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Completed

NCT Number: NCT04091321

Association Between Chronic Headache and Back Pain With Childbirth

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

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Key information

Conditions

Headache Disorders, Secondary Anesthesia Back Pain Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Post-Dural Puncture Headache Signs and Symptoms

Age range

10 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Lucille Packard Children's Hospital

Palo Alto, California, 94305, United States

About this study

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.

Who can participate

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

Inclusion criteria

  • Female representation

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  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 did not gave birth

Secondary outcomes

  1. Migraine

    Time frame: 10 minute questionnaire

    Percent of patients with migraine who gave birth to children/Percent of patients with migraine who 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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 16, 2019
Registry last updated
Sep 24, 2021

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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