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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 22, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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