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HeadacheNCT05140291

Dry Needling for Cervicogenic Headache

A study testing Dry Needling in people with Headache, run by Youngstown State University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Headache
What is being tested?
Dry Needling
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
3 Dec 2021to 30 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

David W Griswold, PhD contact

3307015353

dwgriswold@ysu.edu

United States1 site, 1 recruiting

  • Youngstown State University

    Youngstown, Ohio, 44406

    David W Griswold, PhD, DPT, 330-941-2419, dwgriswold@ysu.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Headache
Being tested
Dry Needling, Sham Dry Needling
Medical subject headings
Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dry NeedlingOther

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

  • 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.

Study groups in NCT05140291
Study groupRoleWhat they receive
Dry needlingExperimentalExperimental Group
Receives: Other: Dry Needling
Sham NeedlingSham comparatorSham Group
Receives: Other: Sham Dry Needling

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    0-10 scale pain intensity

    Measured: <1 hour

Secondary outcomes (3)

  1. 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.

    Measured: <1 hour

  2. 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.

    Measured: <1 hour

  3. 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.

    Measured: <1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2021
  2. Study start3 Dec 2021
  3. Primary completion30 Apr 2022 (estimated)
  4. Study completion30 Apr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double blinded, sham controlled, randomized trial.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05140291
Sponsor's protocol ID
2022-6
Status last verified
Nov 2021
First submitted
29 Oct 2021
Last updated
11 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 31948718

  • 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.

    PubMed 30813155

  • 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.

    PubMed 24623124

Questions about this trial

What is this clinical trial studying?

A study testing Dry Needling in people with Headache, run by Youngstown State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact David W Griswold, PhD (3307015353, dwgriswold@ysu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Headache or neck pain intensity on a Numeric pain rating scale (0-10) (time frame: <1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05140291, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022; AzTrials last refreshed its copy on 29 Oct 2026.

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