Clinical trial NCT04232358: Resistance Training and Injection Treatment for Achilles Enthesopathy
Official title: Resistance Training Supplemented With Either Corticosteroid Injection or Local Anesthesia Injection as Treatment for Achilles Enthesopathy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Achilles Entesopathy
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)
timeFrame: 3, 9 and 12 months
measure: Evaluation of treatment effect measured on a Likert scale.
timeFrame: 1, 2, 3, 6, 9 and 12 months
measure: Ultrasonographic measurement of achilles tendon thickness
timeFrame: 1, 2, 3, 6, 9 and 12 months
measure: Patient self reported activity level in percentage of the pre-injury activity level
timeFrame: 3, 6 and 12 months
measure: Ultrasonographic measurement of achilles tendon doppler activity
timeFrame: 1, 2, 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
References: