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

NCT02839577 | Completed

• 1 other identifier: H-1-2010-052b
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Tendinopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The Visual analogue pain scale (VAS score)

  Baseline, 6 weeks, 12 weeks and 24 weeks

• Ultrasound tendon thickness and color Doppler

  Baseline, 6 weeks, 12 weeks and 24 weeks

Study Arms (2)

High Volume injection (HVI) with corticosteroid

ACTIVE COMPARATOR

* 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

High Volume injection (HVI) without corticosteroid

ACTIVE COMPARATOR

* 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

Interventions

High Volume injection without corticosteroid DRUG

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

Also known as: HVI without corticosteroid

High Volume injection (HVI) with 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.

Also known as: HVI with corticosteroid

High Volume injection (HVI) without corticosteroid

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Institute of Sportsmedicine, Bispebjerg hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Tendinopathy

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 21, 2016
• Study Start: December 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)