Comparative Effects of Therapeutic Ultrasound and Sinus Massage in Chronic Rhinosinusitis: a Randomized Controlled Study

Foundation University Islamabad

Status: Enrolling

Conditions: Chronic Rhinosinusitis (CRS)

Treatments: Procedure: Sinus Massage; Procedure: Therapeutic Ultrasound; Procedure: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT06960876

FUI/CTR/2024/68

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Group A

Experimental group

Description:

All three groups will continue their prescribed steam protocol and medications by the ENT specialist Group A will additionally receive a therapeutic Ultrasound over the maxillary sinus

Treatment:

Procedure: Therapeutic Ultrasound

Group B

Experimental group

Description:

All three groups will continue their prescribed steam protocol and medications by the ENT specialist Group B will additionally receive, sinus massage (pressure \& milking)

Treatment:

Procedure: Sinus Massage

Group C

Active Comparator group

Description:

All three groups will continue their prescribed steam protocol and medications by the ENT specialist Group C will not receive any other adjunct physical therapy treatment (control group)

Treatment:

Procedure: Control group