Clinical trial NCT07002879: Ultrasound-Guided Dry Needling vs PRP for Refractory Lateral Epicondylitis
Official title: Comparison Of Ultrasound-guided Dry Needling and Platelet-rich Plasma Administration in the Treatment of Refractory Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This single-center, randomized, prospective study was conducted between January 2022 and September 2023 with ethics committee approval. Adults aged 18-65 with a clinical diagnosis of lateral epicondylitis-characterized by lateral elbow pain exacerbated by resisted wrist or middle finger extension-and who had not responded to at least six weeks of conservative treatment were included. Exclusion criteria included cervical disc disease, nerve entrapment, arthrosis, uncontrolled metabolic disorders, bleeding disorders, prior elbow surgery or injection, pregnancy, cognitive impairment, or compromised skin at the injection site. A G\*Power sample size calculation determined that at least 50 patients were needed.

Participants were randomly assigned to two groups: 25 received ultrasound-guided dry needling and 25 received platelet-rich plasma (PRP) injections. All participants gave informed consent, and the study adhered to the Declaration of Helsinki. Baseline demographic and clinical data were collected, and the diagnosis was confirmed using Mills, Maudsley, and Thomsen tests, along with grip-strength assessment. Pain and function were evaluated using the PRTEE, Visual Analog Scale (VAS), and QuickDASH questionnaires at baseline, and at 1, 3, and 6 months post-treatment.

Ultrasound imaging was used to identify tendinopathic changes. Local anesthesia was administered with 2 mL of prilocaine.

In the dry needling group, an 18-gauge needle was used to fenestrate the tendon with 40-50 passes in a "peppering" motion under continuous ultrasound guidance.

In the PRP group, 15 mL of blood was drawn, centrifuged, and approximately 2 mL of PRP was injected into the lesion under ultrasound guidance.

After the procedure, patients were advised to apply ice, perform passive stretching, avoid lifting heavy objects, and refrain from NSAID use for two weeks. Gradual return to normal activities was encouraged thereafter to restore full elbow function.


Eligibility criteria: Inclusion Criteria: 18 and 65 years of age, having a clinical diagnosis of lateral epicondylitis based on localized lateral elbow pain exacerbated by resisted wrist or middle finger extension and tenderness over the lateral epicondyle on physical examination, and failure to respond to at least six weeks of conservative treatment.

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Exclusion Criteria:the presence of cervical discopathy or upper extremity nerve entrapment, radiocapitellar arthrosis, uncontrolled metabolic diseases (hypothyroidism, diabetes), bleeding diathesis, a history of previous elbow injection or surgery, pregnancy or lactation, cognitive impairment, and skin compromise at the injection site

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Primary outcomes:
measure: visual analog scale
timeFrame: 1-3-6 months
measure: Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire
timeFrame: 1-3-6 months
measure: Patient-Rated Tennis Elbow Evaluation
timeFrame: 1-3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
References: