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Dry Needling for Cervicogenic Headache

Primary Purpose

Headache

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dry Needling
Sham Dry Needling
Sponsored by
Youngstown State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Youngstown State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Dry needling

Sham Needling

Arm Description

Experimental Group

Sham Group

Outcomes

Primary Outcome Measures

Headache or neck pain intensity on a Numeric pain rating scale (0-10)
0-10 scale pain intensity

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 29, 2021
Last Updated
December 20, 2021
Sponsor
Youngstown State University
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1. Study Identification

Unique Protocol Identification Number
NCT05140291
Brief Title
Dry Needling for Cervicogenic Headache
Official Title
Dry Needling of the Trigeminal Nerve Innervation Field for Cervicogenic Eadache: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Youngstown State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blinded, sham controlled, randomized trial.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Patients will be asked to keep their eyes closed during the treatment. Clinicians will be blinded to group and outcomes
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dry needling
Arm Type
Experimental
Arm Description
Experimental Group
Arm Title
Sham Needling
Arm Type
Sham Comparator
Arm Description
Sham Group
Intervention Type
Other
Intervention Name(s)
Dry Needling
Intervention Description
1/2" needles will placed into defined innervation fields of the trigeminal nerve and rotated. Total time will be 5-7 minutes.
Intervention Type
Other
Intervention Name(s)
Sham Dry Needling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Headache or neck pain intensity on a Numeric pain rating scale (0-10)
Description
0-10 scale pain intensity
Time Frame
<1 hour
Secondary Outcome Measure Information:
Title
Active Range of Motion of the Cervical Spine in degrees of measurement
Description
Active range of motion will be measured in the most painful and or limited plane of movement.
Time Frame
<1 hour
Title
Flexion-rotation test in degrees of measurement
Description
Flexion-rotation test for CGH will be measured to determine any change in measure for c1-c2 mobility.
Time Frame
<1 hour
Title
Pain-pressure threshold in lbs of pressure
Description
Pain-pressure threshold will be measured using an algometer at the innervation zones of the trigeminal nerve and the upper cervical spine.
Time Frame
<1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David W Griswold, PhD
Phone
3307015353
Email
dwgriswold@ysu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Lieber, PhD
Organizational Affiliation
Director of the PhD in Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Youngstown State University
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44406
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David W Griswold, PhD, DPT
Phone
330-941-2419
Email
dwgriswold@ysu.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31948718
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.
Results Reference
background
PubMed Identifier
30813155
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.
Results Reference
background
PubMed Identifier
24623124
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.
Results Reference
background

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Dry Needling for Cervicogenic Headache

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