Prolotherapy vs. Corticosteroid Therapy for the Treatment of Lateral Epicondylitis of the Elbow, A Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- 10 cm Visual Analogue Scale (VAS)
研究概览
简要总结
The purpose of the research is to study the effects of two different injection therapies for the treatment of lateral epicondylitis (tennis elbow). Specifically, we will look at which therapy provides better short and long-term relief of pain, which treatment allows better function and less disability, and which treatment gives back better strength in the affected hand. Each subject will receive only one of the two treatments. Although both of these treatments are usually very well tolerated, it is important to make this comparison because it is believed that one of these therapies may have better long term effectiveness, with a lower cost, and smaller number of potential side effects.
详细描述
Lateral Epicondylitis or tennis elbow is one of the most commonly diagnosed upper-extremity musculoskeletal disorders seen in general practice. It is characterized by painful enthesopathy or tendinosis of the common extensor tendon at the outer region of the elbow at the fibro-osseous junction. "Although tennis elbow" was originally made note of in the medical literature by Runge in 1873, the term derives from "Lawn Tennis Arm" later described by Morris in 1882.
Traditionally, lateral epicondylitis causes characteristic pain in the lateral elbow region and is often associated with significant morbidity. It occurs most commonly in individuals between 40 and 50 years and equally affects both men and women. The dominant arm is involved in 75% of patients. While other etiologies have been proposed, including radial nerve entrapment, it is generally agreed that tennis elbow is the result of repetitive mechanical micro-trauma and overuse, but many cases have no biomechanical association, nor vocational or avocational correlation. This condition is often brought about by repeated flexion and extension of the wrist or by a direct injury to the epicondyle or elbow. However, most patients are unable to recall or to identify a precipitating event. The average duration of an episode of lateral epicondylitis is 6 to 24 months, and 10% to 30% of cases result in work absenteeism, leading to a high loss of productivity. Numerous treatment options have been described for lateral epicondylitis. Most cases are managed in primary care settings, and although there are more than forty possible treatments, there is still a lack of consensus about optimal therapeutic management. Moreover, most of these treatments lack sound scientific evidence.
The preferred method of treatment of lateral epicondylitis often involves corticosteroid injections with or without the addition of local anesthetic. In general, injection of local corticosteroids is commonly used to reduce inflammation in patients with chronic tendinopathies such as lateral epicondylitis. However, since inflammation is not necessarily a major feature in this lesion, and if present, may present a vital component of the healing response. Inhibiting this process may result in a suboptimal outcome. Thereby, despite their popularity, the rationale for use of corticosteroids is controversial and the evidence for long-term benefit lacks. Likewise, potential side effects such as infection, tissue atrophy, pigmentation changes, hyperglycemia, etc. do exist. Moreover, many of the recommendations for the use of corticosteroid injections are anecdotal. In a review by Labelle et al, it was concluded that there was insufficient scientific evidence to support the use of corticosteroids injections for lateral epicondylitis. Assendelft et al came to similar conclusions in his review when he found that existing evidence on corticosteroid injections for lateral epicondylitis was unclear and that questions regarding the optimal timing, dosage, injection, technique, and injection volume remained unanswered.
Prolotherapy, though not as yet extensively studied, is another emerging therapy presenting as an alternative to corticosteroid injection for the treatment of lateral epicondylitis. It continues to rise in popularity, especially by clinicians who commonly treat musculoskeletal injuries. With its early origins dating back to the time of Hippocrates, prolotherapy is defined as the iatrogenic stimulation of wound healing and tissue repair process through the injection of an irritant solution into damaged ligaments, tendons, and joints thus encouraging their healing and repair.
Essentially, this occurs as a result of a localized inflammatory reaction with stimulation of rounds cell infiltration with resultant collagen synthesis, and formation of firm permanent fibrous tissue and bone. The new collagen runs parallel to existing ligaments and tendons and has a linear orientation, resulting in ultimate strengthening and stabilization of the ligament, tendon, or joint with subsequent reduction of pain. It is generally safe and very well tolerated and has been used throughout the western medical community for over 50 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age criteria >18yo, <75yo, history of pain > 3 months, < 2 years; pain on resisted extension of wrist and/or middle finger test, (resisted extension of middle finger at the MCP joint)
- •local tenderness to palpation at the lateral epicondyle
- •subject can read and write in English.
排除标准
- •history of steroid injections within 6 months prior to intervention;
- •other arm/forearm pathology such as radial nerve compression; pregnancy/nursing;
- •known thrombocytopenia, coagulopathy, or bleeding diathesis; history of diffuse pain syndrome;
- •history of Inflammatory Arthropathy;
- •Workman's Compensation (RSI) > 2 years; patients with litigation pending/planned; patients who are unable to return for F/U;
- •intolerance/allergy to local anesthetics or injection corticosteroids; fear of needles; untreated depression;
- •history of narcotic use for pain management greater than 1 month or history of narcotic abuse problem.
结局指标
主要结局
10 cm Visual Analogue Scale (VAS)
Disabilities of the Arm, Shoulder, and Hand (DASH)
次要结局
- Grip Strength
