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Clinical Trials/NCT05875298
NCT05875298Not yet recruitingNot Applicable

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

Cairo University0 sites66 target enrollmentStarted: June 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
66
Primary Endpoint
pressure pain threshold

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Masking Description

opaque sealed envelop

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

physical therapy protocol

Experimental

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

Intervention: physical therapy protocol (Other)

physical therapy protocol and medical drugs

Experimental

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

Intervention: physical therapy protocol and medical drugs (Other)

physical therapy protocol and medical drugs

Experimental

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

Intervention: medical drugs (Other)

medical drugs

Active Comparator

the patients will receive medical drugs twice daily for four weeks

Intervention: medical drugs (Other)

Outcomes

Primary Outcomes

pressure pain threshold

Time Frame: up to four weeks

pressure algometer will be used to measure pressure pain threshold

pain intensity

Time Frame: 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

functional disability

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aya Saeed Halmy

principle investigator

Cairo University

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