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

NCT ID: NCT02417987

Last Updated: 2015-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-11-30

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.

Conditions

Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High Volume injection

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.

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: OTHER

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

Autologous conditioned plasma (ACP)

Intervention Type: BIOLOGICAL

Injection with 4 mls of ACP around the tendon

Autologous conditioned plasma (ACP)

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)

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: OTHER

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

High Volume injection

Intervention Type: DRUG

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

Placebo

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

Group Type: SHAM_COMPARATOR

High Volume injection

Intervention Type: DRUG

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

Autologous conditioned plasma (ACP)

Intervention Type: BIOLOGICAL

Injection with 4 mls of ACP around the tendon

Interventions

Placebo

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

Intervention Type: OTHER

High Volume injection

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

Intervention Type: DRUG

Autologous conditioned plasma (ACP)

Injection with 4 mls of ACP around the tendon

Intervention Type: BIOLOGICAL

Other Intervention Names

Sham treatment; HVI; Platelet-rich plasma (PRP)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anders Ploug Boesen

MD, PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Kjaer, Dr. Med.

Role: PRINCIPAL_INVESTIGATOR

Institute of Sportsmedicine Copenhagen, Bispebjerg Hospital

References

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.

Reference Type: DERIVED

PMID: 28530451 (View on PubMed)

Other Identifiers

H-1-2010-052a

Identifier Type: -

Identifier Source: org_study_id