Clinical trial NCT05442606: 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
Overall status: COMPLETED
Phase: NA
Conditions: Rhinosinusitis
Keywords: Rhinosinusitis
ultrasound therapy
quality of life
pain threshold
manual therapy
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Jouf University
First posted: 2022-07-05
Enrollment: 68
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rhinosinusitis Disability Index (RSDI)
timeFrame: From baseline to 4 weeks after treatment (immediately after the completion of session 12)
Secondary outcomes:
measure: Pressure pain threshold
timeFrame: From baseline to 4 weeks after treatment (immediately after the completion of session 12)
Other outcomes:
Locations:
city: Al Qurayyat
country: Saudi Arabia
facility: Al Qurayyat General Hospital
state: Jouf Region
Study officials:
affiliation: Associate Professor of Physical Therapy
name: Khaled Fouda, PhD
role: PRINCIPAL_INVESTIGATOR
References: