Physiotherapy Protocol in Treating Chronic Rhinosinusitis

October 24, 2023 updated by: Khaled Z. Fouda, Cairo University

Effect of Adding Physiotherapy Program to the Conservative Medical Therapy on Quality of Life and Pain Threshold in Chronic Rhinosinusitis Patients: A Prospective Randomized Controlled Trial

This study aims to investigate the effect of adding of integrated physiotherapy program to the conservative medical therapy on quality of life and pressure pain threshold (PPT) in chronic rhinosinusitis patients. Patients in this study will be randomly assigned into 2 groups. Group A (control group) will receive conservative medical treatment only which prescribed by Ear, Nose and Throat (ENT) specialist, while group B (experimental group) will receive the conservative medical treatment prescribed by ENT specialist in addition to physiotherapy program. Quality of Life (QoL) will be evaluated by Rhinosinusitis Disability Index (RSDI) and PPT will be evaluated by digital algometer at the baseline and immediately after the end of tenth session of treatment for both groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sixty-eight patients will be recruited for this study from Al-Qurayyat General Hospital in Al-Jouf Region, Saudi Arabia, with the following inclusion criteria: patients of both sexes, aged from 30 to 50 years, diagnosed by ENT specialist, with chronic rhinosinusitis with a history of 3 months or longer. The patients will be allocated into two equal groups at random (n = 34). Group A (control group) will receive medication only which prescribed by ENT specialist. Group B (experimental group) will receive prescribed medication by ENT specialist in addition to physiotherapy program which consists of: Ultrasound Therapy: The patients will receive pulsed (duty cycle 50%) US therapy with an intensity of 1 and 0.5 W/cm2 for maxillary and frontal sinus, respectively, with a frequency of 1MHz collimating beam. The small probe US applicator (0.8 cm2) with effective radiating area (ERA) equal 0.6 cm2 and beam non-uniformity ratio (BNR) equal 6:1 will be used to deliver US to the treatment area. The area of US application will be the skin over the cheeks for maxillary sinus and forehead for the frontal sinus. Ultrasound transmission gel will be used between the applicator and the skin, full contact technique in slow circular motion will be used for the duration of 5 minutes over the maxillary sinuses and 4 minutes over the frontal sinuses on each pair of sinuses. Manual Drainage Techniques: for the frontal and maxillary sinuses. Self Massaging Technique: The patients will also advised to perform self-massaging for the frontal and maxillary sinuses from the supine lying position. A demonstration session will be used to provide patients in the experimental group with a full description of the manual therapy procedure before the beginning of the study. The physiotherapy program will be applied 3 times a week (day after day) for 12 treatment sessions.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Jouf Region
      • Al Qurayyat, Jouf Region, Saudi Arabia, 77471
        • Al Qurayyat General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of both sexes
  • Aged from 30 to 50 years
  • Cynically diagnosed by Ear, Nose, and Throat (ENT) specialist, with chronic rhinosinusitis with a history of more than 3 months, confirmed by clinical diagnostic criteria (more than or equal to two major symptoms or one major symptom (nasal obstruction, facial pain/pressure, postnasal drip and hyposmia) and two minor symptoms (headache, halitosis, fatigue, dental pain and ear pain) and also verified by Computed Tomography (CT) scan results .

Exclusion criteria:

  • Having any tumors or cysts (as confirmed by CT scan)
  • Nasal polyps
  • Facial skin lesions or diseases or allergies of the face
  • Pregnancy
  • Metal implants in the face region
  • Previous nasal surgical procedures
  • Impaired thermal sensation (such as uncontrolled diabetes mellitus)
  • Cognitive level impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conservative medical therapy
Patients in this group received only medication prescribed by an Ear, Nose and Throat specialist.
Experimental: Medication and Physiotherapy program
Patients in this group received medication prescribed by an Ear, Nose and Throat specialist, in addition to integrated Physiotherapy program
Other: Ultrasound Therapy
Using an Enraf Nonius Sonoplus 490 from the Netherlands, the patients were asked to lie supine while the therapist stood at the level of the patient's head. The patients received pulsed (duty cycle 50%) US therapy with intensities of 1 and 0.5 W/cm2 for maxillary and frontal sinus, respectively, and a collimating beam frequency of 1MHz. To deliver US to the treatment area, a small probe US applicator (0.8 cm2) with an effective radiating area (ERA) of 0.6 cm2 and a beam non-uniformity ratio (BNR) of 6:1 was used. The skin around the cheeks was used for the maxillary sinus and the forehead for the frontal sinus. Between the applicator and the skin, ultrasound transmission gel was employed, and a full contact technique in slow circular motion was used for 5 minutes over the maxillary sinuses and 4 minutes over the frontal sinuses on each pair of sinuses
Other: Manual Drainage Techniques
Manual Drainage Techniques for the frontal and maxillary sinuses
Other: Self Sinus Massage Technique
Patients will also encouraged to self-massage their frontal and maxillary sinuses while resting supine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rhinosinusitis Disability Index (RSDI)
Time Frame: From baseline to 4 weeks after treatment (immediately after the completion of session 12)
Arabic version of Rhinosinusitis Disability Index will be used to assess the change in quality of life
From baseline to 4 weeks after treatment (immediately after the completion of session 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure pain threshold
Time Frame: From baseline to 4 weeks after treatment (immediately after the completion of session 12)
Wagner FPX25 digital algometer will be used to assess the change in pressure pain threshold
From baseline to 4 weeks after treatment (immediately after the completion of session 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Collaborators

Jouf University

Investigators

  • Principal Investigator: Khaled Fouda, PhD, Associate Professor of Physical Therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 21, 2023

Study Registration Dates

First Submitted

June 26, 2022

First Submitted That Met QC Criteria

June 30, 2022

First Posted (Actual)

July 5, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-13-S-071(071)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The IPD will be shared including a summary of the results after the study completion date.

IPD Sharing Time Frame

The dead time for IPD will be 30 June.2025

IPD Sharing Access Criteria

will be uploaded on the official site of CTR

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Study Data/Documents

  1. Full Paper

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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