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Achilles enthesopathy is a common and often long-lasting injury among exercising individuals. Very little is known regarding the effect of different treatment strategies.
The purpose of the study is to evaluate two treatment strategies for achilles enthesopathy: Resistance training and restricted loading + corticosteroid injection compared to resistance training and restricted loading + local anesthesia injection.
50 patients with achilles enthesopathy are randomly assigned to the two treatment groups in this double blinded RCT.
Achilles enthesopathy is a common and often long-lasting injury among exercising individuals. Symptoms are pain and swelling at the calcaneal insertion of the achilles tendon during and after exercise. Achilles entesopathy has not been thoroughly investigated and consequently, very little is known regarding the effect of different treatment strategies.
The purpose of the study is to evaluate two treatment strategies for achilles enthesopathy: Resistance training and restricted loading + corticosteroid injection compared to resistance training and restricted loading + local anesthesia injection.
It is hypothesized that treatment that includes corticosteroid injection is more effective than treatment that includes injection with local anaesthesia.
50 patients with achilles enthesopathy are randomly assigned to the two treatment groups in this double blinded RCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corticosteroid injections + resistance training | Experimental | Corticosteroid injections every 4 weeks until symptoms resolve with a maximum of 3 injections + resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months |
|
| Local anesthesia injections + resistance training | Placebo Comparator | Local anesthesia injections every 4 weeks until symptoms resolve with a maximum of 3 injections + resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosteroid injection | Drug | Corticosteroid injections are administered ultrasound guided in the bursa adjacent to the achilles tendon insertion every 4 weeks until symptoms resolve with at maximum of 3 injections. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A) | VISA-A is a patient reported outcome measure (PROM). Change from baseline is measured and reported. The scale ranges from 0-100 points. Higher score meaning a better outcome | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A) | VISA-A is a patient reported outcome measure (PROM). Change from baseline is measured and reported. The scale ranges from 0-100 points. Higher score meaning a better outcome | 3, 9 and 12 months |
| Evaluation of treatment effect measured on a Likert scale. |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Copenhagen | 2400 | Denmark |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 27, 2022 | Dec 12, 2022 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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Randomized controlled trial
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| Local anesthesia injections | Drug | Local anesthesia injections are administered ultrasound guided in the bursa adjacent to the achilles tendon insertion every 4 weeks until symptoms resolve with at maximum of 3 injections. |
|
The Likert scale used is an 11-point scale ranging from -5 to +5. +5 is cured and -5 is much worsened, 0 is the status when entering the study |
| 1, 2, 3, 6, 9 and 12 months |
| Ultrasonographic measurement of achilles tendon thickness | Ultrasonographic measurement of achilles tendon thickness in mm is measured relative to the baseline values | 1, 2, 3, 6, 9 and 12 months |
| Patient self reported activity level in percentage of the pre-injury activity level | Self reported activity in percentage of the pre-injury activity level | 3, 6 and 12 months |
| Ultrasonographic measurement of achilles tendon doppler activity | Ultrasonographic measurement of achilles tendon doppler activity is measured (grade I-III) relative to the baseline values | 1, 2, 3, 6, 9 and 12 months |