Physiotherapy Protocol in Treating Chronic Rhinosinusitis
Primary Purpose
Rhinosinusitis
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Ultrasound Therapy
Manual Drainage Techniques
Self Sinus Massage Technique
Sponsored by
About this trial
This is an interventional treatment trial for Rhinosinusitis focused on measuring Rhinosinusitis, ultrasound therapy, quality of life, pain threshold, manual therapy
Eligibility Criteria
Inclusion Criteria:
- Patients of both sexes
- Aged from 18 to 55 years
- Cynically diagnosed by Ear, Nose, and Throat (ENT) specialist, with chronic rhinosinusitis with a history of more than 3 months, confirmed by clinical diagnostic criteria (more than or equal to two major symptoms or one major symptom (nasal obstruction, facial pain/pressure, postnasal drip and hyposmia) and two minor symptoms (headache, halitosis, fatigue, dental pain and ear pain) and also verified by Computed Tomography (CT) scan results .
Exclusion criteria:
- Having any tumors or cysts (as confirmed by CT scan)
- Nasal polyps
- Facial skin lesions or diseases or allergies of the face
- Pregnancy
- Metal implants in the face region
- Previous nasal surgical procedures
- Impaired thermal sensation (such as uncontrolled diabetes mellitus)
- Cognitive level impairment
Sites / Locations
- Al Qurayyat General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Conservative medical therapy
Medication and Physiotherapy program
Arm Description
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
Outcomes
Primary Outcome Measures
Rhinosinusitis Disability Index (RSDI)
Arabic version of Rhinosinusitis Disability Index will be used to assess the change in quality of life
Secondary Outcome Measures
Pressure pain threshold
Wagner FPX25 digital algometer will be used to assess the change in pressure pain threshold
Full Information
NCT ID
NCT05442606
First Posted
June 26, 2022
Last Updated
April 6, 2023
Sponsor
Cairo University
Collaborators
Jouf University
1. Study Identification
Unique Protocol Identification Number
NCT05442606
Brief Title
Physiotherapy Protocol in Treating Chronic Rhinosinusitis
Official Title
Effect of Adding Physiotherapy Program to the Conservative Medical Therapy on Quality of Life and Pain Threshold in Chronic Rhinosinusitis Patients: A Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
March 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Jouf University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinosinusitis
Keywords
Rhinosinusitis, ultrasound therapy, quality of life, pain threshold, manual therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conservative medical therapy
Arm Type
No Intervention
Arm Description
Patients in this group received only medication prescribed by an Ear, Nose and Throat specialist.
Arm Title
Medication and Physiotherapy program
Arm Type
Experimental
Arm Description
Patients in this group received medication prescribed by an Ear, Nose and Throat specialist, in addition to integrated Physiotherapy program
Intervention Type
Other
Intervention Name(s)
Ultrasound Therapy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Manual Drainage Techniques
Intervention Description
Manual Drainage Techniques for the frontal and maxillary sinuses
Intervention Type
Other
Intervention Name(s)
Self Sinus Massage Technique
Intervention Description
Patients will also encouraged to self-massage their frontal and maxillary sinuses while resting supine
Primary Outcome Measure Information:
Title
Rhinosinusitis Disability Index (RSDI)
Description
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)
Secondary Outcome Measure Information:
Title
Pressure pain threshold
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of both sexes
Aged from 30 to 50 years
Cynically diagnosed by Ear, Nose, and Throat (ENT) specialist, with chronic rhinosinusitis with a history of more than 3 months, confirmed by clinical diagnostic criteria (more than or equal to two major symptoms or one major symptom (nasal obstruction, facial pain/pressure, postnasal drip and hyposmia) and two minor symptoms (headache, halitosis, fatigue, dental pain and ear pain) and also verified by Computed Tomography (CT) scan results .
Exclusion criteria:
Having any tumors or cysts (as confirmed by CT scan)
Nasal polyps
Facial skin lesions or diseases or allergies of the face
Pregnancy
Metal implants in the face region
Previous nasal surgical procedures
Impaired thermal sensation (such as uncontrolled diabetes mellitus)
Cognitive level impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled Fouda, PhD
Organizational Affiliation
Associate Professor of Physical Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al Qurayyat General Hospital
City
Al Qurayyat
State/Province
Jouf Region
ZIP/Postal Code
77471
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The IPD will be shared including a summary of the results after the study completion date.
IPD Sharing Time Frame
The dead time for IPD will be 30 June.2025
IPD Sharing Access Criteria
will be uploaded on the official site of CTR
Learn more about this trial
Physiotherapy Protocol in Treating Chronic Rhinosinusitis
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