Effect of Pulsed Electromagnetic Field on Chronic Anal Fissure Healing: A Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in The Realise score.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria included male and female aged 30-60 suffering from Anal fissure symptoms
排除标准
- •Exclusion criteria encompassed urinary tract infection, other Urinary Incontinence types, previous incontinence and previous tumors, metallic implants, Multiple Sclerosis contraindications, cognitive impairments and pacemaker.
结局指标
主要结局
Change in The Realise score.
时间窗: 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.
时间窗: 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.
次要结局
未报告次要终点
研究者
Marwa Ahmed Saad Radwan
Lecturer of physical therapy- Galala university
Galala University