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NCT Number: NCT06960876

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

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.

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Key information

Conditions

Chronic Rhinosinusitis (CRS)

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

Location status: Recruiting

Location contact

Qurat ul ain Saeed, MS-MSKPT

CONTACT

[email protected]

+92 331 5562889

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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)

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)

Primary outcomes

  1. Pain level

    Time frame: 4 weeks

    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.

  2. sino-nasal symptoms

    Time frame: 6 weeks

    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)

  3. health-related quality of life (HRQL) in rhinosinusitis

    Time frame: 6 weeks

    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.

  4. nasal inspiratory flow rate

    Time frame: 6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amna Saeed, DPT

CONTACT

[email protected]

+92 333-5421735

Sponsors and collaborators

Lead sponsor

Foundation University Islamabad

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 7, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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