Superficial Dry Needling for Cervicogenic Headache

NCT ID: NCT05444296

Last Updated: 2022-07-11

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

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-05

Study Completion Date

2023-12-31

Brief Summary

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It is unknown if applying superficial dry needling to the trigeminal innervation field improves pain and disability for patients with cervicogenic headaches. The aim of this study is to determine if superficial dry needling of the trigeminal innervation field improves pain, neck mobility, and disability in patients with cervicogenic headaches. It will also be examined if psychosocial factors such as stress, anxiety, depression and self efficacy influence improvements in pain, range of motion and neck disability.

Detailed Description

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Cervicogenic headache (CGH), is defined by the International Classification of Headache Disorders (ICHD) as a "headache caused by a disorder of the cervical spine and its component bony, disc, and/or soft tissue elements, usually but not invariably accompanied by neck pain. Prevalence of CGH in the general population is between .4-20%. Although the primary source of pain is generated from the upper cervical spinal levels, there is also neuro-anatomical basis of CGH involving the trigeminal nerve.

Dry needling (DN) 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 CGH but DN has only been investigated using trigger point DN to cervical musculature. Superficial DN also reduces pain associated to orthopedic spinal conditions and may be associated with a lower risk of post-treatment soreness.

Non-thrust mobilizations of the cervical spine are an accepted treatment known to reduce pain and disability associated with CGH. Their use has also been recommended in clinical practice guidelines.

This study aims to look investigate whether superficial dry needling targeting the trigeminal innervation sensory field will reduce pain and impairments known to exist in patients with CGH compared to mobilizations of the cervical spine. Mobilizations of the cervical spine are another common treatment that physical therapists employ to treat cervicogenic headaches.

Conditions

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Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single blinded, randomized, active control
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessor will be blind to the type of intervention the participant receives.

Study Groups

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Dry Needling

Experimental group

Group Type EXPERIMENTAL

Superficial 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.

Non-thrust Mobilizations only

Intervention Type OTHER

Non-thrust mobilizations to be applied to the most symptomatic level of the upper cervical spine as determined by a treating physical therapist. The mobilization technique will be applied for 3 bouts of 30 seconds.

Upper Cervical Mobilizations

Active control

Group Type ACTIVE_COMPARATOR

Non-thrust Mobilizations only

Intervention Type OTHER

Non-thrust mobilizations to be applied to the most symptomatic level of the upper cervical spine as determined by a treating physical therapist. The mobilization technique will be applied for 3 bouts of 30 seconds.

Interventions

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Superficial 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

Non-thrust Mobilizations only

Non-thrust mobilizations to be applied to the most symptomatic level of the upper cervical spine as determined by a treating physical therapist. The mobilization technique will be applied for 3 bouts of 30 seconds.

Intervention Type OTHER

Other Intervention Names

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Non-thrust mobilizations

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

* Headache or neck pain \<2/10
* Contraindications to the interventions
* Whiplash associated disorder within 6 weeks
* Pending litigation for neck pain and/or headache.
* Unwilling to cease other care through duration of study
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 Learman, 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

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

Role: primary

330-701-5353

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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2022-186

Identifier Type: -

Identifier Source: org_study_id

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