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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
Alabama Physical Therapy & Acupuncture
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache focused on measuring Cervicogenic, Headache, Neck Pain, Manipulation, Mobilization, Exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 16, 2012
Last Updated
November 12, 2014
Sponsor
Alabama Physical Therapy & Acupuncture
Collaborators
Long Island University
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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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