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Completed

NCT Number: NCT06517654

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

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.

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Key information

Conditions

Endometriosis Dyssomnias Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zeynep Kamil Women and Children's Diseases Training and Research Hospital

Üsküdar, Istanbul, 34668, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EMG-Biofeedback

Device

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.

Rebound Therapy

Other

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.

Home exercise program

Other

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.

Primary outcomes

  1. 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. 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'.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2024
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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