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Completed

NCT Number: NCT02839577

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

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.

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Key information

Conditions

Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendon Injuries Wounds and Injuries

Age range

18 year–59 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Sportsmedicine, Bispebjerg hospital

Copenhagen, 2400, Denmark

About this study

Chronic Achilles tendinopathy (AT) is a common and impairing disorder. High Volume Injection therapy (HVI) seems to show promising results in Achilles tendinopathy (AT). HVI consist of a large volume of saline with a small amount of steroid. Steroid injections is widely used for treating tendinopathy but we know from the literature that steroid injections only gives a fast and short term pain reduction in tendinopathy where HVI seems to show both a short term and a more prolonged effect which could contribute the volume effect (saline).

Aim: 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).

Materials and methods: Healthy males (21-59 years; n=60) with AT is randomly assigned to either 1) HVI with steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 mls saline) or 2) HVI without steroid (50 mls;10 mls 0.5% bupivacaine hydrochloride followed by 40 mls saline) The injections will be performed under ultrasound guidance. All subjects will undergo a 12 week eccentric training program and the subjects will continue eccentric training 3 times per week from week 12 to week 24.

Clinical effects will be assessed as changes in symptoms and pain (VISA-A and VAS score), tendon ultrasound thickness and color Doppler. All outcome measures will be recorded at baseline and again at 6 weeks, 12 weeks and 24 weeks follow-up.

Statistics: All data will be analyzed in SigmaPlot v11 using two-way repeated measures ANOVA with Student-Newman-Keuls Post-hoc test. This is used to see changes over time in all groups (time effect) and differences between groups within time-points (group effect). All data will be presented as mean ± SEM time.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Clinically and ultrasound diagnosed unilateral mid-tendinous Achilles tendinopathy.
  • Symptoms > 3 month

Exclusion criteria

  • Bilateral achilles tendinopathy
  • Insertional tendinopathy
  • Steroid injections < 12 month
  • Diabetes or cardiovascular disease
  • Smoking
  • Treatment with fluoroquinolones < 6 month

Treatment and study plan

High Volume injection without corticosteroid

Drug

Injection with 10 mls 0.5% bupivacaine hydrochloride and

  • 40 ml saline around the tendon.

Other names: HVI without corticosteroid

High Volume injection with corticosteroid

Drug

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

Other names: HVI with corticosteroid

Primary outcomes

  1. The Victorian Institute of Sports Assessment-Achilles questionnaire (VISA-A score)

    Time frame: Baseline, 6 weeks, 12 weeks and 24 weeks

    Changes in VISA-A score over time between the two groups

Secondary outcomes

  1. The Visual analogue pain scale (VAS score)

    Time frame: Baseline, 6 weeks, 12 weeks and 24 weeks

    Changes in VAS score over time between the two groups

  2. Ultrasound tendon thickness and color Doppler

    Time frame: Baseline, 6 weeks, 12 weeks and 24 weeks

    Changes in tendon thickness and color Doppler between the two groups

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

The Effect of High Volume Injection With and Without Steroid in Chronic Achilles Tendinopathy: A Randomized Double Blinded Prospective Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 21, 2016
Registry last updated
Jul 2, 2017

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.

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