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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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;
* Individuals with independent behavioral capacity, who have signed the informed consent form themselves.
Exclusion Criteria:
* 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;
* MRI showing that the injury has involved the lateral collateral ligament, with concurrent cartilage damage.
Primary outcome measure(s)
Assess changes in pain levels using a Visual Analogue Scale (VAS) — From enrollment to the end of treatment at 12 weeks 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) — From enrollment to the end of treatment at 12 weeks 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) — From enrollment to the end of treatment at 12 weeks 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 — From enrollment to the end of treatment at 12 weeks
Trial sites (1)
Facility
City
Region
Status
Shanghai Sixth hospital
Shanghai
Shanghai Municipality
Recruiting
More Shanghai 6th People's Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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