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Completed

NCT Number: NCT07729709

Pulsed Electromagnetic Field on Chronic Anal Fissure Healing

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.

Completed

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Key information

Conditions

Anal Fissure Chronic

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

El Materia teaching hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PEMS, Lidocaine and general advice

Device

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

Lidocaine cream and general advice

Drug

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

Primary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Galala University

Other

Registry information

Official study title

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

Acronym: PEMF

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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