Cross-cultural Adaptation and Validation of the Pelvic Girdle Questionnaire in French Language

Completed

• Conditions: Pelvic Girdle Pain; Postpartum Period; Pregnancy Related

• Registration Number: NCT03436888
• Lead Sponsor: University Hospital, Caen

Brief Summary

The objective of this study is the adaptation of the Pelvic Girdle Questionnaire to the French language from France, and the analysis of its psychometric properties. Firstly, a translation and adaptation process will be performed according to international guidelines. Secondly, the validation process will be performed through a sample of 250 pregnant or postpartum women suffering from pelvic girdle pain. They will fill several questionnaires, including Pelvic Girdle Questionnaire, that will allow us to analyse psychometric properties of the French version.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-19
• Study Start: 2018-03-15
• Status Verified: 2022-02
• Primary Completion: 2023-08-25
• Study Completion: 2023-08-25
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 134

Inclusion Criteria

• Women from 18 years-old, pregnant or having given birth less than one year earlier, with PGP whose onset occurred during pregnancy or within 3 weeks after birth. Registered in the French social security system.

Exclusion Criteria

• Ovarian cysts, uterine fibroids, caesarean section (if subject in postpartum period), radicular pain below the knee, previous surgery on the spine, pelvis or lower limbs, vaginismus-type pelvic pain, spondylolisthesis, inflammatory diseases, prolapse, suspected serious pathology (weakness of the lower limbs, reflex changes or loss of sensation associated with the same spinal nerve), impossibility or difficulty in understanding the questionnaires and subjects needing guardianship/supervision.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disability	up to ten days	Disability will be measured using Pelvic Girdle Questionnaire

Secondary Outcome Measures

Name	Time	Method
Disability: Oswestry disability index	1 day (First appointment)	Disability will be measured using Oswestry disability index
fear-avoidance beliefs: Fear Avoidance Beliefs Questionnaire	1 day (First appointment)	Fear Avoidance Beliefs will be measured using Fear Avoidance Beliefs Questionnaire
Pain Catastrophizing: Pain catastrophizing scale	1 day (First appointment)	Pain catastrophizing will be measured using pain catastrophizing scale
Pain: Visual Analogue Pain Rating Scale	1 day (First appointment)	Pain will be measured using Visual Analogue Pain Rating Scale
health-related quality of life: SF 8 scale	1 day (First appointment)	Health-related quality of life will be measured using SF 8 scale

Trial Locations

Locations (2)

Pôle de Santé de la Grâce de Dieu; 🇫🇷 Caen, France

Caen University Hospital; 🇫🇷 Caen, France