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HeadacheNCT05444296

Superficial Dry Needling for Cervicogenic Headache

A study testing Superficial Dry Needling and Non-thrust Mobilizations only 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 The sponsor has not verified this record for over two years, so it may be out of date.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

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Headache
What is being tested?
Superficial Dry Needling and Non-thrust Mobilizations only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
133 participants
Where
1 siteUnited States
Study dates
5 Jul 2022to 31 Dec 2023
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

  • 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

Trial locations and contacts

1 site in 1 country.

David W Griswold, PhD contact

3307015353

dwgriswold@ysu.edu

United States1 site

  • Youngstown State University

    Youngstown, Ohio, 44406

    David W Griswold, PhD, 330-701-5353, dwgriswold@ysu.edu

Other trials in United States

About this study

Official title: Superficial Dry Needling of the Trigeminal Nerve Innervation Sensory Field for Cervicogenic Headache: a Randomized Clinical Trial

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.

Read the detailed description

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
Headache
Being tested
Superficial Dry Needling, Non-thrust Mobilizations only
Medical subject headings
Headache

What participants receive

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

  • Superficial Dry NeedlingOther

    Also called Non-thrust mobilizations

    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 onlyOther

    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.

Study groups in NCT05444296
Study groupRoleWhat they receive
Dry NeedlingExperimentalExperimental group
Receives: Other: Superficial Dry Needling; Other: Non-thrust Mobilizations only
Upper Cervical MobilizationsActive comparatorActive control
Receives: Other: Non-thrust Mobilizations only

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

    Measured: <1 hour

Secondary outcomes (9)

  1. 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

  2. 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

  3. Patient Health Questionnaire - 9 (PHQ-9)

    Patient Health Questionnaire-9 is used to assess the severity of depression an individual may have. It is scored from 1-27. The lower the score, the lower the severity of depression an individual has.

    Measured: <1 hour

  4. Short Form 36 (SF-36)

    Short Form-36 is used to assess quality of life. Each section of the Short Form 36 is scored with weight scores from 0-100. There is specific coding per section to assess different aspects of quality of life, for example physical functioning, emotional wellbeing. 100 in each section indicates a person is functioning at the highest level possible.

    Measured: <1 hour

  5. Generalized Anxiety Disorder 7 (GAD-7)

    Generalized Anxiety Disorder-7 is used to assess the severity of anxiety an individual may have. The Generalized Anxiety Disorder 7 is scored from 0-21. A lower score indicates less severity of anxiety.

    Measured: <1 hour

  6. Neck Disability Index (NDI)

    Neck Disability Index is used to assess how much an individual's neck pain affects daily life. The Neck Disability Index is scored from 0-50 and transformed into a percentage. This indicates the amount of disability someone has. The lower the score, the less disability is caused by neck pain.

    Measured: <1 hour

  7. Headache Self Efficacy Scale (HSES)

    Headache Self Efficacy Scale is used to assess an individual's belief they can do things to prevent headaches. Higher scores indicate higher self efficacy. The items have scoring from 1-7 with 1 being strongly disagree and 7 being strongly agree. Some items are reverse scored. The scores can range from 79-121.

    Measured: <1 hour

  8. Injection Phobia Scale (IPS)

    The Injection Phobia Scale assesses a person's fear or anxiety toward injections. It is scored 0-32 with the higher score indicating more severity of a phobia of injections.

    Measured: <1 hour

  9. Severity Measure for Specific Phobia-Adult (SMSP-A)

    The Severity Measure for Specific Phobia-Adult assesses symptoms a person feels in response to injections and/or needles. It is scored 0-40 with higher scores indicating more severity of phobia of needles.

    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 posted5 Jul 2022
  2. Study start5 Jul 2022 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (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
Single blinded, randomized, active control
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
133 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05444296
Sponsor's protocol ID
2022-186
Status last verified
Jul 2022
First submitted
27 Jun 2022
Last updated
11 Jul 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 Superficial Dry Needling and Non-thrust Mobilizations only 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 5 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 Jul 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. 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 NCT05444296, 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 Jul 2022.

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