Platelet-rich plasma versus lidocaine as tenotomy adjuvants in people with elbow epicondylopathy: a randomized controlled trial

Abstract

Objectives: To determine the efficacy of platelet-rich plasma (PRP) compared to lidocaine as a tenotomy adjuvant for people with elbow tendinopathy.

Methods: Our study was a parallel-group, double-blind, randomized trial involving 71 patients with recalcitrant elbow tendinopathy who received two sessions of ultrasound-guided tenotomy with either PRP or lidocaine in a tertiary public hospital. The primary end point was the percentage of patients with an improvement exceeding 25% reduction in disability (Spanish version of the Disabilities of the Arm, Shoulder and Hand questionnaires-DASH-E) at 6 and 12 months; the secondary outcome was the percentage of patients exceeding 25% reduction in pain (VAS-P).

Results: There was no evidence of significant differences in the proportion of patients who experienced clinically relevant improvements. After 6 months, 18 patients (78.59%) in the lidocaine group and 19 patients (73.08%) in the PRP group showed improved function above 25% (unadjusted odds ratio, 0.90; 95% confidence interval [CI], 0.90 (0.17 to 4.60)); 21 patients (72.21%) in the lidocaine group versus 22 patients (84.62%) in the PRP group achieved more than 25% pain reduction (unadjusted odds ratio, 0.48; 95% CI, 0.10 to 2.37). After 12 months, 17 patients (70.83%) in the lidocaine group versus 19 patients (76%) in the PRP group had improved function (unadjusted odds ratio, 0.71; 95% CI, 0.13 to 3.84), and 19 patients (76%) in the lidocaine group versus 20 patients (90.91%) in the PRP group had improved pain above 25% (unadjusted odds ratio, 0.35; 95% CI, 0.06 to 2.51). Hypercholesterolemia and baseline vascularization influenced outcomes. There were no differences between groups in the adjusted odds ratios.

Conclusion: PRP results in similar improvements to those obtained with lidocaine. Selecting patients according to their pretreatment status can improve treatment efficacy.

Trial registration: NCT01945528 , EudraCT 2013-000478-32. Registered 18 August 2013, enrolment of the first participant 10 March 2014.

Keywords: Elbow tendinopathy; Epicondylitis; Function; Lateral; Medial; Pain; Platelet-rich plasma; Randomized controlled study; Sonography; Tenotomy.

Fig. 1

Participants’ flow diagram. Asterisk denotes did not receive allocated intervention because of: a horse accident (1), preferred the surgical option (1), entitled for hip surgery (1), had no pain the day of the first intervention (1) and declined without any reason (1). Number sign indicates discontinued intervention because of post-tenotomy pain. During the study, one patient treated with PRP was lost to follow-up after the 6-week assessment and four patients (three from the lidocaine group and one from the PRP group) were lost after the 6-month assessment. We had additional missing data for two main reasons. First, many patients did not fill the DASH properly (i.e., with less than 25 answers over 30 questions, the DASH was not valid for analyses). Second, some patients attended to the echography service during follow-up but failed orthopaedists ‘consultation where clinical data were collected

Fig. 2

Percentage of patients with an improvement exceeding 25% reduction in DASH-E (a) and in VAS-P (b) over 1-year follow-up, after adjusting data for baseline vascularization. DASH-E, Spanish version of the Disabilities of the Arm, Shoulder and Hand questionnaires; VAS-P, visual analogue scale for pain; m, month

Fig. 3

Changes of DASH-E (a) and VAS-P (b) over time, after adjusting data for baseline DASH-E and VAS-P scores, vascular status and hypercholesterolemia. DASH-E, Spanish version of the Disabilities of the Arm, Shoulder and Hand questionnaires; PRP, platelet-rich plasma; VAS-P, visual analogue scale for pain; m, month