Clinical Trials Logo

Clinical Trial Summary

This study aims to investigate the effect of adding of integrated physiotherapy program to the conservative medical therapy on quality of life and pressure pain threshold (PPT) in chronic rhinosinusitis patients. Patients in this study will be randomly assigned into 2 groups. Group A (control group) will receive conservative medical treatment only which prescribed by Ear, Nose and Throat (ENT) specialist, while group B (experimental group) will receive the conservative medical treatment prescribed by ENT specialist in addition to physiotherapy program. Quality of Life (QoL) will be evaluated by Rhinosinusitis Disability Index (RSDI) and PPT will be evaluated by digital algometer at the baseline and immediately after the end of tenth session of treatment for both groups.


Clinical Trial Description

Sixty-eight patients will be recruited for this study from Al-Qurayyat General Hospital in Al-Jouf Region, Saudi Arabia, with the following inclusion criteria: patients of both sexes, aged from 30 to 50 years, diagnosed by ENT specialist, with chronic rhinosinusitis with a history of 3 months or longer. The patients will be allocated into two equal groups at random (n = 34). Group A (control group) will receive medication only which prescribed by ENT specialist. Group B (experimental group) will receive prescribed medication by ENT specialist in addition to physiotherapy program which consists of: Ultrasound Therapy: The patients will receive pulsed (duty cycle 50%) US therapy with an intensity of 1 and 0.5 W/cm2 for maxillary and frontal sinus, respectively, with a frequency of 1MHz collimating beam. The small probe US applicator (0.8 cm2) with effective radiating area (ERA) equal 0.6 cm2 and beam non-uniformity ratio (BNR) equal 6:1 will be used to deliver US to the treatment area. The area of US application will be the skin over the cheeks for maxillary sinus and forehead for the frontal sinus. Ultrasound transmission gel will be used between the applicator and the skin, full contact technique in slow circular motion will be used for the duration of 5 minutes over the maxillary sinuses and 4 minutes over the frontal sinuses on each pair of sinuses. Manual Drainage Techniques: for the frontal and maxillary sinuses. Self Massaging Technique: The patients will also advised to perform self-massaging for the frontal and maxillary sinuses from the supine lying position. A demonstration session will be used to provide patients in the experimental group with a full description of the manual therapy procedure before the beginning of the study. The physiotherapy program will be applied 3 times a week (day after day) for 12 treatment sessions. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05442606
Study type Interventional
Source Cairo University
Contact
Status Completed
Phase N/A
Start date September 1, 2022
Completion date March 21, 2023

See also
  Status Clinical Trial Phase
Not yet recruiting NCT02636790 - Early Versus Late Surgical Wait Times Early Phase 1
Completed NCT02712502 - Levofloxacin in Bacterial Rhinosinussitis N/A
Completed NCT00986830 - Healthcare Utilization and Outcomes of FinESS Treatment in the Office N/A
Completed NCT00534079 - Nasal Inhalation of Pulmozyme in Patients With Cystic Fibrosis and Chronic Rhinosinusitis Phase 3
Completed NCT01955980 - Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis Phase 1/Phase 2
Completed NCT04123405 - Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis Phase 3
Completed NCT00797004 - Olfactory Dysfunction of Rhinosinusitis N/A
Recruiting NCT05494346 - Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction N/A
Not yet recruiting NCT05836935 - Role of Imaging in Complications of Sinusitis N/A
Withdrawn NCT02097576 - Manuka Honey Nasal Rinse Study N/A
Completed NCT01132781 - Theophylline in Rhinitis Phase 2
Recruiting NCT00948519 - Laser Assisted Treatment of Chronic Sinusitis With and Without Light Activated Agents N/A
Completed NCT00554190 - Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel Phase 4
Recruiting NCT03729258 - Efficacy and Safety of Modified Release Cefpodoxime Formulation in the Treatment of Acute Sinusitis. Phase 3
Withdrawn NCT03729310 - Comparison of Two Steroid Nasal Implants Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis Early Phase 1
Recruiting NCT01296919 - The Clinical Significance of the Uncinate Process Histopathology in Chronic Rhinosinusitis N/A
Completed NCT01086839 - Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis N/A
Completed NCT00849953 - FinESS Registry Study N/A
Withdrawn NCT00669799 - Topical Antibiotic Use In Chronic Rhinosinusitis A Double-Blinded, Randomized, Placebo Controlled Study N/A
Completed NCT03229551 - Xylitol for Chronic Sinusitis Phase 2/Phase 3