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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorFoundation University Islamabad

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 20-60 years

Both gender

Diagnosed patients of chronic rhinosinusitis referred by an ENT specialist

Two or more major symptoms for ≥12 weeks. Or

Disqualifiers

Nasal polyps

Current Medical conditions in which ultrasound is contraindicated (20)

Facial metal implants

Face or head tumor/cyst/malignancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Therapeutic Ultrasound

    Procedure/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 Massage

    Procedure/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 group

    Procedure/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)

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention
Group C: Group CActive comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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