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

NCT ID: NCT06537765

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-10
• Study Completion Date: 2024-10-10

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.

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Therapeutic ultrasound (US) Group

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.

Group Type: EXPERIMENTAL

Medical treatment

Intervention Type: DRUG

All women with endometriosis in all groups (A, B, \& C) will receive their medical treatment as prescribed by the gynecologist.

Therapeutic ultrasound (US)

Intervention Type: DEVICE

Women will be asked to assume supine lying position, and the lower abdomen will be cleaned thoroughly with alcohol and dried well thereafter. Ultrasound gel will be distributed over the lower abdomen .The device will be adjusted to Frequency of 1MHz, Mode: continuous wave, Intensity: 1.5W/cm, duration of treatment: 15 minutes for the treatment site, then the skin will be cleaned again to remove ultrasound gel.

Transcutaneous Electrical Nerve Stimulation (TENS) Group

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.

Group Type: EXPERIMENTAL

Medical treatment

Intervention Type: DRUG

All women with endometriosis in all groups (A, B, \& C) will receive their medical treatment as prescribed by the gynecologist.

Transcutaneous electrical nerve stimulation (TENS)

Intervention Type: DEVICE

TENS electrodes will be placed on specific acupuncture points for women in supine position. These points include VB29, ST36, CV6, CV4, LV3, KD3, SP6, and SP9. The treatment aims to improve blood circulation, remove adhesions, regulate menstrual activity and hormones, and prevent new adhesions and menstrual reflux in endometriosis patients.

US + TENS Group

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.

Group Type: EXPERIMENTAL

Medical treatment

Intervention Type: DRUG

All women with endometriosis in all groups (A, B, \& C) will receive their medical treatment as prescribed by the gynecologist.

Therapeutic ultrasound (US)

Intervention Type: DEVICE

Women will be asked to assume supine lying position, and the lower abdomen will be cleaned thoroughly with alcohol and dried well thereafter. Ultrasound gel will be distributed over the lower abdomen .The device will be adjusted to Frequency of 1MHz, Mode: continuous wave, Intensity: 1.5W/cm, duration of treatment: 15 minutes for the treatment site, then the skin will be cleaned again to remove ultrasound gel.

Transcutaneous electrical nerve stimulation (TENS)

Intervention Type: DEVICE

TENS electrodes will be placed on specific acupuncture points for women in supine position. These points include VB29, ST36, CV6, CV4, LV3, KD3, SP6, and SP9. The treatment aims to improve blood circulation, remove adhesions, regulate menstrual activity and hormones, and prevent new adhesions and menstrual reflux in endometriosis patients.

Interventions

Medical treatment

All women with endometriosis in all groups (A, B, \& C) will receive their medical treatment as prescribed by the gynecologist.

Intervention Type: DRUG

Therapeutic ultrasound (US)

Women will be asked to assume supine lying position, and the lower abdomen will be cleaned thoroughly with alcohol and dried well thereafter. Ultrasound gel will be distributed over the lower abdomen .The device will be adjusted to Frequency of 1MHz, Mode: continuous wave, Intensity: 1.5W/cm, duration of treatment: 15 minutes for the treatment site, then the skin will be cleaned again to remove ultrasound gel.

Intervention Type: DEVICE

Transcutaneous electrical nerve stimulation (TENS)

TENS electrodes will be placed on specific acupuncture points for women in supine position. These points include VB29, ST36, CV6, CV4, LV3, KD3, SP6, and SP9. The treatment aims to improve blood circulation, remove adhesions, regulate menstrual activity and hormones, and prevent new adhesions and menstrual reflux in endometriosis patients.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Rania Mohammed Ibrahim Mohammed Derwa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Soheir El-Kosery, PhD

Role: STUDY_CHAIR

Professor of Physical Therapy for Women's Health

Central Contacts

Rania Derwa, B.Sc

Role: CONTACT

raniaderwa2@gmail.com

01017628838

Manal El-Shafei, PhD

Role: CONTACT

Other Identifiers

012/003874

Identifier Type: -

Identifier Source: org_study_id