Association Between Chronic Headache and Back Pain With Childbirth

Completed

• Conditions: Back Pain; Anesthesia; Migraine Disorders; Headache Disorders, Secondary; Post-Dural Puncture Headache

• Registration Number: NCT04091321
• Lead Sponsor: 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

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.

Study Timeline

• Study First Submitted: 2019-09-12
• Study Start: 2019-09-13
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-16
• Primary Completion: 2020-02-26
• Study Completion: 2020-02-26
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-18
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1112

Inclusion Criteria

• Female representation

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chronic headache	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
Chronic back pain	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 Outcome Measures

Name	Time	Method
Migraine	10 minute questionnaire	Percent of patients with migraine who gave birth to children/Percent of patients with migraine who did not gave birth
Temporal coincidence of headache and childbirth	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
Temporal coincidence of headache and dural puncture	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

Trial Locations

Locations (1)

Lucille Packard Children's Hospital; 🇺🇸 Palo Alto, California, United States