Clinical trial NCT06960876: Comparative Effects of Therapeutic Ultrasound and Sinus Massage in Chronic Rhinosinusitis: a Randomized Controlled Study
Official title: Comparative Effects of Therapeutic Ultrasound and Sinus Massage in Chronic Rhinosinusitis: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Rhinosinusitis (CRS)
Keywords: CHRONIC RHINOSINUSITIS
Therapeutic ultrasound
sinus massage
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial. Previous studies show that both therapeutic ultrasound and sinus massage techniques have significant results in Chronic Rhinosinustis (CRS).

However, there is no comparative study carried out between these two to show which technique has more effects in CRS.

This study will determine their comparative effects on:

1. Pain measured on Numerical pain rating scale
2. Sinonasal symptoms measured on sino-nasal outcome test questionaire
3. Quality of life measured on rhinosinusitis disability index (RSDI)
4. Nasal inspiratory airflow measured on peak nasal inspiratory flow meter. Participants of chronic rhinosinusitis will be selected according to the diagnostic criteria of American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) and will be randomly allocated into three groups. All three group will continue to receive medical intervention. Additionally one group will receive therapeutic ultrasound while other group will receive sinus massage. Whereas third group will be control group and won't receive any additional treatment.

Data will be collected at Foundation University College of Physical Therapy and Fauji Foundation Hospital.


Eligibility criteria: Inclusion Criteria:

* Age 20-60 years
* Both gender
* Diagnosed patients of chronic rhinosinusitis referred by an ENT specialist
* According to the AAO-HNS, patients are diagnosed with CRS if they had:
* Two or more major symptoms for ≥12 weeks. Or
* one major symptom with two minor symptoms for ≥12 weeks (19) Major clinical symptoms
* Pain or pressure on the face
* Nasal congestion
* Mucopurulent rhinorrhea either anteriorly, posteriorly, or both
* Hyposmia/anosmia Minor clinical symptoms
* Headache
* Fever
* Pain in the dental area
* Halitosis
* Pain or pressure on the ear
* Cough

Exclusion Criteria:

* Nasal polyps
* Current Medical conditions in which ultrasound is contraindicated (20)
* Facial metal implants
* Face or head tumor/cyst/malignancy
* Deteriorated cognitive level
* Previous surgery on the nose
* Facial bone fracture
* Reduced heat perception
* Ischemic tissues
* Skin allergies/lesions to the face

Primary outcomes:
measure: Pain level
timeFrame: 4 weeks
measure: sino-nasal symptoms
timeFrame: 6 weeks
measure: health-related quality of life (HRQL) in rhinosinusitis
timeFrame: 6 weeks
measure: nasal inspiratory flow rate
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University College of Physical Therapy
Study officials:
References: