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

Pregnancy Related Clinical Trial

— PELVIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03436888
• Other study ID #: 2017-A00949-44
• Status: Completed
• Start date: March 15, 2018
• Est. completion date: August 25, 2023

Study information

• Verified date: February 2022
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: August 25, 2023
• Est. primary completion date: August 25, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Girdle Pain
• Postpartum Period
• Pregnancy Related

Locations

Country	Name	City	State
France	Caen University Hospital	Caen
France	Pôle de Santé de la Grâce de Dieu	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability	Disability will be measured using Pelvic Girdle Questionnaire	up to ten days
Secondary	Disability: Oswestry disability index	Disability will be measured using Oswestry disability index	1 day (First appointment)
Secondary	fear-avoidance beliefs: Fear Avoidance Beliefs Questionnaire	Fear Avoidance Beliefs will be measured using Fear Avoidance Beliefs Questionnaire	1 day (First appointment)
Secondary	Pain Catastrophizing: Pain catastrophizing scale	Pain catastrophizing will be measured using pain catastrophizing scale	1 day (First appointment)
Secondary	health-related quality of life: SF 8 scale	Health-related quality of life will be measured using SF 8 scale	1 day (First appointment)
Secondary	Pain: Visual Analogue Pain Rating Scale	Pain will be measured using Visual Analogue Pain Rating Scale	1 day (First appointment)