Resistance Training and Injection Treatment for Achilles Enthesopathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Resistance Training Supplemented With Either Corticosteroid Injection or Local Anesthesia Injection as Treatment for Achilles Enthesopathy

Conditions
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Achilles Entesopathy

Intervention / Treatment
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* Drug: Corticosteroid injection
* Drug: Local anesthesia injections


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Pain from the achilles tendon insertion/heel for at least 3 months Achilles entesopathy verified by ultrasound Between 18 and 65 years of age Exclusion criteria: Prior surgery in the leg with the exception of knee arthroscopy Known medial conditions including diabetes or rheumatologic diseases Taking pain medication regularly Injection therapy for treatment of achilles entesopathy within the last 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Corticosteroid injections + resistance training<br>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 | Drug: Corticosteroid injection<br>* 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.<br>|
| Placebo Comparator: Local anesthesia injections + resistance training<br>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 | Drug: Local anesthesia injections<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |