Lateral epicondylitis with tendon tear resistant to conservative treatment remains a common clinical condition with limited therapeutic options before surgery is considered. Platelet-rich plasma (PRP) injections are used in tendinopathies because of their potential regenerative properties. More recently, platelet-rich plasma derived from bone marrow aspirate (bone marrow-derived PRP) has emerged as an alternative source of platelets and bioactive factors. However, the clinical implications of its different biological composition compared with peripheral blood-derived PRP remain poorly understood. This monocentric randomized pilot trial aims to assess the feasibility of the intervention and to estimate the effect of bone marrow-derived PRP compared with peripheral blood-derived PRP in patients with resistant partial-thickness lateral epicondylar tendinopathy. Participants will be randomly assigned in a 1:1 ratio to receive either bone marrow-derived PRP or peripheral blood-derived PRP injection. Clinical outcomes, pain, functional scores, imaging findings, safety, and feasibility parameters will be assessed over a 12-month follow-up period. The study is not powered to demonstrate superiority between treatments but is intended to generate preliminary effect estimates and feasibility data for the design of a future confirmatory trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
Participants receive a platelet-rich plasma (PRP) injection prepared from bone marrow aspirate obtained from the posterior iliac crest. After processing, the PRP is injected under ultrasound guidance into the affected lateral elbow tendon.
Participants receive a platelet-rich plasma (PRP) injection prepared from peripheral venous blood. After processing, the PRP is injected under ultrasound guidance into the affected lateral elbow tendon.
Change in QuickDASH score from baseline to 3 months
The primary outcome is the change in the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score between baseline and 3 months. The QuickDASH is a patient-reported questionnaire assessing upper-limb disability and symptoms. Scores range from 0 to 100, with higher scores indicating greater disability.
Time frame: Baseline and 3 months after injection
Change in QuickDASH score at 6 and 12 months
Change in QuickDASH score over time. Scores range from 0 to 100, with higher scores indicating greater disability.
Time frame: Baseline, 6 months, and 12 months after injection
Change in PRTEE score
Change in the Patient-Rated Tennis Elbow Evaluation (PRTEE) score. The PRTEE assesses pain and functional limitations related to lateral elbow tendinopathy. Scores range from 0 to 100, with higher scores indicating worse symptoms and disability.
Time frame: Baseline, 3 months, 6 months, and 12 months after injection
Change in MEPS score
Change in the Mayo Elbow Performance Score (MEPS). The MEPS evaluates pain, range of motion, stability, and function of the elbow. Scores range from 0 to 100, with higher scores indicating better elbow function.
Time frame: Baseline, 3 months, 6 months, and 12 months after injection
Proportion of patients achieving a clinically meaningful improvement
Proportion of participants achieving the minimal clinically important difference (MCID), defined as an improvement of at least 16 points in the QuickDASH score (Scores range from 0 to 100, with higher scores indicating greater disability).
Time frame: 3 months, 6 months, and 12 months after injection
Change in common extensor tendon tear size measured by ultrasound
Change in the size of the common extensor tendon tear measured by ultrasound in longitudinal and transverse planes. Tear size is recorded in millimeters (mm).
Time frame: Baseline, 3 months, 6 months, and 12 months after injection
Rate of surgical treatment during follow-up
Proportion of participants requiring surgical treatment for lateral elbow tendinopathy during the 12-month follow-up period.
Time frame: Up to 12 months after injection
Time to surgery
Time between study inclusion and surgical intervention for lateral elbow tendinopathy.
Time frame: Up to 12 months after injection
Time between study inclusion and surgical intervention for lateral elbow tendinopathy.
Time frame: From injection to 12 months
Participant recruitment rate
Number of participants enrolled divided by the number of eligible participants screened during the recruitment period.
Time frame: Throughout study completion (up to 12 months)
Presence of tendon hypervascularization on ultrasound
Presence or absence of hypervascularization at the common extensor tendon insertion assessed by Doppler ultrasound.
Time frame: Baseline, 3 months, 6 months, and 12 months after injection
Presence of local effusion on ultrasound
Presence or absence of local effusion at the common extensor tendon insertion assessed by ultrasound.
Time frame: Baseline, 3 months, 6 months, and 12 months after injection
Participant retention rate
Proportion of randomized participants who complete the 12-month follow-up.
Time frame: Up to 12 months after injection
Treatment adherence
Proportion of participants who receive the allocated intervention and complete study procedures according to the protocol.
Time frame: From intervention to study completion (12 months)
Completeness of study data collection
Proportion of expected study data collected during follow-up visits.
Time frame: Up to 12 months after injection
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