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

NCT ID: NCT06517654

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-09-01

Brief Summary

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.

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.

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

EMG-Biofeedback

Intervention Type: 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.

Home Exercise Program

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Rebound Therapy

Intervention Type: 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

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Home Exercise Program

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• 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.

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Çağla ÖZGÖREN

Lecturer Çağla ÖZGÖREN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Üsküdar, Istanbul, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Çağla Özgören, Msc

Role: CONTACT

cagla.ozgoren@medipol.edu.tr

5316267328 ext. +90

Ayşe Nur Tunalı, PhD

Role: CONTACT

ntunali@medipol.edu.tr

Facility Contacts

Resul Karakuş, MD

Role: primary

resul-karakus@hotmail.com

Other Identifiers

MedipolU-FTR-ÇÖ-01

Identifier Type: -

Identifier Source: org_study_id