Efficacy of Bee Venom Phonophoresis in Treating Chronic Sinusitis: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Sinusitis Symptom Severity
研究概览
简要总结
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.
详细描述
Chronic sinusitis is a prevalent condition characterized by persistent inflammation of the paranasal sinuses, often resulting in nasal congestion, facial pain, and reduced quality of life. Conventional treatments, including antibiotics, nasal corticosteroids, and decongestants, may provide limited relief and can be associated with adverse effects. Bee venom possesses anti-inflammatory and analgesic properties, while phonophoresis - the use of ultrasound to enhance transdermal drug delivery - can facilitate deeper tissue penetration of therapeutic agents. Combining bee venom with phonophoresis may represent a novel, non-invasive treatment strategy for chronic sinusitis.
This randomized, double-blind, controlled clinical trial (BEE-SONIC) will enroll 30 adult participants aged 18-65 years with clinically diagnosed chronic or acute sinusitis. Participants will be randomly assigned to one of two groups: the intervention group will receive bee venom phonophoresis three times per week for the study duration, and the control group will receive standard care comprising oral decongestants and saline nasal irrigation. Ultrasound parameters for the intervention will be set at a frequency of 1 MHz and low-to-moderate intensity, with each sinus treated for 5-10 minutes per session.
The primary outcome measures are changes in symptom severity assessed by the Sino-Nasal Outcome Test (SNOT-22) and Visual Analog Scale (VAS) for pain, as well as quality of life measured by the SF-33 questionnaire. Secondary outcomes include reductions in facial pain and nasal congestion, and patient satisfaction with the treatment. Data will be collected at baseline, mid-intervention, and post-intervention. Statistical analysis will include descriptive statistics, paired t-tests, and ANOVA, with a significance threshold set at p < 0.05.
Ethics approval has been obtained from Sinai University's Human Research Ethics Committee, and all participants will provide written informed consent prior to study enrollment. Confidentiality will be maintained throughout the trial, and findings will be disseminated through peer-reviewed publications and conference presentations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Double Blind (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Use of systemic corticosteroids, antibiotics, or other medications that may significantly alter sinusitis symptoms within 4 weeks prior to enrollment.
- •Participation in another clinical trial within the past 30 days.
研究组 & 干预措施
Standard Care
Participants receive standard medical treatment for sinusitis, consisting of oral decongestants and saline nasal irrigation, according to local clinical guidelines.
干预措施: Standard Care (oral decongestants + saline nasal irrigation) (Drug)
Bee Venom Phonophoresis
Participants receive bee venom phonophoresis therapy three times per week for the study duration. Ultrasound parameters set at 1 MHz frequency, low-to-moderate intensity, applied in circular or linear motion for 5-10 minutes per sinus. Bee venom is mixed with ultrasound coupling gel and applied to targeted sinus areas.
Intervention Name: Bee Venom Phonophoresis
干预措施: Bee Venom Phonophoresis (Biological)
结局指标
主要结局
Change in Sinusitis Symptom Severity
时间窗: Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).
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).
Change in Pain Intensity
时间窗: Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).
Measured using a Visual Analog Scale (VAS) for facial pain, ranging from 0 (no pain) to 10 (worst imaginable pain).
次要结局
- Change in Quality of Life(Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).)
研究者
Amany Gomaa Atiaa
lecturer
Sinai University