Association Between Chronic Headache and Back Pain With Childbirth

Anesthesia Clinical Trial

Official title:

Association Between Chronic Headache and Back Pain With Childbirth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04091321
• Other study ID #: 52732
• Status: Completed
• Start date: September 13, 2019
• Est. completion date: February 26, 2020

Study information

• Verified date: September 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1112
• Est. completion date: February 26, 2020
• Est. primary completion date: February 26, 2020
• Gender: Female
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Female representation

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Anesthesia
• Back Pain
• Disease
• Headache
• Headache Disorders
• Headache Disorders, Secondary
• Migraine Disorders
• Post-Dural Puncture Headache

Locations

Country	Name	City	State
United States	Lucille Packard Children's Hospital	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Temporal coincidence of back pain and regional anesthesia	Women who developed or had worse back pain within one year of regional anesthesia compared to those who did not have regional anesthesia	10 minute questionnaire
Primary	Chronic headache	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	10 minute questionnaire
Primary	Chronic back pain	Percent of patients with chronic back pain who gave birth to children/Percent of patients with chronic back pain who did not gave birth	10 minute questionnaire
Secondary	Migraine	Percent of patients with migraine who gave birth to children/Percent of patients with migraine who did not gave birth	10 minute questionnaire
Secondary	Temporal coincidence of headache and childbirth	Women who developed or had worse headache within one year of delivery compared to one year of starting to raise a child not delivered	10 minute questionnaire
Secondary	Temporal coincidence of headache and dural puncture	Women who developed or had worse headache within one year of dural puncture compared to those who did not have a dural puncture	10 minute questionnaire