (PSQI). NGF analysis will be evaluated by analyzing serum samples of patients with ELISA kit. Evaluations will be made before and after treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Üsküdar, Istanbul, Turkey (Türkiye), 34668
        • Zeynep Kamil Women and Children's Diseases Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being between 20-50 years old,
  • Being diagnosed with endometriosis,
  • Completing the voluntary consent form,
  • Pain level being at least 4 on the Visual Analog Scale (VAS).

Exclusion Criteria:

Exclusion Criteria for the EMG-Biofeedback Group:

  • Being included in another study during the study period,
  • Being receiving medical treatment for endometriosis,
  • Presence of gynecological bleeding,
  • Presence of communication and cooperation problems,
  • Presence of tubo-ovarian abscess,
  • Active vaginal or urinary tract infection,
  • Pregnancy and giving birth within the last 12 months,
  • Presence of impaired somatosensory status,
  • Not attending 2 consecutive sessions.

Exclusion Criteria for the Rebound Therapy Group:

In addition to the exclusion criteria determined for the EMG-Biofeedback Group;

  • Presence of a neurological or orthopedic disease affecting the lower extremity,
  • History of spine and/or lower extremity orthopedic surgery,
  • Presence of severe arthritis affecting the spine and/or lower extremity,
  • Presence of uncontrolled hypertension and cardiovascular disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 2: Rebound Therapy
In this group, rebound therapy will be performed on a trampoline, along with pelvic floor strengthening training, twice a week. Patients will also follow the home exercise program given to the first group, practicing it 5 days a week. For rebound therapy, a trampoline-based exercise program targeting pelvic floor muscles will be conducted in a clinical setting for 8 weeks, 2 days a week, with 20-minute sessions. Proper breathing patterns will be taught before starting. During rest periods, O2 saturation and maximum heart rate will be monitored. Maximum heart rate will be calculated (HRmax = 208 - 0.7 × age), and exercises will pause if it exceeds 80%. Patients will contract pelvic floor muscles during exercises, with posture corrections provided as needed. Exercise intensity will be progressively increased for adaptation. Home exercises will be demonstrated by a physiotherapist, to be practiced 5 days a week. Patients must report any pain during exercises to the physiotherapist.
Other: Rebound Therapy
The program will be performed in a clinical environment for 8 weeks, 2 days a week, each session will be 30 minutes. The correct breathing pattern will be taught to the patient before starting the exercises. O2 saturation and maximum heart rate will be checked during the rest periods during the exercises. The maximum heart rate will be calculated with the formula (HRmax = 208 - 0.7 × age), and the exercise will be paused when it exceeds 80%. The patient will be asked to contract the pelvic floor muscles during the exercise. Necessary warnings regarding the preservation of posture will be made throughout the exercises. The exercise intensity will be increased progressively in order to ensure the patient's adaptation to the exercises.
Other: Home Exercise Program
Home Exercise Program In addition to EMG-Biofeedback Therapy in Group 1, in addition to Rebound Therapy in Group 2, and in Group 3, only a home exercise program will be applied to patients 5 days a week. The exercise program consists of diaphragmatic breathing, piriformis stretching exercise, adductor stretching exercise, gluteal stretching exercise, cat-camel exercise, happy baby position, deep squat exercise, trunk rotator stretching exercises. Each exercise will be repeated 5 times on the right and left, and 20 seconds will be waited for each repetition.
Active Comparator: Group 3: Home Exercise Group
Home exercise program will be taught to patients in a practical way with the physiotherapist and patients will be asked to practice at home 5 days a week. If the patient feels any pain during the exercises, they will be informed that they must report the situation to the physiotherapist.
Other: Home Exercise Program
Home Exercise Program In addition to EMG-Biofeedback Therapy in Group 1, in addition to Rebound Therapy in Group 2, and in Group 3, only a home exercise program will be applied to patients 5 days a week. The exercise program consists of diaphragmatic breathing, piriformis stretching exercise, adductor stretching exercise, gluteal stretching exercise, cat-camel exercise, happy baby position, deep squat exercise, trunk rotator stretching exercises. Each exercise will be repeated 5 times on the right and left, and 20 seconds will be waited for each repetition.
Active Comparator: Group 1: EMG-Biofeedback
In this group, pelvic floor strengthening training will be conducted with EMG-Biofeedback 2 days a week, and patients will follow a home exercise program 5 days a week. The Neurotrac® Simplex device will be used for EMG-Biofeedback. The EMG reference electrode will be placed on the patient's spina iliaca anterior superor, while two adhesive electrodes will be placed on the perineal muscles. Patients will contract and relax their pelvic floor muscles at 5-second intervals, guided by visual and auditory stimuli on the device or computer screen. Sessions will last 25 minutes, twice a week, for 8 weeks in a clinical environment. Treatment will include visual imagery for better engagement. Scores (%), and the lowest and highest EMG values (mV) will be recorded. Home exercises will be demonstrated by a physiotherapist, to be practiced 5 days a week. Patients will be instructed to report any pain during exercises to the physiotherapist.
Device: EMG-Biofeedback
The Neurotrac® Simplex device will be used for EMG-Biofeedback treatment. As in the muscle strength assessment procedure, the EMG reference electrode will be placed on the patient's forearm, and 2 adhesive electrodes in the EMG channel will be placed on the patient's perineal muscles. The patient will be asked to contract and relax the pelvic floor muscles at certain intervals in accordance with the visual and auditory stimuli made on the device screen or computer screen. The pelvic floor muscle contraction and rest period will last 5 seconds each. The program will continue for 2 days a week, 25 minutes per session and 8 weeks and will be performed in a clinical environment. During the treatment, the treatment will be visualized for the patient with different imagery. At the end of the games played, the patients'; scores (%), the lowest and highest EMG values will be recorded in mV. The treatment will be applied to the patients in two sessions per week.
Other: Home Exercise Program
Home Exercise Program In addition to EMG-Biofeedback Therapy in Group 1, in addition to Rebound Therapy in Group 2, and in Group 3, only a home exercise program will be applied to patients 5 days a week. The exercise program consists of diaphragmatic breathing, piriformis stretching exercise, adductor stretching exercise, gluteal stretching exercise, cat-camel exercise, happy baby position, deep squat exercise, trunk rotator stretching exercises. Each exercise will be repeated 5 times on the right and left, and 20 seconds will be waited for each repetition.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Level
Time Frame: 2 weeks
Pain level will be assessed with the Visual Analog Scale (VAS), a 10 cm line from 'no pain' to 'unbearable pain,' where participants mark their pain level. The value is recorded in cm. 0 point indicates 'no pain', 10 cm indicates 'unbearable pain'.
2 weeks
Pelvic floor muscle strength
Time Frame: 2 weeks
The NeuroTrac® Simplex device will be used for pelvic floor muscle strength assessment by measuring muscle activation in millivolts (mV). The assessment, performed with the patient in the lithotomy position, involves placing the EMG reference electrode on the spina iliaca anterior superior and 2 adhesive electrodes on the perineal muscles. Patients will contract and relax their muscles following auditory and visual stimuli on the screen (10 sec contraction/10 sec rest). The average, minimum, and maximum mV values will be used in the study. To ensure accuracy, measurements will be repeated 3 times and averaged.
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nerve Growth Factor (NGF) Analysis
Time Frame: 2 weeks
NGF levels will be analyzed using plasma samples from 3 ml blood samples. Within 30 minutes of collection, the blood will be centrifuged at 1000 x g for 15 minutes at 2-8°C. The plasma will be numbered, transferred to centrifuge tubes, and stored at -80°C until analysis. The analysis will use the Cusabio-Human NGF ELISA Kit (Catalog number: CSB-E04683h) following the kit protocol, with NGF values measured in pg/ml using a Biotek Synergy HTX device. The analysis will be repeated 3 times, and the average value will be taken. NGF sensitivity was 15 pg/ml. The Cusabio-Human NGF ELISA Kit's sensitivity range of 6.86 pg/ml-5000 pg/ml is suitable for patients with endometriosis.
2 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life level
Time Frame: 2 weeks
Participants' quality of life will be assessed using the Endometriosis Health Profile Questionnaire (EHP-30), which evaluates health-related quality of life over the past four weeks. Scores range from 0 (best health) to 100 points (worst health).
2 weeks
Sleep quality level
Time Frame: 2 weeks
Sleep quality will be measured with the Pittsburgh Sleep Quality Index (PSQI), covering a one-month period. Scores range from 0 to 21 points, with higher scores indicating poorer sleep quality.
2 weeks
Perceived stress level
Time Frame: 2 weeks
Stress level will be assessed with the Perceived Stress Scale, consisting of 14 questions scored between 0-56 points. Higher scores indicate higher stress levels. Scores between 0-35 points indicate adequate stress coping, while scores between 36-56 points indicate inadequate stress coping.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MedipolU-FTR-ÇÖ-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Safety Concerns

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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