Effect of Ultrasound-Guided Dry Needling Targeting Rectus Capitus Posterior Major on Individuals With Headaches
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Post-needling soreness
研究概览
简要总结
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.
详细描述
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) 2. 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°. 3. Landmark Identification & Needle Insertion:
- 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.)
- Needle Insertion: Sterile, 0.25 gauge/diameter, 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.
- 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/out within the muscle to visualize needle placement on ultrasound
- Randomization of technique order (Method 1 vs. Method 2) will be generated using the list randomizer from https://www.random.org/lists/
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Fibromyalgia
- •Cervical radiculopathy
- •Inability to tolerate prone positioning for the duration of the procedure.
研究组 & 干预措施
Dry needling
干预措施: Dry needling (Other)
结局指标
主要结局
Post-needling soreness
时间窗: 24-48 hours post-data collection
Subjective outcome measures: • Post-data collection reports of post-needling soreness (Dichotomous report: Yes or No)
Numeric Pain Rating Scale
时间窗: Baseline immediately pre-data collection and then again 24-48 hours post-data collection
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
时间窗: Baseline immediately pre-data collection and then again 24-48 hours post-data collection
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
次要结局
- Frequency of successful needle placement into the Rectus Capitus Posterior Major(Baseline)
- Length of unused needle at the point of bony contact(Baseline)
- Frequency of needle placement reaching a bony structure(Baseline)