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NCT Number: NCT04232358

Resistance Training and Injection Treatment for Achilles Enthesopathy

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Achilles Entesopathy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corticosteroid injection

Drug

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

Drug

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.

Primary outcomes

  1. Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)

    Time frame: 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 outcomes

  1. Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A)

    Time frame: 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

  2. Evaluation of treatment effect measured on a Likert scale.

    Time frame: 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

  3. Ultrasonographic measurement of achilles tendon thickness

    Time frame: 1, 2, 3, 6, 9 and 12 months

    Ultrasonographic measurement of achilles tendon thickness in mm is measured relative to the baseline values

  4. Patient self reported activity level in percentage of the pre-injury activity level

    Time frame: 3, 6 and 12 months

    Self reported activity in percentage of the pre-injury activity level

  5. Ultrasonographic measurement of achilles tendon doppler activity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jan 18, 2020
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.