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Efficacy of Bee Venom Phonophoresis in Treating Chronic Sinusitis:

ConditionsChronic SinusitisAcute SinusitisRhinosinusitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSinai University

About this trial

This double-blind, randomized controlled trial (BEE-SONIC) aims to evaluate the efficacy of bee venom phonophoresis in the treatment of chronic sinusitis. Thirty adult patients (aged 18-65 years) with clinically diagnosed chronic or acute sinusitis will be randomized into two groups: the intervention group will receive bee venom phonophoresis using low-to-moderate intensity ultrasound, while the control group will receive standard care consisting of oral decongestants and saline nasal irrigation. Primary outcomes include improvement in symptom severity (SNOT-22, Visual Analog Scale) and quality of life (SF-33). Secondary outcomes include reduction in facial pain, nasal congestion, and patient satisfaction. Data will be collected at baseline, midpoint, and post-intervention, and analyzed using paired t-tests and ANOVA. The study has received ethics approval from Sinai University's Human Research Ethics Committee, and informed consent will be obtained from all participants.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 to 65 years.

Clinical diagnosis of chronic sinusitis (symptoms ≥ 12 weeks) or acute sinusitis confirmed by an otolaryngologist.

Willing and able to provide written informed consent.

Disqualifiers

Known allergy or hypersensitivity to bee venom or bee products.

Skin conditions (e.g., eczema, dermatitis, open wounds) over the area of ultrasound application.

Severe comorbid medical conditions (e.g., uncontrolled asthma, autoimmune disease, malignancy).

Pregnancy or breastfeeding.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bee Venom Phonophoresis

    Device

    Ultrasound therapy device

  • Standard Care (oral decongestants + saline nasal irrigation)

    Drug

    (oral decongestants + saline nasal irrigation)

  • Bee Venom Phonophoresis

    Biological/Vaccine

    bee venom extract prepared for topical use)

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Bee Venom PhonophoresisExperimental treatment 2 interventions
Group B: Standard CarePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Sinusitis Symptom Severity

Measured using the Sino-Nasal Outcome Test (SNOT-22) questionnaire, which assesses nasal, facial, and functional symptoms on a 0-5 Likert scale (total score range: 0-110; higher scores indicate worse symptoms).

Time frame
Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).
2

Change in Pain Intensity

Measured using a Visual Analog Scale (VAS) for facial pain, ranging from 0 (no pain) to 10 (worst imaginable pain).

Time frame
Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).

Secondary outcomes

1

Change in Quality of Life

Measured using the SF-36 questionnaire, which assesses physical, emotional, and social health domains.

Time frame
Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sinai University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: