Dexamethasone Phonophoresis Versus Laser Acupuncture on Chronic Rhinosinusitis

Cairo University (CU)

Status: Invitation-only

Conditions: Chronic Rhinosinusitis (CRS)

Treatments: Device: Laser Acupuncture; Other: Traditional medication; Combination Product: Dexamethasone phonophoresis

Study type: Interventional

Funder types: Other

Identifiers

NCT06616792

P.T.REC/012/005254

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Group (A)

Experimental group

Description:

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.

Treatment:

Combination Product: Dexamethasone phonophoresis

Other: Traditional medication

Group (B)

Experimental group

Description:

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.

Treatment:

Other: Traditional medication

Device: Laser Acupuncture

Group (C)

Active Comparator group

Description:

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

Treatment:

Other: Traditional medication