Achilles Tendinopathy Treated With Heavy Slow Resistance Training Supplemented With Injection of Glucocorticosteroid or Local Anaesthetic.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- VISA-A score
研究概览
简要总结
The purpose of this study is to compare in a randomized double blinded controlled trial the effect of heavy slow resistance exercises combined with ultrasound guided injections with local anesthetic with or without glucocorticosteroid in patients with achilles tendinopathy.
详细描述
Achilles tendinopathy is a common and often longlasting condition especially in a sports population. The highest incidence is seen in sports involving running and jumping.
As the primary treatment eccentric exercises is recommended and 60-90% will benefit by that. Other studies have shown equal effect of stretching exercises. In a new study heavy slow resistance exercises has proven effective in achilles tendinopathy and the best treatment in lig.patellae tendinopathy.
Injection with glucocorticosteroid is often used in the daily clinic, though inflammation is rarely found. Fredberg 2004 found a good short term effect of glucocorticosteroid injection in an RCT, but no effect in the long term, which the investigators explained by an aggressive rehabilitation with running after a few days. Even though 60-90% will benefit from exercises in efficacy studies, a recent pragmatic effectiveness study by Weetke 2015 found that only 26% did benefit from training alone, but if supplemented by need with 1-3 injections of glucocorticosteroid 76% achieved excellent or good result.
To our knowledge no randomized clinical trials have investigated the combined effect of training and injections. The hypothesis of this study is, that training and slowly progressive rehabilitation combined with glucocorticosteroid injections will have better effect than the same training and rehabilitation combined with injections of local anesthetic.
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
- Quadruple (Participant, Care Provider, 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
- •Midsubstance pain in the achilles tendon
- •Symptoms for at least 3 months
- •Ultrasound scanning at the first visit shows thickness of the achilles tendon above 7 mm or 20% thicker than the contralateral.
- •Patient can read and understand danish
排除标准
- •Earlier operations in the foot and leg, that is judged to complicate training
- •known arthritis.
- •known diabetes
- •Leg ulcerations or infections in the foot.
- •Judged unable to comply with the training protocol.
- •Daily use of pain killers
- •Glucocorticosteroid injection to the diseased achilles tendon within the last 6 months.
- •Earlier allergic reactions to glucocorticosteroid or local anesthetic.
- •Pregnancy or planning to become pregnant
- •BMI above 30.
研究组 & 干预措施
Training and glucocorticosteroid
Patients are instructed to carry out strengthening exercises for the diseased achilles tendon 3 times a week. Physiotherapist will instruct all patients in these heavy slow resistance exercises. First time one week after the first injection, and then every month.
All patients are informed to a reduction in running and jumping sports for the first 3 months, thereafter slowly progressing to normal sports activity.
Ultrasound guided injection with glucocorticosteroid: 1ml Lidocain 5 mg/ml and 1 ml methylprednisolone 40mg/ml in Kagers triangle underneath the thickest part of the achilles tendon. Injection is given every months until the tendon pain is markedly diminished (max 3 injections).
干预措施: Reduction in running and jumping (Behavioral)
Training and glucocorticosteroid
Patients are instructed to carry out strengthening exercises for the diseased achilles tendon 3 times a week. Physiotherapist will instruct all patients in these heavy slow resistance exercises. First time one week after the first injection, and then every month.
All patients are informed to a reduction in running and jumping sports for the first 3 months, thereafter slowly progressing to normal sports activity.
Ultrasound guided injection with glucocorticosteroid: 1ml Lidocain 5 mg/ml and 1 ml methylprednisolone 40mg/ml in Kagers triangle underneath the thickest part of the achilles tendon. Injection is given every months until the tendon pain is markedly diminished (max 3 injections).
干预措施: Training (Other)
Training and glucocorticosteroid
Patients are instructed to carry out strengthening exercises for the diseased achilles tendon 3 times a week. Physiotherapist will instruct all patients in these heavy slow resistance exercises. First time one week after the first injection, and then every month.
All patients are informed to a reduction in running and jumping sports for the first 3 months, thereafter slowly progressing to normal sports activity.
Ultrasound guided injection with glucocorticosteroid: 1ml Lidocain 5 mg/ml and 1 ml methylprednisolone 40mg/ml in Kagers triangle underneath the thickest part of the achilles tendon. Injection is given every months until the tendon pain is markedly diminished (max 3 injections).
干预措施: Ultrasound guided injection with Glucocorticosteroid (Drug)
Training and local anesthetic
Patients are instructed to carry out strengthening exercises for the diseased achilles tendon 3 times a week. Physiotherapist will instruct all patients in these heavy slow resistance exercises. First time one week after the first injection, and then every month.
All patients are informed to a reduction in running and jumping sports for the first 3 months, thereafter slowly progressing to normal sports activity.
Ultrasound guided injection with local anaestethic: 1ml Lidocain 5 mg/ml and 1 ml intralipid (for blinding) in Kagers triangle underneath the thickest part of the achilles tendon. Injection is given every months until the tendon pain is markedly diminished (max 3 injections).
干预措施: Reduction in running and jumping (Behavioral)
Training and local anesthetic
Patients are instructed to carry out strengthening exercises for the diseased achilles tendon 3 times a week. Physiotherapist will instruct all patients in these heavy slow resistance exercises. First time one week after the first injection, and then every month.
All patients are informed to a reduction in running and jumping sports for the first 3 months, thereafter slowly progressing to normal sports activity.
Ultrasound guided injection with local anaestethic: 1ml Lidocain 5 mg/ml and 1 ml intralipid (for blinding) in Kagers triangle underneath the thickest part of the achilles tendon. Injection is given every months until the tendon pain is markedly diminished (max 3 injections).
干预措施: Training (Other)
Training and local anesthetic
Patients are instructed to carry out strengthening exercises for the diseased achilles tendon 3 times a week. Physiotherapist will instruct all patients in these heavy slow resistance exercises. First time one week after the first injection, and then every month.
All patients are informed to a reduction in running and jumping sports for the first 3 months, thereafter slowly progressing to normal sports activity.
Ultrasound guided injection with local anaestethic: 1ml Lidocain 5 mg/ml and 1 ml intralipid (for blinding) in Kagers triangle underneath the thickest part of the achilles tendon. Injection is given every months until the tendon pain is markedly diminished (max 3 injections).
干预措施: Ultrasound guided injection with local anaestethic (Drug)
结局指标
主要结局
VISA-A score
时间窗: 6 month
VISA-A score is a validated score for patients with achilles tendinopathy. score 0-100.
次要结局
- VISA-A score(3, 12, 24 months)
- Ultrasound scanning(3, 6, 12, 24 months)
- Global rating scale for recovery(1, 2, 3, 6, 12, 24 months)
研究者
Finn Elkjær Johannsen
chief physician, MD, specialist in Rheumatology
Bispebjerg Hospital