NCT00246350

Brief Summary

This study will determine the effectiveness of spinal manipulation in reducing pain in people with chronic headaches accompanied by neck pain. This study will also determine the number of spinal manipulation treatments necessary for optimal pain relief.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 31, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

November 22, 2010

Status Verified

November 1, 2010

Enrollment Period

2.8 years

First QC Date

September 13, 2005

Last Update Submit

November 19, 2010

Conditions

Headache Disorders

Keywords

HeadachesSpinal manipulationMassagechiropractic

Outcome Measures

Primary Outcomes (1)

  • Modified Von Korff pain scale for headaches

Secondary Outcomes (5)

  • Modified Von Korff disability scale for headaches

  • Number of cervicogenic headaches

  • general physical and mental health status

  • patient satisfaction

  • neck pain

Study Arms (4)

1

ACTIVE COMPARATOR

8 light massage treatments

Procedure: massage

2

ACTIVE COMPARATOR

16 light massage treatments

Procedure: massage

3

EXPERIMENTAL

8 spinal manipulation treatments

Procedure: spinal manipulation

4

EXPERIMENTAL

16 spinal manipulation treatments

Procedure: Spinal manipulation

Interventions

massagePROCEDURE

8 light massage treatments and hot pack

1
Spinal manipulationPROCEDURE

8 high velocity, low amplitude spinal manipulation treatments and hot pack

3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of cervicogenic headaches

You may not qualify if:

  • Contraindications to spinal manipulation or massage
  • Use of chiropractic or therapeutic massage care prior to study entry
  • Use of any prophylactic prescription medication
  • Involved in any type of lawsuit prior to study entry
  • Headaches with several different causes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western States Chiropractic College

Portland, Oregon, 97230, United States

Location

Related Publications (5)

  • Haas M, Groupp E, Aickin M, Fairweather A, Ganger B, Attwood M, Cummins C, Baffes L. Dose response for chiropractic care of chronic cervicogenic headache and associated neck pain: a randomized pilot study. J Manipulative Physiol Ther. 2004 Nov-Dec;27(9):547-53. doi: 10.1016/j.jmpt.2004.10.007.

    PMID: 15614241BACKGROUND

  • Haas M, Spegman A, Peterson D, Aickin M, Vavrek D. Dose response and efficacy of spinal manipulation for chronic cervicogenic headache: a pilot randomized controlled trial. Spine J. 2010 Feb;10(2):117-28. doi: 10.1016/j.spinee.2009.09.002.

    PMID: 19837005RESULT

  • Haas M, Aickin M, Vavrek D. A preliminary path analysis of expectancy and patient-provider encounter in an open-label randomized controlled trial of spinal manipulation for cervicogenic headache. J Manipulative Physiol Ther. 2010 Jan;33(1):5-13. doi: 10.1016/j.jmpt.2009.11.007.

    PMID: 20114095RESULT

  • Haas M, Schneider M, Vavrek D. Illustrating risk difference and number needed to treat from a randomized controlled trial of spinal manipulation for cervicogenic headache. Chiropr Osteopat. 2010 May 24;18:9. doi: 10.1186/1746-1340-18-9.

    PMID: 20497573RESULT

  • Vavrek D, Haas M, Peterson D. Physical examination and self-reported pain outcomes from a randomized trial on chronic cervicogenic headache. J Manipulative Physiol Ther. 2010 Jun;33(5):338-48. doi: 10.1016/j.jmpt.2010.05.004.

    PMID: 20605552RESULT

MeSH Terms

Conditions

Headache DisordersHeadache

Interventions

MassageManipulation, Spinal

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Mitchell Haas, DC

    University of Western States

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

October 31, 2005

Study Start

September 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

November 22, 2010

Record last verified: 2010-11

Locations

US(1)