Clinical trial NCT02417987: High Volume Injection or Autologous Conditioned Plasma (ACP) in Chronic Achilles Tendinopathy
Official title: High Volume Injection (HVI) or Autologous Conditioned Plasma (ACP) in Chronic Achilles Tendinopathy: A Randomized Controlled Double Blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tendinopathy
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2015-04-16
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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)

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: VISA-A score
timeFrame: Baseline, 6 weeks, 12 weeks and 24 weeks
Secondary outcomes:
measure: VAS score
timeFrame: Baseline, 6 weeks, 12 weeks and 24 weeks
measure: Ultrasound tendon thickness and doppler activity
timeFrame: Baseline, 6 weeks, 12 weeks and 24 weeks
Other outcomes:
measure: Muscle function performance test (total workload)
timeFrame: Baseline, 6 weeks, 12 weeks and 24 weeks
Locations:
Study officials:
affiliation: Institute of Sportsmedicine Copenhagen, Bispebjerg Hospital
name: Michael Kjaer, Dr. Med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.