Treatment of Lateral Epicondylitis With Platelet-Rich Plasma Versus Saline: A Double-Blinded Randomized Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 主要终点
- Ultrasound tendon
研究概览
简要总结
Lateral epicondylitis (LE), also known as tennis elbow, has an estimated prevalence in the general population of 1% to 3%, peaking at age 45 years to 54 years and affect both men and women equally. A randomised controlled trial published in The Lancet showed that 83% of the patients suffering from LE of more than 6 weeks duration on wait-and-see policy recovered only after 1 year without any therapeutic interventions. The costs associated with LE is substantial as patients not only incur hefty healthcare costs but also lose their productivity owing to their long recovery period.
Currently, there is a paucity of evidence worldwide for the efficacy of PRP injections compared to control in LE. This randomised controlled trial aims to compare the efficacy of PRP versus placebo (saline) injections in adults with LE.
详细描述
The pathogenesis of LE was initially believed to be a generalised inflammatory process. However, in 1979, the pathology was better understood as invading immature fibroblasts disorganizing the normal collagen architecture of the elbow, associated with immature vascular responses to cellular repair. There is a variety of treatment modalities available for LE, varying from watchful waiting without any therapeutic interventions, pharmaceutical methods such as prescribing non-steroidal anti-inflammatory drugs, physiotherapy such as encouraging bracing and exercise, injections, and surgical modalities once non-surgical options fail.
For many years, injection with glucocorticoids has remained the mainstay of treatment. However, several studies have proven that the effects of corticosteroid injections do not seem to last in the long-term, amongst which a trial published in The Lancet showed that long-term differences at 52 weeks between injections and physiotherapy was significantly in favour of physiotherapy. Recently, many studies worldwide have demonstrated that platelet-rich-plasma (PRP) stimulates cartilage repair by actively secreting growth factors which activate cell proliferation and differentiation thereby promoting tissue regeneration. It has been postulated that PRP stimulates repair mechanisms within tendons and hence promote tendon healing.
However, there is a paucity of evidence worldwide for the efficacy of PRP injections compared to control in LE. Currently, PRP treatment is not formally recognized as a treatment modality for LE in Singapore, with the accepted indications for PRP treatment being limited to non-surgical treatment of acute muscle and ligamentous injuries, and the biological augmentation of acute Achilles tendon repairs.
This randomised controlled trial aims to compare the efficacy of PRP versus placebo (saline) injections in adults with LE.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Both the patients and the outcome assessor will be blinded in this trial.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of age >21 years old
- •History of chronic pain on the lateral side of the elbow and pain on lateral epicondyle on direct palpation and resisted dorsiflexion of the wrist for more than 3 months
- •Ability of patients to provide informed consent
排除标准
- •Previous tennis elbow surgery to affected elbow
- •Previous corticosteroid injections to affected elbow
- •Concurrent complementary and alternative medicine (CAM) treatments e.g. acupuncture
- •Inflammatory diseases / infection / fracture / trauma
- •Neck pain on ipsilateral side
- •Chronic pain syndromes
- •Malignancies
- •Pregnant or lactating females
- •Consistent use of NSAIDs within 48 hours of procedure
- •Systemic use of corticosteroids within 2 weeks
- •History of anemia, any blood disorders, hypothyroidism
结局指标
主要结局
Ultrasound tendon
时间窗: 6 months
Ultrasonographic changes in tendon thickness and color Doppler activity will be recorded
Visual analog scale (VAS) pain with contraction of extensor carpi radialis brevis and extensor digitorum communis
时间窗: 6 months
Rated from 0 (no pain) to 5 (extremely pain)
Patient-Related Tennis Elbow Evaluation (PRTEE) functional disability
时间窗: 6 months
Rates from 0 (no difficulty) to 10 (unable to do) on specific activities and usual activities. Specific activities include turning doorknob or key, carrying grocery bag or briefcase by handle, lifting full coffee cup or glass of milk to mouth, opening jars, pulling up pants, wringing out washcloths or wet towels. Usual activities include personal activities (dressing, washing), household work (cleaning, maintenance), work (job), recreational or sporting activities.
Visual analog scale (VAS) pain with resisted wrist extension
时间窗: 6 months
Rated from 0 (no pain) to 5 (extremely pain)
Patient-Related Tennis Elbow Evaluation (PRTEE) pain in affected arm
时间窗: 6 months
Rates pain from 0 (no pain) to 10 (worst imaginable) for at rest, doing task with repeated arm movement, carrying plastic bag of groceries, when pain was least, when pain was worst
次要结局
未报告次要终点
研究者
Kenon Chua Ser
Orthopaedic Surgery Registrar
Singapore General Hospital