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

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

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.

Study Overview

• Status: Completed
• Conditions: Tendinopathy
• Intervention / Treatment: Drug: High Volume injection without corticosteroid; Drug: High Volume injection with corticosteroid

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Institute of Sportsmedicine, Bispebjerg hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: High Volume injection without corticosteroid; Injection with 10 mls 0.5% bupivacaine hydrochloride and • 40 ml saline around the tendon.; Other Names: HVI without corticosteroid
Active Comparator: 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.	Drug: High Volume injection with corticosteroid; Injection with 10 mls 0.5% bupivacaine hydrochloride, 20 mg Depomedrol and 40 ml saline around the tendon.; Other Names: HVI with corticosteroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Victorian Institute of Sports Assessment-Achilles questionnaire (VISA-A score)	Changes in VISA-A score over time between the two groups	Baseline, 6 weeks, 12 weeks and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Visual analogue pain scale (VAS score)	Changes in VAS score over time between the two groups	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	Baseline, 6 weeks, 12 weeks and 24 weeks

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: July 18, 2016
• First Posted (Estimate): July 21, 2016

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 30, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: H-1-2010-052b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO