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

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

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)

Study Overview

• Status: Completed
• Conditions: Tendinopathy
• Intervention / Treatment: Other: Placebo; Biological: Autologous conditioned plasma (ACP); Drug: High Volume injection

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle function performance test (total workload)	See the muscle function performance (total workload- heel raise test) performed over time due to the effect of treatment between groups (HVI, ACP and Plc)	Baseline, 6 weeks, 12 weeks and 24 weeks

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: November 4, 2014
• First Submitted That Met QC Criteria: April 15, 2015
• First Posted (ESTIMATE): April 16, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): April 21, 2015
• Last Update Submitted That Met QC Criteria: April 20, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: H-1-2010-052a