Comparison of the Effectiveness of EMG-Biofeedback and Rebound Therapy in Patients With Endometriosis
NCT Number: NCT06517654
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endometriosis
Interventions: DEVICE: EMG-Biofeedback|OTHER: Rebound Therapy
Sponsor: Medipol University
Sex: FEMALE
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-09-01
Locations: Zeynep Kamil Women and Children's Diseases Training and Research Hospital, Üsküdar, İstanbul, 34668, Turkey

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.

Primary Outcome Measures: Pelvic 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 forearm and 2 adhesive electrodes on the perineal muscles. Patients will contract and relax their muscles following auditory and visual stimuli on the screen (5 sec contraction/5 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|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'., 2 weeks
Secondary Outcome Measures: 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., 2 weeks
Other Outcome Measures: Quality of life level, 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, 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, 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