Chronic Maxillary SinusitisCRSNCT05875298
Implementation Of Physical Therapy Protocol In Management Of Chronic Maxillary Sinusitis
A study testing physical therapy protocol, physical therapy protocol and medical drugs and medical drugs in people with Chronic Maxillary Sinusitis, run by Cairo University.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Maxillary Sinusitis
- What is being tested?
- physical therapy protocol, physical therapy protocol and medical drugs and medical drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Implementation Of Physical Therapy Protocol In Management Of Chronic Maxillary Sinusitis :A Randomized Controlled Trial
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.
- Conditions
- Chronic Maxillary Sinusitis
- Being tested
- physical therapy protocol, physical therapy protocol and medical drugs, medical drugs
- Keywords
- physical therapy protocol, chronic maxillary sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapy protocolOther
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.
physical therapy protocol and medical drugsOther
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.
medical drugsOther
The drugs will be concentrated sea water 3% and Local corticosteroids nasal spray.
| Study group | Role | What they receive |
|---|---|---|
| physical therapy protocol | Experimental | the patients will receive physical therapy protocol three times a week for four weeks Receives: Other: physical therapy protocol |
| 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 Receives: Other: physical therapy protocol and medical drugs; Other: medical drugs |
| medical drugs | Active comparator | the patients will receive medical drugs twice daily for four weeks Receives: Other: medical drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to four weeks
pressure pain threshold
pressure algometer will be used to measure pressure pain threshold
Measured: 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
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Maxillary SinusitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- physical therapy protocol and medication
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Saeed Halmy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875298
- Sponsor's protocol ID
- P.T.REC/012/003842
- Acronym
- CRS
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Of Physical Therapy Protocol In Management Of Chronic Maxillary Sinusitis :A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05875298
- Acronym / sponsor ID
- CRS / P.T.REC/012/003842
- Conditions
- Chronic Maxillary Sinusitis
- Keywords
- physical therapy protocol, chronic maxillary sinusitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- physical therapy protocol and medication
| Arm | Type | Receives |
|---|---|---|
| physical therapy protocol | Experimental | Other: physical therapy protocolthe patients will receive physical therapy protocol three times a week for four weeks |
| physical therapy protocol and medical drugs | Experimental | Other: physical therapy protocol and medical drugs, Other: medical drugsthe patients will receive physical therapy protocol three times a week for four weeks and medication twice daily for four weeks |
| medical drugs | Active comparator | Other: medical drugsthe patients will receive medical drugs twice daily for four weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical therapy protocolthe 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. | Other | physical therapy protocol |
| physical therapy protocol and medical drugsthe 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 | physical therapy protocol and medical drugs |
| medical drugsThe drugs will be concentrated sea water 3% and Local corticosteroids nasal spray. | Other | medical drugs, physical therapy protocol and medical drugs |
Primary outcome
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
pressure pain threshold
Time frame: up to four weeks
pressure algometer will be used to measure pressure pain threshold
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
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Maxillary Sinusitis, Sinusitis, Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy protocol, physical therapy protocol and medical drugs and medical drugs in people with Chronic Maxillary Sinusitis, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (time frame: up to four weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.