Pelvic Girdle PainPELVICNCT03436888
Cross-cultural Adaptation and Validation of the Pelvic Girdle Questionnaire in French Language
An observational study of Pelvic Girdle Pain and Pregnancy Related, run by University Hospital, Caen at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Girdle Pain, Pregnancy Related, Postpartum Period
- How many people
- 134 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Mar 2018to 25 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Pôle de Santé de la Grâce de Dieu
Caen, 14000
Caen University Hospital
Caen, 14033
About this study
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
- Medical subject headings
- Pelvic Girdle Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
Disability will be measured using Pelvic Girdle Questionnaire
Measured: up to ten days
Secondary outcomes (5)
Disability: Oswestry disability index
Disability will be measured using Oswestry disability index
Measured: 1 day (First appointment)
fear-avoidance beliefs: Fear Avoidance Beliefs Questionnaire
Fear Avoidance Beliefs will be measured using Fear Avoidance Beliefs Questionnaire
Measured: 1 day (First appointment)
Pain Catastrophizing: Pain catastrophizing scale
Pain catastrophizing will be measured using pain catastrophizing scale
Measured: 1 day (First appointment)
health-related quality of life: SF 8 scale
Health-related quality of life will be measured using SF 8 scale
Measured: 1 day (First appointment)
Pain: Visual Analogue Pain Rating Scale
Pain will be measured using Visual Analogue Pain Rating Scale
Measured: 1 day (First appointment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start15 Mar 2018
- Primary completion25 Aug 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Girdle PainStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436888
- Sponsor's protocol ID
- 2017-A00949-44
- Acronym
- PELVIC
- Status last verified
- Feb 2022
- First submitted
- 16 Nov 2017
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation and Validation of the Pelvic Girdle Questionnaire in French Language
- ClinicalTrials.gov ID
- NCT03436888
- Acronym / sponsor ID
- PELVIC / 2017-A00949-44
- Conditions
- Pelvic Girdle Pain, Pregnancy Related, Postpartum Period
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disability
Time frame: up to ten days
Disability will be measured using Pelvic Girdle Questionnaire
5 secondary outcomes
Disability: Oswestry disability index
Time frame: 1 day (First appointment)
fear-avoidance beliefs: Fear Avoidance Beliefs Questionnaire
Time frame: 1 day (First appointment)
Pain Catastrophizing: Pain catastrophizing scale
Time frame: 1 day (First appointment)
health-related quality of life: SF 8 scale
Time frame: 1 day (First appointment)
Pain: Visual Analogue Pain Rating Scale
Time frame: 1 day (First appointment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Girdle Pain and Pregnancy Related, run by University Hospital, Caen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability (time frame: up to ten days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.