NCT01509326

Brief Summary

This study will investigate the effect of chiropractic treatment with and without the use of an acupressure pillow for cervical headaches. Subjects will be randomly allocated to groups with and without the pillow and will be followed for five weeks. The primary outcome measure will be headache frequency. The investigators predict that the group using the pillow on a daily basis will demonstrate significantly greater decrease in headache frequency over a 5-week interval.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 13, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

January 13, 2012

Status Verified

January 1, 2012

Enrollment Period

9 months

First QC Date

January 4, 2012

Last Update Submit

January 10, 2012

Conditions

Keywords

headachechiropracticmanipulationacupressureself-care

Outcome Measures

Primary Outcomes (1)

  • Headache frequency from a Headache Diary

    Daily Headache Diary

    change from baseline in headache frequency at 5 weeks

Secondary Outcomes (3)

  • Headache disability

    baseline / end of treatment (5 weeks)

  • Treatment satisfaction

    end of treatment (5 weeks)

  • Adverse events

    up to five weeks

Study Arms (2)

Chiropractic

ACTIVE COMPARATOR

spinal manipulation, mobilization, massage, advice, exercises

Other: chiropractic treatment

Chiropractic PLUS pillow

EXPERIMENTAL

spinal manipulation, mobilization, massage, advice, exercises, pillow

Device: Dr. Zaxx pillow

Interventions

12 sessions over 4 weeks

Chiropractic

Daily use of an acupressure pillow

Chiropractic PLUS pillow

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • males and females
  • ages 21-60
  • recurrent headaches
  • sub-occipital tenderness
  • a minimum of 4 headaches per month

You may not qualify if:

  • migraine with aura
  • sinus headache
  • any other organic pathology
  • any contraindications to cervical manipulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canadian Memorial Chiropractic College

Toronto, Ontario, M2H 3J1, Canada

RECRUITING

Related Publications (1)

  • Vernon H, Jansz G, Goldsmith CH, McDermaid C. A randomized, placebo-controlled clinical trial of chiropractic and medical prophylactic treatment of adults with tension-type headache: results from a stopped trial. J Manipulative Physiol Ther. 2009 Jun;32(5):344-51. doi: 10.1016/j.jmpt.2009.04.004.

    PMID: 19539116BACKGROUND

Related Links

MeSH Terms

Conditions

Post-Traumatic HeadacheTension-Type HeadacheMigraine DisordersHeadache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeadache Disorders, PrimaryPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Howard Vernon, DC, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 13, 2012

Study Start

January 1, 2012

Primary Completion

October 1, 2012

Study Completion

November 1, 2012

Last Updated

January 13, 2012

Record last verified: 2012-01

Locations