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

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.

Predictors of Outcome Following Tenotomy in Patients with Recalcitrant Epicondylopathy.

BACKGROUND: Elbow tendinopathies are associated with tenderness, pain, and functional disability with ensuing socioeconomic costs. There is lack of consensus regarding the best treatment for patients recalcitrant to first-line conservative treatments. Percutaneous needle tenotomy is considered a regenerative approach that injures the tendon to elicit a healing response. OBJECTIVE: To investigate whether demographic characteristics, clinical factors, baseline sonographic entities, or their interactions are related to the likelihood of responding positively to needle tenotomy over a 1-year follow-up period. DESIGN: Prospective case series. SETTING: Tertiary institutional hospital. PARTICIPANTS: Patients with elbow tendinopathy for whom conservative treatments had failed and who had persistent symptoms lasting for at least 3 months. METHODS: Patients underwent needle tenotomy with or without PRP followed by a lighter needle tenotomy within a 2-week interval as part of treatment. MAIN OUTCOME MEASUREMENTS: Disabilities of the Arm, Shoulder and Hand (DASH) and Visual Analogue Scale for pain (VAS-P) scores were assessed before intervention (baseline) and at 6 weeks and 3, 6, and 12 months after intervention. A generalized linear mixed effects model was created to examine whether injectate type, clinical, demographic, or pretreatment sonographic entities or their interactions influenced clinical outcomes. RESULTS: The authors analyzed 74 elbows (71 patients). At baseline, analyzed patients (mean age: 49.48 years; 51.35% women) scored 43.30 and 5.83 on the DASH and VAS-P, respectively. Pretreatment tendon vascularization was a predictor of pain (P = .011) and DASH score changes (P = .019). The linear mixed effect model revealed that male gender and hypercholesterolemia were associated with enhanced functional recovery, (P = .020 and P < .001, respectively). Moreover, the interactions between pretreatment vascular status (P = .039), echotexture (P = .037) and enthesophytes (P = .028) influenced the temporal pattern of functional recovery after needle tenotomy. CONCLUSIONS: Baseline patient characteristics, such as gender and hypercholesterolemia, along with ultrasound features may be predictive of outcomes following needle tenotomy for elbow tendinopathy. LEVEL OF EVIDENCE: IV (NCT01945528).

Platelet-rich plasma (PRP) in chronic epicondylitis: study protocol for a randomized controlled trial.

BACKGROUND: Tendinopathy is a difficult problem to manage and can result in significant patient morbidity. Currently, the clinical use of platelet-rich plasma (PRP) in painful tendons is widespread but its efficacy remains controversial. METHODS/DESIGN: This study is a single-center, randomized double-blind controlled trial. Eighty patients will be allocated to have ultrasound (US)-guided needling combined with a leukocyte-depleted (that is, pure) PRP or lidocaine each alternate week for a total of two interventions. Outcome data will be collected before intervention, and at 6 weeks, 3, 6, and 12 months after intervention. MAIN OUTCOME MEASURE: Changes in pain and activity levels, as assessed by Disabilities of the Arm, Shoulder and Hand (DASH-E, Spanish version) score, at 6 months. We will compare the percentage of patients in each group that achieve a successful treatment defined as a reduction of at least 25% in the DASH-E score. Secondary outcome measures include changes in DASH-E at 3 and 12 months, changes in pain as assessed by the visual analogue scale (VAS) at the 6-week, 3-, 6-, and 12-month follow-up, changes in sonographic features and neovascularity, and percentage of patients in each group with adverse reactions at 3, 6, and 12 months. DISCUSSION: The results of this study will provide insights into the effect of pure PRP in tendon and may contribute to identifying the best protocol for PRP application in tendinopathies. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01945528.