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The Effect of High Volume Injection With and Without Steroid in Chronic Achilles Tendinopathy

NCT02839577 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-07-02

No results posted yet for this study

Summary

The aim of the study is to determine the effect of steroid in High Volume Injection (HVI) compared to HVI without steroid (volume effect) in functional outcomes and ultrasound tendon thickness and Color Doppler activity in chronic Achilles tendinopathy (AT).

Healthy males with AT will be randomly assigned to either 1) HVI with steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 ml saline) or 2) HVI without steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride followed by 40 ml saline).

All subjects will perform a 12-wk eccentric training program with further eccentric training 3 times per week from week 12 to week 24.

Clinical examinations and ultrasound will be performed at baseline (before treatment) with follow-ups after 6 weeks, 12 weeks and again after 24 weeks prior to baseline to see any possible changes and differences between the two groups.

Conditions

  • Tendinopathy

Interventions

DRUG

High Volume injection without corticosteroid

Injection with 10 mls 0.5% bupivacaine hydrochloride and • 40 ml saline around the tendon.

DRUG

High Volume injection with corticosteroid

Injection with 10 mls 0.5% bupivacaine hydrochloride, 20 mg Depomedrol and 40 ml saline around the tendon.

Sponsors & Collaborators

  • Bispebjerg Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-07-31
Completion
2014-12-31

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 NCT02839577 on ClinicalTrials.gov