Anal Fissure ChronicPhase 3PEMFNCT07729709
Pulsed Electromagnetic Field on Chronic Anal Fissure Healing
A Phase 3 study testing PEMS, Lidocaine and general advice and Lidocaine cream and general advice in people with Anal Fissure Chronic, run by Galala University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Anal Fissure Chronic
- What is being tested?
- PEMS, Lidocaine and general advice and Lidocaine cream and general advice
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2026to 30 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The inclusion criteria included male and female aged 30-60 suffering from Anal fissure symptoms
Who cannot join
- Exclusion criteria encompassed urinary tract infection, other Urinary Incontinence types, previous incontinence and previous tumors, metallic implants, Multiple Sclerosis contraindications, cognitive impairments and pacemaker.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anal Fissure Chronic
- Being tested
- PEMS, Lidocaine and general advice, Lidocaine cream and general advice
- Keywords
- pulsed electromagnetic stimulation field, Chronic anal fissure, The (WHOQOL) -Brief, The Realise score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEMS, Lidocaine and general adviceDevice
Also called Pulsed Electromagnetic stimulation field and medical treatment
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.
Lidocaine cream and general adviceDrug
Also called Medical treatment
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Lidocaine cream and general advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Before the beginning of treatment sessions and after 4 weeks of treatment sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start3 Jan 2026
- Primary completion22 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anal Fissure ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ahmed Saad Radwan, Galala University
- Investigators
- Marwa A Radwan, Ph.D., Principal investigator, Lecturer in Galala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729709
- Sponsor's protocol ID
- P.T.REC/012/006349
- Acronym
- PEMF
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD needed for international publication
Publications
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.
PubMed 29324868Hong 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.
PubMed 36674651Lv 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.
PubMed 33554390Gordon GA. Designed electromagnetic pulsed therapy: clinical applications. J Cell Physiol. 2007 Sep;212(3):579-82. doi: 10.1002/jcp.21025.
PubMed 17577213Picciariello 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.
PubMed 33987779Skevington 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.
PubMed 15085902
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulsed Electromagnetic Field on Chronic Anal Fissure Healing: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07729709
- Acronym / sponsor ID
- PEMF / P.T.REC/012/006349
- Conditions
- Anal Fissure Chronic
- Keywords
- pulsed electromagnetic stimulation field, Chronic anal fissure, The (WHOQOL) -Brief, The Realise score
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Galala UniversityUniversity, hospital or other
- Study start
- 3 Jan 2026 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PEMS, Lidocaine and general advice | Experimental | Device: PEMS, Lidocaine and general advicePretreatment 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. |
| Lidocaine cream and general advice | Placebo comparator | Drug: Lidocaine cream and general advicePretreatment 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The inclusion criteria included male and female aged 30-60 suffering from Anal fissure symptoms
Key exclusion criteria (1 listed)
- Exclusion criteria encompassed urinary tract infection, other Urinary Incontinence types, previous incontinence and previous tumors, metallic implants, Multiple Sclerosis contraindications, cognitive impairments and pacemaker.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEMS, Lidocaine and general adviceAlso: Pulsed Electromagnetic stimulation field and medical treatmentPEMF 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. | Device | PEMS, Lidocaine and general advice |
| Lidocaine cream and general adviceAlso: Medical treatmentAll 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. | Drug | Lidocaine cream and general advice |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Results publication: PubMed 29324868Choi 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.
- Results publication: PubMed 36674651Hong 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.
- Results publication: PubMed 33554390Lv 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.
- Results publication: PubMed 17577213Gordon GA. Designed electromagnetic pulsed therapy: clinical applications. J Cell Physiol. 2007 Sep;212(3):579-82. doi: 10.1002/jcp.21025.
- Results publication: PubMed 33987779Picciariello 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.
- Results publication: PubMed 15085902Skevington 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.
- Reference linksLink provided by the sponsor.
- Reference linksLink provided by the sponsor.
- Reference linksLink provided by the sponsor.
- Reference linksLink provided by the sponsor.
- Reference linksLink provided by the sponsor.
- Reference linksLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD needed for international publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa A Radwan, Ph.D. principal investigator
Lecturer in Galala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PEMS, Lidocaine and general advice and Lidocaine cream and general advice in people with Anal Fissure Chronic, run by Galala University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in The Realise score. (time frame: Before the beginning of the sessions and after 4 weeks after completion of treatment sessions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07729709, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.