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Recruiting NCT06960876

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

No phase Interventional Chronic Rhinosinusitis (CRS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Therapeutic Ultrasound, Sinus Massage, Control group.
Who it may be relevant to
Registry conditions: Chronic Rhinosinusitis (CRS). Basic parameters: 20 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure 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.
  • 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)
  • 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)

Primary outcome measures

  • Pain level [Time frame: 4 weeks]
  • sino-nasal symptoms [Time frame: 6 weeks]
  • health-related quality of life (HRQL) in rhinosinusitis [Time frame: 6 weeks]
  • nasal inspiratory flow rate [Time frame: 6 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Foundation University College of Physical Therapy — Islamabad

Identifiers

NCT: NCT06960876 · FUI/CTR/2024/68

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗