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

NCT06517654 | Completed

• 1 other identifier: MedipolU-FTR-ÇÖ-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

Endometriosis; Pain; Quality of Life; Sleep Quality

Outcome Measures

Primary Outcomes (2)

• 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 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 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 Outcomes (1)

• Nerve Growth Factor (NGF) Analysis

  2 weeks

Other Outcomes (3)

• Quality of life level

  2 weeks

• Sleep quality level

  2 weeks

• Perceived stress level

  2 weeks

Study Arms (3)

Group 1: EMG-Biofeedback

ACTIVE COMPARATOR

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.

Device: EMG-Biofeedback; Other: Home Exercise Program

Group 2: Rebound Therapy

ACTIVE COMPARATOR

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.

Other: Rebound Therapy; Other: Home Exercise Program

Group 3: Home Exercise Group

ACTIVE COMPARATOR

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.

Other: Home Exercise Program

Interventions

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.

Group 1: EMG-Biofeedback

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.

Group 2: Rebound Therapy

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.

Group 1: EMG-Biofeedback; Group 2: Rebound Therapy; Group 3: Home Exercise Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: Women diagnosed with endometriosis are eligible to participate in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

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

Üsküdar, Istanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Endometriosis; Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Çağla ÖZGÖREN

Model Details: Three parallel treatment groups.

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 24, 2024
• Study Start: September 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 21, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)