Dry Needling for Cervicogenic Headache

NCT ID: NCT05140291

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-03

Study Completion Date

2022-04-30

Brief Summary

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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

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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

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Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blinded, sham controlled, randomized trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Patients will be asked to keep their eyes closed during the treatment. Clinicians will be blinded to group and outcomes

Study Groups

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Dry needling

Experimental Group

Group Type EXPERIMENTAL

Dry Needling

Intervention Type OTHER

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

Sham Needling

Sham Group

Group Type SHAM_COMPARATOR

Sham Dry Needling

Intervention Type OTHER

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.

Interventions

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Dry Needling

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

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Youngstown State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ken Lieber, PhD

Role: STUDY_DIRECTOR

Director of the PhD in Health Sciences

Locations

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Youngstown State University

Youngstown, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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David W Griswold, PhD

Role: CONTACT

3307015353

Facility Contacts

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David W Griswold, PhD, DPT

Role: primary

330-941-2419

References

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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.

Reference Type BACKGROUND
PMID: 31948718 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30813155 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24623124 (View on PubMed)

Other Identifiers

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2022-6

Identifier Type: -

Identifier Source: org_study_id

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