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Clinical Trials/NCT03436888
NCT03436888
Completed
N/A

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

University Hospital, Caen2 sites in 1 country134 target enrollmentMarch 15, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pelvic Girdle Pain
Sponsor
University Hospital, Caen
Enrollment
134
Locations
2
Primary Endpoint
Disability
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 15, 2018
End Date
August 25, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Disability

Time Frame: up to ten days

Disability will be measured using Pelvic Girdle Questionnaire

Secondary Outcomes

  • Disability: Oswestry disability index(1 day (First appointment))
  • fear-avoidance beliefs: Fear Avoidance Beliefs Questionnaire(1 day (First appointment))
  • Pain Catastrophizing: Pain catastrophizing scale(1 day (First appointment))
  • Pain: Visual Analogue Pain Rating Scale(1 day (First appointment))
  • health-related quality of life: SF 8 scale(1 day (First appointment))

Study Sites (2)

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