Chronic Rhinosinusitis (CRS)NCT06960876
Comparative Effects of Therapeutic Ultrasound and Sinus Massage in Chronic Rhinosinusitis: a Randomized Controlled Study
A study testing Therapeutic Ultrasound and Sinus Massage in people with Chronic Rhinosinusitis (CRS), run by Foundation University Islamabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Chronic Rhinosinusitis (CRS)
- What is being tested?
- Therapeutic Ultrasound and Sinus Massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Jul 2024to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- Facial bone fracture
- Reduced heat perception
- Ischemic tissues
- Skin allergies/lesions to the face
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Islamabad, 44000
Qurat ul ain Saeed, MS-MSKPT, +92 331 5562889, quratulain.saeed@fui.edu.pk
About this 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.
Read more
This study will determine their comparative effects on:
- Pain measured on Numerical pain rating scale
- Sinonasal symptoms measured on sino-nasal outcome test questionaire
- Quality of life measured on rhinosinusitis disability index (RSDI)
- 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)
- Being tested
- Therapeutic Ultrasound, Sinus Massage, Control group
- Keywords
- CHRONIC RHINOSINUSITIS, Therapeutic ultrasound, sinus massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic UltrasoundProcedure or surgery
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 MassageProcedure or surgery
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 groupProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: 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) Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start18 Jul 2024
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (CRS)Studies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960876
- Sponsor's protocol ID
- FUI/CTR/2024/68
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Therapeutic Ultrasound and Sinus Massage in Chronic Rhinosinusitis: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06960876
- Acronym / sponsor ID
- FUI/CTR/2024/68
- Conditions
- Chronic Rhinosinusitis (CRS)
- Keywords
- CHRONIC RHINOSINUSITIS, Therapeutic ultrasound, sinus massage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Pain measured on Numerical pain rating scale
- Sinonasal symptoms measured on sino-nasal outcome test questionaire
- Quality of life measured on rhinosinusitis disability index (RSDI)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Therapeutic UltrasoundAll 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 B | Experimental | Procedure: Sinus MassageAll three groups will continue their prescribed steam protocol and medications by the ENT specialist Group B will additionally receive, sinus massage (pressure \& milking) |
| Group C | Active comparator | Procedure: Control groupAll 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) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (10 listed)
- Nasal polyps
- Current Medical conditions in which ultrasound is contraindicated (20)
- Facial metal implants
- Face or head tumor/cyst/malignancy
- Deteriorated cognitive level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic UltrasoundAll 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 or surgery | Group A |
| Sinus MassageAll three groups will continue their prescribed steam protocol and medications by the ENT specialist. This group will additionally receive, sinus massage (pressure \& milking) | Procedure or surgery | Group B |
| Control groupAll 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) | Procedure or surgery | Group C |
Primary outcome
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.
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)
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Ultrasound and Sinus Massage in people with Chronic Rhinosinusitis (CRS), run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amna Saeed, DPT (+92 333-5421735, amnasheroz4322@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.