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Headache Disorders, PrimaryNCT07309874

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

A study testing Dry needling in people with Headache Disorders, Primary and Headache, Cervicogenic, run by Texas Tech University Health Sciences Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Dry needling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
1 Mar 2026to 1 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • Diabetes
  • Cancer
  • Fibromyalgia
  • Cervical radiculopathy
  • Inability to tolerate prone positioning for the duration of the procedure.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gary A Kearns, PT, ScD contact

12142448398

gary.kearns@ttuhsc.edu

Jace A Brown, PT, PhD contact

9406897716

jbrown34@twu.edu

United States1 site, 1 recruiting
  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430-0001

    Gary Kearns, 214-244-8398, gary.kearns@ttuhsc.edu

    Recruiting

Other trials in United States

About this study

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.

Read the 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.
  • 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)
  1. 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°.
  2. 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/
  1. 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.
  2. 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

Being tested
Dry needling
Keywords
Headache, cervical spine, suboccipital muscles, needle placement
Medical subject headings
Headache Disorders, Primary, Post-Traumatic Headache, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dry needlingOther

    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.

Study groups in NCT07309874
Study groupRoleWhat they receive
Dry needlingExperimentalNot described
Receives: Other: Dry needling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-needling soreness

    Subjective outcome measures:

    • Post-data collection reports of post-needling soreness (Dichotomous report: Yes or No)

    Measured: 24-48 hours post-data collection

  2. Numeric Pain Rating Scale

    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

    Measured: Baseline immediately pre-data collection and then again 24-48 hours post-data collection

  3. Headache Disability Index

    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

    Measured: Baseline immediately pre-data collection and then again 24-48 hours post-data collection

Secondary outcomes (3)
  1. Frequency of needle placement reaching a bony structure

    For each needle insertion, a dichotomous decision (Yes vs. No) will be made via ultrasound imaging if the needle reached the occiput (bony structure)

    Measured: Baseline

  2. Frequency of successful needle placement into the Rectus Capitus Posterior Major

    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

    Measured: Baseline

  3. Length of unused needle at the point of bony contact

    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)

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2025
  2. Study start1 Mar 2026
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07309874
Sponsor's protocol ID
IRB-FY2026-36
Other IDs
No funding number available
Status last verified
Sep 2026
First submitted
20 Nov 2025
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no need to share IPD with other investigators. Once completed, there will be no need to access any IPD in the future.

Publications

  • Kearns GA, Lierly M, Gilbert KK, Dommerholt J. Guidelines to minimize risk when dry needling the rectus capitus posterior major muscle. Musculoskelet Sci Pract. 2025 Apr;76:103260. doi: 10.1016/j.msksp.2025.103260. Epub 2025 Jan 10.

    PubMed 39823665
  • Kearns GA, Hooper TL, Brismee JM, Allen B, Lierly M, Gilbert KK, Pendergrass TJ, Edwards D. Influence of clinical experience on accuracy and safety of obliquus capitus inferior dry needling in unembalmed cadavers. Physiother Theory Pract. 2022 Dec;38(12):2052-2061. doi: 10.1080/09593985.2021.1901326. Epub 2021 Mar 15.

    PubMed 33719823
  • Kearns G, Fernandez-De-Las-Penas C, Brismee JM, Gan J, Doidge J. New perspectives on dry needling following a medical model: are we screening our patients sufficiently? J Man Manip Ther. 2019 Jul;27(3):172-179. doi: 10.1080/10669817.2019.1567011. Epub 2019 Jan 19.

    PubMed 30935332
  • GBD 2016 Headache Collaborators. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):954-976. doi: 10.1016/S1474-4422(18)30322-3.

    PubMed 30353868
  • Stovner LJ, Hagen K, Linde M, Steiner TJ. The global prevalence of headache: an update, with analysis of the influences of methodological factors on prevalence estimates. J Headache Pain. 2022 Apr 12;23(1):34. doi: 10.1186/s10194-022-01402-2.

    PubMed 35410119
  • Jung A, Carvalho GF, Szikszay TM, Pawlowsky V, Gabler T, Luedtke K. Physical Therapist Interventions to Reduce Headache Intensity, Frequency, and Duration in Patients With Cervicogenic Headache: A Systematic Review and Network Meta-Analysis. Phys Ther. 2024 Feb 1;104(2):pzad154. doi: 10.1093/ptj/pzad154.

    PubMed 37941472
  • Pourahmadi M, Dommerholt J, Fernandez-de-Las-Penas C, Koes BW, Mohseni-Bandpei MA, Mansournia MA, Delavari S, Keshtkar A, Bahramian M. Dry Needling for the Treatment of Tension-Type, Cervicogenic, or Migraine Headaches: A Systematic Review and Meta-Analysis. Phys Ther. 2021 May 4;101(5):pzab068. doi: 10.1093/ptj/pzab068.

    PubMed 33609358
  • Navarro-Santana MJ, Sanchez-Infante J, Fernandez-de-Las-Penas C, Cleland JA, Martin-Casas P, Plaza-Manzano G. Effectiveness of Dry Needling for Myofascial Trigger Points Associated with Neck Pain Symptoms: An Updated Systematic Review and Meta-Analysis. J Clin Med. 2020 Oct 14;9(10):3300. doi: 10.3390/jcm9103300.

    PubMed 33066556
  • Chys M, De Meulemeester K, De Greef I, Murillo C, Kindt W, Kouzouz Y, Lescroart B, Cagnie B. Clinical Effectiveness of Dry Needling in Patients with Musculoskeletal Pain-An Umbrella Review. J Clin Med. 2023 Feb 2;12(3):1205. doi: 10.3390/jcm12031205.

    PubMed 36769852

Questions about this trial

What is this clinical trial studying?

A study testing Dry needling in people with Headache Disorders, Primary and Headache, Cervicogenic, run by Texas Tech University Health Sciences Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gary A Kearns, PT, ScD (12142448398, gary.kearns@ttuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-needling soreness (time frame: 24-48 hours post-data collection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07309874, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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