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RecruitingNCT06960876Updated May 7, 2025

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

An interventional study of Therapeutic Ultrasound and Sinus Massage in Chronic Rhinosinusitis (CRS), sponsored by Foundation University Islamabad. Recruiting at 1 site in Pakistan. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-05-07.

Sponsored by Foundation University Islamabad · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Registered 9 months after the study started (first participant enrolled Jul 2024, registered Apr 2025).
  • Started Jul 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Rhinosinusitis (CRS)

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Keywords

  • CHRONIC RHINOSINUSITIS
  • Therapeutic ultrasound
  • sinus massage
03

In context

Rhinosinusitis

251 studies on the registry are indexed under Rhinosinusitis; 69 are open to participants now.

This study's planned enrollment of 60 is below the median of 74 across 177 interventional studies indexed under Rhinosinusitis.

Browse Rhinosinusitis studies →

Lead sponsor

Foundation University Islamabad is the lead sponsor of 255 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Nasal polyps
  • Current Medical conditions in which ultrasound is (20)
  • Facial metal implants
  • Face or head tumor/cyst/
  • Deteriorated cognitive level
  • Previous surgery on the nose
  • Facial bone fracture
  • Reduced heat perception
  • Ischemic tissues
  • Skin allergies/lesions to the face
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    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

    Procedure: Therapeutic Ultrasound

  • Experimental
    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)

    Procedure: Sinus Massage

  • Active comparator
    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)

    Procedure: Control group

Interventions

  • ProcedureTherapeutic 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.

  • ProcedureSinus 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)

  • ProcedureControl 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)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 weeks

  2. 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)

    Time frame: 6 weeks

  3. 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.

    Time frame: 6 weeks

  4. 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.

    Time frame: 6 weeks

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Jun 2025, 11 months after the start.

Of 33 interventional studies with no phase under Rhinosinusitis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2025
First posted
May 7, 2025
StartActual
Jul 18, 2024
Primary completionEst.
Jun 20, 2025
CompletionEst.
Jun 20, 2025
Last update
May 7, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06960876
Responsible party
Sponsor
First posted
May 7, 2025
Start date
Jul 18, 2024
Primary completion
Jun 20, 2025 (estimated)
Completion
Jun 20, 2025 (estimated)
Last update
May 7, 2025

Study contacts

Amna Saeed, DPT
Contact
amnasheroz4322@gmail.com
+92 333-5421735

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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