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

Bispebjerg Hospital

Status: Completed

Conditions: Tendinopathy

Treatments: Other: Placebo; Drug: High Volume injection; Biological: Autologous conditioned plasma (ACP)

Study type: Interventional

Funder types: Other

Identifiers

NCT02417987

H-1-2010-052a

Details and patient eligibility

About

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)

Full 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.

Enrollment: 60 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

60 participants in 3 patient groups

High Volume injection

Active Comparator group

Description:

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.

Treatment:

Biological: Autologous conditioned plasma (ACP)

Other: Placebo

Autologous conditioned plasma (ACP)

Active Comparator group

Description:

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)

Treatment:

Drug: High Volume injection

Other: Placebo

Placebo

Sham Comparator group

Description:

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

Treatment:

Biological: Autologous conditioned plasma (ACP)

Drug: High Volume injection