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

NCT ID: NCT06960876

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-18
• Study Completion Date: 2025-06-20

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.

Conditions

Chronic Rhinosinusitis (CRS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

Therapeutic Ultrasound

Intervention Type: PROCEDURE

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

Group B

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

Group Type: EXPERIMENTAL

Sinus Massage

Intervention Type: PROCEDURE

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

Group C

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)

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: PROCEDURE

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

Interventions

Therapeutic Ultrasound

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

Intervention Type: PROCEDURE

Sinus Massage

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

Intervention Type: PROCEDURE

Control group

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation University Islamabad

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Foundation University College of Physical Therapy

Islamabad, , Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Amna Saeed, DPT

Role: CONTACT

amnasheroz4322@gmail.com

+92 333-5421735

Facility Contacts

Qurat ul ain Saeed, MS-MSKPT

Role: primary

quratulain.saeed@fui.edu.pk

+92 331 5562889

Other Identifiers

FUI/CTR/2024/68

Identifier Type: -

Identifier Source: org_study_id