Pulsed Electromagnetic Field on Chronic Anal Fissure Healing

NCT07729709 | Completed Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: P.T.REC/012/006349
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

pulsed electromagnetic stimulation field; Chronic anal fissure; The (WHOQOL) -Brief; The Realise score

Outcome Measures

Primary Outcomes (2)

• Change in The Realise score.

  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.

  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

Study Arms (2)

PEMS, Lidocaine and general advice

EXPERIMENTAL

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 advice

PLACEBO 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

Interventions

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.

Also known as: Pulsed Electromagnetic stimulation field and medical treatment

PEMS, Lidocaine and general advice

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.

Also known as: Medical treatment

Lidocaine cream and general advice

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Galala University: lead

Study Sites (1)

El Materia teaching hospital

Cairo, Egypt

Location

Related Publications (6)

• Choi HMC, Cheung AKK, Ng GYF, Cheing GLY. Effects of pulsed electromagnetic field (PEMF) on the tensile biomechanical properties of diabetic wounds at different phases of healing. PLoS One. 2018 Jan 11;13(1):e0191074. doi: 10.1371/journal.pone.0191074. eCollection 2018.

  PMID: 29324868 RESULT

• Hong JE, Lee CG, Hwang S, Kim J, Jo M, Kang DH, Yoo SH, Kim WS, Lee Y, Rhee KJ. Pulsed Electromagnetic Field (PEMF) Treatment Ameliorates Murine Model of Collagen-Induced Arthritis. Int J Mol Sci. 2023 Jan 6;24(2):1137. doi: 10.3390/ijms24021137.

  PMID: 36674651 RESULT

• Lv H, Liu J, Zhen C, Wang Y, Wei Y, Ren W, Shang P. Magnetic fields as a potential therapy for diabetic wounds based on animal experiments and clinical trials. Cell Prolif. 2021 Mar;54(3):e12982. doi: 10.1111/cpr.12982. Epub 2021 Feb 8.

  PMID: 33554390 RESULT

• Gordon GA. Designed electromagnetic pulsed therapy: clinical applications. J Cell Physiol. 2007 Sep;212(3):579-82. doi: 10.1002/jcp.21025.

  PMID: 17577213 RESULT

• Picciariello A, Lobascio P, Spazzafumo L, Rinaldi M, Dibra R, Trigiante G, Laforgia R, Pezzolla A, Altomare DF. The REALISE score: a new statistically validated scoring system to assess the severity of anal fissures. Tech Coloproctol. 2021 Aug;25(8):935-940. doi: 10.1007/s10151-021-02459-y. Epub 2021 May 13.

  PMID: 33987779 RESULT

• Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.

  PMID: 15085902 RESULT

Related Links

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Study Officials

• Marwa A Radwan, Ph.D.

  Lecturer in Galala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy- Galala university

Model Details: A randomized controlled trial. 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 twice daily and general advice. For 4 weeks, the control group (B) received the same medical treatment (Lidocaine twice daily) 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 Record Dates

• First Submitted: July 21, 2026
• First Posted: July 27, 2026
• Study Start: January 3, 2026
• Primary Completion: May 22, 2026
• Study Completion: May 30, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)