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Implementation Of Physical Therapy Protocol In Management Of Chronic Maxillary Sinusitis (CRS)

Primary Purpose

Chronic Maxillary Sinusitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
physical therapy protocol
physical therapy protocol and medical drugs
medical drugs
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Maxillary Sinusitis focused on measuring physical therapy protocol, chronic maxillary sinusitis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    physical therapy protocol

    physical therapy protocol and medical drugs

    medical drugs

    Arm Description

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

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

    the patients will receive medical drugs twice daily for four weeks

    Outcomes

    Primary Outcome Measures

    pain intensity
    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
    pressure algometer will be used to measure pressure pain threshold
    functional disability
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 16, 2023
    Last Updated
    May 16, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05875298
    Brief Title
    Implementation Of Physical Therapy Protocol In Management Of Chronic Maxillary Sinusitis
    Acronym
    CRS
    Official Title
    Implementation Of Physical Therapy Protocol In Management Of Chronic Maxillary Sinusitis :A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2023 (Anticipated)
    Study Completion Date
    September 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Maxillary Sinusitis
    Keywords
    physical therapy protocol, chronic maxillary sinusitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    physical therapy protocol and medication
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    opaque sealed envelop
    Allocation
    Randomized
    Enrollment
    66 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    physical therapy protocol
    Arm Type
    Experimental
    Arm Description
    the patients will receive physical therapy protocol three times a week for four weeks
    Arm Title
    physical therapy protocol and medical drugs
    Arm Type
    Experimental
    Arm Description
    the patients will receive physical therapy protocol three times a week for four weeks and medication twice daily for four weeks
    Arm Title
    medical drugs
    Arm Type
    Active Comparator
    Arm Description
    the patients will receive medical drugs twice daily for four weeks
    Intervention Type
    Other
    Intervention Name(s)
    physical therapy protocol
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    physical therapy protocol and medical drugs
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    medical drugs
    Intervention Description
    The drugs will be concentrated sea water 3% and Local corticosteroids nasal spray.
    Primary Outcome Measure Information:
    Title
    pain intensity
    Description
    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
    Time Frame
    up to four weeks
    Title
    pressure pain threshold
    Description
    pressure algometer will be used to measure pressure pain threshold
    Time Frame
    up to four weeks
    Title
    functional disability
    Description
    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
    Time Frame
    up to four weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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