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

Sponsor

University Hospital, Caen (Other)

Overall Status

Recruiting

CT.gov ID

NCT03436888

Collaborator

(none)

250

Enrollment

Locations

51.5

Anticipated Duration (Months)

125

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Girdle Pain Pregnancy Related Postpartum Period

Study Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Mar 15, 2018

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Outcome Measures

Primary Outcome Measures

Disability [up to ten days]
Disability will be measured using Pelvic Girdle Questionnaire

Secondary Outcome Measures

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
health-related quality of life: SF 8 scale [1 day (First appointment)]
Health-related quality of life will be measured using SF 8 scale
Pain: Visual Analogue Pain Rating Scale [1 day (First appointment)]
Pain will be measured using Visual Analogue Pain Rating Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pôle de Santé de la Grâce de Dieu	Caen		France	14000
2	Caen University Hospital	Caen		France	14033

Sponsors and Collaborators

University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT03436888

Other Study ID Numbers:

2017-A00949-44

First Posted:

Feb 19, 2018

Last Update Posted:

Mar 3, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pelvic Girdle Pain

Study Results

No Results Posted as of Mar 3, 2022