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Completed

NCT Number: NCT02417987

High Volume Injection or Autologous Conditioned Plasma (ACP) in Chronic Achilles Tendinopathy

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)

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Key information

Conditions

Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendon Injuries Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

Chronic Achilles tendinopathy (AT) is a common and impairing disorder. Only sparse scientific evidence exists for the present used treatments and no golden standard treatment exists so far.

Aim: The aim of the study is in AT patients to examine and compare the effect of high volume injection (HVI) or autologous conditioned plasma (ACP) in combination with eccentric training to placebo treatment (sham treatment and eccentric exercises).

Materials and methods: Healthy males (21-59 years; n=60) with AT is 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. Participants will treated on 4 successive occasions with 2 weeks (wks) interval (HVI will only be injected once at baseline, the 3 following injections will be placebo). The injections will be performed under ultrasound guidance. All subjects will undergo a 12-wk eccentric training program. Clinical effects will be assessed as changes in symptoms and pain (VISA-A and VAS score), tendon ultrasound thickness and muscle function (one-legged heel-rise test). All outcome measures will be recorded at baseline and again at 6 weeks, 12 week and 6 month follow-up.

Results: Will se the changes and differences between groups (HVI, ACP and Placebo) in VISA-A scores, VAS scores, ultrasound (tendon thickness) and muscle function.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Placebo

Other

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

Other names: Sham treatment

High Volume injection

Drug

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

Other names: HVI

Autologous conditioned plasma (ACP)

Biological

Injection with 4 mls of ACP around the tendon

Other names: Platelet-rich plasma (PRP)

Primary outcomes

  1. VISA-A score

    Time frame: Baseline, 6 weeks, 12 weeks and 24 weeks

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

Secondary outcomes

  1. VAS score

    Time frame: Baseline, 6 weeks, 12 weeks and 24 weeks

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

  2. Ultrasound tendon thickness and doppler activity

    Time frame: Baseline, 6 weeks, 12 weeks and 24 weeks

    See the changes in tendon thickness over time due to the effect of treatment between groups (HVI, ACP and Plc)

Other outcomes

  1. Muscle function performance test (total workload)

    Time frame: Baseline, 6 weeks, 12 weeks and 24 weeks

    See the muscle function performance (total workload- heel raise test) performed over time due to the effect of treatment between groups (HVI, ACP and Plc)

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

High Volume Injection (HVI) or Autologous Conditioned Plasma (ACP) in Chronic Achilles Tendinopathy: A Randomized Controlled Double Blinded Trial

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 16, 2015
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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