Implementation Of Physical Therapy Protocol In Management Of Chronic Maxillary Sinusitis
CRS
1 other identifier
interventional
66
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2023
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2023
CompletedFirst Posted
Study publicly available on registry
May 25, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedMay 25, 2023
May 1, 2023
3 months
May 16, 2023
May 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
up to four weeks
pressure pain threshold
pressure algometer will be used to measure pressure pain threshold
up to four weeks
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
up to four weeks
Study Arms (3)
physical therapy protocol
EXPERIMENTALthe patients will receive physical therapy protocol three times a week for four weeks
physical therapy protocol and medical drugs
EXPERIMENTALthe patients will receive physical therapy protocol three times a week for four weeks and medication twice daily for four weeks
medical drugs
ACTIVE COMPARATORthe patients will receive medical drugs twice daily for four weeks
Interventions
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.
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.
The drugs will be concentrated sea water 3% and Local corticosteroids nasal spray.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- opaque sealed envelop
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
May 16, 2023
First Posted
May 25, 2023
Study Start
June 1, 2023
Primary Completion
September 1, 2023
Study Completion
September 1, 2023
Last Updated
May 25, 2023
Record last verified: 2023-05