Association Between Chronic Headache and Back Pain With Childbirth

NCT ID: NCT04091321

Last Updated: 2021-09-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-13
• Study Completion Date: 2020-02-26

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Chronic Headache

Women who endorse chronic headache

No interventions assigned to this group

Chronic Back Pain

Women who endorse chronic back pain

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Female representation

Exclusion Criteria

• None

• Minimum Eligible Age: 10 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Pamela Flood

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lucille Packard Children's Hospital

Palo Alto, California, United States

Countries

United States

References

Zhang M, Cooley C, Ziadni MS, Mackey I, Flood P. Association between history of childbirth and chronic, functionally significant back pain in later life. BMC Womens Health. 2023 Jan 3;23(1):4. doi: 10.1186/s12905-022-02023-2.

Reference Type: DERIVED

PMID: 36597120 (View on PubMed)

Other Identifiers

52732

Identifier Type: -

Identifier Source: org_study_id