Pulsed Electromagnetic Field on Chronic Anal Fissure Healing (PEMF)

July 23, 2026 updated by: Marwa Ahmed Saad Radwan, Galala University

Effect of Pulsed Electromagnetic Field on Chronic Anal Fissure Healing: A Randomized Controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial was conducted on 100 chronic Anal fissure participants aged 30-60 years. Participants were equally randomized into the study (A) and control (B) groups. The study group (A) underwent 12 sessions of Pulsed Electromagnetic Stimulation (PEMS) (30 min/session; 3 sessions a week/4 weeks), Lidocaine cream and general advice. For 4 weeks. The control group (B) received the same medical treatment (Lidocaine cream) and general advice. The World Health Organization Quality of Life (WHOQOL) -Brief and The Realise score were used to measure the severity of symptoms and quality of life in both groups before and after the treatment.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • El Materia teaching hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEMS, Lidocaine and general advice
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
PEMF 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 around anus twice daily and general advice for 4 weeks.
Other Names:
  • Pulsed Electromagnetic stimulation field and medical treatment
Placebo Comparator: Lidocaine cream and general advice
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
All patients begin medical 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 for 4 weeks.
Other Names:
  • Medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in The Realise score.
Time Frame: Before the beginning of the sessions and after 4 weeks after completion of treatment sessions
The Realise score is a statistically validated scoring system designed to quantify the severity of Anal fissure (AF) and aid in the assessment and management of the condition. It consists of five items, each scored from 0 to 10 for pain intensity and from 1 to 5 for quality of life, duration of pain, use of painkillers, and bleeding. The score is the sum of these points, with a maximum score of 30. The Realise score has been shown to be highly correlated (r = 0.99) and has a good coefficient of repeatability, making it a reliable tool for clinical trials and treatment comparisons
Before the beginning of the sessions and after 4 weeks after completion of treatment sessions
Change in The World Health Organization Quality of Life (WHOQOL) -Brief.
Time Frame: Before the beginning of treatment sessions and after 4 weeks of treatment sessions

A shorter 26-item version that provides a practical alternative while maintaining reliability and validity that evaluates quality of life across six key domains Physical health - energy, fatigue, pain, sleep, and daily functioning. Psychological well-being - self-esteem, body image, positive and negative feelings, and cognitive functioning.

Level of independence - mobility, activities of daily living, work capacity, and dependence on medical treatment.

Social relationships - personal relationships, social support, and sexual activity.

Environment - financial resources, safety, access to information, leisure opportunities, and physical environment.

Spirituality, religion, and personal beliefs - meaning of life, faith, and personal values.
Before the beginning of treatment sessions and after 4 weeks of treatment sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galala University

Investigators

  • Principal Investigator: Marwa A Radwan, Ph.D., Lecturer in Galala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2026

Primary Completion (Actual)

May 22, 2026

Study Completion (Actual)

May 30, 2026

Study Registration Dates

First Submitted

July 21, 2026

First Submitted That Met QC Criteria

July 23, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P.T.REC/012/006349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD needed for international publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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