Combined Effect of Therapeutic Ultrasound and Trans Cutaneous Electrical Nerve Stimulation on Endometriosis

Cairo University (CU)

Status: Not yet enrolling

Conditions: Endometriosis

Treatments: Drug: Medical treatment; Device: Therapeutic ultrasound (US); Device: Transcutaneous electrical nerve stimulation (TENS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06537765

012/003874

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: Female

Ages: 25 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

Therapeutic ultrasound (US) Group

Experimental group

Description:

It will include 15 women, who will receive their hormonal treatment as prescribed by the gynecologist in addition to, Therapeutic US, 3 sessions, per week for eight weeks.

Treatment:

Device: Therapeutic ultrasound (US)

Drug: Medical treatment

Transcutaneous Electrical Nerve Stimulation (TENS) Group

Experimental group

Description:

It will include 15 women, who will receive their hormonal treatment as prescribed by the gynecologist in addition to, TENS therapy, 3 sessions, per week for eight weeks.

Treatment:

Device: Transcutaneous electrical nerve stimulation (TENS)

Drug: Medical treatment

US + TENS Group

Experimental group

Description:

It will include 15 women, who will receive their hormonal treatment as prescribed by the gynecologist in addition to, both Therapeutic US and TENS therapy, 3 sessions, per week for eight weeks.

Treatment:

Device: Transcutaneous electrical nerve stimulation (TENS)

Device: Therapeutic ultrasound (US)

Drug: Medical treatment