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High-Volume Image-Guided Injection in Chronic Midportion Achilles Tendinopathy

NCT02996409 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-08-15

No results posted yet for this study

Summary

Overuse injury of the Achilles tendon is a common entity in athletes. Currently, the usual treatment for chronic midportion Achilles tendinopathy is an eccentric exercise program. In most cases this gives satisfactory results, however there is a significant group of patients in which the exercise program is not sufficient. Prior to our study, three United Kingdom based studies have investigated the efficacy of High-Volume Image-Guided Injections (HVIGI's) in chronic midportion Achilles tendinopathy. They all showed promising results. However none of these studies had an adequate control group. This double-blind, placebo-controlled, randomized clinical trial will investigate the value of a High-Volume Image-Guided Injection in chronic midportion Achilles tendinopathy.

Conditions

  • Tendinopathy
  • Achilles Tendon Pain
  • Injection Site Fibrosis

Interventions

DRUG

HVIGI

High Volume Image-Guided Injection with a saline/lidocain solution

DRUG

LVIGI

Placebo control with injection of a saline/lidocain solution (low volume)

OTHER

Progressive exercise program

A 12-week during progressive exercise training program consisting of isometric, isotonic and eccentric calf exercises.

Sponsors & Collaborators

  • Dutch Arthritis Association

    collaborator INDUSTRY

  • The Anna Foundation

    collaborator OTHER

  • Erasmus Medical Center

    lead OTHER

Principal Investigators

  • R.J. de Vos, PhD · Erasmus MC University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2019-07-31
Completion
2019-07-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02996409 on ClinicalTrials.gov