An interventional study of High Volume injection without corticosteroid and High Volume injection with corticosteroid in Tendinopathy, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by Bispebjerg Hospital · Not applicable, Interventional, and Treatment
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.
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.
415 studies on the registry are indexed under Tendinopathy; 63 are open to participants now.
This study's enrollment of 28 is below the median of 50 across 341 interventional studies indexed under Tendinopathy.
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Exclusion Criteria:
* 10 mls 0.5% bupivacaine hydrochloride * 20 mg of Depomedrol (40 mg/ml methylprednisolonacetat) * 40 mls saline (NaCl) HVI with corticosteroid is injected one time at baseline and compared to HVI without corticosteroid.
Drug: High Volume injection without corticosteroid
* 10 mls 0.5% bupivacaine hydrochloride * 40 mls saline (NaCl) HVI with corticosteroid is injected one time at baseline and compared to HVI with corticosteroid.
Drug: High Volume injection with corticosteroid
Injection with 10 mls 0.5% bupivacaine hydrochloride and • 40 ml saline around the tendon.
Also known as: HVI without corticosteroid
Injection with 10 mls 0.5% bupivacaine hydrochloride, 20 mg Depomedrol and 40 ml saline around the tendon.
Also known as: HVI with corticosteroid
The Victorian Institute of Sports Assessment-Achilles questionnaire (VISA-A score)
Changes in VISA-A score over time between the two groups
Time frame: Baseline, 6 weeks, 12 weeks and 24 weeks
The Visual analogue pain scale (VAS score)
Changes in VAS score over time between the two groups
Time frame: Baseline, 6 weeks, 12 weeks and 24 weeks
Ultrasound tendon thickness and color Doppler
Changes in tendon thickness and color Doppler between the two groups
Time frame: Baseline, 6 weeks, 12 weeks and 24 weeks
Plan to share: No
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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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