Epicondylitis Clinical Trial
Official title:
Treatment of Epicondylitis by Ultrasound-guided Local Injections of Autologous Conditioned Plasma (ACP®): a Double-blind Placebo-controlled Randomized Clinical Trial With One-year Follow-up
The purpose of this study is to assess efficacy of two intra-tendinous injections of platelet-rich plasma (PRP) on epicondylitis of recent evolution (≤ 3 months) compared compared to two intra-tendinous injections of saline solution (placebo).
This was a prospective double-blind placebo-controlled randomized trial. Two
ultrasound-guided injections of either PRP (ACP®, Arthrex) or saline solution were performed
at 4 weeks interval.
Exclusion criterion was previous corticosteroid infiltration. All infiltrations were
performed by Dr Bernard Montalvan. The selection of patients and the evaluation were
conducted by Dr Patrick Le Goux who did not know which treatment had been allocated to which
patient.
In the facility, no one apart from the investigators had access to full patient data.
An independent company represented by Mrs Amandine Ramseyer was hired to design, follow and
carry the statistical analysis of the study. The data she got from the investigators were
anonymous.
Patients were monitored by an independent evaluator blinded to treatment at baseline and 1,
3, 6 and 12 months follow-up.
Secondary criteria were the Roles-Maudsley score and the assessment of pain on isometric
contraction of the extensor carpi radialis brevis and of the extensor digitorum communis.
The main evaluation criterion was the relative improvement from baseline to 6 months in pain
score on visual analog scale (0-10).
Intragroup and intergroup intention-to-treat analyses were performed using Student's
t-tests, applying the last-observation carried forward method. Differences of proportions
were tested using chi-square. The sample size calculated was 22 patients per group so that
this study had a power of 90% with typeI error rate α=0.05 to demonstrate a significant
greater improvement of the global pain score of at least 10%, in the PRP over the placebo
group with a standard deviation of 0.10. A "p" value of less than 0.05 was considered to be
statistically significant. The SPSS software (version 19 for Windows) was used to perform
statistics.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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