Clinical trial NCT05444296: Superficial Dry Needling for Cervicogenic Headache
Official title: Superficial Dry Needling of the Trigeminal Nerve Innervation Sensory Field for Cervicogenic Headache: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Headache
Lead sponsor: Youngstown State University
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blinded, randomized, active control
Primary purpose: TREATMENT

Brief summary: It is unknown if applying superficial dry needling to the trigeminal innervation field improves pain and disability for patients with cervicogenic headaches. The aim of this study is to determine if superficial dry needling of the trigeminal innervation field improves pain, neck mobility, and disability in patients with cervicogenic headaches. It will also be examined if psychosocial factors such as stress, anxiety, depression and self efficacy influence improvements in pain, range of motion and neck disability.

Detailed description: Cervicogenic headache (CGH), is defined by the International Classification of Headache Disorders (ICHD) as a "headache caused by a disorder of the cervical spine and its component bony, disc, and/or soft tissue elements, usually but not invariably accompanied by neck pain. Prevalence of CGH in the general population is between .4-20%. Although the primary source of pain is generated from the upper cervical spinal levels, there is also neuro-anatomical basis of CGH involving the trigeminal nerve.

Dry needling (DN) 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 CGH but DN has only been investigated using trigger point DN to cervical musculature. Superficial DN also reduces pain associated to orthopedic spinal conditions and may be associated with a lower risk of post-treatment soreness.

Non-thrust mobilizations of the cervical spine are an accepted treatment known to reduce pain and disability associated with CGH. Their use has also been recommended in clinical practice guidelines.

This study aims to look investigate whether superficial dry needling targeting the trigeminal innervation sensory field will reduce pain and impairments known to exist in patients with CGH compared to mobilizations of the cervical spine. Mobilizations of the cervical spine are another common treatment that physical therapists employ to treat cervicogenic headaches.

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:

* Headache or neck pain \<2/10
* Contraindications to the interventions
* Whiplash associated disorder within 6 weeks
* Pending litigation for neck pain and/or headache.
* Unwilling to cease other care through duration of study

Primary outcomes:
measure: Headache or neck pain intensity on a Numeric pain rating scale (0-10)
timeFrame: <1 hour
Secondary outcomes:
measure: Flexion Rotation Test in degrees of measurement
timeFrame: <1 hour
measure: Active Range of Motion of the Cervical Spine in degrees of measurement
timeFrame: <1 hour
measure: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: <1 hour
measure: Short Form 36 (SF-36)
timeFrame: <1 hour
measure: Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: <1 hour
measure: Neck Disability Index (NDI)
timeFrame: <1 hour
measure: Headache Self Efficacy Scale (HSES)
timeFrame: <1 hour
measure: Injection Phobia Scale (IPS)
timeFrame: <1 hour
measure: Severity Measure for Specific Phobia-Adult (SMSP-A)
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 Learman, 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.