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| ID | Type | Description | Link |
|---|---|---|---|
| No funding number available | Other Grant/Funding Number | Texas Society for Advancement of Health Professions Research and Innovative Practice Grant Award |
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| Name | Class |
|---|---|
| Texas Woman's University | OTHER |
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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)
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°.
Landmark Identification & Needle Insertion:
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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dry needling | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline |
| Frequency of successful needle placement into the Rectus Capitus Posterior Major |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gary A Kearns, PT, ScD | Contact | 12142448398 | gary.kearns@ttuhsc.edu | |
| Jace A Brown, PT, PhD | Contact | 9406897716 | jbrown34@twu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gary A Kearns, PT, ScD | Texas Tech University Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Tech University Health Sciences Center | Recruiting | Lubbock | Texas | 79430-0001 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39823665 | Background | 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. | |
| 33719823 | 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. |
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There is no need to share IPD with other investigators. Once completed, there will be no need to access any IPD in the future.
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| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D051298 | Post-Traumatic Headache |
| D006261 | Headache |
| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000079245 | Dry Needling |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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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.
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|
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 | 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 |
| 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 | Baseline during primary data collection and then again 6 months post-data collection |
| 30935332 | 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. |
| 30353868 | 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. |
| 35410119 | 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. |
| 37941472 | 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. |
| 33609358 | 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. |
| 33066556 | 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. |
| 36769852 | 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. |
| D051271 | Headache Disorders, Secondary |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |