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

NCT06960876 | Recruiting

• 1 other identifier: FUI/CTR/2024/68
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Pain measured on Numerical pain rating scale
2. 2.Sinonasal symptoms measured on sino-nasal outcome test questionaire
3. 3.Quality of life measured on rhinosinusitis disability index (RSDI)
4. 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.

Conditions

Chronic Rhinosinusitis (CRS)

Keywords

CHRONIC RHINOSINUSITIS; Therapeutic ultrasound; sinus massage

Outcome Measures

Primary Outcomes (4)

• Pain level

  The numeric pain rating scale will be used. The participants rate their pain from 0-10. Scoring: 0 shows no pain, whereas 10 represents the worst pain.

  4 weeks

• sino-nasal symptoms

  Sino-nasal outcome test questionnaire for assessing sino-nasal symptoms The SNOT-22 is a 22-item treatment outcome measure designed for people with chronic sinonasal conditions. The SNOT-22 has been evaluated and is based on a Likert scale. Scoring: 0="No problem", 1="Very mild problem", 2="Mild or slight problem", 3="Moderate problem", 4="Severe problem", and 5="Problem as bad as it can be." Higher scores on SNOT-22 survey items indicate worse patient function or more severe symptoms (total score range: 0-110)

  6 weeks

• health-related quality of life (HRQL) in rhinosinusitis

  Rhino Sinusitis Disability Index (RSDI) for measuring health-related quality of life (HRQL) in rhinosinusitis The purpose of this scale is to identify difficulties experienced due to nose or sinus problems. The Rhinosinusitis Disability Index (RSDI) has a total score range of 0-120 and consists of 30 items.

  6 weeks

• nasal inspiratory flow rate

  Peak nasal inspiratory flow meter to evaluate nasal inspiratory flow rate during maximal inspiration It works when a patient inhales through the nose causing air to be drawn through the meter, a cursor moves along the scale to indicate the speed of inhalation. The flow rate achieved can be noted by checking the position of the cursor against the calibrated scale.

  6 weeks

Study Arms (3)

Group A

EXPERIMENTAL

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

Procedure: Therapeutic Ultrasound

Group B

EXPERIMENTAL

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

Procedure: Sinus Massage

Group C

ACTIVE COMPARATOR

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)

Procedure: Control group

Interventions

Therapeutic Ultrasound 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 A

Sinus Massage 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 B

Control group 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)

Group C

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

RECRUITING

MeSH Terms

Interventions

Ultrasonic Therapy; Control Groups

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Amna Saeed, DPT

CONTACT

+92 333-5421735; amnasheroz4322@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: July 18, 2024
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-04

Locations

PA (1)