The Effect of Repetitive Transcranial Magnetic Stimulation Combined With Anti-inflammatory Diet on Constipation and Quality of Life in Patients With Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Health-Related Quality of Life (HRQOL)
研究概览
简要总结
Fifty six patients with Crohn's disease of both genders with age 40 - 60 year old suffering from constipation, physical and functional limitations participated in this study. The participants were selected from Outpatient clinic of Faculty of Physical Therapy, Suez Canal University, Egypt and randomly distributed into two groups equal in number. Group (A): 25 patients who received rTMS 5 times per week in addition to anti-inflammatory diet for 4 weeks. While, Group (B): 25 patients received anti-inflammatory diet program for 4 weeks. Primary outcome measures were Quality of life questionnaire and Constipation severity index while Interlukins inflammatory markers was the secondary outcome measure.
详细描述
- Subjects:
Fifty six patients of both genders with age 40 - 60 year old suffering from suffering from constipation, physical and functional limitations will participate in this study. The participants will be selected from Outpatient clinic of Faculty of Physical Therapy, Suez Canal University, Egypt and randomly distributed into two groups equal in number.
Group (A): 25 patients who received rTMS 5 times per week in addition to anti-inflammatory diet for 4 weeks.
Group (B): 25 patients received anti-inflammatory diet program for 4 weeks. 2. Equipment:
Therapeutic equipment:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Patients' age was ranged between 40-60 years old, (2) Both gender 50 patients participated in this study, (3) moderately to severely active refractory CD > 4 months after diagnosis, (4) All the patients were free from genitourinary infections, (5) Neurologically free patient, (6) Patients who were able to comprehend command and willing to participate in the study, (7) Informed consent was obtained from all patients enrolled in the trial, (8) Clinical diagnosis of Alzheimer's Disease and (9) Must be able to swallow tablets.
排除标准
- •(1) Epilepsy or seizures, (2) Metal implants in the head, skull, or neck, (3) Implanted medical devices, (4) Severe traumatic brain injury, (5) Skull fracture, (6) brain surgery, (7) Any neurological disorders that may increase risk, (8) severe cardiovascular conditions, (9) severe psychiatric disorders, (10) skin lesions, infections, (11) significant dermatological conditions at the electrode placement sites on the scalp, (12) Insulin dependent diabetes and (13) Thyroid disease.
研究组 & 干预措施
Repetitive transcranial magnetic stimulation combined with anti-inflammatory diet
25 patients received 1 Hz rTMS, the right dorsolateral prefrontal cortex (DLPFC) was selected as the stimulation site plus anti-inflammatory diet (unprocessed, anti-inflammatory foods, rich in microbiota-accessible carbohydrates, lean protein, and omega-3 fatty acids) for a period of 4 weeks.
干预措施: Repetitive transcranial magnetic stimulation (Device)
Anti-inflammatory diet
25 patients received anti-inflammatory diet (unprocessed, anti-inflammatory foods, rich in microbiota-accessible carbohydrates, lean protein, and omega-3 fatty acids) for a period of 4 weeks.
干预措施: Anti-inflammatory diet (Dietary Supplement)
Repetitive transcranial magnetic stimulation combined with anti-inflammatory diet
25 patients received 1 Hz rTMS, the right dorsolateral prefrontal cortex (DLPFC) was selected as the stimulation site plus anti-inflammatory diet (unprocessed, anti-inflammatory foods, rich in microbiota-accessible carbohydrates, lean protein, and omega-3 fatty acids) for a period of 4 weeks.
干预措施: Anti-inflammatory diet (Dietary Supplement)
结局指标
主要结局
Health-Related Quality of Life (HRQOL)
时间窗: 4 weeks
HRQOL is serving as a primary indicator of therapeutic success. In patients with CD, HRQOL is often compromised by both physical symptoms and psychological distress. Utilizing specialized instruments such as the Inflammatory Bowel Disease Questionnaire (IBDQ) or the Short Form-36 (SF-36) allows researchers to quantify the holistic benefits of multimodal interventions, including neuromodulation via rTMS and dietary modifications, which aim to alleviate the psychosocial burden and functional limitations associated with chronic intestinal inflammation.
Constipation Severity Index (CSI)
时间窗: 4 weeks
CSI is evaluating the intensity of these symptoms across sub-domains including obstructive defecation and colonic inertia. In the context of rTMS and anti-inflammatory diets, the CSI provides a sensitive measure to track how brain-gut axis modulation influences bowel frequency and ease of evacuation, offering a standardized numerical value to assess the reduction in clinical symptom severity over the course of the intervention.
次要结局
- Interlukins inflammatory markers (IIM)(4 weeks)
研究者
Mona Mohamed Amin Ziethar
Lecturer at Department of Surgery and Burn - Faculty of Physical Therapy - Cairo University
Cairo University