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

Study Overview
=================
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.

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

Conditions
-----------------
Tendinopathy

Intervention / Treatment
-----------------
* Other: Placebo
* Drug: High Volume injection
* Biological: Autologous conditioned plasma (ACP)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Volume injection<br>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: Placebo<br>* The skin was penetrated with a needle and few drops of saline injected in the soft tissue away from the tendon<br>* Other names: Sham treatment;Biological: Autologous conditioned plasma (ACP)<br>* Injection with 4 mls of ACP around the tendon<br>* Other names: Platelet-rich plasma (PRP);|
| Active Comparator: Autologous conditioned plasma (ACP)<br>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: Placebo<br>* The skin was penetrated with a needle and few drops of saline injected in the soft tissue away from the tendon<br>* Other names: Sham treatment;Drug: High Volume injection<br>* Injection with10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol 40 mls saline (NaCl) around the tendon<br>* Other names: HVI;|
| Sham Comparator: Placebo<br>A few drops of saline is injected in the soft tissue away from the tendon. | Drug: High Volume injection<br>* Injection with10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol 40 mls saline (NaCl) around the tendon<br>* Other names: HVI;Biological: Autologous conditioned plasma (ACP)<br>* Injection with 4 mls of ACP around the tendon<br>* Other names: Platelet-rich plasma (PRP);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score | See the changes in VAS score over time due to the effect of treatment between groups (HVI, ACP and Plc) | Baseline, 6 weeks, 12 weeks and 24 weeks | 
| Ultrasound tendon thickness and doppler activity | See the changes in tendon thickness over time due to the effect of treatment between groups (HVI, ACP and Plc) | Baseline, 6 weeks, 12 weeks and 24 weeks |