Evaluate the safety and preliminary efficacy of human induced pluripotent stem cell-derived extracellular vesicle (iEV) injection in the treatment of lateral epicondylitis of the humerus.
Diagnosed with lateral epicondylitis by clinical symptom examination and MRI or ultrasound, without obvious tendon tear;
Unilateral lateral elbow pain lasting for more than 12 weeks;
Pain is provoked by at least 2 of the following methods, with a pain VAS score exceeding 3: maximum grip strength, palpation of the lateral epicondyle of the elbow and surrounding area, resisted dorsiflexion of the wrist or middle finger, or stretching of the forearm extensor muscles under a pain-free grip state;
Having received physical therapy or non-steroidal anti-inflammatory drug treatment with poor efficacy;
Complaints of ipsilateral muscle pain caused by other reasons in the past 6 months;
Presence of ipsilateral neurogenic, inflammatory, or systemic joint diseases;
A history of previous lateral epicondylitis (LET) surgery in the past 6 months;
Subjects deemed unsuitable for participating in the trial due to other conditions, as judged by the researcher;
Parallel
iEV
Biological/Vaccineinduced pluripotent stem cell-derived extracellular vesicles
PRP
Biological/VaccinePRP injection
immobilization
Other interventionimmobilization
Assess changes in pain levels using a Visual Analogue Scale (VAS)
Assess changes in pain levels using the Visual Analogue Scale (VAS). The scale ranges from 0 (no pain) to 10 (the most severe pain), where a higher score indicates more severe pain (worse outcome) and a lower score indicates less severe pain (better outcome).
Evaluate changes in functional outcomes through patient-rated tennis elbow assessments (PRTEE)
To assess changes in functional outcomes, the Patient-Rated Tennis Elbow Evaluation (PRTEE) is utilized. This scale encompasses 15 items, divided into two dimensions: the pain dimension (5 items) and the function dimension (10 items). It uses a 0-10 scoring system, where a higher total score indicates more severe functional impairment (worse outcome), and a lower total score indicates less severe functional impairment (better outcome).
Assess changes in functional outcomes using the Mayo Elbow Performance Score (MEPS)
To assess changes in elbow function, the Mayo Elbow Performance Score (MEPS) is employed. This scale ranges from 0 to 100, where a higher score indicates better elbow function (better outcome) and a lower score indicates worse elbow function (worse outcome).
Incidence of adverse events
Changes in the results of the SF-36 Quality of Life Questionnaire
Changes in functional outcomes assessed by the Subjective Elbow Value (SEV)
MRI imaging assessment at 3 months after injection
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