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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06960876
Enrollment
60
Registered
2025-05-07
Start date
2024-07-18
Completion date
2025-06-20
Last updated
2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rhinosinusitis (CRS)

Keywords

CHRONIC RHINOSINUSITIS, Therapeutic ultrasound, sinus massage

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. 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

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)

Sponsors

Foundation University Islamabad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain level4 weeksThe 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 symptoms6 weeksSino-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 rhinosinusitis6 weeksRhino 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 rate6 weeksPeak 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.

Countries

Pakistan

Contacts

Primary ContactAmna Saeed, DPT
amnasheroz4322@gmail.com+92 333-5421735

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026