Effect of Ultrasound-Guided Dry Needling Targeting Rectus Capitus Posterior Major on Individuals With Headaches

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTexas Tech University Health Sciences Center

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Dry needling

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Dry needlingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

1

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
2

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

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