Clinical trial NCT06537765: Combined Effect of Therapeutic Ultrasound and Trans Cutaneous Electrical Nerve Stimulation on Endometriosis
Official title: Combined Effect of Therapeutic Ultrasound and Trans Cutaneous Electrical Nerve Stimulation on Endometriosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometriosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 45
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to investigate the combined effect of therapeutic ultrasound and transcutaneous electrical nerve stimulation (TENS) on relieving adhesions and pain related to endometriosis.

Detailed description: Endometriosis affects 10-15% of reproductive-age women, causing pelvic pain and infertility. While laparoscopy is the primary treatment, it has risks. Medications are also used but often have side effects. Complementary therapies like acupuncture, yoga, and physical therapy modalities show promise. Therapeutic ultrasound has demonstrated effectiveness in managing chronic pain and adhesions associated with endometriosis. Transcutaneous electrical nerve stimulation (TENS) has shown positive results in pain relief and potentially improving uterine conditions for implantation. This study aims to investigate the combined effect of therapeutic ultrasound and TENS on endometriosis-related adhesion and pain, providing valuable information for physical therapists in treating this condition.

Eligibility criteria: Inclusion Criteria:

* Forty-five women clinically diagnosed by the gynecologist with endometriosis will be included in the study.
* Abdominal wall endometriosis will be diagnosed via Color Doppler ultrasonography.
* Their ages will range from 25 to 35 years old.
* Their body mass index (BMI) will be ranged from 25 to 35 Kg/m2.
* All patients have reported mild to moderate endometriosis symptoms such as (chronic pelvic pain (CPP), dysmenorrhea, dyspareunia, pain with bowel movements and urination and excessive bleeding) as recorded by Endometriosis Health profile questionnaire (EHP30).
* All patients use continuous hormonal treatment for at least 3 months.

Exclusion Criteria:

* Severe endometriosis which is diagnosed by the gynecologist.
* Pregnancy, peacemaker, epilepsy, cardiac arrhythmia, cancer, acute inflammatory pelvic disease.
* Use of injectable hormonal therapy within the previous 6 weeks.
* Patients with contraindication of ultrasound (Patients with reduced sensation to pain and/or heat, local malignancy, local acute infection and over areas of thrombosis or other vascular abnormalities).
* Cognitive deficiency and difficulty to understand instructions or use the instruments.

Primary outcomes:
measure: Assessment of adhesion size
timeFrame: 8 weeks
measure: The McGill pain questionnaire (MPQ)
timeFrame: 8 weeks
measure: The Endometriosis Health profile (EHP30) questionnaire
timeFrame: 8 weeks
Secondary outcomes:
measure: The Health-related quality of life (HRQOL-36) questionnaire
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Physical Therapy for Women's Health
name: Soheir El-Kosery, PhD
role: STUDY_CHAIR
References: