Physiotherapy Protocol in Treating Chronic Rhinosinusitis

NCT05442606 | Completed

• 1 other identifier: H-13-S-071(071)
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rhinosinusitis

Keywords

Rhinosinusitis; ultrasound therapy; quality of life; pain threshold; manual therapy

Outcome Measures

Primary Outcomes (1)

• Rhinosinusitis Disability Index (RSDI)

  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 Outcomes (1)

• Pressure pain threshold

  From baseline to 4 weeks after treatment (immediately after the completion of session 12)

Study Arms (2)

Conservative medical therapy

NO INTERVENTION

Patients in this group received only medication prescribed by an Ear, Nose and Throat specialist.

Medication and Physiotherapy program

EXPERIMENTAL

Patients in this group received medication prescribed by an Ear, Nose and Throat specialist, in addition to integrated Physiotherapy program

Other: Ultrasound Therapy; Other: Manual Drainage Techniques; Other: Self Sinus Massage Technique

Interventions

Ultrasound Therapy OTHER

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

Medication and Physiotherapy program

Manual Drainage Techniques OTHER

Manual Drainage Techniques for the frontal and maxillary sinuses

Medication and Physiotherapy program

Self Sinus Massage Technique OTHER

Patients will also encouraged to self-massage their frontal and maxillary sinuses while resting supine

Medication and Physiotherapy program

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead
• Jouf University: collaborator

Study Sites (1)

Al Qurayyat General Hospital

Qurayyat, Jouf Region, 77471, Saudi Arabia

Location

Related Links

• Free Full Paper

MeSH Terms

Conditions

Rhinosinusitis

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Study Officials

• Khaled Fouda, PhD

  Associate Professor of Physical Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical therapy

Study Record Dates

• First Submitted: June 26, 2022
• First Posted: July 5, 2022
• Study Start: September 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 21, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The dead time for IPD will be 30 June.2025
• Access Criteria: will be uploaded on the official site of CTR

Locations

SA (1)