Prenatal Yoga for Pregnancy Related Back Pain

Pregnancy Related Clinical Trial

Official title:

Prenatal Yoga for Pregnancy Related Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03651232
• Other study ID #: 2014P000344
• Status: Completed
• Phase: N/A
• Start date: April 21, 2015
• Est. completion date: June 30, 2016

Study information

• Verified date: August 2018
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot feasibility study investigating prenatal yoga for pregnancy related back pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• uncomplicated pregnancies starting at 12-26 weeks of gestation

• pregnant women with and without back pain who had no regular yoga practice.

Exclusion Criteria:

• significant back pathology

• pregnancy complications

• non-English speaking

• otherwise were not able to participate (eg. transportation, scheduling issues)

Related Conditions & MeSH terms

• Back Pain
• Pregnancy Related

Intervention

Behavioral:
• yoga
once weekly group yoga class for 12 weeks
• support group
once weekly group support class for 12 weeks

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of recruitment	recruitment rate	baseline
Secondary	back pain disability	Roland Morris Disability Questionnaire (range 0-24), lower better	baseline, 4, 8, 12 weeks
Secondary	back pain severity	Back Pain Severity Visual Analogue Scale (rage 0-10), lower better	baseline, 4, 8, 12 weeks
Secondary	pregnancy symptoms	Pregnancy Symptom Inventory (range 0-123), lower better	baseline, 4, 8, 12 weeks
Secondary	depression	Edinburgh Postnatal Depression Scale (range 0-30), lower better	baseline, 4, 8, 12 weeks
Secondary	quality of lfe	Short Form-12 (range 12-56), higher better	baseline, 4, 8, 12 weeks
Secondary	childbirth experience	Childbirth Experience (range 19-76), higher better	postpartum visit
Secondary	mobility lab- speed	instrumented gait speed	baseline, 4, 8, 12 weeks
Secondary	acceptability	class attendance	4,8, 12 weeks, postpartum
Secondary	mobility lab- double support	double support time	baseline, 4, 8, 12 weeks
Secondary	mobility lab- TUG	timed up and go time	baseline, 4, 8, 12 weeks
Secondary	mobility lab- turn	turn time	baseline, 4, 8, 12 weeks