Resistance Training and Injection Treatment for Achilles Enthesopathy

August 25, 2023 updated by: Simon Doessing, M.D., PhD, Bispebjerg Hospital

Resistance Training Supplemented With Either Corticosteroid Injection or Local Anesthesia Injection as 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Corticosteroid injections + resistance training
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
Drug: 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.
Placebo Comparator: Local anesthesia injections + resistance training
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
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3, 9 and 12 months
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
1, 2, 3, 6, 9 and 12 months
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
1, 2, 3, 6, 9 and 12 months
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
3, 6 and 12 months
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
1, 2, 3, 6, 9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2021

Primary Completion (Estimated)

May 4, 2024

Study Completion (Estimated)

May 4, 2025

Study Registration Dates

First Submitted

January 12, 2020

First Submitted That Met QC Criteria

January 15, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-19041374

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Achilles Entesopathy

Clinical Trials on Corticosteroid injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe