NCT05140291

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

December 3, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

January 11, 2022

Status Verified

November 1, 2021

Enrollment Period

5 months

First QC Date

October 29, 2021

Last Update Submit

December 20, 2021

Conditions

Headache

Outcome Measures

Primary Outcomes (1)

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

    0-10 scale pain intensity

    <1 hour

Secondary Outcomes (3)

  • Active Range of Motion of the Cervical Spine in degrees of measurement

    <1 hour

  • Flexion-rotation test in degrees of measurement

    <1 hour

  • Pain-pressure threshold in lbs of pressure

    <1 hour

Study Arms (2)

Dry needling

EXPERIMENTAL

Experimental Group

Other: Dry Needling

Sham Needling

SHAM COMPARATOR

Sham Group

Other: Sham Dry Needling

Interventions

Dry NeedlingOTHER

1/2" needles will placed into defined innervation fields of the trigeminal nerve and rotated. Total time will be 5-7 minutes.

Dry needling
Sham Dry NeedlingOTHER

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.

Sham Needling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pain \<2/10
  • Contraindications to the interventions
  • Whiplash associated disorder within 6 weeks
  • Pending litigation for neck pain and/or headache.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Youngstown State University

Youngstown, Ohio, 44406, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 31948718BACKGROUND

  • 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.

    PMID: 30813155BACKGROUND

  • 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.

    PMID: 24623124BACKGROUND

MeSH Terms

Conditions

Headache

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Ken Lieber, PhD

    Director of the PhD in Health Sciences

    STUDY DIRECTOR

Central Study Contacts

David W Griswold, PhD

CONTACT

3307015353dwgriswold@ysu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Patients will be asked to keep their eyes closed during the treatment. Clinicians will be blinded to group and outcomes
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double blinded, sham controlled, randomized trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2021

First Posted

December 1, 2021

Study Start

December 3, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

January 11, 2022

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)