Manual Therapy and Exercise in Patients With Cervicogenic Headache
Primary Purpose
Cervicogenic Headache
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thrust Manipulation
Non-thrust Mobilization and Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Cervicogenic Headache focused on measuring Cervicogenic, Headache, Neck Pain, Manipulation, Mobilization, Exercise
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of cervicogenic headache as defined by Cervicogenic Headache International Study Group criteria
- Headache frequency of at least one per week for a minimum of 3 months
- Minimum pain score (NPRS) of 2/10 and minimum disability score (NDI) of 10/50
Exclusion Criteria:
- Bilateral headaches
- Presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia or hyperlipidemia
- Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
- History of whiplash injury within the last 6 weeks
- Diagnosis of cervical spinal stenosis
- Bilateral upper extremity symptoms
- Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes)
Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
- Muscle weakness involving a major muscle group of the upper extremity.
- Diminished upper extremity deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors
- Diminished or absent sensation to pinprick in any upper extremity dermatome
- Prior surgery to the neck or thoracic spine.
- Involvement in litigation or worker's compensation regarding their neck pain and/or headaches.
- Physical therapy or chiropractic treatment for neck pain or headache in the 3 months before baseline examination.
- Any condition that might contraindicate spinal manipulative therapy
Sites / Locations
- Alabama Physical Therapy & Acupuncture
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Thrust manipulation
Non-thrust mobilization and exercise
Arm Description
Outcomes
Primary Outcome Measures
Headache Frequency
The number of headache days in the past week (as registered in headache diary)
Headache Frequency
The number of headache days in the past week (as registered in headache diary)
Headache Frequency
The number of headache days in the past week (as registered in headache diary)
Headache Frequency
The number of headache days in the past week (as registered in headache diary)
Headache Intensity
Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.
Headache Intensity
Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.
Headache Intensity
Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.
Headache Intensity
Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.
Headache Duration
Average number of headache hours in the last week (as registered in the headache diary)
Headache Duration
Average number of headache hours in the last week (as registered in the headache diary)
Headache Duration
Average number of headache hours in the last week (as registered in the headache diary)
Headache Duration
Average number of headache hours in the last week (as registered in the headache diary)
Neck Disability Index (NDI)
Neck pain and disability
Neck Disability Index (NDI)
Neck pain and disability
Neck Disability Index (NDI)
Neck pain and disability
Neck Disability Index (NDI)
Neck pain and disability
Secondary Outcome Measures
Global Rating of Change (GROC)
Perceived improvement.
Global Rating of Change (GROC)
Perceived improvement.
Global Rating of Change (GROC)
Perceived improvement.
Analgesic Use
Analgesic (medication intake) use per day (as registered in the headache diary).
Analgesic Use
Analgesic (medication intake) use per day (as registered in the headache diary).
Full Information
NCT ID
NCT01580280
First Posted
April 16, 2012
Last Updated
November 12, 2014
Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Long Island University
1. Study Identification
Unique Protocol Identification Number
NCT01580280
Brief Title
Manual Therapy and Exercise in Patients With Cervicogenic Headache
Official Title
Effect of Upper Cervical and Upper Thoracic Thrust Manipulation Versus Mobilization and Exercise in Patients With Cervicogenic Headache
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Long Island University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hypothesis: The group of cervicogenic headache patients receiving upper cervical and upper thoracic thrust manipulation will demonstrate significant and clinically important changes in outcomes when compared to the mobilization and exercise group.
Detailed Description
Patients with cervicogenic headache will be randomized to receive 6-8 sessions over 2-4 weeks of either: (1) upper cervical and upper thoracic thrust manipulation, or (2) upper cervical and upper thoracic non-thrust mobilization and range of motion, strength and postural exercises.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache
Keywords
Cervicogenic, Headache, Neck Pain, Manipulation, Mobilization, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thrust manipulation
Arm Type
Experimental
Arm Title
Non-thrust mobilization and exercise
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Thrust Manipulation
Other Intervention Name(s)
High-velocity low-amplitude thrust manipulation of the spine
Intervention Description
Upper cervical and upper thoracic thrust manipulation for 6-8 sessions over 2-4 weeks.
Intervention Type
Other
Intervention Name(s)
Non-thrust Mobilization and Exercise
Other Intervention Name(s)
Non-thrust mobilization to cervical and thoracic spines, Cervical range of motion, strength, and postural exercises
Intervention Description
Upper cervical and upper thoracic non-thrust mobilization and exercise for 6-8 sessions over 2-4 weeks.
Primary Outcome Measure Information:
Title
Headache Frequency
Description
The number of headache days in the past week (as registered in headache diary)
Time Frame
Baseline
Title
Headache Frequency
Description
The number of headache days in the past week (as registered in headache diary)
Time Frame
1-week
Title
Headache Frequency
Description
The number of headache days in the past week (as registered in headache diary)
Time Frame
4-weeks
Title
Headache Frequency
Description
The number of headache days in the past week (as registered in headache diary)
Time Frame
3-months
Title
Headache Intensity
Description
Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.
Time Frame
Baseline
Title
Headache Intensity
Description
Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.
Time Frame
1-week
Title
Headache Intensity
Description
Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.
Time Frame
4-weeks
Title
Headache Intensity
Description
Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.
Time Frame
3-months
Title
Headache Duration
Description
Average number of headache hours in the last week (as registered in the headache diary)
Time Frame
Baseline
Title
Headache Duration
Description
Average number of headache hours in the last week (as registered in the headache diary)
Time Frame
1-week
Title
Headache Duration
Description
Average number of headache hours in the last week (as registered in the headache diary)
Time Frame
4-weeks
Title
Headache Duration
Description
Average number of headache hours in the last week (as registered in the headache diary)
Time Frame
3-months
Title
Neck Disability Index (NDI)
Description
Neck pain and disability
Time Frame
Baseline
Title
Neck Disability Index (NDI)
Description
Neck pain and disability
Time Frame
1-week
Title
Neck Disability Index (NDI)
Description
Neck pain and disability
Time Frame
4-weeks
Title
Neck Disability Index (NDI)
Description
Neck pain and disability
Time Frame
3-months
Secondary Outcome Measure Information:
Title
Global Rating of Change (GROC)
Description
Perceived improvement.
Time Frame
1-week
Title
Global Rating of Change (GROC)
Description
Perceived improvement.
Time Frame
4-weeks
Title
Global Rating of Change (GROC)
Description
Perceived improvement.
Time Frame
3-months
Title
Analgesic Use
Description
Analgesic (medication intake) use per day (as registered in the headache diary).
Time Frame
Baseline
Title
Analgesic Use
Description
Analgesic (medication intake) use per day (as registered in the headache diary).
Time Frame
3-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of cervicogenic headache as defined by Cervicogenic Headache International Study Group criteria
Headache frequency of at least one per week for a minimum of 3 months
Minimum pain score (NPRS) of 2/10 and minimum disability score (NDI) of 10/50
Exclusion Criteria:
Bilateral headaches
Presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia or hyperlipidemia
Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
History of whiplash injury within the last 6 weeks
Diagnosis of cervical spinal stenosis
Bilateral upper extremity symptoms
Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes)
Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
Muscle weakness involving a major muscle group of the upper extremity.
Diminished upper extremity deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors
Diminished or absent sensation to pinprick in any upper extremity dermatome
Prior surgery to the neck or thoracic spine.
Involvement in litigation or worker's compensation regarding their neck pain and/or headaches.
Physical therapy or chiropractic treatment for neck pain or headache in the 3 months before baseline examination.
Any condition that might contraindicate spinal manipulative therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marshall Hagins, PT, PhD
Organizational Affiliation
Long Island University
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Physical Therapy & Acupuncture
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36117
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21979312
Citation
Dunning JR, Cleland JA, Waldrop MA, Arnot CF, Young IA, Turner M, Sigurdsson G. Upper cervical and upper thoracic thrust manipulation versus nonthrust mobilization in patients with mechanical neck pain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):5-18. doi: 10.2519/jospt.2012.3894. Epub 2011 Sep 30.
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
derived
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Manual Therapy and Exercise in Patients With Cervicogenic Headache
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