Faculty of Physical Therapy
Giza, Giza Governorate, 12613, Egypt
Location status: Recruiting
NCT Number: NCT07531342
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.
Interested in participating?
Request Info40 year–60 year
All sexes
Interventional
Not applicable
Giza, Giza Governorate, 12613, Egypt
Location status: Recruiting
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.
Therapeutic equipment:
Measurement equipment:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients received 1 Hz rTMS, the right dorsolateral prefrontal cortex (DLPFC) was selected as the stimulation site. The stimulation frequency was set to 1 Hz for a period of 4 weeks.
Patients received unprocessed, anti-inflammatory foods, rich in microbiota-accessible carbohydrates, lean protein, and omega-3 fatty acids for a period of 4 weeks.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks
(IIM) particularly pro-inflammatory cytokines such as IL-6, IL-1β, and IL-17, are central to the pathogenesis of Crohn's disease, driving the transmural inflammatory response and tissue damage. Monitoring these biomarkers offers objective evidence of systemic and mucosal inflammation levels.
Contact information is provided by the study sponsor or research team.
Cairo University
Other
The Effect of Repetitive Transcranial Magnetic Stimulation Combined With Anti-inflammatory Diet on Constipation and Quality of Life in Patients With Crohn's Disease
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