Clinical trial NCT05140291: Dry Needling for Cervicogenic Headache
Official title: Dry Needling of the Trigeminal Nerve Innervation Field for Cervicogenic Eadache: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Headache
Lead sponsor: Youngstown State University
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded, sham controlled, randomized trial.
Primary purpose: TREATMENT

Brief summary: Currently, it is unknown if dry needling when performed to the trigeminal innervation field improves neck pain and or headache for patients with cervicogenic headaches. The aim of this study is to determine if dry needling of the trigeminal innervation field improves pain, pain-pressure thresholds, and neck mobility in patients with cervicogenic headaches, with or without migraine.

Detailed description: Dry needling is a widely used intervention performed by physical therapists for a wide range of musculoskeletal and neurological conditions. Dry needling has been shown to be beneficial for cervicogenic headaches but treatment is typically applied to the neck. It is well-established that cervical pain can upregulate the trigeminal nerve and vice versa in various forms of headaches. Thus, it is plausable that reducing inflammation and irritation of the trigeminal nerve may in fact reduce neck pain and impairments. This study aims to look investigate whether dry needling the trigeminal innervation field will reduce pain and impairments known to exist in patients with cervicogenic headaches compared to a sham comparator. The study is a pilot trial for a larger RCT and will look at immediate effects only.

Eligibility criteria: Inclusion Criteria:

* Aged 18 or older
* Symptoms: (1)Unilateral pain starting in the neck and radiating to the frontotemporal region or posterior fossa, (2) pain aggravated by neck movement, (3) restricted cervical range of motion, (4) non-throbbing and non-lancinatingnpain, 5) dysfunction/headache pain in at least one of the joints of the upper cervical spine(C0-C4), and (6) headache frequency of at least 1 per week over a period greater than 3 months.

Exclusion Criteria

* Pain \<2/10
* Contraindications to the interventions
* Whiplash associated disorder within 6 weeks
* Pending litigation for neck pain and/or headache.

Primary outcomes:
measure: Headache or neck pain intensity on a Numeric pain rating scale (0-10)
timeFrame: <1 hour
Secondary outcomes:
measure: Active Range of Motion of the Cervical Spine in degrees of measurement
timeFrame: <1 hour
measure: Flexion-rotation test in degrees of measurement
timeFrame: <1 hour
measure: Pain-pressure threshold in lbs of pressure
timeFrame: <1 hour
Other outcomes:
Locations:
city: Youngstown
country: United States
facility: Youngstown State University
state: Ohio
Study officials:
affiliation: Director of the PhD in Health Sciences
name: Ken Lieber, PhD
role: STUDY_DIRECTOR
References:
citation: Vazquez-Justes D, Yarzabal-Rodriguez R, Domenech-Garcia V, Herrero P, Bellosta-Lopez P. Effectiveness of dry needling for headache: A systematic review. Neurologia (Engl Ed). 2020 Jan 13:S0213-4853(19)30144-6. doi: 10.1016/j.nrl.2019.09.010. Online ahead of print. English, Spanish.
citation: Gildir S, Tuzun EH, Eroglu G, Eker L. A randomized trial of trigger point dry needling versus sham needling for chronic tension-type headache. Medicine (Baltimore). 2019 Feb;98(8):e14520. doi: 10.1097/MD.0000000000014520.
citation: France S, Bown J, Nowosilskyj M, Mott M, Rand S, Walters J. Evidence for the use of dry needling and physiotherapy in the management of cervicogenic or tension-type headache: a systematic review. Cephalalgia. 2014 Oct;34(12):994-1003. doi: 10.1177/0333102414523847. Epub 2014 Mar 12.