Text Size

Manual Therapy and Exercise in Patients With Cervicogenic Headache

This study is currently recruiting participants.
Verified March 2013 by Alabama Physical Therapy & Acupuncture
Sponsor:
Collaborator:
Long Island University
Information provided by (Responsible Party):
Alabama Physical Therapy & Acupuncture
ClinicalTrials.gov Identifier:
NCT01580280
First received: April 16, 2012
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Cervicogenic Headache
 Other: Thrust Manipulation
Other: Non-thrust Mobilization and Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Upper Cervical and Upper Thoracic Thrust Manipulation Versus Mobilization and Exercise in Patients With Cervicogenic Headache

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alabama Physical Therapy & Acupuncture:

Primary Outcome Measures:
  • Headache Frequency [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The number of headache days in the past week (as registered in headache diary)

  • Headache Frequency [ Time Frame: 1-week ] [ Designated as safety issue: No ]
    The number of headache days in the past week (as registered in headache diary)

  • Headache Frequency [ Time Frame: 4-weeks ] [ Designated as safety issue: No ]
    The number of headache days in the past week (as registered in headache diary)

  • Headache Frequency [ Time Frame: 3-months ] [ Designated as safety issue: No ]
    The number of headache days in the past week (as registered in headache diary)

  • Headache Intensity [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.

  • Headache Intensity [ Time Frame: 1-week ] [ Designated as safety issue: No ]
    Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.

  • Headache Intensity [ Time Frame: 4-weeks ] [ Designated as safety issue: No ]
    Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.

  • Headache Intensity [ Time Frame: 3-months ] [ Designated as safety issue: No ]
    Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.

  • Headache Duration [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Average number of headache hours in the last week (as registered in the headache diary)

  • Headache Duration [ Time Frame: 1-week ] [ Designated as safety issue: No ]
    Average number of headache hours in the last week (as registered in the headache diary)

  • Headache Duration [ Time Frame: 4-weeks ] [ Designated as safety issue: No ]
    Average number of headache hours in the last week (as registered in the headache diary)

  • Headache Duration [ Time Frame: 3-months ] [ Designated as safety issue: No ]
    Average number of headache hours in the last week (as registered in the headache diary)

  • Neck Disability Index (NDI) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Neck pain and disability

  • Neck Disability Index (NDI) [ Time Frame: 1-week ] [ Designated as safety issue: No ]
    Neck pain and disability

  • Neck Disability Index (NDI) [ Time Frame: 4-weeks ] [ Designated as safety issue: No ]
    Neck pain and disability

  • Neck Disability Index (NDI) [ Time Frame: 3-months ] [ Designated as safety issue: No ]
    Neck pain and disability


Secondary Outcome Measures:
  • Global Rating of Change (GROC) [ Time Frame: 1-week ] [ Designated as safety issue: No ]
    Perceived improvement.

  • Global Rating of Change (GROC) [ Time Frame: 4-weeks ] [ Designated as safety issue: No ]
    Perceived improvement.

  • Global Rating of Change (GROC) [ Time Frame: 3-months ] [ Designated as safety issue: No ]
    Perceived improvement.

  • Analgesic Use [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Analgesic (medication intake) use per day (as registered in the headache diary).

  • Analgesic Use [ Time Frame: 3-months ] [ Designated as safety issue: No ]
    Analgesic (medication intake) use per day (as registered in the headache diary).


Estimated Enrollment: 112
Study Start Date: April 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thrust manipulation Other: Thrust Manipulation
Upper cervical and upper thoracic thrust manipulation for 6-8 sessions over 2-4 weeks.
Other Name: High-velocity low-amplitude thrust manipulation of the spine
Active Comparator: Non-thrust mobilization and exercise Other: Non-thrust Mobilization and Exercise
Upper cervical and upper thoracic non-thrust mobilization and exercise for 6-8 sessions over 2-4 weeks.
Other Names:
  • Non-thrust mobilization to cervical and thoracic spines
  • Cervical range of motion, strength, and postural exercises

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of cervicogenic headache as defined by International Headache Society 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580280

Contacts
Contact: James Dunning, DPT, FAAOMPT 801-707-9056 jamesdunning@hotmail.com

Locations
United States, Alabama
Alabama Physical Therapy & Acupuncture Recruiting
Montgomery, Alabama, United States, 36117
Contact: James Dunning, DPT, MSc     801-707-9056     jamesdunning@hotmail.com    
Principal Investigator: James Dunning, DPT, MSc            
Sponsors and Collaborators
Alabama Physical Therapy & Acupuncture
Long Island University
Investigators
Study Chair: Marshall Hagins, PT, PhD Long Island University
  More Information

Publications:

Responsible Party: Alabama Physical Therapy & Acupuncture
ClinicalTrials.gov Identifier: NCT01580280     History of Changes
Other Study ID Numbers: 12/01-006
Study First Received: April 16, 2012
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Alabama Physical Therapy & Acupuncture:
Cervicogenic
Headache
Neck Pain
 Manipulation
Mobilization
Exercise

Additional relevant MeSH terms:
Headache
Post-Traumatic Headache
Pain
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013