An interventional study of Dry needling in Headache Disorders, Primary and Headache, Cervicogenic, sponsored by Texas Tech University Health Sciences Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Texas Tech University Health Sciences Center · Not applicable, Interventional, and Treatment
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.
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:
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)
Landmark Identification \& Needle Insertion:
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
42 studies on the registry are indexed under Headache Disorders, Primary; 13 are open to participants now.
This study's planned enrollment of 50 is close to the median of 50 across 19 interventional studies indexed under Headache Disorders, Primary.
Browse Headache Disorders, Primary studies →Texas Tech University Health Sciences Center is the lead sponsor of 100 studies on the registry; 14 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Post-needling soreness
Subjective outcome measures: • Post-data collection reports of post-needling soreness (Dichotomous report: Yes or No)
Time frame: 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
Time frame: 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
Time frame: Baseline immediately pre-data collection and then again 24-48 hours post-data collection
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)
Time frame: Baseline
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
Time frame: Baseline
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)
Time frame: Baseline
Intra-rater Reliability: Frequency of needle placement reaching a bony structure
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
Time frame: 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
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
Time frame: Baseline during primary data collection and then again 6 months post-data collection
Plan to share: 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.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.
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