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

NCT03436888 | Completed

• 1 other identifier: 2017-A00949-44
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 2

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.

Conditions

Pelvic Girdle Pain; Pregnancy Related; Postpartum Period

Outcome Measures

Primary Outcomes (1)

• Disability

  Disability will be measured using Pelvic Girdle Questionnaire

  up to ten days

Secondary Outcomes (5)

• 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)

• health-related quality of life: SF 8 scale

  1 day (First appointment)

• Pain: Visual Analogue Pain Rating Scale

  1 day (First appointment)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (2)

Pôle de Santé de la Grâce de Dieu

Caen, 14000, France

Location

Caen University Hospital

Caen, 14033, France

Location

MeSH Terms

Conditions

Pelvic Girdle Pain

Condition Hierarchy (Ancestors)

Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: February 19, 2018
• Study Start: March 15, 2018
• Primary Completion: August 25, 2023
• Study Completion: August 25, 2023
• Last Updated: November 28, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)