Achilles Tendinopathy Treated With Training and Injections

NCT02580630 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-07-22

No results posted yet for this study

Summary

The purpose of this study is to compare in a randomized double blinded controlled trial the effect of heavy slow resistance exercises combined with ultrasound guided injections with local anesthetic with or without glucocorticosteroid in patients with achilles tendinopathy.

Conditions

  • Achilles Tendinopathy

Interventions

BEHAVIORAL

Reduction in running and jumping

Advocate to avoid running and jumping sports for the first 3 months, thereafter slowly progressing to normal sport activity.

OTHER

Training

Patients are instructed to carry out strengthening exercises for the diseased achilles tendon 3 times a week. Physiotherapist will instruct all patients in these heavy slow resistance exercises. First time one week after the first injection, and then week 3, 6, 10. The patient will register all training on a diary and on an App.

DRUG

Ultrasound guided injection with Glucocorticosteroid

Ultrasound guided injection in Kagers triangle underneath the thickest part of the achilles tendon with 1ml Lidocain 5 mg/ml and 1 ml methylprednisolone 40mg/ml. Injection is given every months until the tendon pain is markedly reduced (VAS morning pain: 0-20, and VAS training pain: 0-40, and Global recovery rating scale (-5 to +5) is +3 to +5 ). (max 3 injections).

DRUG

Ultrasound guided injection with local anaestethic

Ultrasound guided injection in Kagers triangle underneath the thickest part of the achilles tendon with 1ml Lidocain 5 mg/ml and 1 ml of intralipid (for blinding). Injection is given every months until the tendon pain is markedly reduced (VAS morning pain: 0-20, and VAS training pain: 0-40, and Global recovery rating scale (-5 to +5) is +3 to +5 ). (max 3 injections).

Sponsors & Collaborators

  • The Danish Rheumatism Association

    collaborator OTHER
  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Finn E Johannsen, MD · Institute of Sports Medicine Copenhagen, University of Copenhagen, Denmark

  • Jens L Olesen, MD, PhD · Institute of Sports Medicine Copenhagen, University of Copenhagen, Denmark

  • Michael S Rathleff, PT, PhD · Research Unit for General Practice in Aalborg, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2020-12-20
Completion
2020-12-20

Countries

  • Denmark

Study Locations

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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 NCT02580630 on ClinicalTrials.gov