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

Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417987
• Other study ID #: H-1-2010-052a
• Status: Completed
• Phase: N/A
• First received: November 4, 2014
• Last updated: April 20, 2015
• Start date: May 2012
• Est. completion date: November 2014

Study information

• Verified date: April 2015
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tendinopathy

Intervention

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

Drug:
• High Volume injection
Injection with10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol 40 mls saline (NaCl) around the tendon

Biological:
• Autologous conditioned plasma (ACP)
Injection with 4 mls of ACP around the tendon

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes