Achilles Entesopathy
Conditions
Brief summary
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
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.
Interventions
DRUGCorticosteroid injection
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.
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.
Sponsors
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A) | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A) | 3, 9 and 12 months | 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 |
| Evaluation of treatment effect measured on a Likert scale. | 1, 2, 3, 6, 9 and 12 months | 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 |
| Ultrasonographic measurement of achilles tendon thickness | 1, 2, 3, 6, 9 and 12 months | Ultrasonographic measurement of achilles tendon thickness in mm is measured relative to the baseline values |
| Patient self reported activity level in percentage of the pre-injury activity level | 3, 6 and 12 months | Self reported activity in percentage of the pre-injury activity level |
| Ultrasonographic measurement of achilles tendon doppler activity | 1, 2, 3, 6, 9 and 12 months | Ultrasonographic measurement of achilles tendon doppler activity is measured (grade I-III) relative to the baseline values |
Countries
Denmark
Outcome results
None listed