Combined Effect of Therapeutic Ultrasound and Trans Cutaneous Electrical Nerve Stimulation on Endometriosis
NCT Number: NCT06537765
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endometriosis
Interventions: DRUG: Medical treatment|DEVICE: Therapeutic ultrasound (US)|DEVICE: Transcutaneous electrical nerve stimulation (TENS)
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-10
Completion Date: 2024-10-10

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.

Primary Outcome Measures: 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 Outcome Measures: The Health-related quality of life (HRQOL-36) questionnaire, The Health-related quality of life (HRQOL-36) questionnaire will be used to assess health related quality of life for all women with endometriosis in all groups (A, B \& C) before and after the end of treatment program. It is a reliable and validated disease specific questionnaire with 36 questions that encompass five core scales: pain, control and powerlessness, emotional well-being, social support, and self- image. Questions are asked regarding endometriosis and are answered on a 5-points Likert scale, where 0=never, 1=rarely, 2=sometimes, 3=often, and 4=always. Raw scores for the questions within a scale are summed and transformed to a 0-100 scale, with higher scores indicating worse health-related quality of life., 8 weeks