Prolotherapy for the treatement of chronic lateral epicondylitis

增殖疗法治疗慢性外上髁炎

• 批准号: 7678410
• 负责人: Ronald M. Glick
• 金额: $ 18.56万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-01 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7678410
• 关键词: Acute; Adult; Affect; Articular ligaments; Bilateral; Blinded; Chronic; Future; Individual; Injection of therapeutic agent; Irritants; Manuals; Measures; Musculoskeletal; Musculoskeletal Pain; Needles; Pain; Procedures; Productivity; Questionnaires; Randomized; Research; Safety; Solutions; Steroids; Techniques; Tendon structure; Tennis Elbow; Therapeutic Effect; Work; chronic pain; disability; effective therapy; functional disability; middle age; prolotherapy; public health relevance; randomized placebo controlled trial; response

DESCRIPTION (provided by applicant): 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. Public Health Relevance: Lateral epicondylitis is a common and often disabling condition, most prominently affecting manual laborers and recreational athletes, with chronicity occurring in as many as 50% of individuals. Prolotherapy is a safe and easily administered injection technique that is commonly used to treat musculoskeletal pain, but studies have been limited and inconclusive. This randomized placebo controlled study will explore the possible efficacy of prolotherapy for lateral epicondylitis and determine an optimal control procedure for future prolotherapy research.

描述（由申请人提供）：外侧上con炎（LE）或网球肘是一种常见且经常残疾的状况，影响年轻和中年成年人通常是手动工作者和休闲运动员。它会导致重大的疼痛和残疾，限制工作效率以及个人参与和享受娱乐活动的能力。像许多其他慢性肌肉骨骼状况一样，LE通常对急性治疗产生不完全的反应，从而导致慢性疼痛和残疾。促进疗法（PRT）涉及将刺激性或增生溶液注射到肌腱，韧带和关节中，以治疗慢性肌肉骨骼疼痛。我们将进行3组随机，盲试验，以确定PRT注射在治疗慢性LE时的安全性和功效。此外，我们将寻求确定PRT的任何有益效应的程度是从深针放置而得出的，而不是注射液的特定效果。这项研究的具体目的是：1）确定PRT是否对患有慢性LE的个体是一种安全，耐受性且有效的治疗； 2）确定仅深针放置是否导致治疗效果，而与注射剂无关。为了实现这些目标，我们将使用自评量表，问卷和身体措施来衡量疼痛和残疾的指标。受试者将在随机分组之前对两个因素进行分层：1）单侧与双侧LE； 2）在前6个月内用类固醇治疗。如果有效，与其他两组相比，接受PRT的受试者将显示出更大的疼痛和功能障碍减少。这项研究将通过确定可能是最佳控制状况来指导未来的有关疗法的研究。此外，进一步的研究可以探索负责任何有益作用的机制。 公共卫生相关性：外侧上con炎是一种常见且经常残疾的疾病，最显着影响了体力劳动的劳动者和娱乐运动员，多达50％的人发生了慢性病。 Prolotherapy是一种安全且易于给药的注射技术，通常用于治疗肌肉骨骼疼痛，但研究是有限且尚无定论的。这项随机的安慰剂对照研究将探索促进疗法对外侧上con炎的可能功效，并确定对未来促进疗法研究的最佳控制程序。