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

Medipol University

Status: Enrolling

Conditions: Endometriosis

Treatments: Device: EMG-Biofeedback; Other: Home Exercise Program; Other: Rebound Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06517654

MedipolU-FTR-ÇÖ-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

Group 1: EMG-Biofeedback

Active Comparator group

Description:

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.

Treatment:

Other: Home Exercise Program

Device: EMG-Biofeedback

Group 2: Rebound Therapy

Active Comparator group

Description:

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.

Treatment:

Other: Rebound Therapy

Other: Home Exercise Program

Group 3: Home Exercise Group

Active Comparator group

Description:

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.

Treatment:

Other: Home Exercise Program