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

NCT07309874 | Recruiting

• 2 other identifiers: IRB-FY2026-36No funding number available
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Headache Disorders, Primary; Headache, Cervicogenic

Keywords

Headache; cervical spine; suboccipital muscles; needle placement

Outcome Measures

Primary Outcomes (3)

• Post-needling soreness

  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

  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

  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 Outcomes (3)

• Frequency of needle placement reaching a bony structure

  Baseline

• Frequency of successful needle placement into the Rectus Capitus Posterior Major

  Baseline

• Length of unused needle at the point of bony contact

  Baseline

Other Outcomes (2)

• Intra-rater Reliability: Frequency of needle placement reaching a bony structure

  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

  Baseline during primary data collection and then again 6 months post-data collection

Study Arms (1)

Dry needling

EXPERIMENTAL

Other: Dry needling

Interventions

Dry needling OTHER

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.

Dry needling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Woman's University: collaborator
• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430-0001, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 39823665 BACKGROUND

• 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.

  PMID: 33719823 BACKGROUND

• 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.

  PMID: 30935332 BACKGROUND

• 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.

  PMID: 30353868 BACKGROUND

• 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.

  PMID: 35410119 BACKGROUND

• 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.

  PMID: 37941472 BACKGROUND

• 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.

  PMID: 33609358 BACKGROUND

• 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.

  PMID: 33066556 BACKGROUND

• 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.

  PMID: 36769852 BACKGROUND

MeSH Terms

Conditions

Headache Disorders, Primary; Post-Traumatic Headache; Headache

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Secondary; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Gary A Kearns, PT, ScD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gary A Kearns, PT, ScD

CONTACT

12142448398; gary.kearns@ttuhsc.edu

Jace A Brown, PT, PhD

CONTACT

9406897716; jbrown34@twu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: November 20, 2025
• First Posted: December 30, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)