Superficial Dry Needling for Cervicogenic Headache

NCT05444296 | Unknown

• 1 other identifier: 2022-186
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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, 0 is no pain, 10 is severe pain, the lower the score the better

  <1 hour

Secondary Outcomes (9)

• Flexion Rotation Test in degrees of measurement

  <1 hour

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

  <1 hour

• Patient Health Questionnaire - 9 (PHQ-9)

  <1 hour

• Short Form 36 (SF-36)

  <1 hour

• Generalized Anxiety Disorder 7 (GAD-7)

  <1 hour

Study Arms (2)

Dry Needling

EXPERIMENTAL

Experimental group

Other: Superficial Dry Needling; Other: Non-thrust Mobilizations only

Upper Cervical Mobilizations

ACTIVE COMPARATOR

Active control

Other: Non-thrust Mobilizations only

Interventions

Superficial Dry Needling OTHER

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

Also known as: Non-thrust mobilizations

Dry Needling

Non-thrust Mobilizations only 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.

Dry Needling; Upper Cervical Mobilizations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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:

• 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

Sponsors & Collaborators

• Youngstown State University: lead

Study Sites (1)

Youngstown State University

Youngstown, Ohio, 44406, United States

Location

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: 31948718 BACKGROUND

• 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: 30813155 BACKGROUND

• 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: 24623124 BACKGROUND

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ken Learman, PhD

  Director of the PhD in Health Sciences

  STUDY DIRECTOR

Central Study Contacts

David W Griswold, PhD

CONTACT

3307015353; dwgriswold@ysu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will be blind to the type of intervention the participant receives.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blinded, randomized, active control

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 5, 2022
• Study Start: July 5, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)