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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03436888
Other study ID # 2017-A00949-44
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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