NCT07074249

Brief Summary

The aim of this study is to evaluate the accuracy of blinded invasive interventions (dry needling) on the deep paraspinal muscles of the lumbar region (iliocostalis lumborum, longissimus thoracis, and multifidus) to reach the anatomical target. The accuracy of the interventions will be evaluated observationally with ultrasonography after the procedure.

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
20

participants targeted

Target at below P25 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
27 days until next milestone

First Posted

Study publicly available on registry

July 20, 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 needlingultrasound guidance

Outcome Measures

Primary Outcomes (1)

  • "Anatomical Accuracy of Blind Dry Needling Procedures on the Lumbar Paraspinal Muscles: An Ultrasonography-Assisted Observational Study"

    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)

Blind Dry Needling Lumbar Paraspinal Muscles

EXPERIMENTAL

All interventions will be performed by a physical medicine and rehabilitation specialist with clinical experience. * Targeted muscles: * \*Iliocostalis lumborum (ICL)\* * \*Longissimus thoracis (LT)\* * \*Multifidus (M)\* * Interventions will be performed from the right side, between the L2-L5 levels. * A total of \*three different dry needling applications\* will be performed for these three muscles for each participant.

Procedure: "Anatomical Accuracy of Blind Dry Needling Procedures on the Lumbar Paraspinal Muscles: An Ultrasonography-Assisted Observational Study"

Ultrasound-Guided Needle Location Verification

EXPERIMENTAL

All interventions will be performed by a physical medicine and rehabilitation specialist with clinical experience. \* Targeted muscles: \* \*Iliocostalis lumborum (ICL)\* \* \*Longissimus thoracis (LT)\* \* \*Multifidus (M)\* \* Interventions will be performed from the right side, between the L2-L5 levels. \* A total of \*three different dry needling applications\* will be performed for these three muscles for each participant. After the needling procedure, a second clinician evaluates the needle's location in the muscle using ultrasonography.

Procedure: "Anatomical Accuracy of Blind Dry Needling Procedures on the Lumbar Paraspinal Muscles: An Ultrasonography-Assisted Observational Study"

Interventions

* All interventions will be performed by a physical medicine and rehabilitation specialist with clinical experience. * Targeted muscles: * \*Iliocostalis lumborum (ICL)\* * \*Longissimus thoracis (LT)\* * \*Multifidus (M)\* * Interventions will be performed from the right side, between the L2-L5 levels. * A total of \*three different dry needling applications\* will be performed for these three muscles for each participant.

Blind Dry Needling Lumbar Paraspinal MusclesUltrasound-Guided Needle Location Verification

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18-65
  • Individuals with nonspecific low back or back pain and planned physical therapy
  • Individuals with suspected MPS, especially in the paraspinal muscles
  • Individuals with indications for dry needling
  • Those who can cooperate with the procedure and give written consent

You may not qualify if:

  • \* Anticoagulant use
  • History of spine surgery, deformity, severe scoliosis
  • Regional skin lesion or infection
  • Patients who cannot cooperate
  • Pregnancy
  • Serious systemic diseases such as malignancy or neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

nurmuhammet tas, dr.

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 20, 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