An interventional study of Ultrasound Therapy and Manual Drainage Techniques in Rhinosinusitis, sponsored by Cairo University. Completed at 1 site in Saudi Arabia. Open to participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-10-26.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.
This study's enrollment of 68 is above the median of 60 across 227 interventional studies indexed under Rhinosinusitis.
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Exclusion criteria:
Patients in this group received only medication prescribed by an Ear, Nose and Throat specialist.
Patients in this group received medication prescribed by an Ear, Nose and Throat specialist, in addition to integrated Physiotherapy program
Other: Ultrasound Therapy · Other: Manual Drainage Techniques · Other: Self Sinus Massage Technique
Using an Enraf Nonius Sonoplus 490 from the Netherlands, the patients were asked to lie supine while the therapist stood at the level of the patient's head. The patients received pulsed (duty cycle 50%) US therapy with intensities of 1 and 0.5 W/cm2 for maxillary and frontal sinus, respectively, and a collimating beam frequency of 1MHz. To deliver US to the treatment area, a small probe US applicator (0.8 cm2) with an effective radiating area (ERA) of 0.6 cm2 and a beam non-uniformity ratio (BNR) of 6:1 was used. The skin around the cheeks was used for the maxillary sinus and the forehead for the frontal sinus. Between the applicator and the skin, ultrasound transmission gel was employed, and a full contact technique in slow circular motion was used for 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
Patients will also encouraged to self-massage their frontal and maxillary sinuses while resting supine
Rhinosinusitis Disability Index (RSDI)
Arabic version of Rhinosinusitis Disability Index will be used to assess the change in quality of life
Time frame: From baseline to 4 weeks after treatment (immediately after the completion of session 12)
Pressure pain threshold
Wagner FPX25 digital algometer will be used to assess the change in pressure pain threshold
Time frame: From baseline to 4 weeks after treatment (immediately after the completion of session 12)
Plan to share: Yes — The IPD will be shared including a summary of the results after the study completion date.
Supporting information: Study protocol
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Cairo University