About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
History of cervical spine trauma or surgery
Diagnosed bleeding disorder
Currently using anticoagulant medications
Currently using anti-platelet medications
Trial design
Single group
Treatments tested in this trial
Dry needling
Other interventionEach 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.
Treatment groups
Trial outcomes
Primary outcomes
Post-needling soreness
Subjective outcome measures: • Post-data collection reports of post-needling soreness (Dichotomous report: Yes or No)
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
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
Secondary outcomes
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)
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
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)
Other outcomes
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
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
Sponsors and contacts
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Texas Tech University Health Sciences Center
Lead sponsor
Texas Woman's University
Collaborator