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Completed

NCT Number: NCT01580280

Manual Therapy and Exercise in Patients With Cervicogenic Headache

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alabama Physical Therapy & Acupuncture

Montgomery, Alabama, 36117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thrust manipulation

Other

Upper cervical and upper thoracic thrust manipulation for 6-8 sessions over 2-4 weeks.

Other names: High-velocity low-amplitude thrust manipulation of the spine

Non-thrust Mobilization and Exercise

Other

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

Primary outcomes

  1. Headache Frequency

    Time frame: Baseline

    The number of headache days in the past week (as registered in headache diary)

  2. Headache Frequency

    Time frame: 1-week

    The number of headache days in the past week (as registered in headache diary)

  3. Headache Frequency

    Time frame: 4-weeks

    The number of headache days in the past week (as registered in headache diary)

  4. Headache Frequency

    Time frame: 3-months

    The number of headache days in the past week (as registered in headache diary)

  5. Headache Intensity

    Time frame: Baseline

    Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.

  6. Headache Intensity

    Time frame: 1-week

    Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.

  7. Headache Intensity

    Time frame: 4-weeks

    Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.

  8. Headache Intensity

    Time frame: 3-months

    Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.

  9. Headache Duration

    Time frame: Baseline

    Average number of headache hours in the last week (as registered in the headache diary)

  10. Headache Duration

    Time frame: 1-week

    Average number of headache hours in the last week (as registered in the headache diary)

  11. Headache Duration

    Time frame: 4-weeks

    Average number of headache hours in the last week (as registered in the headache diary)

  12. Headache Duration

    Time frame: 3-months

    Average number of headache hours in the last week (as registered in the headache diary)

  13. Neck Disability Index (NDI)

    Time frame: Baseline

    Neck pain and disability

  14. Neck Disability Index (NDI)

    Time frame: 1-week

    Neck pain and disability

  15. Neck Disability Index (NDI)

    Time frame: 4-weeks

    Neck pain and disability

  16. Neck Disability Index (NDI)

    Time frame: 3-months

    Neck pain and disability

Secondary outcomes

  1. Global Rating of Change (GROC)

    Time frame: 1-week

    Perceived improvement.

  2. Global Rating of Change (GROC)

    Time frame: 4-weeks

    Perceived improvement.

  3. Global Rating of Change (GROC)

    Time frame: 3-months

    Perceived improvement.

  4. Analgesic Use

    Time frame: Baseline

    Analgesic (medication intake) use per day (as registered in the headache diary).

  5. Analgesic Use

    Time frame: 3-months

    Analgesic (medication intake) use per day (as registered in the headache diary).

Sponsors and collaborators

Lead sponsor

Alabama Physical Therapy & Acupuncture

Other

Collaborators

  • Long Island University

Registry information

Official study title

Effect of Upper Cervical and Upper Thoracic Thrust Manipulation Versus Mobilization and Exercise in Patients With Cervicogenic Headache

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 19, 2012
Registry last updated
Nov 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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