Botulinum Toxin Versus Active Strength Training in Treatment of the Lateral Epicondylitis - A Single-Blinded, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Pain, 100 mm visual analogue scale, change from baseline
研究概览
简要总结
The purpose of this study is to compare efficacy, feasibility and cost effectiveness of botulinum toxin type A injections to active nine weeks strength training and stretching program in the treatment of the chronic lateral epicondylitis.
The main hypothesis is that the botulinum toxin type A injections may enable more rapid pain relief while strength training may provide better functional results and less relapses during the follow-up.
详细描述
INTRODUCTION:
Lateral epicondylitis (tennis elbow) is a frequent repetitive stress injury, affecting the common extensor muscles at the lateral humeral epicondyle. Lateral epicondylitis has a well-known spontaneous healing tendency. Still the prevalence of the chronic lateral epicondylitis is 1.4% in working populations causing significant occupational disability and financial burden.
Systematic reviews of the effectiveness of different treatment modalities for lateral epicondylitis present conflicting results. There are no consistent guidelines for management of the prolonged lateral epicondylitis. Progressive strengthening and stretching exercises as well as botulinum toxin type A injections have been suggested to be effective in treatment of chronic cases. However, there are only a few studies comparing different treatment modalities and botulinum toxin treatment have not been included in any of these.
The purpose of this study is to compare efficacy, feasibility and cost effectiveness of the botulinum toxin type A injections to active nine weeks strength training and stretching program in the treatment of the chronic lateral epicondylitis.
The main hypothesis is that the botulinum toxin type A injections may enable more rapid pain relief while strength training may provide better functional results and less relapses during the follow-up.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pain at the lateral side of the elbow over 3 months
- •local tenderness on palpation over the lateral epicondyle
- •positive Mill's sign
- •lateral elbow pain progression on resisted wrist and/or middle finger extension
- •involved in working life
排除标准
- •bilateral symptoms or simultaneous medial epicondylitis
- •verified or suspected cervical radiculopathy or affected limb neuropathy
- •congenital or acquired deformities of the elbow
- •previous surgery of the elbow
- •infection, dislocation, tendon ruptures, or fractures in the area
- •systemic musculoskeletal or neurological disorders, incl. rheumatic diseases and fibromyalgia
- •allergy, antibodies or other contraindications for botulinum toxin
- •severe depression, chronic pain syndrome or somatisation disorder
- •ongoing retirement process
- •pregnancy or breastfeeding
- •current participation in other clinical trials
研究组 & 干预措施
Active strength training and stretching
Active strength training and stretching
干预措施: Active strength training and stretching (Behavioral)
Botulinum toxin type A injections
Botulinum toxin type A injections
干预措施: Botulinum toxin type A (Botox®, Allergan) (Drug)
结局指标
主要结局
Pain, 100 mm visual analogue scale, change from baseline
时间窗: 0, 6, 13, 26, 39, 52 weeks
Grip strength (pain free and maximal), hydraulic hand dynamometer, change from baseline
时间窗: 0, 6, 13, 26, 39, 52 weeks
次要结局
- Days in sick leave(0, 6, 13, 26, 39, 52 weeks)
- Treatment adverse effects(0, 6, 13, 26, 39, 52 weeks)
- Isometric wrist extension and flexion strength, digital hanging scale with rigid bench frame, change from baseline(0, 6, 13, 26, 39, 52 weeks)
- Economic evaluation of interventions, direct and indirect costs(0, 6, 13, 26, 39, 52 weeks)
- General improvement, 7-point Likert scale(0, 6, 13, 26, 39, 52 weeks)
- Experienced disability, 100 mm visual analogue scale, change from baseline(0, 6, 13, 26, 39, 52 weeks)
- Experienced forearm pain and disability, The Patient-Rated Tennis Elbow Evaluation (PRTEE)(0, 6, 13, 26, 39, 52 weeks)
研究者
Aki Vainionpaa
Specialist in Physical Medicine and Rehabilitation
Seinajoki Central Hospital