Superficial Dry Needling for Cervicogenic Headache

Headache Clinical Trial

Official title:

Superficial Dry Needling of the Trigeminal Nerve Innervation Sensory Field for Cervicogenic Headache: a Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05444296
• Other study ID #: 2022-186
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 5, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: Youngstown State University
• Contact: David W Griswold, PhD
• Phone: 3307015353
• Email: dwgriswold[@]ysu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 133
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Post-Traumatic Headache

Intervention

Other:
• Superficial Dry Needling
1/2" needles will placed into defined innervation fields of the trigeminal nerve and rotated. Total time will be 5-7 minutes.
• Non-thrust Mobilizations only
Non-thrust mobilizations to be applied to the most symptomatic level of the upper cervical spine as determined by a treating physical therapist. The mobilization technique will be applied for 3 bouts of 30 seconds.

Locations

Country	Name	City	State
United States	Youngstown State University	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Youngstown State University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View Citation

Gildir S, Tüzün 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. — View Citation

Vázquez-Justes D, Yarzábal-Rodríguez R, Doménech-García V, Herrero P, Bellosta-López P. Effectiveness of dry needling for headache: A systematic review. Neurologia (Engl Ed). 2020 Jan 13. pii: S0213-4853(19)30144-6. doi: 10.1016/j.nrl.2019.09.010. [Epub ahead of print] Review. English, Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache or neck pain intensity on a Numeric pain rating scale (0-10)	0-10 scale pain intensity, 0 is no pain, 10 is severe pain, the lower the score the better	<1 hour
Secondary	Flexion Rotation Test in degrees of measurement	Flexion-rotation test for CGH will be measured to determine any change in measure for c1-c2 mobility.	<1 hour
Secondary	Active Range of Motion of the Cervical Spine in degrees of measurement	Active range of motion will be measured in the most painful and or limited plane of movement.	<1 hour
Secondary	Patient Health Questionnaire - 9 (PHQ-9)	Patient Health Questionnaire-9 is used to assess the severity of depression an individual may have. It is scored from 1-27. The lower the score, the lower the severity of depression an individual has.	<1 hour
Secondary	Short Form 36 (SF-36)	Short Form-36 is used to assess quality of life. Each section of the Short Form 36 is scored with weight scores from 0-100. There is specific coding per section to assess different aspects of quality of life, for example physical functioning, emotional wellbeing. 100 in each section indicates a person is functioning at the highest level possible.	<1 hour
Secondary	Generalized Anxiety Disorder 7 (GAD-7)	Generalized Anxiety Disorder-7 is used to assess the severity of anxiety an individual may have. The Generalized Anxiety Disorder 7 is scored from 0-21. A lower score indicates less severity of anxiety.	<1 hour
Secondary	Neck Disability Index (NDI)	Neck Disability Index is used to assess how much an individual's neck pain affects daily life. The Neck Disability Index is scored from 0-50 and transformed into a percentage. This indicates the amount of disability someone has. The lower the score, the less disability is caused by neck pain.	<1 hour
Secondary	Headache Self Efficacy Scale (HSES)	Headache Self Efficacy Scale is used to assess an individual's belief they can do things to prevent headaches. Higher scores indicate higher self efficacy. The items have scoring from 1-7 with 1 being strongly disagree and 7 being strongly agree. Some items are reverse scored. The scores can range from 79-121.	<1 hour
Secondary	Injection Phobia Scale (IPS)	The Injection Phobia Scale assesses a person's fear or anxiety toward injections. It is scored 0-32 with the higher score indicating more severity of a phobia of injections.	<1 hour
Secondary	Severity Measure for Specific Phobia-Adult (SMSP-A)	The Severity Measure for Specific Phobia-Adult assesses symptoms a person feels in response to injections and/or needles. It is scored 0-40 with higher scores indicating more severity of phobia of needles.	<1 hour