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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 134

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • Caen University Hospital
  • Caen, France, 14000
    • Pôle de Santé de la Grâce de Dieu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult pregnant or in postpartum period females suffering of pelvic girdle pain. The symptoms must occur during pregnancy or within 3 weeks after childbirth.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability	Disability will be measured using Pelvic Girdle Questionnaire	up to ten days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Actual): August 25, 2023
• Study Completion (Actual): August 25, 2023

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Pain; Pelvic Pain; Pelvic Girdle Pain
• Other Study ID Numbers: 2017-A00949-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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