Dexamethasone Phonophoresis Versus Laser Acupuncture on Chronic Rhinosinusitis

NCT ID: NCT06616792

Last Updated: 2024-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Rhinosinusitis (CRS)

Keywords

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Dexamethasone Phonophoresis, Laser Acupuncture, Chronic Rhinosinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group (A)

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 Type EXPERIMENTAL

Dexamethasone phonophoresis

Intervention Type COMBINATION_PRODUCT

Ultrasound therapeutic device with the use of 0.4% Dexamethasone sodium phosphate gel for phonophoresis.

Traditional medication

Intervention Type OTHER

Each participant in this group receive the traditional medication.

Group (B)

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.

Group Type EXPERIMENTAL

Laser Acupuncture

Intervention Type DEVICE

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 medication

Intervention Type OTHER

Each participant in this group receive the traditional medication.

Group (C)

Each participant in this group will receive the traditional medication only.

Group Type ACTIVE_COMPARATOR

Traditional medication

Intervention Type OTHER

Each participant in this group receive the traditional medication.

Interventions

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Dexamethasone phonophoresis

Ultrasound therapeutic device with the use of 0.4% Dexamethasone sodium phosphate gel for phonophoresis.

Intervention Type COMBINATION_PRODUCT

Laser Acupuncture

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,

Intervention Type DEVICE

Traditional medication

Each participant in this group receive the traditional medication.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* 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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Walaa Abd Elaziem Abd Elaziz

Walaa Abd Elaziem Abd Elaziz

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Walaa Abd Elaziem Abd Elaziz Walaa Abd Elaziem Abd Elaziz, Doctoral degree

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Faculty of Physical therapy, Cairo University

Dokki, Giza Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 34423908 (View on PubMed)

Lee 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.

Reference Type BACKGROUND
PMID: 36091598 (View on PubMed)

Naghdi 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.

Reference Type BACKGROUND
PMID: 36538169 (View on PubMed)

Other Identifiers

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P.T.REC/012/005254

Identifier Type: -

Identifier Source: org_study_id