Dry Needling for Cervicogenic Headache

Headache Clinical Trial

Official title:

Dry Needling of the Trigeminal Nerve Innervation Field for Cervicogenic Eadache: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05140291
• Other study ID #: 2022-6
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: November 2021
• 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

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• 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

• Pain <2/10

• Contraindications to the interventions

• Whiplash associated disorder within 6 weeks

• Pending litigation for neck pain and/or headache.

Related Conditions & MeSH terms

• Headache

Intervention

Other:
• Dry Needling
1/2" needles will placed into defined innervation fields of the trigeminal nerve and rotated. Total time will be 5-7 minutes.
• Sham Dry Needling
Needle handles inside of guide tubes will be tapped in a way similar to an actual needle being set but the sham needles will be blunted.

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	<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	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	Pain-pressure threshold in lbs of pressure	Pain-pressure threshold will be measured using an algometer at the innervation zones of the trigeminal nerve and the upper cervical spine.	<1 hour