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

NCT ID: NCT02839577

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-12-31

Brief 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.

Detailed Description

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.

Conditions

Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High Volume injection (HVI) with corticosteroid

• 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.

Group Type: ACTIVE_COMPARATOR

High Volume injection without corticosteroid

Intervention Type: DRUG

Injection with 10 mls 0.5% bupivacaine hydrochloride and

• 40 ml saline around the tendon.

High Volume injection (HVI) 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.

Group Type: ACTIVE_COMPARATOR

High Volume injection with corticosteroid

Intervention Type: DRUG

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

Interventions

High Volume injection without corticosteroid

Injection with 10 mls 0.5% bupivacaine hydrochloride and

• 40 ml saline around the tendon.

Intervention Type: DRUG

High Volume injection with corticosteroid

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

Intervention Type: DRUG

Other Intervention Names

HVI without corticosteroid; HVI with corticosteroid

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anders Ploug Boesen

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute of Sportsmedicine, Bispebjerg hospital

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-1-2010-052b

Identifier Type: -

Identifier Source: org_study_id