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Association Between Chronic Headache and Back Pain With Childbirth

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ClinicalTrials.gov Identifier: NCT04091321
Recruitment Status : Active, not recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Pamela Flood, Stanford University

Brief Summary:

This study uses a single questionnaire to evaluate two separate primary outcomes:

  1. To identify association between chronic headache in women who have given birth to children as compared to a control group of women who have raised children but have not given birth to them
  2. To identify association between chronic back pain in women who have given birth to children as compared to a control group of women who have raised children but have not given birth to them

Condition or disease
Headache Disorders, Secondary Post-Dural Puncture Headache Migraine Disorders Back Pain Anesthesia

Detailed Description:

Chronic headache and back pain have an excess prevalence in women as compared to men. This study uses a single survey that uses logic to assess for association between childbirth and chronic headache and between childbirth and chronic back pain using screening questions. The questions are, "Do you suffer from chronic headaches" and "Do you suffer from chronic back pain". Depending on the answer to the screening question, the subject will be given further questions only related to the syndrome that they endorsed.

Arm 1) There is an association between chronic headache and childbirth over and above raising children. Secondary outcomes are temporal association between onset or worsening of headache and childbirth, association between migraine headache and childbirth, association between chronic headache and anesthetic complications.

Arm 2) There is an association between chronic back pain and childbirth over and above raising children. Secondary outcomes are temporal association between onset or worsening of back pain and childbirth, association between chronic headache and anesthesia.


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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Association Between Chronic Headache and Back Pain With Childbirth
Actual Study Start Date : September 13, 2019
Estimated Primary Completion Date : September 12, 2020
Estimated Study Completion Date : September 12, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Chronic Headache
Women who endorse chronic headache
Chronic Back Pain
Women who endorse chronic back pain



Primary Outcome Measures :
  1. Chronic headache [ Time Frame: 10 minute questionnaire ]
    Percent of patients with chronic headache who gave birth to children/Percent of patients with chronic headache who raised children but did not gave birth

  2. Chronic back pain [ Time Frame: 10 minute questionnaire ]
    Percent of patients with chronic back pain who gave birth to children/Percent of patients with chronic back pain who raised children but did not gave birth


Secondary Outcome Measures :
  1. Migraine [ Time Frame: 10 minute questionnaire ]
    Percent of patients with migraine who gave birth to children/Percent of patients with migraine who raised children but did not gave birth

  2. Temporal coincidence of headache and childbirth [ Time Frame: 10 minute questionnaire ]
    Women who developed or had worse headache within one year of delivery compared to one year of starting to raise a child not delivered

  3. Temporal coincidence of headache and dural puncture [ Time Frame: 10 minute questionnaire ]
    Women who developed or had worse headache within one year of dural puncture compared to those who did not have a dural puncture


Other Outcome Measures:
  1. Temporal coincidence of back pain and regional anesthesia [ Time Frame: 10 minute questionnaire ]
    Women who developed or had worse back pain within one year of regional anesthesia compared to those who did not have regional anesthesia



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Sampling Method:   Non-Probability Sample
Study Population
Chronic pain patients who have elected to be contacted for research studies
Criteria

Inclusion Criteria:

  • Female representation

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091321


Locations
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United States, California
Lucille Packard Children's Hospital
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Stanford University

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Responsible Party: Pamela Flood, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04091321     History of Changes
Other Study ID Numbers: 52732
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Depending on agreement. De identified data only

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Post-Dural Puncture Headache
Headache Disorders
Headache Disorders, Secondary
Disease
Back Pain
Headache
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Primary
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases