Chronic Rhinosinusitis (CRS)NCT06616792
Dexamethasone Phonophoresis Versus Laser Acupuncture on Chronic Rhinosinusitis
A study testing Dexamethasone phonophoresis, Laser Acupuncture and Traditional medication in people with Chronic Rhinosinusitis (CRS), run by Cairo University at 1 site in Egypt.
Trial summary
This study is designed to provide a comprehensive overview of evidence concerning the efficacy and safety of dexamethasone phonophoresis and laser acupuncture for treatment of chronic rhinosinusitis. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Chronic Rhinosinusitis (CRS)
- What is being tested?
- Dexamethasone phonophoresis, Laser Acupuncture and Traditional medication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to Feb 2025
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range between 30 to 50 years.
- Male and female patients will participate in the study.
- All patients have chronic rhinosinusitis, who are experiencing 12 weeks or longer of 2 or more of the following signs and symptoms:
- mucopurulent drainage (anterior, posterior, or both) nasal obstruction (congestion) facial pain-pressure-fullness, or decreased sense of smell
- All patients enrolled in the study will have their informed consent.
Who cannot join
- Patients with metal implants (pacemakers, dental implants, or any other implants).
- Patients with cancer, pregnancy or impaired vascular circulation.
- Patients who suffer from mental or psychological disorders.
- Patients with any systemic diseases that may interfere with the objectives of the study.
- Patients with long-term use of corticosteroids or immunosuppressive agents.
- Congenital defects on face and nose.
Show all 12Show fewer
- Fracture of nose or face.
- Patients who are contraindicated for corticosteroids use in patient who will receive dexamethasone phonophoresis.
- Allergic patients.
- Pervious nasal surgery.
- Patients with nasal septum deviation.
- patients who had used antihistamines within 1 week, topical corticosteroids within2 weeks, systemic corticosteroids within 4 weeks, anti-cholinergic drugs within 3 days, antileukotriene drugs within 1 week, decongestants within 3 days, tricyclic antidepressants or phenothiazines within 2 weeks, non-steroidal analgesics within 2 weeks or any medication that may interfere with the objectives of the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical therapy, Cairo University
Dokki, Giza Governorate, 12611
About this study
This study is designed to provide a comprehensive overview of evidence concerning the efficacy and safety of dexamethasone phonophoresis and laser acupuncture for treatment of chronic rhinosinusitis.
- Conditions
- Chronic Rhinosinusitis (CRS)
- Being tested
- Dexamethasone phonophoresis, Laser Acupuncture, Traditional medication
- Keywords
- Dexamethasone Phonophoresis, Laser Acupuncture, Chronic Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone phonophoresisCombination product
Ultrasound therapeutic device with the use of 0.4% Dexamethasone sodium phosphate gel for phonophoresis.
Laser AcupunctureDevice
low level laser therapy placed in contact with the skin perpendicular over the body acupoints (LI 4) - (LI 20) - (EX- HN5) - (GV 20) - (GV 24) - (ST3) - (ST 7) in both sides and on (EX-HN3) acupoint,
Traditional medicationOther
Each participant in this group receive the traditional medication.
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Experimental | Each participant in this group will receive dexamethasone phonophoresis, US with the use of 0.4% Dexamethasone sodium phosphate gel for phonophoresis. over maxillary and frontal sinuses for 3 sessions per week for one month, in addition to the traditional medication. |
| Group (B) | Experimental | Each participant in this group will receive low level laser placed in contact with the skin perpendicular over the body acupoints (LI 4) - (LI 20) - (EX- HN5) - (GV 20) - (GV 24) - (ST3) - (ST 7) in both sides and on (EX-HN3) acupoint, with a duration of 90 sec for each point three times per week for a month., in addition to the traditional medication. Receives: Device: Laser Acupuncture; Other: Traditional medication |
| Group (C) | Active comparator | Each participant in this group will receive the traditional medication only. Receives: Other: Traditional medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sino nasal Outcome Test 22 (SNOT-22)
This is a Quality Of Life Questionnaire specifically designed for sinusitis patient. It consists of 22 item sinus specific question which has to be administered to the patient and the total sum of all the items will be recorded based on the severity of the patient's condition and the scores will be calculated
Measured: one month
Computerized Tomography Scan
CT scan will be used for assessment of mucosal thickening of maxillary sinuses, which is based on 0-3 system: 0 = clear, 1= mild or moderate mucosal thickening, 2 = severe mucosal thickening, 3 = total opacification
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Jul 2024
- Primary completionJan 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis (CRS)Studies 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
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Abd Elaziem Abd Elaziz, Cairo University
- Investigators
- Walaa Abd Elaziem Abd Elaziz Walaa Abd Elaziem Abd Elaziz, Doctoral degree, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616792
- Sponsor's protocol ID
- P.T.REC/012/005254
- Status last verified
- Jun 2024
- First submitted
- 25 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: pre and post assessment measures results of: 1. Sino nasal Outcome Test 22 (SNOT-22) 2. Computerized Tomography Scan:
Publications
da Silva GS, Dos Santos Isoppo K. Therapeutic ultrasound as a treatment for chronic rhinosinusitis: A systematic review. Clin Respir J. 2021 Dec;15(12):1275-1285. doi: 10.1111/crj.13441. Epub 2021 Aug 29.
PubMed 34423908Lee B, Kwon CY, Park MY. Acupuncture for the Treatment of Chronic Rhinosinusitis: A PRISMA-Compliant Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2022 Aug 31;2022:6429836. doi: 10.1155/2022/6429836. eCollection 2022.
PubMed 36091598Naghdi S, Ansari NN, Varedi M, Fathali M, Zarrin M, Kashi-Alashti M, HasanNia F. Use of low-level laser therapy for patients with chronic rhinosinusitis: a single-blind, sham-controlled clinical trial. Lasers Med Sci. 2022 Dec 20;38(1):5. doi: 10.1007/s10103-022-03684-z.
PubMed 36538169
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Phonophoresis Versus Laser Acupuncture on Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT06616792
- Acronym / sponsor ID
- P.T.REC/012/005254
- Conditions
- Chronic Rhinosinusitis (CRS)
- Keywords
- Dexamethasone Phonophoresis, Laser Acupuncture, Chronic Rhinosinusitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 27 Sep 2024 (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 is designed to provide a comprehensive overview of evidence concerning the efficacy and safety of dexamethasone phonophoresis and laser acupuncture for treatment of chronic rhinosinusitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Experimental | –Each participant in this group will receive dexamethasone phonophoresis, US with the use of 0.4% Dexamethasone sodium phosphate gel for phonophoresis. over maxillary and frontal sinuses for 3 sessions per week for one month, in addition to the traditional medication. |
| Group (B) | Experimental | Device: Laser Acupuncture, Other: Traditional medicationEach participant in this group will receive low level laser placed in contact with the skin perpendicular over the body acupoints (LI 4) - (LI 20) - (EX- HN5) - (GV 20) - (GV 24) - (ST3) - (ST 7) in both sides and on (EX-HN3) acupoint, with a duration of 90 sec for each point three times per week for a month., in addition to the traditional medication. |
| Group (C) | Active comparator | Other: Traditional medicationEach participant in this group will receive the traditional medication only. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age range between 30 to 50 years.
- Male and female patients will participate in the study.
- All patients have chronic rhinosinusitis, who are experiencing 12 weeks or longer of 2 or more of the following signs and symptoms:
- mucopurulent drainage (anterior, posterior, or both) nasal obstruction (congestion) facial pain-pressure-fullness, or decreased sense of smell
- All patients enrolled in the study will have their informed consent.
Key exclusion criteria (12 listed)
- Patients with metal implants (pacemakers, dental implants, or any other implants).
- Patients with cancer, pregnancy or impaired vascular circulation.
- Patients who suffer from mental or psychological disorders.
- Patients with any systemic diseases that may interfere with the objectives of the study.
- Patients with long-term use of corticosteroids or immunosuppressive agents.
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 |
|---|---|---|
| Dexamethasone phonophoresisUltrasound therapeutic device with the use of 0.4% Dexamethasone sodium phosphate gel for phonophoresis. | Combination product | – |
| Laser Acupuncturelow level laser therapy placed in contact with the skin perpendicular over the body acupoints (LI 4) - (LI 20) - (EX- HN5) - (GV 20) - (GV 24) - (ST3) - (ST 7) in both sides and on (EX-HN3) acupoint, | Device | Group (B) |
| Traditional medicationEach participant in this group receive the traditional medication. | Other | Group (B), Group (C) |
Primary outcome
Sino nasal Outcome Test 22 (SNOT-22)
Time frame: one month
This is a Quality Of Life Questionnaire specifically designed for sinusitis patient. It consists of 22 item sinus specific question which has to be administered to the patient and the total sum of all the items will be recorded based on the severity of the patient's condition and the scores will be calculated
Computerized Tomography Scan
Time frame: one month
CT scan will be used for assessment of mucosal thickening of maxillary sinuses, which is based on 0-3 system: 0 = clear, 1= mild or moderate mucosal thickening, 2 = severe mucosal thickening, 3 = total opacification
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Results publication: PubMed 34423908da Silva GS, Dos Santos Isoppo K. Therapeutic ultrasound as a treatment for chronic rhinosinusitis: A systematic review. Clin Respir J. 2021 Dec;15(12):1275-1285. doi: 10.1111/crj.13441. Epub 2021 Aug 29.
- Results publication: PubMed 36091598Lee B, Kwon CY, Park MY. Acupuncture for the Treatment of Chronic Rhinosinusitis: A PRISMA-Compliant Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2022 Aug 31;2022:6429836. doi: 10.1155/2022/6429836. eCollection 2022.
- Results publication: PubMed 36538169Naghdi S, Ansari NN, Varedi M, Fathali M, Zarrin M, Kashi-Alashti M, HasanNia F. Use of low-level laser therapy for patients with chronic rhinosinusitis: a single-blind, sham-controlled clinical trial. Lasers Med Sci. 2022 Dec 20;38(1):5. doi: 10.1007/s10103-022-03684-z.
- Individual participant dataSharing planned: Undecided. pre and post assessment measures results of: 1. Sino nasal Outcome Test 22 (SNOT-22) 2. Computerized Tomography Scan:
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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.
Walaa Abd Elaziem Abd Elaziz Walaa Abd Elaziem Abd Elaziz, Doctoral degree principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone phonophoresis, Laser Acupuncture and Traditional medication in people with Chronic Rhinosinusitis (CRS), run by Cairo University at 1 site in Egypt.
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 5 inclusion and 12 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 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Sino nasal Outcome Test 22 (SNOT-22) (time frame: one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06616792, which also lists 3 linked publications.
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 27 Sep 2024.