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

Not Applicable

Recruiting

• Conditions: Endometriosis
• Interventions: Other: Rebound Therapy; Device: EMG-Biofeedback

• Registration Number: NCT06517654
• Lead Sponsor: Medipol University

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.

Study Timeline

• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-18
• Study First Posted: 2024-07-24
• Study Start: 2024-09-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Rebound Therapy	Rebound Therapy	In this group, the exercise program created to strengthen the pelvic floor muscles of the patients will be applied to the patients on a trampoline. The program will be performed in a clinical environment for 8 weeks, 2 days a week, each session will be 20 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 maintenance 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.
Group 1: EMG-Biofeedback	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.

Primary Outcome Measures

Name	Time	Method
Pelvic floor muscle strength	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.
Pain Level	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 Outcome Measures

Name	Time	Method
Nerve Growth Factor (NGF) Analysis	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.

Trial Locations

Locations (1)

Zeynep Kamil Women and Children's Diseases Training and Research Hospital; 🇹🇷 Üsküdar, İstanbul, Turkey