Prolotherapy for the Treatment of Chronic Lateral Epicondylitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- McGill Pain Questionnaire
研究概览
简要总结
Lateral epicondylitis (LE), or tennis elbow, is a common and often disabling condition affecting young and middle-aged adults-most commonly manual workers and recreational athletes. It results in significant pain and disability, limiting work productivity and an individual's ability to participate in and enjoy recreational activities. Like many other chronic musculoskeletal conditions LE often shows an incomplete response to acute treatments, leading to chronic pain and disability. Prolotherapy (PrT) involves the injection of an irritant or proliferant solution into tendons, ligaments, and joints to treat chronic musculoskeletal pain. We will be conducting a 3-group randomized, blinded trial to determine the safety and efficacy of PrT injections in the treatment of chronic LE. Additionally, we will seek to determine to what extent any beneficial effect of PrT is derived from deep needle placement vs. a specific effect of the injectate. The specific aims for this study are: 1) to determine if PrT is a safe, well-tolerated, and effective treatment for individuals with chronic LE; and 2) to determine whether the deep needle placement alone is responsible for the therapeutic effect, independent of injectate. In order to accomplish these aims, we will measure indicators of pain and disability using self-rating scales, questionnaires and physical measures. Subjects will be stratified prior to randomization on two factors: 1) unilateral vs. bilateral LE; and 2) treatment with steroids within the prior 6 months. If effective, subjects receiving PrT will show greater reduction of pain and functional impairment compared with the other two groups. This research will guide future studies on prolotherapy by determining what may be the best control condition. Additionally, further studies may explore the mechanism responsible for any beneficial effect.
详细描述
Same
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Ages 18-65, as younger individuals are more likely to have other developmental conditions and older individuals are more likely to have a significant arthritic component to their elbow pain;
- •Ability to speak, read, and write English;
- •Unilateral or bilateral lateral elbow pain associated with findings on exam consistent with LE and absence of other conditions that can mimic LE such as radial tunnel syndrome.
- •Functional impairment, due to the diagnosis of LE, with a Nirschl Pain Phase Scale (NPPS) rating of Phase 4 or higher.
排除标准
- •Other conditions that result in significant impairment in upper extremity function such as fibromyalgia, rotator cuff tendonitis, cervical radiculopathy, or carpal tunnel syndrome;
- •Prior surgery of the involved elbow;
- •Known allergy to lidocaine or dextrose;
- •Presence of an autoimmune condition such as rheumatoid arthritis, given that a possible immune mechanism is hypothesized for PrT.
- •Presence of known immune dysfunction, such as with HIV/AIDS, as it might raise the risk for development of infection from injections;
- •Ongoing treatment with systemic corticosteroids or immunosuppressant medications, as they may block a potential immune mechanism of the PrT and increase the risk for infection;
- •Active diagnosis of malignancy anywhere in the body, given potential of any concurrent immune dysfunction to impact on the response to PrT;
- •Treatment with any anticoagulant medication beyond 1 aspirin per day, given the potential to increase bleeding or bruising associated with injections;
- •Presence of a coagulopathy, given the potential to increase bleeding or bruising associated with injections;
- •Pregnancy-as there is no research documenting safety of PrT during pregnancy;
- •Medical necessity for taking ongoing nonsteroidal anti-inflammatory medication, beyond 1 aspirin per day for cardiac prevention, as this may diminish the effect of PrT;
- •Corticosteroid injection within the 6 weeks prior to entry into the study, as this may diminish the effect of the PrT.
- •Prior treatment with PrT for any condition, as this may impact on blinding.
研究组 & 干预措施
Group 1-Prolotherapy
Deep injection with 15% dextrose in lidocaine
干预措施: Prolotherapy (Drug)
Group 2-Deep Saline/Lidocaine
Deep injection with saline/lidocaine
干预措施: Placebo (Procedure)
Group 3-Superficial Saline/lidocaine
Superficial injection with saline/lidocaine
干预措施: Placebo (Procedure)
结局指标
主要结局
McGill Pain Questionnaire
时间窗: 6 weeks and 12 weeks post intervention
This is a pain severity rating. 15 adjectival descriptors of pain are scored on a 0-3 scale for a total score of 0-45 with a high score reflecting greater pain severity.
次要结局
- Grip Strength(6 weeks and 12 weeks post-intervention)
- Pain Threshold on Dolorimetry(6 and 12 weeks post-intervention)
- Nirschl Pain Phase Scale(6 and 12 weeks post-intervention)
- QuickDASH(6 weeks and 12 weeks post-intervention)
研究者
Ronald M. Glick
Assistant Professor
University of Pittsburgh