[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07309874":3,"trial-entities:NCT07309874":141,"trial-summary:NCT07309874":144},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":37,"secondary_outcomes":49,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":14,"eligibility_criteria":63,"std_ages":82,"locations":85,"central_contacts":100,"overall_officials":108,"references":111,"see_also_links":140},"NCT07309874","IRB-FY2026-36","Effect of Ultrasound-Guided Dry Needling Targeting Rectus Capitus Posterior Major on Individuals With Headaches","RECRUITING","2026-06-01","2026-03","2026-04-01","2026-03-01","Texas Tech University Health Sciences Center","OTHER",false,"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.\n\nThe 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.\n\nPROCEDURE: Each participant will complete one study visit lasting approximately 60 minutes. During each data collection session:\n\n1. Screening: Participants will undergo screening for inclusion and exclusion criteria.\n\n   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)\n2. 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°.\n3. Landmark Identification \\& Needle Insertion:\n\n   * 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.)\n   * Needle Insertion: Sterile, 0.25 gauge\u002Fdiameter, 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.\n   * 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\u002Fout within the muscle to visualize needle placement on ultrasound\n   * Randomization of technique order (Method 1 vs. Method 2) will be generated using the list randomizer from https:\u002F\u002Fwww.random.org\u002Flists\u002F\n4. 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.\n5. 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.\n\nIMMEDIATE 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)\n\nPOST-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\u002FNo), 2) NRPS including Current rating, Best rating and Worst rating in the last 24-48 hours, and 3) Headache Disability Index",[18,19],"Headache Disorders, Primary","Headache, Cervicogenic",[21,22,23,24],"Headache","cervical spine","suboccipital muscles","needle placement","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},50,"ESTIMATED",[33],{"type":13,"name":34,"description":35,"armGroupLabels":36},"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.",[34],[38,42,46],{"measure":39,"description":40,"timeFrame":41},"Post-needling soreness","Subjective outcome measures:\n\n• Post-data collection reports of post-needling soreness (Dichotomous report: Yes or No)","24-48 hours post-data collection",{"measure":43,"description":44,"timeFrame":45},"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",{"measure":47,"description":48,"timeFrame":45},"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",[50,54,57],{"measure":51,"description":52,"timeFrame":53},"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",{"measure":55,"description":56,"timeFrame":53},"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",{"measure":58,"description":59,"timeFrame":53},"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)","ALL","18 Years","65 Years",{"inclusion":64,"exclusion":69,"raw_text":81},[65,66,67,68],"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\u002F10","No history of cervical spine surgery or neurological disorders",[70,71,72,73,74,75,76,77,78,79,80],"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.","Inclusion Criteria:\n\n* Reports of a headache within the last 6 months (no minimum or maximum frequency or duration)\n* Current reports of headache\n* Tenderness to palpation of suboccipital muscles with Numeric Pain Rating Scale score ≥ 2\u002F10\n* No history of cervical spine surgery or neurological disorders\n\nExclusion Criteria:\n\n* History of cervical spine trauma or surgery\n* Diagnosed bleeding disorder\n* Currently using anticoagulant medications\n* Currently using anti-platelet medications\n* Diagnosed systemic joint diseases such as rheumatoid arthritis\n* Active infection\n* Diabetes\n* Cancer\n* Fibromyalgia\n* Cervical radiculopathy\n* Inability to tolerate prone positioning for the duration of the procedure.",[83,84],"ADULT","OLDER_ADULT",[86],{"facility":12,"status":7,"city":87,"state":88,"zip":89,"country":90,"contacts":91,"geoPoint":97},"Lubbock","Texas","79430-0001","United States",[92],{"name":93,"role":94,"phone":95,"email":96},"Gary Kearns","CONTACT","214-244-8398","gary.kearns@ttuhsc.edu",{"lat":98,"lon":99},33.57786,-101.85517,[101,104],{"name":102,"role":94,"phone":103,"email":96},"Gary A Kearns, PT, ScD","12142448398",{"name":105,"role":94,"phone":106,"email":107},"Jace A Brown, PT, PhD","9406897716","jbrown34@twu.edu",[109],{"name":102,"affiliation":12,"role":110},"PRINCIPAL_INVESTIGATOR",[112,116,119,122,125,128,131,134,137],{"pmid":113,"type":114,"citation":115},"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\u002Fj.msksp.2025.103260. Epub 2025 Jan 10.",{"pmid":117,"type":114,"citation":118},"33719823","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\u002F09593985.2021.1901326. Epub 2021 Mar 15.",{"pmid":120,"type":114,"citation":121},"30935332","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\u002F10669817.2019.1567011. Epub 2019 Jan 19.",{"pmid":123,"type":114,"citation":124},"30353868","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\u002FS1474-4422(18)30322-3.",{"pmid":126,"type":114,"citation":127},"35410119","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\u002Fs10194-022-01402-2.",{"pmid":129,"type":114,"citation":130},"37941472","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\u002Fptj\u002Fpzad154.",{"pmid":132,"type":114,"citation":133},"33609358","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\u002Fptj\u002Fpzab068.",{"pmid":135,"type":114,"citation":136},"33066556","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\u002Fjcm9103300.",{"pmid":138,"type":114,"citation":139},"36769852","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\u002Fjcm12031205.",[],{"nct_id":4,"conditions":142,"biomarkers":143},[21],[],{"nct_id":4,"found":145,"summary":146,"prompt_version":156},true,{"design":147,"status":148,"heading":149,"summary":150,"follow_up":151,"word_count":152,"commitments":153,"compensation":154,"drugs_mentioned":155},"This is a single-arm study, meaning all participants will receive the dry needling intervention. It plans to enroll 50 participants.","completed","Ultrasound-Guided Dry Needling for Headaches","This study is looking at how a treatment called dry needling might help people with headaches, including tension-type, migraine, and cervicogenic (neck-related) headaches. Dry needling involves inserting very thin needles into tight muscles, specifically the rectus capitus posterior major muscles at the base of your skull, which can contribute to headaches. Researchers will use ultrasound to guide the needles and test two different insertion angles (30 degrees and 45 degrees). They want to see if this treatment reduces headache pain and disability. You might be able to join if you are between 18 and 65 years old, have had headaches in the last six months, and have tenderness in your neck muscles. The study will measure how much soreness you feel after needling, your pain levels, and how headaches affect your daily life. The current status of this study is unclear.","Your post-needling soreness, pain levels, and headache disability will be measured again 24-48 hours after the data collection session.",141,"You will have one study visit lasting about 60 minutes. During this visit, you will be screened, complete pain and disability questionnaires, and receive the dry needling procedure.","Not stated in the trial record.",[34],"v2"]