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

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 1112

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Lucille Packard Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Chronic pain patients who have elected to be contacted for research studies

Description

Inclusion Criteria:

• Female representation

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraine	Percent of patients with migraine who gave birth to children/Percent of patients with migraine who did not gave birth	10 minute questionnaire
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 13, 2019
• Primary Completion (ACTUAL): February 26, 2020
• Study Completion (ACTUAL): February 26, 2020

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (ACTUAL): September 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 18, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Back Pain; Disease; Migraine Disorders; Headache; Headache Disorders, Secondary; Headache Disorders; Post-Dural Puncture Headache
• Other Study ID Numbers: 52732

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Depending on agreement. De identified data only

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No