Resistance Training and Injection Treatment for Achilles Enthesopathy
- Conditions
- Achilles Entesopathy
- Interventions
- Drug: Corticosteroid injectionDrug: Local anesthesia injections
- Registration Number
- NCT04232358
- Lead Sponsor
- Bispebjerg Hospital
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Corticosteroid injections + resistance training Corticosteroid injection 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 Local anesthesia injections 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
Trial Locations
- Locations (1)
Bispebjerg Hospital
🇩🇰Copenhagen, Denmark