NCT07042997

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

September 21, 2025

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2025

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

1 day

First QC Date

June 20, 2025

Last Update Submit

September 8, 2025

Conditions

Keywords

lateral epicondylitisdry needlingtrigger pointultrasound guidance

Outcome Measures

Primary Outcomes (1)

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

    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

Study Arms (2)

lateral epicondylitis and with at least one active trigger point

EXPERIMENTAL

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

Ultrasound-Guided Needle Location Verification

EXPERIMENTAL

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

Interventions

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".

Ultrasound-Guided Needle Location Verificationlateral epicondylitis and with at least one active trigger point

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
DR.

Study Record Dates

First Submitted

June 20, 2025

First Posted

June 29, 2025

Study Start

September 21, 2025

Primary Completion

September 22, 2025

Study Completion

September 23, 2025

Last Updated

September 15, 2025

Record last verified: 2025-09