NCT02417987

Brief Summary

The aim of the study is to examine patients with chronic Achilles Tendinopathy (AT) and to compare the effect of high volume injection (HVI) or autologous conditioned plasma (ACP) in combination with eccentric training to placebo treatment (sham treatment combined with eccentric exercises). Healthy males with AT will be randomly assigned to either 1) HVI (50 mls;10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol followed by 40 mls saline), 2) ACP (\~ 4 mls) or 3) Placebo (Plc) treatment. All subjects will perform a 12-wk eccentric training program and examinations will be done 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 groups (HVI, ACP and Plc)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

2.3 years

First QC Date

November 4, 2014

Last Update Submit

April 20, 2015

Conditions

Tendinopathy

Outcome Measures

Primary Outcomes (1)

  • VISA-A score

    See the changes in VISA-A score over time due to the effect of treatment between groups (HVI, ACP and Plc)

    Baseline, 6 weeks, 12 weeks and 24 weeks

Secondary Outcomes (2)

  • VAS score

    Baseline, 6 weeks, 12 weeks and 24 weeks

  • Ultrasound tendon thickness and doppler activity

    Baseline, 6 weeks, 12 weeks and 24 weeks

Other Outcomes (1)

  • Muscle function performance test (total workload)

    Baseline, 6 weeks, 12 weeks and 24 weeks

Study Arms (3)

High Volume injection

ACTIVE COMPARATOR

A total volume of 50 ml: * 10 mls 0.5% bupivacaine hydrochloride and * 20 mg of Depomedrol (hydrocortisone) * 40 mls saline (NaCl) HVI is injected one time at baseline and thereafter the group received sham treatment at 2 weeks, 4 weeks and after 6 weeks.

Other: PlaceboBiological: Autologous conditioned plasma (ACP)

Autologous conditioned plasma (ACP)

ACTIVE COMPARATOR

Whole blood was drawn from the patients using arthrex system (total of 10 mls whole blood). After that the whole blood is spined for 5 minutes and ACP with platelets and growth factors is separated from the red and white blood cells (4 mls). The ACP is injected 4 times (at baseline, 2 weeks, 4 weeks and after 6 weeks)

Other: PlaceboDrug: High Volume injection

Placebo

SHAM COMPARATOR

A few drops of saline is injected in the soft tissue away from the tendon.

Drug: High Volume injectionBiological: Autologous conditioned plasma (ACP)

Interventions

PlaceboOTHER

The skin was penetrated with a needle and few drops of saline injected in the soft tissue away from the tendon

Also known as: Sham treatment
Autologous conditioned plasma (ACP)High Volume injection
High Volume injectionDRUG

Injection with10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol 40 mls saline (NaCl) around the tendon

Also known as: HVI
Autologous conditioned plasma (ACP)Placebo
Autologous conditioned plasma (ACP)BIOLOGICAL

Injection with 4 mls of ACP around the tendon

Also known as: Platelet-rich plasma (PRP)
High Volume injectionPlacebo

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Clinically and ultrasound diagnosed unilateral midt-tendinous achilles tendinopathy
  • Symptoms \> 3 month
  • No steroid injections \< 6 month
  • males with BMI \<30 between 18-60 years.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Boesen AP, Hansen R, Boesen MI, Malliaras P, Langberg H. Effect of High-Volume Injection, Platelet-Rich Plasma, and Sham Treatment in Chronic Midportion Achilles Tendinopathy: A Randomized Double-Blinded Prospective Study. Am J Sports Med. 2017 Jul;45(9):2034-2043. doi: 10.1177/0363546517702862. Epub 2017 May 22.

    PMID: 28530451DERIVED

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Study Officials

  • Michael Kjaer, Dr. Med.

    Institute of Sportsmedicine Copenhagen, Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

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

November 4, 2014

First Posted

April 16, 2015

Study Start

May 1, 2012

Primary Completion

August 1, 2014

Study Completion

November 1, 2014

Last Updated

April 21, 2015

Record last verified: 2015-04