Physiotherapy Alone, in Combination With Corticosteroid Injection or Wait-and-see for Acute Lateral Epicondylitis in General Practice: a Randomised, Placebo-controlled Study With 12 Months Follow-up
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Treatment Success - Event Rates in Each Group
研究概览
简要总结
The purpose of this study is to compare the clinical effect of physiotherapy alone or combined with corticosteroid injection in the initial treatment of lateral epicondylitis in a primary care setting.
To find the short and long term effect of physiotherapy with Mill's manipulation, deep friction massage and exercise therapy.
To ascertain wether the outcome is influenced by corticosteroid injection, which has been shown to be of benefit alone in the short term?
详细描述
Much has been written about lateral epicondylitis/tennis elbow reflecting the existence of many treatments for the condition. However, there is no consensus as to which treatment gives the best results.
Based on the latest meta-studies and reviews from the Cochrane Library, one may conclude that there is evidence of a short-term effect of topical or per oral NSAIDs. The same is true for manipulation and exercise. Corticosteroid injection has also been shown to have short-term effect, but not beyond 6 weeks. Ultrasound has a possible short-term effect based on one meta-analysis. Extra corporeal shock wave therapy does not seem to be effective. The treatment with acupuncture, orthosis, surgery or long-term NSAIDs has no support in the literature, and it is impossible to draw any conclusions about the effects or absence thereof. In fact, there is scant support for any long-term treatment in the literature.
We have found two studies to be of special interest (see citations below). Both have been done in a primary care setting with one-year follow up. One study compares corticosteroid injection with physical therapy (ultrasound, manipulation and exercise) and a wait-and-see group. The other compares corticosteroid injection with naproxen orally and placebo-medication. Both conclude that corticosteroid injection is a safe and effective treatment as pain-relief during the first 6 weeks, and that the effect of this treatment is better than physical therapy, wait-and-see and naproxen orally within the same time-frame. Physical therapy in one study gives some, but not statistically significantly better long-term (one year) effect than wait-and-see treatment.
There seems to be some indication that corticosteroid injection is a good alternative for the first 6 weeks. We find there is a good reason to investigate the long-term effects of physical therapy. At the same time, it would be interesting to see whether the good initial response from corticosteroid injection may be extended if combined with physiotherapy.
This randomised, placebo-controlled study will be conducted in general practice in the town of Sarpsborg, Ostfold County, Norway including patient aged 18-70 years with pain of recent onset from the lateral part of the elbow. After a treatment-period of 6 weeks, the patient is followed for a total of 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years
- •Pain from the lateral part of the elbow
- •The pain increases on resisted dorsiflexion of the wrist with the elbow extended and the fingers flexed or the pain increases on resisted radial deviation of the wrist or the pain increases on resisted extension of the
排除标准
- •Duration of complaints less than 2 weeks or more than 3 months
- •The tenderness is located within the muscle body itself in the proximal part of the short radial extensors muscle of the wrist (Cyriax type IV)
- •Treatment within the last 12 months for the same condition with corticosteroid injection or physiotherapy
- •Bilateral complaints
- •Previous surgical treatment for lateral epicondylitis
- •Deformities of the elbow (congenital or acquired)
- •Cervical radiculopathy or referred pain from neck or shoulder
- •Previous fractures or tendon ruptures in the elbow
- •Systemic musculoskeletal disease
- •Previous allergic reactions to corticosteroids or lidocaine
- •Contraindications to corticosteroids or NSAIDs:
- •On-going or previous gastro-intestinal bleeding
- •previous ulcer or dyspepsia, severe asthma
- •on-going systemic infection
- •local skin-infection
- •recently vaccinated with live virus
- •coagulopathies
- •systemic lupus erythematodes
- •severe liver- or kidney-disease
- •heart failure
- •use of warfarin or NSAIDS
- •Pregnancy or breast-feeding
- •Fertile females not on effective birth control
- •Psycho-social or other reasons for not being able to participate throughout the study.
研究组 & 干预措施
1
Corticosteroid injection in combination with physical therapy
Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days
干预措施: triamcinolone (Drug)
1
Corticosteroid injection in combination with physical therapy
Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days
干预措施: Lidocaine (Drug)
1
Corticosteroid injection in combination with physical therapy
Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days
干预措施: Physiotherapy (Other)
1
Corticosteroid injection in combination with physical therapy
Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days
干预措施: Naproxen (Drug)
2
Placebo injection in combination with physical therapy
Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days
干预措施: Placebo (Drug)
2
Placebo injection in combination with physical therapy
Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days
干预措施: Lidocaine (Drug)
2
Placebo injection in combination with physical therapy
Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days
干预措施: Physiotherapy (Other)
2
Placebo injection in combination with physical therapy
Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days
干预措施: Naproxen (Drug)
3
Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days
干预措施: Naproxen (Drug)
结局指标
主要结局
Treatment Success - Event Rates in Each Group
时间窗: 6 - 52 weeks
Unadjusted event rates of treatment success, defined as participants rating themselves 'much improved' or 'completely recovered' on a six point scale. Percentage with 99% confidence interval.
次要结局
- Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale)(6 weeks)
- Pain Free Function Index of Everyday Activities(52 weeks)
- Pain-free Grip Strength Ratio(52 weeks)
- Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors(26 weeks)
- Maximum Grip Strength Ratio(52 weeks)
- Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors(52 weeks)
- No Pain on Three Point Likert Scale on Isometric Extension of Third Finger(52 weeks)
- Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).(26 weeks)
- Pain as Recorded by the Study Doctors on a 100 mm VAS-scale(52 weeks)
- Affected Function on a 100 mm VAS-scale as Recorded by the Study Doctors(52 weeks)
- No Pain on Three Point Likert Scale on Dorsiflexion of Wrist(52 weeks)
研究者
Morten Lindbaek
Professor Dr.med
University of Oslo