Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
København NV, dk-2400, Denmark
NCT Number: NCT02580630
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
København NV, dk-2400, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Advocate to avoid running and jumping sports for the first 3 months, thereafter slowly progressing to normal sport activity.
Other names: Impact reduction
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 week 3, 6, 10. The patient will register all training on a diary and on an App.
Other names: Heavy slow resistance training
Ultrasound guided injection in Kagers triangle underneath the thickest part of the achilles tendon with 1ml Lidocain 5 mg/ml and 1 ml methylprednisolone 40mg/ml. Injection is given every months until the tendon pain is markedly reduced (VAS morning pain: 0-20, and VAS training pain: 0-40, and Global recovery rating scale (-5 to +5) is +3 to +5 ). (max 3 injections).
Other names: Glucocorticosteroid
Ultrasound guided injection in Kagers triangle underneath the thickest part of the achilles tendon with 1ml Lidocain 5 mg/ml and 1 ml of intralipid (for blinding). Injection is given every months until the tendon pain is markedly reduced (VAS morning pain: 0-20, and VAS training pain: 0-40, and Global recovery rating scale (-5 to +5) is +3 to +5 ). (max 3 injections).
Other names: local anaestethic
Time frame: 6 month
VISA-A score is a validated score for patients with achilles tendinopathy. score 0-100.
Time frame: 3, 12, 24 months
Time frame: 1, 2, 3, 6, 12, 24 months
11 point box scale
Time frame: 3, 6, 12, 24 months
measurement of the thickness of the achilles tendon and evaluating the tendon structure and flow on a 4 point scale (Newman grading scale)
Time frame: week 1,2,3,4,5,6,7,8,9,10,11,12,13
100 mm VAS score for morning pain (average in the week), 100 mm VAS score for pain during training (average in the week). Compliance to the treatment, Side effects to injections is described.
Bispebjerg Hospital
Other
Achilles Tendinopathy Treated With Heavy Slow Resistance Training Supplemented With Injection of Glucocorticosteroid or Local Anaesthetic.
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