Physiotherapy Protocol in Treating Chronic Rhinosinusitis

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05442606

Collaborator

Jouf University (Other)

Enrollment

Location

Arms

9.5

Anticipated Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinosinusitis	Other: Sniff Relief Sinus Mask Other: Ultrasound Therapy Other: Manual Drainage Techniques Other: Self Sinus Massage Technique	N/A

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 18 to 55 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: Sniff Relief Sinus Mask: which adjusted to give mild comfortable warmth for 7 minutes. 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 10 treatment sessions.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 15, 2022

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

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: Sniff Relief Sinus Mask This mask provides warmth to the nose and surrounding areas. This nasal mask has eye holes and an adjustable velcro head strap, as well as an adjustable temperature control, that adjusted to provide mild, comfortable warmth for 7 minutes 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

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: Sniff Relief Sinus Mask

This mask provides warmth to the nose and surrounding areas. This nasal mask has eye holes and an adjustable velcro head strap, as well as an adjustable temperature control, that adjusted to provide mild, comfortable warmth for 7 minutes

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

Outcome Measures

Primary Outcome Measures

Rhinosinusitis Disability Index (RSDI) [From baseline to 3 weeks after treatment (immediately after the completion of session 10)]
Arabic version of Rhinosinusitis Disability Index will be used to assess the change in quality of life

Secondary Outcome Measures

Pressure pain threshold [From baseline to 3 weeks after treatment (immediately after the completion of session 10)]
Wagner FPX25 digital algometer will be used to assess the change in pressure pain threshold

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients of both sexes
Aged from 18 to 55 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al Qurayyat General Hospital	Al Qurayyat	Jouf Region	Saudi Arabia	77471

Sponsors and Collaborators

Cairo University
Jouf University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Khaled Z. Fouda, Associate Professor of Physical therapy, Cairo University

ClinicalTrials.gov Identifier:

NCT05442606

Other Study ID Numbers:

H-13-S-071(071)

First Posted:

Jul 5, 2022

Last Update Posted:

Jul 5, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Khaled Z. Fouda, Associate Professor of Physical therapy, Cairo University

Additional relevant MeSH terms:

Sinusitis

Study Results

No Results Posted as of Jul 5, 2022