Effect of Ultrasound-Guided Dry Needling Targeting Rectus Capitus Posterior Major on Individuals With Headaches

March 31, 2026 updated by: Texas Tech University Health Sciences Center

Headaches such as tension-type, migraine, and cervicogenic (neck-related) headaches are among the most common and disabling conditions worldwide. and are often associated with tight or sensitive muscles at the base of the skull, which can contribute to headaches. Dry needling involves inserting a very thin, sterile needle into tight muscle areas known as trigger points to relieve pain and muscle tension. When applied to the deep neck muscles, including those beneath the skull, dry needling may reduce headache symptoms. The suboccipital region contains important structures such as the vertebral artery, greater occipital nerve, and spinal cord, which requires precise needle placement to maintain safety. Many needling techniques used in this region have not been validated for accuracy or safety in living subjects. This study will use real-time ultrasound imaging to guide dry needling of the rectus capitis posterior major muscle and directly visualize nearby structures to minimize risk.

The main goals of this research are to examine the effects of a single session of ultrasound-guided dry needling on headache symptoms and to confirm the safety, accuracy, and consistency of the proposed needling technique using ultrasound imaging.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

RESEARCH DESIGN: Prospective, single-arm, repeated-measures interventional study with secondary observational ultrasound validation of two insertion angles and intra-rater test-retest reliability of ultrasound assessments at ~6 months.

PROCEDURE: Each participant will complete one study visit lasting approximately 60 minutes. During each data collection session:

  1. Screening: Participants will undergo screening for inclusion and exclusion criteria.

    o Eligible participants will then complete: A Numeric Pain Rating Scale (NPRS) of their headache pain on a scale from 0 to 10 (0 = no pain; 10 = worse pain) including: Current rating; Best rating; Worst rating in the past 6 months; Complete the Headache Disability Index (HDI)

  2. Positioning: Participants will be positioned prone on a treatment table with cervical spine alignment monitored using an inclinometer to ensure cervical lordosis is under 10°.

  3. Landmark Identification & Needle Insertion:

    • Landmark Identification: The PI will palpate and mark two bony landmarks in the upper neck including: 1. The C2 Spinous process, a distinct bone that can be felt at the top of the spine below the skull, and 2. The C1 Transverse process, a bony ridge located just below and slightly to the side of the base of the skull at ~45-degree angle from the ear. (These landmarks will help determine the correct location for the needle insertion.)
    • Needle Insertion: Sterile, 0.25 gauge/diameter, 40 mm needles will be used. A new needle will be used for each individual needle insertion before being discarded in a sharps container. The needle will be inserted just below the base of the skull, slightly off the center line of the neck. Each participant will have two separate needle insertions during the single data collection visit. Two dry needle insertion techniques will be performed in a randomized order: Method 1: 30° (relative to the frontal plane) insertion angle toward the occiput, and Method 2: 45° (relative to the frontal plane) insertion angle toward the occiput.
    • Needle Target: The target of the needle is a deep muscle (Rectus Capitus Posterior Major) that attaches to the base of the skull (occiput). For both methods, the needle will be advanced until bony contact is achieved, and then slightly pulled in/out within the muscle to visualize needle placement on ultrasound
    • Randomization of technique order (Method 1 vs. Method 2) will be generated using the list randomizer from https://www.random.org/lists/
  4. Ultrasound Imaging: An investigator will use a Sonosite PX ultrasound device to capture still images and 3-second video clips of needle placement relative to the RCPMaj and surrounding anatomy. Participants may be asked to laterally deviate their eyes to assist in muscle visualization.
  5. Data Collection: Investigators will record whether a bony backdrop was felt, if the needle reached the RCPMaj, and the length of unused needle remaining outside the skin as well as if the needle pierce through the vertebral artery.

IMMEDIATE POST-PROCEDURE: Participants will be asked to rate their current level of pain immediately following the intervention on the NPRS from 0 to 10 (0 = no pain; 10 = worse pain)

POST-PROCEDURE FOLLOW UP VISIT: 24-48 hours following data collection, participants will be asked to complete the following via a secure, anonymous online survey link to the electronic platform Qualtrics®. Participants will be sent an email with the secure survey link and reminder of their unique study ID. Participants will only use their unique assigned study ID. No identifying information (name, email address, or IP address) will be collected in Qualtrics® survey responses. Participants will report: 1) Post-needling soreness (Yes/No), 2) NRPS including Current rating, Best rating and Worst rating in the last 24-48 hours, and 3) Headache Disability Index

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Lubbock, Texas, United States, 79430-0001
        • Recruiting
        • Texas Tech University Health Sciences Center
        • Contact:

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:

  • Reports of a headache within the last 6 months (no minimum or maximum frequency or duration)
  • Current reports of headache
  • Tenderness to palpation of suboccipital muscles with Numeric Pain Rating Scale score ≥ 2/10
  • No history of cervical spine surgery or neurological disorders

Exclusion Criteria:

  • History of cervical spine trauma or surgery
  • Diagnosed bleeding disorder
  • Currently using anticoagulant medications
  • Currently using anti-platelet medications
  • Diagnosed systemic joint diseases such as rheumatoid arthritis
  • Active infection
  • Diabetes
  • Cancer
  • Fibromyalgia
  • Cervical radiculopathy
  • Inability to tolerate prone positioning for the duration of the procedure.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dry needling
Other: Dry needling
Each subject will receive two separate dry needle insertions targeting the rectus capitus posterior major. Method 1 will be 30 degrees (relative to the frontal plane) insertion angle toward the occiput. Method 2 will be 45 degrees (relative to the frontal plane) insertion angle toward the occiput.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-needling soreness
Time Frame: 24-48 hours post-data collection

Subjective outcome measures:

• Post-data collection reports of post-needling soreness (Dichotomous report: Yes or No)
24-48 hours post-data collection
Numeric Pain Rating Scale
Time Frame: Baseline immediately pre-data collection and then again 24-48 hours post-data collection
Numeric Pain Rating Scale (0 = no pain; 10 = worst pain): Pre-data collection will include Current rating, Best rating in past 6 months, and Worst rating in past 6 months. Post-data collection will include Current rating, Best rating in past 24-48 hours, and Worst rating in past 24-48 hours
Baseline immediately pre-data collection and then again 24-48 hours post-data collection
Headache Disability Index
Time Frame: Baseline immediately pre-data collection and then again 24-48 hours post-data collection
Headache Disability Index: Scores range from 0 to 100. A total score of 10-28 is considered mild disability. A total score of 30-48 is considered moderate disability. A total score of 50-68 is severe disability. A total score of 72-100 is considered complete disability. Participants will complete the Headache Disability Index immediately pre-data collection and then 24-48 hours post-data collection
Baseline immediately pre-data collection and then again 24-48 hours post-data collection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of needle placement reaching a bony structure
Time Frame: Baseline
For each needle insertion, a dichotomous decision (Yes vs. No) will be made via ultrasound imaging if the needle reached the occiput (bony structure)
Baseline
Frequency of successful needle placement into the Rectus Capitus Posterior Major
Time Frame: Baseline
For each needle insertion, a dichotomous decision (Yes vs. No) will be made via ultrasound imaging if the needle reached the Rectus Capitus Posterior Major
Baseline
Length of unused needle at the point of bony contact
Time Frame: Baseline
For each needle insertion, the length of needle remaining outside the skin will be measured in millimeters for each time the needle reaches the occiput (bony contact)
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-rater Reliability: Frequency of needle placement reaching a bony structure
Time Frame: Baseline during primary data collection and then again 6 months post-data collection
Intra-rater reliability (Cohen's kappa) will be calculated for identification of needle placement at time 0 and 6-month follow-up review. Investigators will assess secondary outcomes of frequency of needle placement reaching a bony structure at time 0 (baseline) and then again at 6 months post-data collection. The 6 month post-data collection decisions will be made from a 10 second video clip taken during primary data collection
Baseline during primary data collection and then again 6 months post-data collection
Intra-rater Reliability: Frequency of Needle Placement into Rectus Capitus Posterior Major
Time Frame: Baseline during primary data collection and then again 6 months post-data collection
Intra-rater reliability (Cohen's kappa) will be calculated for identification of needle placement at time 0 and 6-month follow-up review. Investigators will assess secondary outcomes of frequency of successful needle placement into the Rectus Capitus Posterior Major at time 0 (baseline) and then again at 6 months post-data collection. The 6 month post-data collection decisions will be made from a 10 second video clip taken during primary data collection
Baseline during primary data collection and then again 6 months post-data collection

Collaborators and Investigators

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

Sponsor

Texas Tech University Health Sciences Center

Collaborators

Texas Woman's University

Investigators

  • Principal Investigator: Gary A Kearns, PT, ScD, Texas Tech University Health Sciences Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

December 15, 2025

First Posted (Actual)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-FY2026-36
  • No funding number available (Other Grant/Funding Number: Texas Society for Advancement of Health Professions Research and Innovative Practice Grant Award)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no need to share IPD with other investigators. Once completed, there will be no need to access any IPD in the future.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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