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Pelvic Girdle PainNCT05751460

Translation and Validation of Pelvic Girdle Questionnaire in Urdu Language

An observational study of Pelvic Girdle Pain, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Urdu version of pelvic girdle questionnaire was drafted, tested for its reliability and validity on patients with pelvic girdle pain. Urdu version was linguistically acceptable and accurate for pregnant and post partum females with pelvic girdle pain. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Pelvic Girdle Pain
What is being tested?
Straight leg raise
How many people
125 participants
Where
1 sitePakistan
Study dates
2 Jan 2021to 31 Jan 2022
How long will I take part?
1 Week
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 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Female pregnant and post partum with pelvic girdle pain

Who may be able to join

  • Age 18-50 years
  • Only Females
  • Able to read Urdu Language
  • Pregnant women (gestational week 30-38)
  • Postpartum women (given birth less than one year earlier)

Who cannot join

  • Any neurological diseases (reflex changes \& loss of sensation)
  • Unstable medical conditions leading to fatigue
  • Those that have prolapse or severe urinary disease
  • Previous surgery on pelvis, lower limb or spine
  • Cannot Understand Urdu
  • Difficulty in understanding the Pelvic girdle questionnaire

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Faiza Kalsoom

    Gujrat, Punjab Province, 50931

Other trials in Pakistan

About this study

Urdu version of pelvic girdle questionnaire was drafted, tested for its reliability and validity on patients with pelvic girdle pain. Urdu version was linguistically acceptable and accurate for pregnant and post partum females with pelvic girdle pain. The result seems comparable to all the other versions and especially with original Norwegian version. This instrument is understandable and easy to find disability during pregnancy and post partum duration. It showed a good content, construct and convergent validity also present high internal consistency and test retest reliability.

Read the detailed description

The Pelvic Girdle Questionnaire is the only specific instrument designed to evaluate pain and activity limitations in pregnant or postpartum women with pelvic girdle pain. This study aimed to translate the Pelvic girdle questionnaire in Urdu language for Pakistani female patients and to verify the validation of the psychometric items of the Pelvic girdle questionnaire in population of Pakistan. The purpose of this study was to translate the Pelvic Girdle Questionnaire into Urdu and find out cross-culture validity and reliability of Urdu Pelvic girdle questionnaire among pregnant and postpartum females. A cultural adaptation and translation study was performing according to international guidelines. Study was conducted at different hospital settings. Pre test was conducted among 16 females during pregnancy \& post-partum.

Key words: Disability Evaluation, Female, Urdu, Pelvic Girdle Pain and physiopathology, Pregnancy, Surveys and Questionnaires, Translation.

Being tested
Straight leg raise
Medical subject headings
Pelvic Girdle Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Straight leg raiseOther

    Also called Pelvic girdle questionnaire

    Diagnostic test, tool for *g*

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Content validity

    Content validity score measured by content validity index. Assessment of 25 items by Clinician and native speaker experts rate all the items and all the value are above 0.70.Lower value was 0.92 and the highest value is 1 which is maximum value. Maximum score is given to 4, 5, 6,10,11,12,17,18,22 and 24 by experts (medical specialist and native speakers).

    Measured: "through study completion, an average of 1 year"

Secondary outcomes (1)

  1. Internal consistency:

    Cronbach's alpha was used for reliability. The reliability and internal consistency of PGQ for PGP patients Cronbach's alpha in week one and week two is 0.977 and 0.976 respectively. The value of α for activity subscale (1-20) is 0.986 and symptom subscale (21- 25) is 0.970.

    Measured: "upto two weeks"

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2023
  2. Study start2 Jan 2021
  3. Primary completion31 Jan 2022
  4. Study completion31 Jan 2022

Resources

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
Other
Enrolment
125 participants (actual)
Target duration
1 Week
IDs, dates and publications
ClinicalTrials.gov ID
NCT05751460
Sponsor's protocol ID
Faiza Kalsoom
Status last verified
Feb 2023
First submitted
21 Oct 2022
Last updated
2 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cong H, Liu H, Sun Y, Gao J, Liu J, Ma L, Stuge B, Chen L. Cross-cultural adaptation, reliability, and validity of a Chinese version of the pelvic girdle questionnaire. BMC Pregnancy Childbirth. 2021 Jun 30;21(1):470. doi: 10.1186/s12884-021-03962-8.

    PubMed 34193061

  • Sakamoto A, Hoshi K, Gamada K. Transcultural Reliability and Validity of the Japanese-Language Version of the Pelvic Girdle Questionnaire. J Manipulative Physiol Ther. 2020 Jan;43(1):68-77. doi: 10.1016/j.jmpt.2018.11.019. Epub 2020 Feb 13.

    PubMed 32061416

  • Acharya RS, Tveter AT, Grotle M, Khadgi B, Koju R, Eberhard-Gran M, Stuge B. Cross-Cultural Adaptation and Validation of the Nepali Version of the Pelvic Girdle Questionnaire. J Manipulative Physiol Ther. 2020 Mar-Apr;43(3):257-265. doi: 10.1016/j.jmpt.2019.04.009. Epub 2020 Jul 29.

    PubMed 32739042

  • Munisamy A, Sahid, Sheerad Hussin, Muhammad. Content Validation and Content Validity Index Calculation of B40 Household's Financial Literacy. Turkish Online Journal of Qualitative Inquiry. 202112(8).

  • Dunn G, Egger MJ, Shaw JM, Yang J, Bardsley T, Powers E, Nygaard IE. Trajectories of lower back, upper back, and pelvic girdle pain during pregnancy and early postpartum in primiparous women. Womens Health (Lond). 2019 Jan-Dec;15:1745506519842757. doi: 10.1177/1745506519842757.

    PubMed 30991911

  • Gutke A, Stuge B, Elden H, Sandell C, Asplin G, Fagevik Olsen M. The Swedish version of the pelvic girdle questionnaire, cross-cultural adaptation and validation. Disabil Rehabil. 2020 Apr;42(7):1013-1020. doi: 10.1080/09638288.2018.1515991. Epub 2019 Feb 1.

    PubMed 30707631

  • Rashidi Fakari F, Kariman N, Ozgoli G, Ghare Naz MS, Ghasemi V, Rashidi Fakari F, Ebadi A. Iranian version of Pelvic Girdle Questionnaire: Psychometric properties and cultural adaptation. J Res Med Sci. 2019 May 22;24:43. doi: 10.4103/jrms.JRMS_391_18. eCollection 2019.

    PubMed 31160910

  • Fagundes FML, Cabral CMN. Cross-cultural adaptation of the Pelvic Girdle Questionnaire (PGQ) into Brazilian Portuguese and clinimetric testing of the PGQ and Roland Morris questionnaire in pregnancy pelvic pain. Braz J Phys Ther. 2019 Mar-Apr;23(2):132-139. doi: 10.1016/j.bjpt.2018.11.003. Epub 2018 Nov 17.

    PubMed 30501939

  • Starzec M, Truszczynska-Baszak A, Stuge B, Tarnowski A, Rongies W. Cross-cultural Adaptation of the Pelvic Girdle Questionnaire for the Polish Population. J Manipulative Physiol Ther. 2018 Oct;41(8):698-703. doi: 10.1016/j.jmpt.2018.04.002. Epub 2018 Dec 26.

    PubMed 30594333

  • Girard MP, O'Shaughnessy J, Doucet C, Lardon E, Stuge B, Ruchat SM, Descarreaux M. Validation of the French-Canadian Pelvic Girdle Questionnaire. J Manipulative Physiol Ther. 2018 Mar-Apr;41(3):234-241. doi: 10.1016/j.jmpt.2018.01.001. Epub 2018 Feb 15.

    PubMed 29456093

Questions about this trial

What is this clinical trial studying?

An observational study of Pelvic Girdle Pain, run by Riphah International University at 1 site in Pakistan.

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 5 inclusion and 6 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 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. 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?

Content validity (time frame: "through study completion, an average of 1 year"). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05751460, which also lists 10 linked publications.

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 2 Mar 2023.

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