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Clinical trial

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

ID
Name
H-19041374
Description
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.
Trial arms
Trial start
2021-05-04
Estimated PCD
2024-05-04
Trial end
2025-05-04
Status
Active (not recruiting)
Treatment
Corticosteroid 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.
Arms:
Corticosteroid injections + resistance training
Local anesthesia 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.
Arms:
Local anesthesia injections + resistance training
Size
50
Primary endpoint
Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)
6 months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2023-08-29

1 organization

2 products

1 indication

Organization
Bispebjerg Hospital
Product
Corticosteroid
Indication
Achilles Tendinopathy
Product
Local anesthesia