Phonophoresis With Bee Venom: Evaluating Its Efficacy in Managing Pain and Enhancing Mobility in Knee Osteoarthritis Patients
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 Pain Intensity
研究概览
简要总结
Brief Summary:
This single-blind, randomized controlled trial will investigate the efficacy of bee venom phonophoresis in managing pain and improving mobility in patients with knee osteoarthritis. Thirty adults aged 40-75 years with clinically and radiographically confirmed knee osteoarthritis will be randomly assigned to receive either bee venom phonophoresis or placebo phonophoresis with a neutral gel. Ultrasound parameters will be standardized for all participants.
Primary outcomes are pain reduction, measured by the Visual Analog Scale (VAS), and functional mobility, assessed by the Timed Up and Go (TUG) test. The secondary outcome is walking endurance, measured by the Six-Minute Walk Test (6MWT). Assessments will be conducted at baseline and post-intervention.
The study is designed to determine whether bee venom phonophoresis offers greater clinical benefit compared to placebo phonophoresis, potentially providing a non-invasive, adjunctive treatment option for knee osteoarthritis. Ethical approval has been obtained from the Faculty of Physical Therapy, Sinai University, and all participants will provide written informed consent.
详细描述
Detailed Description:
Knee osteoarthritis (OA) is a chronic, degenerative joint disease characterized by cartilage loss, joint space narrowing, pain, stiffness, and functional impairment. It is a leading cause of disability worldwide, particularly among older adults. Conventional management includes pharmacologic interventions such as oral analgesics and nonsteroidal anti-inflammatory drugs, and non-pharmacologic approaches such as exercise therapy and physiotherapy. However, these treatments may not provide adequate symptom relief and can be associated with side effects, prompting the search for alternative or adjunctive therapies.
Phonophoresis, an ultrasound-based technique that enhances transdermal drug delivery, has been investigated as a non-invasive intervention for musculoskeletal pain management. Bee venom, used in traditional medicine for inflammatory and arthritic conditions, possesses anti-inflammatory, analgesic, and immunomodulatory properties. Combining bee venom with phonophoresis may enhance penetration into periarticular tissues, potentially improving clinical outcomes in OA patients.
This single-blind, randomized controlled trial will enroll 30 adults aged 40-75 years with clinically and radiographically confirmed knee osteoarthritis. Participants will be randomly allocated to one of two groups:
Experimental group: Bee venom phonophoresis using standardized ultrasound parameters (frequency, intensity, duration).
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
Single Blind
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-75 years
- •Clinically and radiographically confirmed knee osteoarthritis
- •Moderate to severe pain (VAS ≥ 4)
- •Willingness to provide informed consent
排除标准
- •Allergy to bee products or topical agents used in the study
- •Knee surgery or trauma in the past year
- •Intra-articular injection in the past 6 months
- •Other musculoskeletal or systemic conditions affecting the knees (e.g., rheumatoid arthritis)
- •Pregnancy or contraindication to ultrasound therapy
研究组 & 干预措施
Bee Venom Phonophoresis
Participants receive bee venom phonophoresis therapy applied to the affected knee(s) using standardized ultrasound parameters. Bee venom topical preparation will be mixed with ultrasound coupling gel and applied to the treatment area. Ultrasound will be delivered at a standardized frequency, intensity, and duration determined before study commencement.
干预措施: Ultrasound therapy unit (Device)
Bee Venom Phonophoresis
Participants receive bee venom phonophoresis therapy applied to the affected knee(s) using standardized ultrasound parameters. Bee venom topical preparation will be mixed with ultrasound coupling gel and applied to the treatment area. Ultrasound will be delivered at a standardized frequency, intensity, and duration determined before study commencement.
干预措施: Bee venom topical preparation (for phonophoresis) (Biological)
Control - Placebo Phonophoresis
Participants receive placebo phonophoresis using the same ultrasound parameters as the experimental group, but with a neutral coupling gel that does not contain bee venom. This ensures the same patient experience without the active bee venom component.
干预措施: Ultrasound therapy unit (Device)
结局指标
主要结局
Change in Pain Intensity
时间窗: Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).
Measured using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity.
Change in Functional Mobility
时间窗: Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).
Measured using the Timed Up and Go (TUG) test, which records the time (in seconds) taken for a participant to stand up from a chair, walk 3 meters, turn, return, and sit down. Lower times indicate better mobility.
次要结局
- Change in Walking Endurance(Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).)
研究者
Amany Gomaa Atiaa
lecturer
Sinai University