Treatment of Epicondylitis by Ultrasound-guided Local Injections of PRP (Platelet Rich Plasma)
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|ClinicalTrials.gov Identifier: NCT02378285|
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : March 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Epicondylitis||Device: ACP Other: Saline solution||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2014|
Active Comparator: PRP group
ACP infiltration: 2 mL at 0 and 4 weeks with ultrasound guidance
ACP is prepared using the Autologous Conditioned Plasma (ACP®) device from Arthrex (Naples, Florida, USA), following the supplier instructions. 2 mL of ACP are transferred in a standard 2 mL injection syringe by a nurse. The standard 2 mL injection syringe is then given to the physician.The patient is installed on a table with his arm in supine position. A local subcutaneous anesthesia (2 ml of 1% lidocaine) is done just before the infiltration by the physician. The infiltration is then done guided by ultrasound.
Placebo Comparator: Saline solution group
Saline solution infiltration: 2mL at 0 and 4 weeks with ultrasound guidance
Other: Saline solution
2 mL of saline solution are placed in a standard injection syringe by a nurse. The syringe is then given to the physician. The patient is installed on a table with his arm in supine position. A local subcutaneous anesthesia (2 ml of 1% lidocaine) is done just before the infiltration by the physician. The infiltration is then done guided by ultrasound.
- Global pain score [ Time Frame: 1 year ]
- Roles and Maudsley score [ Time Frame: 1 year ]
- Pain on ECRB* contraction [ Time Frame: 1 year ]% positive
- Pain on EDC** contraction [ Time Frame: 1 year ]% positive
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378285
|Hôpital Ambroise Paré|
|Boulogne, France, 92100|
|Study Director:||Philippe Hardy, Pr||Hospital Ambroise Paré Paris|