The Effect of High Volume Injection With and Without Steroid in Chronic Achilles Tendinopathy: A Randomized Double Blinded Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- The Victorian Institute of Sports Assessment-Achilles questionnaire (VISA-A score)
研究概览
简要总结
The aim of the study is to determine the effect of steroid in High Volume Injection (HVI) compared to HVI without steroid (volume effect) in functional outcomes and ultrasound tendon thickness and Color Doppler activity in chronic Achilles tendinopathy (AT).
Healthy males with AT will be randomly assigned to either 1) HVI with steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 ml saline) or 2) HVI without steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride followed by 40 ml saline).
All subjects will perform a 12-wk eccentric training program with further eccentric training 3 times per week from week 12 to week 24.
Clinical examinations and ultrasound will be performed at baseline (before treatment) with follow-ups after 6 weeks, 12 weeks and again after 24 weeks prior to baseline to see any possible changes and differences between the two groups.
详细描述
Chronic Achilles tendinopathy (AT) is a common and impairing disorder. High Volume Injection therapy (HVI) seems to show promising results in Achilles tendinopathy (AT). HVI consist of a large volume of saline with a small amount of steroid. Steroid injections is widely used for treating tendinopathy but we know from the literature that steroid injections only gives a fast and short term pain reduction in tendinopathy where HVI seems to show both a short term and a more prolonged effect which could contribute the volume effect (saline).
Aim: The aim of the study is to determine the effect of steroid in High Volume Injection (HVI) compared to HVI without steroid (volume effect) in functional outcomes and ultrasound tendon thickness and Color Doppler activity in chronic Achilles tendinopathy (AT).
Materials and methods
Healthy males (21-59 years; n=60) with AT is randomly assigned to either 1) HVI with steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 mls saline) or 2) HVI without steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride followed by 40 mls saline) The injections will be performed under ultrasound guidance. All subjects will undergo a 12 week eccentric training program and the subjects will continue eccentric training 3 times per week from week 12 to week 24.
Clinical effects will be assessed as changes in symptoms and pain (VISA-A and VAS score), tendon ultrasound thickness and color Doppler. All outcome measures will be recorded at baseline and again at 6 weeks, 12 weeks and 24 weeks follow-up.
Statistics: All data will be analyzed in SigmaPlot v11 using two-way repeated measures ANOVA with Student-Newman-Keuls Post-hoc test. This is used to see changes over time in all groups (time effect) and differences between groups within time-points (group effect). All data will be presented as mean ± SEM time.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Clinically and ultrasound diagnosed unilateral mid-tendinous Achilles tendinopathy.
- •Symptoms > 3 month
排除标准
- •Bilateral achilles tendinopathy
- •Insertional tendinopathy
- •Steroid injections < 12 month
- •Diabetes or cardiovascular disease
- •Treatment with fluoroquinolones < 6 month
研究组 & 干预措施
High Volume injection (HVI) with corticosteroid
- 10 mls 0.5% bupivacaine hydrochloride
- 20 mg of Depomedrol (40 mg/ml methylprednisolonacetat)
- 40 mls saline (NaCl)
HVI with corticosteroid is injected one time at baseline and compared to HVI without corticosteroid.
干预措施: High Volume injection without corticosteroid (Drug)
High Volume injection (HVI) without corticosteroid
- 10 mls 0.5% bupivacaine hydrochloride
- 40 mls saline (NaCl)
HVI with corticosteroid is injected one time at baseline and compared to HVI with corticosteroid.
干预措施: High Volume injection with corticosteroid (Drug)
结局指标
主要结局
The Victorian Institute of Sports Assessment-Achilles questionnaire (VISA-A score)
时间窗: Baseline, 6 weeks, 12 weeks and 24 weeks
Changes in VISA-A score over time between the two groups
次要结局
- The Visual analogue pain scale (VAS score)(Baseline, 6 weeks, 12 weeks and 24 weeks)
- Ultrasound tendon thickness and color Doppler(Baseline, 6 weeks, 12 weeks and 24 weeks)
研究者
Anders Ploug Boesen
MD, PhD
Bispebjerg Hospital