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Completed

NCT Number: NCT01530321

Cervicogenic Headache Dose-Response

This study will determine the number of visits to a chiropractor for spinal manipulation and light massage necessary for the optimal relief of cervicogenic headache (headache with associated neck pain). Effectiveness of care will also be determined.

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Key information

Conditions

Cervicogenic Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases Post-Traumatic Headache

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Northwestern Health Sciences University, Bloomington, Minnesota, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • chronic cervicogenic headache
  • threshold pain level
  • threshold headache frequency
  • independently ambulatory
  • English literate
  • candidate for spinal manipulation

Exclusion criteria

  • contraindication to thrust spinal manipulation or massage
  • most other headache types
  • Recent manual/exercise therapy from licensed provider for head/neck
  • threshold pain medication use
  • pregnancy
  • involvement with another pain study
  • suspicion of unmanaged depression
  • most cancers
  • hypertension (at least stage II)
  • complicating neurological/spinal conditions
  • pre-randomization noncompliance or cannot/will not comply with protocols
  • health-related litigation, claims, or disability compensation

Treatment and study plan

Spinal Manipulation

Other

5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.

Light Massage

Other

5 minutes of light pressure massage to the neck and upper back

Primary outcomes

  1. Headache days change from baseline for cervicogenic headache

    Time frame: 0, 6, 12, 24, 39, 52 weeks

    Days with cervicogenic headache in the last four weeks from a daily headache diary. Change score = follow-up score - baseline score)

Secondary outcomes

  1. Average pain change from baseline for cervicogenic headache

    Time frame: 0, 6, 12, 24, 39, 52 weeks

    Average cervicogenic headache pain in the last four weeks evaluated by averaging daily headache diary pain scores. Pain is rated on a 0 to 11 numeric rating scale.

  2. Headache-related disability change from baseline for cervicogenic headaches

    Time frame: 0, 6, 12, 24, 39, 52 weeks

    Headache Impact Test (HIT-6)

  3. Headache-related disability days change from baseline

    Time frame: 0, 6, 12, 24, 39, 52 weeks

    Number of days in the last four weeks from recall unable to carry out daily work for at least one half day because of cervicogenic headache.

  4. EuroQol-5D change from baseline

    Time frame: 0, 12, 24, 39, 52 weeks

    Health-related quality of life

  5. Average pain change from baseline for neck

    Time frame: 0, 6, 12, 24, 39, 52 weeks

    Average neck pain in the last four weeks from recall. Pain is rated on a 0 to 11 numeric rating scale.

  6. Neck pain days change from baseline

    Time frame: 0, 6, 12, 24, 39, 52 weeks

    Number of days with neck pain in last 4 weeks from recall.

  7. medication use change from baseline

    Time frame: 0, 6, 12, 24, 39, 52 weeks

    Number days of use of prescription and nonprescription medications for headaches with neck pain

  8. Outside Care change from baseline

    Time frame: 0, 6, 12, 24, 39, 52 weeks

    Visits to providers outside the study for care of cervicogenic headache. Includes hospital and emergency room visits

  9. Patient Satisfaction

    Time frame: week 12

    Likert scale for success of care

  10. Objective biomechanical measures change from baseline

    Time frame: 0, 6 weeks

    Measures of cervical joint function and kinematics including global range of motion, spinal segmental joint restriction, pain pressure thresholds

  11. Quality-adjusted life years change from baseline

    Time frame: 0, 12, 24, 39, 52 weeks

    utility for cost-effectiveness analysis

  12. Direct & Indirect costs change from baseline

    Time frame: 0, 6, 12, 24, 39, 52 weeks

    Health services; lost work days and productivity

  13. Perceived headache average pain change from baseline for cervicogenic headache

    Time frame: 0, 6, 12, 24, 39, 52 weeks

    Perceived change in average pain from baseline on a -10 to +10 (21-point) numeric rating scale

  14. Perceived headache improvement from baseline for cervicogenic headache

    Time frame: 0, 6, 12, 24, 39, 52 weeks

    Perceived cervicogenic headache improvement from baseline on a 9-point Likert-like scale.

Sponsors and collaborators

Lead sponsor

University of Western States

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Dose-Response of Manipulation for Cervicogenic Headache

Acronym: CGH D-R

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 9, 2012
Registry last updated
Nov 20, 2018

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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