Achilles Entesopathy Clinical Trial
Official title:
Resistance Training Supplemented With Either Corticosteroid Injection or Local Anesthesia Injection as Treatment for Achilles Enthesopathy
| Verified date | August 2023 |
| Source | Bispebjerg Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 50 |
| Est. completion date | May 4, 2025 |
| Est. primary completion date | May 4, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Bispebjerg Hospital | Copenhagen |
| Lead Sponsor | Collaborator |
|---|---|
| Bispebjerg Hospital |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |