CRS: Implementation Of Physical Therapy Protocol In Management Of Chronic Maxillary Sinusitis

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05875298

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

this study will be conducted to investigate the effect of physical therapy protocol and medication on pain, pressure pain threshold and dysfunction in patients with Chronic Maxillary Sinusitis

Condition or Disease	Intervention/Treatment	Phase
Chronic Maxillary Sinusitis	Other: physical therapy protocol Other: physical therapy protocol and medical drugs Other: medical drugs	N/A

Detailed Description

Rhino sinusitis is one of the most common health-care problems worldwide and its prevalence and incidence is increasing. Chronic Sinusitis is a big health problem worldwide that affects almost 15% of humans. The most affected sinus is the maxillary sinus as its drainage orifice through the hiatus semilunaris is badly placed near the roof of the sinus. The first line of treatment for sinusitis is mostly medical drugs including antimicrobial drugs, decongestants, nasal sprays, corticosteroids, and antihistamine drugs which can effectively dry the mucus. Physical therapy also offers a variety of treatment approaches for sinusitis. It includes various electrotherapy modalities, manual drainage techniques, suboccipital release for sinus headaches, needling, and rhino flow therapy. In spite of many studies and treatment approaches done on sinusitis, there are limitations faced in evidence of which approval is most effective, The objective of our study is to investigate the effect of physical therapy protocol in people with chronic maxillary sinusitis.sixty six patients with chronic maxillary sinusitis will be allocated randomly to three groups; one group will receive physical therapy protocol, second one will receive medication only and the third one will receive physical therapy protocol and medication for four weeks.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

physical therapy protocol and medicationphysical therapy protocol and medication

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

opaque sealed envelop

Primary Purpose:

Treatment

Official Title:

Implementation Of Physical Therapy Protocol In Management Of Chronic Maxillary Sinusitis :A Randomized Controlled Trial

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: physical therapy protocol the patients will receive physical therapy protocol three times a week for four weeks	Other: physical therapy protocol the patients will receive physical therapy protocol in the form of therapeutic ultrasound (pulsed mode n An intensity of 1.7 W/cm² for maxillary, respectively in A frequency of 1.7 MHz in Duration of treatment of ten minutes for each maxillary sinus and five minutes for each side), Hot pack that will be applied eight minutes at each maxillary area and manual drainage technique for maxillary sinus.
Experimental: physical therapy protocol and medical drugs the patients will receive physical therapy protocol three times a week for four weeks and medication twice daily for four weeks	Other: physical therapy protocol and medical drugs the patients will receive physical therapy protocol and medical drugs in the form of therapeutic ultrasound (pulsed mode n An intensity of 1.7 W/cm² for maxillary, respectively in A frequency of 1.7 MHz in Duration of treatment of ten minutes for each maxillary sinus and five minutes for each side), Hot pack that will be applied eight minutes at each maxillary area and manual drainage technique for maxillary sinus. The drugs will be concentrated sea water 3% and Local corticosteroids nasal spray. Other: medical drugs The drugs will be concentrated sea water 3% and Local corticosteroids nasal spray.
Active Comparator: medical drugs the patients will receive medical drugs twice daily for four weeks	Other: medical drugs The drugs will be concentrated sea water 3% and Local corticosteroids nasal spray.

Arm

Intervention/Treatment

Experimental: physical therapy protocol

the patients will receive physical therapy protocol three times a week for four weeks

Other: physical therapy protocol

the patients will receive physical therapy protocol in the form of therapeutic ultrasound (pulsed mode n An intensity of 1.7 W/cm² for maxillary, respectively in A frequency of 1.7 MHz in Duration of treatment of ten minutes for each maxillary sinus and five minutes for each side), Hot pack that will be applied eight minutes at each maxillary area and manual drainage technique for maxillary sinus.

Experimental: physical therapy protocol and medical drugs

the patients will receive physical therapy protocol three times a week for four weeks and medication twice daily for four weeks

Other: physical therapy protocol and medical drugs

the patients will receive physical therapy protocol and medical drugs in the form of therapeutic ultrasound (pulsed mode n An intensity of 1.7 W/cm² for maxillary, respectively in A frequency of 1.7 MHz in Duration of treatment of ten minutes for each maxillary sinus and five minutes for each side), Hot pack that will be applied eight minutes at each maxillary area and manual drainage technique for maxillary sinus. The drugs will be concentrated sea water 3% and Local corticosteroids nasal spray.

Other: medical drugs

The drugs will be concentrated sea water 3% and Local corticosteroids nasal spray.

Active Comparator: medical drugs

the patients will receive medical drugs twice daily for four weeks

Other: medical drugs

The drugs will be concentrated sea water 3% and Local corticosteroids nasal spray.

Outcome Measures

Primary Outcome Measures

pain intensity [up to four weeks]
by visual analogue scale (VAS) 10 cm line with 2 ends, 0 and 10 ends 0 end means no pain 10 end means the worst pain
pressure pain threshold [up to four weeks]
pressure algometer will be used to measure pressure pain threshold
functional disability [up to four weeks]
Rhinosinusitis Disability Index will be used to assess functional disability in patients with chronic maxillary sinusitis.it consists of 30 items divided between three main domains: physical, functional, and emotional. Responses are provided using a 5-point Likert scale, and scores range from 0 to 150, with higher scores indicating that CRS exerts a greater impact on quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients clinically diagnosed by ENT Physician with chronic maxillary sinusitis With a history of 3 months or longer.
Age group from 18 to 50 years

Exclusion Criteria:

Local contraindications for face mobilization or massage. (abrasions, skin conditions, broken bones) Medical contraindications. (bacterial infections, conjunctivitis, styes)
Duration of onset less than 2 months Headache due to reasons other than chronic sinusitis (TMJD, cervicogenic headache, underlying neurological diseases, anxiety-related, etc)
Patients with surgery performed in the past 1 year for maxillary sinusitis Cognition level impairment
Metal implants in the face region

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aya Saeed Halmy, principle investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT05875298

Other Study ID Numbers:

P.T.REC/012/003842

First Posted:

May 25, 2023

Last Update Posted:

May 25, 2023

Last Verified:

May 1, 2023

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

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

Keywords provided by Aya Saeed Halmy, principle investigator, Cairo University

physical therapy protocol

chronic maxillary sinusitis

Additional relevant MeSH terms:

Sinusitis

Maxillary Sinusitis

Study Results

No Results Posted as of May 25, 2023