A Prospective Evaluation of the Clinical Effectiveness of Perineural Dextrose and Conventional Local Anesthetic Injections in Patients With Symptomatic Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Change in Knee Pain Intensity (Visual Analog Scale [VAS])
研究概览
简要总结
This prospective observational study aims to compare the clinical effectiveness of perineural 5% dextrose injections and perineural local anesthetic injections in patients with symptomatic knee osteoarthritis. Adult patients receiving routine perineural injection therapy will be followed for six months. Pain intensity and functional outcomes will be assessed at baseline and at 1, 3, and 6 months after treatment using validated clinical assessment tools.
详细描述
Knee osteoarthritis is a common degenerative joint disease associated with chronic pain, functional limitation, and reduced quality of life. Various non-surgical treatment modalities have been used to manage symptoms; however, the effectiveness of these treatments may be limited due to the complex pain mechanisms involved in osteoarthritis.
Perineural injection therapy has gained increasing attention as a minimally invasive treatment option targeting neurogenic inflammation around peripheral sensory nerves. Perineural 5% dextrose injection is thought to reduce pain by modulating neurogenic inflammation, while local anesthetic injections are commonly used in clinical practice for symptomatic relief.
This study is designed as a prospective observational cohort study conducted in a routine clinical setting. Patients aged 40 to 65 years with symptomatic knee osteoarthritis who are treated with perineural injections as part of standard care will be included. The choice of injectate (perineural 5% dextrose or perineural local anesthetic) will be determined based on clinical considerations and patient preference; no randomization or protocol-driven assignment will be performed.
Pain severity will be evaluated using the Visual Analog Scale (VAS). Functional status will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Additional clinical parameters, including knee range of motion measured by goniometry and quadriceps muscle strength assessed by manual muscle testing, will also be recorded. Assessments will be performed at baseline, and at 1, 3, and 6 months following treatment.
Clinical outcomes of the two treatment groups will be compared to evaluate changes in pain and functional status over time. The findings of this study are expected to contribute real-world evidence regarding the clinical effectiveness of perineural 5% dextrose and local anesthetic injections in the management of symptomatic knee osteoarthritis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic knee osteoarthritis
- •Clinical/radiological diagnosis
- •Knee pain ≥ 3 months
- •Written informed consent
排除标准
- •Prior knee surgery
- •Recent intra-articular injection
- •Inflammatory rheumatic disease
- •Severe systemic or neurological disease
- •Pregnancy or breastfeeding
研究组 & 干预措施
Perineural 5% Dextrose Group
Patients with symptomatic knee osteoarthritis receiving perineural 5% dextrose injections as part of routine clinical care.
干预措施: Perineural 5% Dextrose Injection (Procedure)
Perineural Local Anesthetic Group
Patients with symptomatic knee osteoarthritis receiving perineural local anesthetic injections as part of routine clinical care.
干预措施: Perineural Local Anesthetic Injection (Procedure)
结局指标
主要结局
Change in Knee Pain Intensity (Visual Analog Scale [VAS])
时间窗: Baseline, 1 month, 3 months, and 6 months
Change in Knee Pain Intensity (Visual Analog Scale \[VAS\]) Change from baseline in knee pain intensity measured using the Visual Analog Scale (VAS), a 100-mm horizontal line anchored at 0 = no pain and 100 = worst imaginable pain; higher scores indicate worse pain.
次要结局
- Change in Knee Range of Motion(Baseline, 1 month, 3 months, and 6 months)
- Change in Quadriceps Muscle Strength(Baseline, 1 month, 3 months, and 6 months)
- Change in Functional Status (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC])(Baseline, 1 month, 3 months, and 6 months)
研究者
Nadide Koca
Principal Investigator, M.D., Physical Medicine and Rehabilitation
Ankara Training and Research Hospital
