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

Not Applicable

Completed

• Conditions: Tendinopathy
• Interventions: Other: Placebo; Drug: High Volume injection; Biological: Autologous conditioned plasma (ACP)

• Registration Number: NCT02417987
• Lead Sponsor: Bispebjerg Hospital

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.

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2014-08
• Study Completion: 2014-11
• Study First Submitted: 2014-11-04
• Status Verified: 2015-04
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-16
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Autologous conditioned plasma (ACP)	Placebo	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)
Placebo	High Volume injection	A few drops of saline is injected in the soft tissue away from the tendon.
Placebo	Autologous conditioned plasma (ACP)	A few drops of saline is injected in the soft tissue away from the tendon.
High Volume injection	Placebo	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.
High Volume injection	Autologous conditioned plasma (ACP)	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.
Autologous conditioned plasma (ACP)	High Volume injection	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)

Primary Outcome Measures

Name	Time	Method
VISA-A score	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 Outcome Measures

Name	Time	Method
Ultrasound tendon thickness and doppler activity	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)
VAS score	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)