Chronic Hip PainNCT03006094
The Greek Version of the Chronic Pain Grade Questionnaire (CPGQ)
An observational study of Chronic Hip Pain, run by Asklepieion Voulas General Hospital at 1 site in Greece.
Trial summary
The aim of the present study is to investigate and report on the psychometric properties of a Greek version of the Chronic Pain Grade Questionnaire (CPGQ). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hip Pain
- How many people
- 87 participants
- Where
- 1 siteGreece
- Study dates
- May 2014to Jan 2018
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Orthopaedic outpatients
Who may be able to join
- chronic hip pain (persistent or recurrent hip pain for at least 12 weeks)
Who cannot join
- severe systemic disease that is a constant threat to life
- known psychiatric disorder
- impaired cognition or dementia
- mother language other than Greek
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity, Reliability and Responsiveness of the Greek Version of the Chronic Pain Grade Questionnaire (CPGQ) in Chronic Hip Pain Sufferers
The aim of the present study is to investigate and report on the psychometric properties of a Greek version of the Chronic Pain Grade Questionnaire (CPGQ).
Read the detailed description
The Chronic Pain Grade Questionnaire (CPGQ) is designed to evaluate overall severity of chronic pain based on two dimensions, pain intensity and pain-related disability. Currently, there is no reliable, valid and sensitive to change self-report instrument as brief and easy to understand and complete as the CPGQ available in Greek. A culturally adapted version of the CPGQ would facilitate the study of chronic pain and its implications in the Greek population and allow for cross-cultural comparisons. The aim of the present study is to examine the validity, reliability and responsiveness of a Greek version of the CPGQ in chronic hip pain sufferers.
- Conditions
- Chronic Hip Pain
- Keywords
- questionnaire, hip, pain
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Factor analysis of the Greek version of the CPGQ
Measured: At recruitment (baseline)
Correlations between the CPGQ items, total, subscale scores and the SF-12 PCS, MCS scores
Measured: At recruitment (baseline)
Cronbach's alpha values for the total scale and each subscale of the Greek version of the CPGQ
Measured: At recruitment (baseline)
Intraclass correlation coefficient (ICC) values for the total scale and each sub scale of the Greek version of the CPGQ
Measured: 48 hours
Change in CPGQ total scale and subscale scores
Recruited subjects who will undergo total hip replacement surgery will complete the Greek version of the CPGQ and report their improvement using a dichotomous variable (Yes or No improvement) six months postoperatively.
Measured: At recruitment (baseline) and 6 months following total hip replacement surgery
Secondary outcomes (2)
Percentage of patients who were able to complete the Greek version of the CPGQ by themselves
Measured: At recruitment (baseline)
Time employed in filling out the Greek version of the CPGQ
Measured: At recruitment (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startMay 2014
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hip PainStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asklepieion Voulas General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Maria Diakomi, Asklepieion Voulas General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006094
- Sponsor's protocol ID
- 242
- Status last verified
- Mar 2018
- First submitted
- 22 Dec 2016
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity, Reliability and Responsiveness of the Greek Version of the Chronic Pain Grade Questionnaire (CPGQ) in Chronic Hip Pain Sufferers
- ClinicalTrials.gov ID
- NCT03006094
- Acronym / sponsor ID
- 242
- Conditions
- Chronic Hip Pain
- Keywords
- questionnaire, hip, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Asklepieion Voulas General HospitalOther government
- Study start
- May 2014 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 30 Dec 2016 (estimated)
- 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 aim of the present study is to investigate and report on the psychometric properties of a Greek version of the Chronic Pain Grade Questionnaire (CPGQ).
Detailed description
The Chronic Pain Grade Questionnaire (CPGQ) is designed to evaluate overall severity of chronic pain based on two dimensions, pain intensity and pain-related disability. Currently, there is no reliable, valid and sensitive to change self-report instrument as brief and easy to understand and complete as the CPGQ available in Greek. A culturally adapted version of the CPGQ would facilitate the study of chronic pain and its implications in the Greek population and allow for cross-cultural comparisons. The aim of the present study is to examine the validity, reliability and responsiveness of a Greek version of the CPGQ in chronic hip pain sufferers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Orthopaedic outpatients
Key inclusion criteria (1 listed)
- chronic hip pain (persistent or recurrent hip pain for at least 12 weeks)
Key exclusion criteria (4 listed)
- severe systemic disease that is a constant threat to life
- known psychiatric disorder
- impaired cognition or dementia
- mother language other than Greek
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
Factor analysis of the Greek version of the CPGQ
Time frame: At recruitment (baseline)
Correlations between the CPGQ items, total, subscale scores and the SF-12 PCS, MCS scores
Time frame: At recruitment (baseline)
Cronbach's alpha values for the total scale and each subscale of the Greek version of the CPGQ
Time frame: At recruitment (baseline)
Intraclass correlation coefficient (ICC) values for the total scale and each sub scale of the Greek version of the CPGQ
Time frame: 48 hours
Change in CPGQ total scale and subscale scores
Time frame: At recruitment (baseline) and 6 months following total hip replacement surgery
Recruited subjects who will undergo total hip replacement surgery will complete the Greek version of the CPGQ and report their improvement using a dichotomous variable (Yes or No improvement) six months postoperatively.
2 secondary outcomes
Percentage of patients who were able to complete the Greek version of the CPGQ by themselves
Time frame: At recruitment (baseline)
Time employed in filling out the Greek version of the CPGQ
Time frame: At recruitment (baseline)
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 6 Mar 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hip Pain, run by Asklepieion Voulas General Hospital at 1 site in Greece.
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 4 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 6 Mar 2018. 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 Greece. 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?
Factor analysis of the Greek version of the CPGQ (time frame: At recruitment (baseline)). The study lists 5 primary outcomes in all. 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 6 Mar 2018.