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| Name | Class |
|---|---|
| The Danish Rheumatism Association | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training and glucocorticosteroid | Active Comparator | 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). |
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| Training and local anesthetic | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduction in running and jumping | Behavioral | Advocate to avoid running and jumping sports for the first 3 months, thereafter slowly progressing to normal sport activity. |
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| Measure | Description | Time Frame |
|---|---|---|
| VISA-A score | VISA-A score is a validated score for patients with achilles tendinopathy. score 0-100. | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| VISA-A score | 3, 12, 24 months | |
| Global rating scale for recovery | 11 point box scale | 1, 2, 3, 6, 12, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| patient pain and exercise diary | 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. | week 1,2,3,4,5,6,7,8,9,10,11,12,13 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Finn E Johannsen, MD | Institute of Sports Medicine Copenhagen, University of Copenhagen, Denmark | Principal Investigator |
| Jens L Olesen, MD, PhD | Institute of Sports Medicine Copenhagen, University of Copenhagen, Denmark | Principal Investigator |
| Michael S Rathleff, PT, PhD | Research Unit for General Practice in Aalborg, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Sports Medicine Copenhagen, Bispebjerg Hospital | København NV | dk-2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35816306 | Derived | Johannsen F, Olesen JL, Ohlenschlager TF, Lundgaard-Nielsen M, Cullum CK, Jakobsen AS, Rathleff MS, Magnusson PS, Kjaer M. Effect of Ultrasonography-Guided Corticosteroid Injection vs Placebo Added to Exercise Therapy for Achilles Tendinopathy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2219661. doi: 10.1001/jamanetworkopen.2022.19661. |
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| ID | Term |
|---|---|
| D012420 | Running |
| ID | Term |
|---|---|
| D008124 | Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Training | Other | 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. |
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| Ultrasound guided injection with Glucocorticosteroid | Drug | 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). |
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| Ultrasound guided injection with local anaestethic | Drug | 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). |
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| Ultrasound scanning |
measurement of the thickness of the achilles tendon and evaluating the tendon structure and flow on a 4 point scale (Newman grading scale) |
| 3, 6, 12, 24 months |
| D015444 | Exercise |
| D009043 | Motor Activity |