Clinical trial NCT06517654: Comparison of the Effectiveness of EMG-Biofeedback and Rebound Therapy in Patients With Endometriosis
Official title: Comparison of the Effectiveness of EMG-Biofeedback and Rebound Therapy in Patients With Endometriosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Keywords: Endometriosis
Pain
Quality of Life
Sleep Quality
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 42
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three parallel treatment groups.
Primary purpose: TREATMENT

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.

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:

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.

Primary outcomes:
measure: Pelvic floor muscle strength
timeFrame: 2 weeks
measure: Pain Level
timeFrame: 2 weeks
Secondary outcomes:
measure: Nerve Growth Factor (NGF) Analysis
timeFrame: 2 weeks
Other outcomes:
measure: Quality of life level
timeFrame: 2 weeks
measure: Sleep quality level
timeFrame: 2 weeks
measure: Perceived stress level
timeFrame: 2 weeks
Locations:
city: Üsküdar
country: Turkey
facility: Zeynep Kamil Women and Children's Diseases Training and Research Hospital
state: İstanbul
Study officials:
References: