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

NCT06537765 | Not Yet Recruiting

• 1 other identifier: 012/003874
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (3)

• Assessment of adhesion size

  New Color Doppler Ultrasound scanner will be used in the study to assess adhesion size for all women with endometriosis in all groups (A, B, \& C) before and after the study, and this procedure will be applied by the gynecologist.

  8 weeks

• The McGill pain questionnaire (MPQ)

  The pain intensity for all groups (A, B, \& C) will be assessed using the McGill Pain Questionnaire (MPQ) before and after the treatment program. The MPQ is a comprehensive tool that evaluates various dimensions of a patient's pain experience through three parts. The first part includes an anatomical drawing where the patient marks the location of their pain. The second part is a Verbal Descriptor Scale (VDS) for the patient to indicate the intensity of their current pain. The third part is an inventory of 72 descriptive adjectives to detail the pain further. The MPQ measures three key aspects: (1) the pain rating index, which assigns numerical values to each word descriptor, (2) the number of words chosen, and (3) the present pain intensity on a 1-5 scale (1 for mild, 2 for discomforting, 3 for distressing, 4 for horrible, and 5 for excruciating).

  8 weeks

• The Endometriosis Health profile (EHP30) questionnaire

  The Endometriosis Health profile (EHP30) questionnaire will be used to assess symptoms of endometriosis in all groups (A, B \& C) before and after the end of treatment program. It is self-reporting instrument that contains a core questionnaire consisting of 30 items assessing five dimensions. The five dimensions included pain, control and impotence, emotional well-being, social support, and self -image. Each scale is converted into a score from 0 to 100, with a lower score representing a better quality of life.

  8 weeks

Secondary Outcomes (1)

• The Health-related quality of life (HRQOL-36) questionnaire

  8 weeks

Study Arms (3)

Therapeutic ultrasound (US) Group

EXPERIMENTAL

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.

Drug: Medical treatment; Device: Therapeutic ultrasound (US)

Transcutaneous Electrical Nerve Stimulation (TENS) Group

EXPERIMENTAL

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.

Drug: Medical treatment; Device: Transcutaneous electrical nerve stimulation (TENS)

US + TENS Group

EXPERIMENTAL

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.

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

Interventions

Medical treatment DRUG

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

Therapeutic ultrasound (US) Group; Transcutaneous Electrical Nerve Stimulation (TENS) Group; US + TENS Group

Therapeutic ultrasound (US) 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.

Therapeutic ultrasound (US) Group; US + TENS Group

Transcutaneous electrical nerve stimulation (TENS) 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.

Transcutaneous Electrical Nerve Stimulation (TENS) Group; US + TENS Group

Eligibility Criteria

• Age: 25 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Endometriosis

Interventions

Ultrasonic Therapy; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Soheir El-Kosery, PhD

  Professor of Physical Therapy for Women's Health

  STUDY CHAIR

Central Study Contacts

Rania Derwa, B.Sc

CONTACT

01017628838; raniaderwa2@gmail.com

Manal El-Shafei, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 5, 2024
• Study Start: August 10, 2024
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08