Pulsed Electromagnetic Field on Chronic Anal Fissure Healing | NCT07729709

NCT07729709

Overview

NCT ID: NCT07729709
Lead Sponsor: Galala UniversityOTHER
Official Title: Effect of Pulsed Electromagnetic Field on Chronic Anal Fissure Healing: A Randomized Controlled Trial.
Brief Summary: The purpose of this study is to find the effect of Pulsed Electromagnetic Field on chronic Anal fissure healing. Included both male and female aged 30-60 suffering from Anal fissure symptoms.

It aims to answer is:

There is no significant effect of Pulsed Electromagnetic Field on chronic Anal fissure healing.

There is a significant effect of Pulsed Electromagnetic Field on chronic Anal fissure healing.
Conditions: Anal Fissure Chronic
Interventions

Status and Timeline

Status: Completed
Last Update Posted: Jul 27, 2026Actual
Start Date: Jan 3, 2026Actual
Primary Completion Date: May 22, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

The inclusion criteria included male and female aged 30-60 suffering from Anal fissure symptoms

Exclusion Criteria:

Exclusion criteria encompassed urinary tract infection, other Urinary Incontinence types, previous incontinence and previous tumors, metallic implants, Multiple Sclerosis contraindications, cognitive impairments and pacemaker.

Study Plan

Study Type: Interventional
Phase: Phase 3
Enrollment: 100Actual
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Contacts and Locations

Central Contacts: No data available
Locations: El Materia teaching hospital

Similar Studies

Masking Description

Employing the sealed envelope technique, an independent investigator randomly allocated participants into two equal groups (n = 50): The study group (A) and the control group (B). Group A received PEMS therapy in addition to Lidocaine cream treatment and general advice. While Group B received Lidocaine cream with general advice, The envelopes contained letters designating assignments to either the study or control arm. We blinded the patients to the group randomization. The study did not exclude any participants after randomization

Participant Group/Arms

PEMS, Lidocaine and general adviceExperimental

Pretreatment all patients were evaluated by using The World Health Organization Quality of Life (WHOQOL) -Brief and The Realise score. Each patient was asked to relax by emptying their bladder, then assume a comfortable supine lying position, remove any metals and earpieces if present, and cover their self with a cotton sheet. The solenoid was adjusted, so that it covered the pelvic region. All patients begin PEMS (3 session per week- every session 30 minute for 4 weeks). The treatment session consists of 3 phases; first phase consists of 10 min with intensity 100%- frequency 1 Hz, second phase consist of 10 min with intensity 100%- frequency 1-50 Hz, third phase consist of 10 min with intensity 90% - frequency 50 Hz. in addition to Lidocaine cream use twice daily around anus and general advice. After 4 weeks of PEMS sessions reevaluation was done with The World Health Organization Quality of Life (WHOQOL) -Brief and The Realise score.

Device: PEMS, Lidocaine and general advice

Lidocaine cream and general advicePlacebo Comparator

Pretreatment all patients were evaluated by using The World Health Organization Quality of Life (WHOQOL) -Brief and The Realise score. All patients begin treatment with Lidocaine cream twice daily around anus and received general advice with types of food taken to prevent constipation and increase fluid intake and not to beer down during micturition. After 4 weeks of medical treatment reevaluation was done by The World Health Organization Quality of Life (WHOQOL) -Brief and The Realise score.

Drug: Lidocaine cream and general advice