Anal Fissure Chronic
Conditions
Keywords
pulsed electromagnetic stimulation field, Chronic anal fissure, The (WHOQOL) -Brief, The Realise score
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.
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.
Interventions
DEVICEPEMS, 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.
DRUGLidocaine 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.
Sponsors
Galala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* The inclusion criteria included male and female aged 30-60 suffering from Anal fissure symptoms
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in The Realise score. | 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. | 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. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMarwa A Radwan, Ph.D.
Lecturer in Galala University
Outcome results
None listed