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Completed

NCT Number: NCT07002879

Ultrasound-Guided Dry Needling vs PRP for Refractory Lateral Epicondylitis

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

dry needle

Procedure

An 18-gauge needle was first used to fenestrate the common extensor tendon and lateral periosteum. Once adequate anesthesia was confirmed, an 18-gauge needle was inserted along the tendon's longitudinal axis (without exiting the skin) and advanced in a "peppering" motion 40 to 50 passes from superficial to deep layers over approximately two minutes

Platelet rich plasma

Procedure

A 15 mL peripheral blood sample was drawn and centrifuged at 3 000 rpm for 3 minutes. Approximately 2 mL of PRP was aspirated directly from the buffy coat and injected into the epicondylar region under ultrasound guidance.

Primary outcomes

  1. visual analog scale

    Time frame: 1-3-6 months

  2. Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire

    Time frame: 1-3-6 months

  3. Patient-Rated Tennis Elbow Evaluation

    Time frame: 1-3-6 months

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

Comparison Of Ultrasound-guided Dry Needling and Platelet-rich Plasma Administration in the Treatment of Refractory Lateral Epicondylitis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 4, 2025
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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