Back to resultsEffects of Cervical Manual Therapy on Cervicogenic Headache
Primary Purpose
Unilateral Headache, Musculoskeletal Neck Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cervical Spine Mobilization
Cervical Spine Manipulation
Sponsored by
About this trial
This is an interventional treatment trial for Unilateral Headache focused on measuring Cervicogenic Headache, Manual Therapy, Joint Position Sense, Balance
Eligibility Criteria
Inclusion Criteria:
- Over the age of 18
- Signs and symptoms consistent with cervicogenic headache (including unilateral headache, headache that improves or resolves as cervical disorder or lesion improves or resolves, headache that is made worse with cervical movement or sustained painful neck positions, reduced cervical range of motion
- Headache frequency of at least once a week for 3 months
Exclusion Criteria:
- Bilateral headaches
- Non-musculoskeletal red flags
- Two or more positive neurologic signs indicative of nerve root compression
- Diagnosed with cervical spinal stenosis
- Bilateral upper extremity symptoms
- Symptoms indicative of central nervous system lesion
- History of whiplash injury within the previous 6 weeks
- Prior head or neck surgery
- Has received treatment for head or neck pain from any practitioner within the previous month
- Has received physical therapy or chiropractic treatment for head or neck pain within the previous 3 months
- Having a known vestibular or balance dysfunction (BPPV, unilateral vestibular loss, etc.)
- Other headaches that do not originate from the cervical spine, primarily migraine, vascular (cervical artery dysfunction), and tension-type headache.
Sites / Locations
- Shenandoah University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Cervical Spine Mobilization Group
Cervical Spine Manipulation Group
Control Group
Arm Description
Subjects with cervicogenic headache who will be assigned to cervical spine mobilization group and receive intervention directed to C1/2 of ipsilateral side of unilateral dominant headache.
Subjects with cervicogenic headache who will be assigned to cervical spine manipulation group and receive intervention directed to C1/2 of ipsilateral side of unilateral dominant headache.
No intervention. Subjects in this groups will wait for 5 minutes between pre- and post-testing of dependent variables.
Outcomes
Primary Outcome Measures
Change in Cervical Flexion Rotation Test (CFRT)
The Cervical Range of Motion (CROM) instrument will be placed on the subject. The subject will lie supine on the treatment table. The investigator will then passively flex the entire cervical spine and then rotate the head to both the left and right. The range of motion available in each direction, as measured by the CROM, will be recorded.
Secondary Outcome Measures
Change in Joint Position Error
The subject will have a small laser pointer mounted onto a lightweight headband, which they will wear. The patient will be seated 90 cm from the wall. The starting point that is projected by the laser on the bullseye is marked. The patient will have their eyes closed and will perform an active neck movement. After this, the patient will return their head as accurately as possible to the starting position. This will include 6 trials, which will include cervical flexion, extension and rotation. The final laser position is measured against the starting position in centimeters. Errors will be measured following active return from cervical extension, flexion and rotation.
Change in Balance as measured by NeuroCom Balance Master
A pre-programmed option on the NeuroCom Balance Master will be utilized to assess the Modified Clinical test of Sensory Interaction on Balance (mCTSIB). Three different conditions will be utilized and each condition will last 30 secs. Three trials will be completed for each condition.First, the subject will be asked to maintain their balance while their eyes are closed. The amount of postural sway that they demonstrate will be recorded. Second, the subject will be asked to maintain their balance with their eyes open while the platform on the NeuroCom Balance Master force plate moves. The amount of postural sway demonstrated will be recorded. Third, the subject will be asked to rotate their head all the way to the left, then rotate their head all the way to the right. They will continue rotating between sides for the duration of the 30 second trial. The amount of postural sway that they demonstrate will be recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03385889
Brief Title
Effects of Cervical Manual Therapy on Cervicogenic Headache
Official Title
Effects of Cervical Spine Manual Therapy on Range of Motion, Joint Position Sense, and Balance in Participants With Cervicogenic Headache
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenandoah 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
The effects of cervical spine manual therapy, including mobilization and manipulation, on cervical spine range of motion, joint position sense, and balance is unknown among individuals with cervicogenic headache. Previous studies have indicated improved frequency of headache, decreased perceived disability, and demonstrated improved neuromuscular function following upper cervical manipulation. Other authors report improved cervical spine range of motion, joint position sense, and balance following cervical spine manual therapy for individuals with cervicogenic dizziness. Through an experimental design, this study aims to determine the effects of cervical spine manual therapy on variables such as cervical spine range motion, joint position sense, and balance among individuals with headache of a cervical spine origin.
Detailed Description
A convenience sample will be utilized to obtain subjects who suffer from cervicogenic headaches, as defined by the International Headache Classification. Subjects will be given an online medical screening questionnaire to differentiate and screen additional types of headache symptoms (migraine, cluster, tension-type, for example) and identify possible contraindications for manual therapy treatment techniques and exclude individuals if necessary. Subjects will be randomized into one of three groups (upper cervical mobilization, upper cervical manipulation, or control) and be tested with the Cervical Flexion Rotation Test, Joint Position Error testing, and sensorimotor balance testing via NeuroCom Balance Master. Subjects with cervicogenic headaches will receive their assigned intervention and dependent variables will be reassessed immediately, as well as 4-weeks after initial intervention. Individuals in either intervention group (mobilization or manipulation) will also complete a specific home-exercise program, which has been reported to improve upper cervical range of motion, to the C1/2 segment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Headache, Musculoskeletal Neck Pain
Keywords
Cervicogenic Headache, Manual Therapy, Joint Position Sense, Balance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pre-test, Post-test, control group design 3 groups - mobilization, manipulation, control
Masking
Outcomes Assessor
Masking Description
Assessors of joint position sense, balance, and cervical spine range of motion via the Cervical Flexion Rotation Test will be blinded to group allocation
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cervical Spine Mobilization Group
Arm Type
Experimental
Arm Description
Subjects with cervicogenic headache who will be assigned to cervical spine mobilization group and receive intervention directed to C1/2 of ipsilateral side of unilateral dominant headache.
Arm Title
Cervical Spine Manipulation Group
Arm Type
Experimental
Arm Description
Subjects with cervicogenic headache who will be assigned to cervical spine manipulation group and receive intervention directed to C1/2 of ipsilateral side of unilateral dominant headache.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention. Subjects in this groups will wait for 5 minutes between pre- and post-testing of dependent variables.
Intervention Type
Procedure
Intervention Name(s)
Cervical Spine Mobilization
Intervention Description
C1/2 graded mobilizations (Grade III/IV) provided to C1/2 segment on ipsilateral side of unilateral headache. Mobilizations will be completed for 3 sets of 30 seconds.
Intervention Type
Procedure
Intervention Name(s)
Cervical Spine Manipulation
Intervention Description
C1/2 manipulation (Grade V) provided to C1/2 segment on ipsilateral side of unilateral headache. The goal of the manipulation technique is to elicit an audible cavitation. If no cavitation is achieved upon the first attempt, a second and final attempt will be completed. No more than two attempts will be utilized per each subject in this allocated group.
Primary Outcome Measure Information:
Title
Change in Cervical Flexion Rotation Test (CFRT)
Description
The Cervical Range of Motion (CROM) instrument will be placed on the subject. The subject will lie supine on the treatment table. The investigator will then passively flex the entire cervical spine and then rotate the head to both the left and right. The range of motion available in each direction, as measured by the CROM, will be recorded.
Time Frame
Post-Intervention, 4-weeks
Secondary Outcome Measure Information:
Title
Change in Joint Position Error
Description
The subject will have a small laser pointer mounted onto a lightweight headband, which they will wear. The patient will be seated 90 cm from the wall. The starting point that is projected by the laser on the bullseye is marked. The patient will have their eyes closed and will perform an active neck movement. After this, the patient will return their head as accurately as possible to the starting position. This will include 6 trials, which will include cervical flexion, extension and rotation. The final laser position is measured against the starting position in centimeters. Errors will be measured following active return from cervical extension, flexion and rotation.
Time Frame
Post-Intervention, 4-weeks
Title
Change in Balance as measured by NeuroCom Balance Master
Description
A pre-programmed option on the NeuroCom Balance Master will be utilized to assess the Modified Clinical test of Sensory Interaction on Balance (mCTSIB). Three different conditions will be utilized and each condition will last 30 secs. Three trials will be completed for each condition.First, the subject will be asked to maintain their balance while their eyes are closed. The amount of postural sway that they demonstrate will be recorded. Second, the subject will be asked to maintain their balance with their eyes open while the platform on the NeuroCom Balance Master force plate moves. The amount of postural sway demonstrated will be recorded. Third, the subject will be asked to rotate their head all the way to the left, then rotate their head all the way to the right. They will continue rotating between sides for the duration of the 30 second trial. The amount of postural sway that they demonstrate will be recorded.
Time Frame
Post-Intervention, 4-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over the age of 18
Signs and symptoms consistent with cervicogenic headache (including unilateral headache, headache that improves or resolves as cervical disorder or lesion improves or resolves, headache that is made worse with cervical movement or sustained painful neck positions, reduced cervical range of motion
Headache frequency of at least once a week for 3 months
Exclusion Criteria:
Bilateral headaches
Non-musculoskeletal red flags
Two or more positive neurologic signs indicative of nerve root compression
Diagnosed with cervical spinal stenosis
Bilateral upper extremity symptoms
Symptoms indicative of central nervous system lesion
History of whiplash injury within the previous 6 weeks
Prior head or neck surgery
Has received treatment for head or neck pain from any practitioner within the previous month
Has received physical therapy or chiropractic treatment for head or neck pain within the previous 3 months
Having a known vestibular or balance dysfunction (BPPV, unilateral vestibular loss, etc.)
Other headaches that do not originate from the cervical spine, primarily migraine, vascular (cervical artery dysfunction), and tension-type headache.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Abraham, PhD, PT
Organizational Affiliation
Shenandoah University
Official's Role
Study Director
Facility Information:
Facility Name
Shenandoah University
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23771276
Citation
Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
Results Reference
background
PubMed Identifier
26852024
Citation
Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.
Results Reference
result
PubMed Identifier
24792139
Citation
Reid SA, Callister R, Katekar MG, Rivett DA. Effects of cervical spine manual therapy on range of motion, head repositioning, and balance in participants with cervicogenic dizziness: a randomized controlled trial. Arch Phys Med Rehabil. 2014 Sep;95(9):1603-12. doi: 10.1016/j.apmr.2014.04.009. Epub 2014 May 2.
Results Reference
result
PubMed Identifier
19411769
Citation
Kristjansson E, Treleaven J. Sensorimotor function and dizziness in neck pain: implications for assessment and management. J Orthop Sports Phys Ther. 2009 May;39(5):364-77. doi: 10.2519/jospt.2009.2834.
Results Reference
result
PubMed Identifier
25983238
Citation
de Vries J, Ischebeck BK, Voogt LP, van der Geest JN, Janssen M, Frens MA, Kleinrensink GJ. Joint position sense error in people with neck pain: A systematic review. Man Ther. 2015 Dec;20(6):736-44. doi: 10.1016/j.math.2015.04.015. Epub 2015 May 2.
Results Reference
result
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Effects of Cervical Manual Therapy on Cervicogenic Headache
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