Ultrasound-guided needling of a deep neck (suboccipital) muscle for headache relief
Effect of Ultrasound-Guided Dry Needling Targeting Rectus Capitus Posterior Major on Individuals With Headaches
This trial will try ultrasound-guided dry needling of a deep neck muscle to see if it reduces headache pain in adults who have recent headaches and tenderness at the base of the skull.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Texas Tech University Health Sciences Center Academic / other |
| Locations | 1 site (Lubbock, Texas) |
| Trial ID | NCT07309874 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm, repeated-measures interventional study enrolling adults with recent headaches and palpation tenderness of the suboccipital muscles. Each participant attends one approximately 60-minute visit during which baseline pain (Numeric Pain Rating Scale) and the Headache Disability Index are recorded, cervical position is standardized, and the principal investigator uses real-time ultrasound to guide dry needling of the rectus capitis posterior major while visualizing adjacent structures. The protocol also includes secondary ultrasound validation of two needle insertion angles and intra-rater test-retest reliability of ultrasound assessments at around six months. Sterile 0.25 gauge, 40 mm needles are used and bony landmarks (C2 spinous process and C1 transverse process) are identified to minimize risk.
Who should consider this trial
Good fit: Adults who have had a headache within the past six months, currently have headache symptoms, and show tenderness of the suboccipital muscles, without prior cervical spine surgery or contraindicating medical conditions, are the ideal candidates.
Not a fit: People without suboccipital muscle tenderness, or with excluded conditions such as prior cervical spine trauma or surgery, bleeding disorders, use of anticoagulant or antiplatelet medications, diabetes, active infection, cancer, fibromyalgia, cervical radiculopathy, or inability to tolerate prone positioning may not benefit or be eligible.
Why it matters
Potential benefit: If successful, the procedure could reduce headache pain and improve function while demonstrating a safer, image-guided approach for deep suboccipital needling.
How similar studies have performed: Some prior dry needling studies for tension-type and cervicogenic headaches have shown symptom improvement, but ultrasound-guided needling of the rectus capitis posterior major with live-subject validation is largely novel and not well validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lubbock, Texas
- Texas Tech University Health Sciences Center — Lubbock, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Gary A Kearns, PT, ScD — Texas Tech University Health Sciences Center
- Study coordinator: Gary A Kearns, PT, ScD
- Email: gary.kearns@ttuhsc.edu
- Phone: 12142448398
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.