Superficial Dry Needling for Cervicogenic Headache
Primary Purpose
Headache
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Superficial Dry Needling
Non-thrust Mobilizations only
Sponsored by
About this trial
This is an interventional treatment trial for Headache
Eligibility Criteria
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
Sites / Locations
- Youngstown State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dry Needling
Upper Cervical Mobilizations
Arm Description
Experimental group
Active control
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05444296
First Posted
June 27, 2022
Last Updated
July 6, 2022
Sponsor
Youngstown State University
1. Study Identification
Unique Protocol Identification Number
NCT05444296
Brief Title
Superficial Dry Needling for Cervicogenic Headache
Official Title
Superficial Dry Needling of the Trigeminal Nerve Innervation Sensory Field for Cervicogenic Headache: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 5, 2022 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Youngstown State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blinded, randomized, active control
Masking
Outcomes Assessor
Masking Description
Outcome assessor will be blind to the type of intervention the participant receives.
Allocation
Randomized
Enrollment
133 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dry Needling
Arm Type
Experimental
Arm Description
Experimental group
Arm Title
Upper Cervical Mobilizations
Arm Type
Active Comparator
Arm Description
Active control
Intervention Type
Other
Intervention Name(s)
Superficial Dry Needling
Other Intervention Name(s)
Non-thrust mobilizations
Intervention Description
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
Intervention Name(s)
Non-thrust Mobilizations only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Headache or neck pain intensity on a Numeric pain rating scale (0-10)
Description
0-10 scale pain intensity, 0 is no pain, 10 is severe pain, the lower the score the better
Time Frame
<1 hour
Secondary Outcome Measure Information:
Title
Flexion Rotation Test in degrees of measurement
Description
Flexion-rotation test for CGH will be measured to determine any change in measure for c1-c2 mobility.
Time Frame
<1 hour
Title
Active Range of Motion of the Cervical Spine in degrees of measurement
Description
Active range of motion will be measured in the most painful and or limited plane of movement.
Time Frame
<1 hour
Title
Patient Health Questionnaire - 9 (PHQ-9)
Description
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.
Time Frame
<1 hour
Title
Short Form 36 (SF-36)
Description
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.
Time Frame
<1 hour
Title
Generalized Anxiety Disorder 7 (GAD-7)
Description
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.
Time Frame
<1 hour
Title
Neck Disability Index (NDI)
Description
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.
Time Frame
<1 hour
Title
Headache Self Efficacy Scale (HSES)
Description
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.
Time Frame
<1 hour
Title
Injection Phobia Scale (IPS)
Description
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.
Time Frame
<1 hour
Title
Severity Measure for Specific Phobia-Adult (SMSP-A)
Description
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.
Time Frame
<1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David W Griswold, PhD
Phone
3307015353
Email
dwgriswold@ysu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Learman, PhD
Organizational Affiliation
Director of the PhD in Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Youngstown State University
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44406
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David W Griswold, PhD
Phone
330-701-5353
Email
dwgriswold@ysu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31948718
Citation
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.
Results Reference
background
PubMed Identifier
30813155
Citation
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.
Results Reference
background
PubMed Identifier
24623124
Citation
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.
Results Reference
background
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Superficial Dry Needling for Cervicogenic Headache
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