ClinicalTrials.gg
Not yet recruitingNCT05875298CRSUpdated May 25, 2023

Implementation Of Physical Therapy Protocol In Management Of Chronic Maxillary Sinusitis

An interventional study of physical therapy protocol and physical therapy protocol and medical drugs in Chronic Maxillary Sinusitis, sponsored by Cairo University. Not yet recruiting. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-05-25.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2023, 3 years 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Chronic Maxillary Sinusitis

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Keywords

  • physical therapy protocol
  • chronic maxillary sinusitis
03

In context

Sinusitis

256 studies on the registry are indexed under Sinusitis; 23 are open to participants now.

This study's planned enrollment of 66 is close to the median of 60 across 196 interventional studies indexed under Sinusitis.

Browse Sinusitis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Local 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
66 participants (estimated)

Study arms

  • Experimental
    physical therapy protocol

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

    Other: physical therapy protocol

  • 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 · Other: medical drugs

  • Active comparator
    medical drugs

    the patients will receive medical drugs twice daily for four weeks

    Other: medical drugs

Interventions

  • Otherphysical 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.

  • Otherphysical 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.

  • Othermedical drugs

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to four weeks

  2. pressure pain threshold

    pressure algometer will be used to measure pressure pain threshold

    Time frame: up to four weeks

  3. 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

    Time frame: up to four weeks

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2023; primary completion for Sep 2023, 3 months later.

Of 29 interventional studies with no phase under Sinusitis, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 63. This study's planned 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 16, 2023
First posted
May 25, 2023
StartEst.
Jun 1, 2023
Primary completionEst.
Sep 1, 2023
CompletionEst.
Sep 1, 2023
Last update
May 25, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05875298
Lead sponsor
Cairo University
Responsible party
Aya Saeed Halmy (principle investigator, Cairo University) — Principal investigator
First posted
May 25, 2023
Start date
Jun 1, 2023 (estimated)
Primary completion
Sep 1, 2023 (estimated)
Completion
Sep 1, 2023 (estimated)
Last update
May 25, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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