NCT07079033

Brief Summary

The aim of this study is to evaluate the accuracy of invasive interventions (dry needling or injection) performed on specific muscles of the hip region in reaching the anatomical target. The accuracy of the interventions performed with a blinded method will be compared with an observational assessment supported by ultrasonography. The interventions will be performed by a physician with clinical experience, and the anatomical location of the needle tip will be evaluated by a second physician with ultrasonography after each procedure. The targeted muscles include the iliacus, pectineus, sartorius, tensor fascia latae, and rectus femoris. Each participant will be subjected to interventions for five different muscles, and a total of at least 40 injection interventions will be analyzed. Ultrasonography will be used only for observation and verification purposes; no pharmacological substances will be applied during the procedure. All procedures will be performed under sterile conditions, and participants will be monitored for 24 hours for possible pain, bruising, or complications. Participants will be informed about the content and purpose of the study, and written informed consent forms will be obtained. The study does not have a therapeutic purpose and is only intended to investigate targeting accuracy. The data to be obtained is expected to contribute to the determination of anatomical accuracy rates in clinical practices and the improvement of interventional training processes.

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 23, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 28, 2025

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

2 days

First QC Date

June 23, 2025

Last Update Submit

September 18, 2025

Conditions

Keywords

dry needlingtrigger pointultrasound guidance

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Blinded Dry Needling Injections

    Proportion of injection attempts in which the needle accurately reaches the intended target muscle using the blinded (anatomical landmark-based) technique, as confirmed by ultrasonography.

    Immediately after each injection attempt

Secondary Outcomes (1)

  • Accuracy Rate per Target Muscle

    Immediately after each injection attempt

Other Outcomes (1)

  • Inter-Operator Variability in Injection Accuracy

    2 week

Study Arms (1)

Blind Dry Needling Lumbar Paraspinal Muscles

EXPERIMENTAL

Dry needling is performed using anatomical landmarks without ultrasound guidance. Needle placement is then confirmed via ultrasound imaging.

Procedure: Blinded Dry Needling

Interventions

Dry needling is performed using anatomical landmarks without ultrasound guidance. Needle placement is then confirmed via ultrasound imaging.

Blind Dry Needling Lumbar Paraspinal Muscles

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 to 65 years
  • Individuals with nonspecific hip, groin, or anterior thigh pain who are scheduled for physical therapy
  • Clinical suspicion of myofascial pain syndrome, particularly involving muscles around the hip
  • Patients with clinical indication for dry needling or similar invasive treatments (e.g., targeting muscles such as iliacus, pectineus, sartorius)
  • Ability to cooperate with the procedure
  • Ability to provide written informed consent

You may not qualify if:

  • Use of anticoagulant medications (due to increased risk of bleeding)
  • Severe hip osteoarthritis, presence of hip prosthesis, history of previous hip surgery, or significant anatomical deformity
  • Active infection or skin lesion at the planned injection site
  • Inability to cooperate or communicate effectively
  • Pregnancy
  • Presence of serious systemic illnesses (e.g., malignancy, neurological disorders)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

nurmuhammet tas

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Dry needling is performed using anatomical landmarks without ultrasound guidance. Needle placement is then confirmed via ultrasound imaging.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr.

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 22, 2025

Study Start

September 28, 2025

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data (IPD) from this study.