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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
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.
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.
Zeynep Kamil Women and Children's Diseases Training and Research Hospital
Üsküdar, Istanbul, Turkey (Türkiye)
RECRUITINGPelvic floor muscle strength
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.
Time frame: 2 weeks
Pain Level
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'.
Time frame: 2 weeks
Nerve Growth Factor (NGF) Analysis
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.
Time frame: 2 weeks
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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.