Ultrasound Evaluation of Blind Dry Needling in Lateral Epicondylitis

The aim of this clinical study is to evaluate the accuracy and consistency of the blinded needling procedure by evaluating the dry needling procedure under ultrasound guidance in patients diagnosed with lateral epicondylitis and with at least one active trigger point (MTrP) in the forearm extensor muscles. The study is a prospective, double-blind validation study.

Participants: Volunteers aged 18-70 years, who have pain in the lateral epicondyle region for at least 6 weeks and who have active trigger points in the forearm extensor muscles detected by physical examination will be included in the study. Written informed consent will be obtained from all participants.

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Key information

Conditions

Lateral Epicondylitis Arm Injuries Elbow Injuries Elbow Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Tennis Elbow Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Muscle Selection and Application Protocol All patients will be prescribed nonsteroidal anti-inflammatory (NSAID) and analgesic treatments in accordance with clinical standards, and the use of a wrist splint will be recommended to support symptom control. Four muscles are targeted during the evaluation: Extensor carpi radialis brevis (ECRB), Extensor carpi radialis longus (ECRL), Extensor digitorum communis (EDC), and Brachioradialis (BR).

Blinded Dry Needling Application The first clinician determines the active TrP by manual palpation and performs dry needling without the use of ultrasound (blinded). The needling procedure is performed in accordance with the intramuscular TrP localization and techniques in Myofascial Pain and Dysfunction: The Trigger Point Manual.

The patient is placed in the supine position. The needle used is a Hua - Long brand 0.30 x 30 mm single-use sterile acupuncture needle. The needle is advanced to the TrP and modulated until a local twitch response is obtained. If the patient experiences significant discomfort, the procedure is terminated.

Ultrasound-Guided Needle Location Verification After the needling procedure, a second clinician evaluates the needle's location in the muscle using ultrasonography. This clinician is blinded to the target muscle. Imaging is performed in accordance with the guidance of 'Ultrasound of the Musculoskeletal System' Using a high-resolution linear probe (5-12 MHz) , the muscle in which the needle tip is located is monitored in real time in the transverse and longitudinal planes. Whether the needle is in the targeted muscle is recorded as "correct" or "incorrect".

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Volunteers aged 18-70 years,
who have pain in the lateral epicondyle region for at least 6 weeks
who have active trigger points in the forearm extensor muscles detected by physical examination

Exclusion criteria

Those who have not complained of pain in the lateral epicondyle region for at least 6 weeks

Treatment and study plan

Evaluation of Anatomical Accuracy in Targeting Forearm Extensor Muscles with Blind Dry Needling in Patients with Lateral Epicondylitis Using Ultrasound Guidance

Procedure

Using a high-resolution linear probe (5-12 MHz) , the muscle in which the needle tip is located is monitored in real time in the transverse and longitudinal planes. Whether the needle is in the targeted muscle is recorded as "correct" or "incorrect".

Primary outcomes

Evaluation of Anatomical Accuracy in Targeting Forearm Extensor Muscles with Blind Dry Needling in Patients with Lateral Epicondylitis Using Ultrasound Guidance

Time frame: 2 week

Correct placement rates will be calculated for each muscle. The agreement between the ultrasound and verification results of the blinded applications will be evaluated with Kappa statistics. Chi-square test or McNemar test will be used for differences between muscles.

Sponsors and collaborators

Lead sponsor

nurmuhammet tas

Other Gov

Registry information

Official study title

Evaluation of Anatomical Accuracy in Targeting Forearm Extensor Muscles With Blind Dry Needling in Patients With Lateral Epicondylitis Using Ultrasound Guidance

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jun 29, 2025
Registry last updated: Sep 15, 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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