Dry Needling for Cervicogenic Headache

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

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.

Study Overview

• Status: Recruiting
• Conditions: Headache
• Intervention / Treatment: Other: Dry Needling; Other: Sham Dry Needling

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Youngstown, Ohio, United States, 44406
      • Recruiting
      • Youngstown State University
      • Contact: David W Griswold, PhD, DPT; Phone Number: 330-941-2419; Email: dwgriswold@ysu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry needling; Experimental Group	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 Comparator: Sham Needling; Sham Group	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache or neck pain intensity on a Numeric pain rating scale (0-10)	0-10 scale pain intensity	<1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Youngstown State University
• Investigators: Study Director: Ken Lieber, PhD, Director of the PhD in Health Sciences

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2021
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache
• Other Study ID Numbers: 2022-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No