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

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ClinicalTrials.gov Identifier: NCT03436888
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : March 3, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Study Description
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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
Pelvic Girdle Pain Pregnancy Related Postpartum Period

Study Design
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Study Type : Observational
Estimated 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 : March 15, 2018
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Disability [ Time Frame: up to ten days ]
    Disability will be measured using Pelvic Girdle Questionnaire


Secondary Outcome Measures :
  1. Disability: Oswestry disability index [ Time Frame: 1 day (First appointment) ]
    Disability will be measured using Oswestry disability index

  2. fear-avoidance beliefs: Fear Avoidance Beliefs Questionnaire [ Time Frame: 1 day (First appointment) ]
    Fear Avoidance Beliefs will be measured using Fear Avoidance Beliefs Questionnaire

  3. Pain Catastrophizing: Pain catastrophizing scale [ Time Frame: 1 day (First appointment) ]
    Pain catastrophizing will be measured using pain catastrophizing scale

  4. health-related quality of life: SF 8 scale [ Time Frame: 1 day (First appointment) ]
    Health-related quality of life will be measured using SF 8 scale

  5. Pain: Visual Analogue Pain Rating Scale [ Time Frame: 1 day (First appointment) ]
    Pain will be measured using Visual Analogue Pain Rating Scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436888


Contacts
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Contact: Michèle Godignon +33231063106 godignon-m@chu-caen.fr
Contact: Cathy Gaillard +33231063106 gaillard-c@club-internet.fr

Locations
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France
Pôle de Santé de la Grâce de Dieu Recruiting
Caen, France, 14000
Contact: Arnaud Tabard, MD    +33231703224    arnaud.tabart@pole-sante-gdd.fr   
Caen University Hospital Recruiting
Caen, France, 14033
Contact: Michèle Godignon    +33231063106    godignon-m@chu-caen.fr   
Contact: Cathy Gaillard    +33231063106    gaillard-c@chu-caen.fr   
Sponsors and Collaborators
University Hospital, Caen
More Information
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03436888    
Other Study ID Numbers: 2017-A00949-44
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pelvic Girdle Pain
Musculoskeletal Pain
Pain
Neurologic Manifestations
Pelvic Pain