Ultrasound Evaluation of Blind Dry Needling in Lateral Epicondylitis

September 8, 2025 updated by: nurmuhammet tas

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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".

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lateral epicondylitis and with at least one active trigger point
The first clinician determines the active TrP by manual palpation and performs dry needling without the use of ultrasound (blinded).
Procedure: Evaluation of Anatomical Accuracy in Targeting Forearm Extensor Muscles with Blind Dry Needling in Patients with Lateral Epicondylitis Using Ultrasound Guidance
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".
Experimental: Ultrasound-Guided Needle Location Verification
After the needling procedure, a second clinician evaluates the needle's location in the muscle using ultrasonography.
Procedure: Evaluation of Anatomical Accuracy in Targeting Forearm Extensor Muscles with Blind Dry Needling in Patients with Lateral Epicondylitis Using Ultrasound Guidance
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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

nurmuhammet tas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 21, 2025

Primary Completion (Estimated)

September 22, 2025

Study Completion (Estimated)

September 23, 2025

Study Registration Dates

First Submitted

June 20, 2025

First Submitted That Met QC Criteria

June 20, 2025

First Posted (Actual)

June 29, 2025

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ErzurumNMT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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