PainNCT03415737
Validity of the Turkish Version of the Profile Fitness Mapping Neck Questionnaire for Patients With Neck Pain
An observational study of Pain and Neck Pain, run by HATİCE ÇETİN at 1 site in Turkey (Türkiye).
Trial summary
As patients improve on one parametric result, the results on the other parametric may worsen, but the total score may not be affected. For this reason, it would be useful to make measurements that evaluate all the parameters of the patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Neck Pain, Evaluations, Diagnostic Self
- What is being tested?
- Questionnaire
- How many people
- 235 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2018to 15 Jan 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with neck pain
Who may be able to join
- Neck pain for more than six months during activity or rest
- Having a problem with the neck based on clinical examination and story
Who cannot join
- Having neurological problems
- Having vestibular or cerebellar problems
Trial locations and contacts
1 site in 1 country.
About this study
As patients improve on one parametric result, the results on the other parametric may worsen, but the total score may not be affected. For this reason, it would be useful to make measurements that evaluate all the parameters of the patients. Thus, it would be more advantageous to score both pain and symptoms separately, as well as activity limitations. Therefore, neck specific surveys are needed to meet this need.
For this reason, this study was planned to determine the validity of the questionnaire named "Profile Fitness Mapping Neck Questionnaire" in patients with neck pain.
Read the detailed description
The translation of the original version of "Profile Fitness Mapping Neck Questionnaire" to Turkish will be translated by two independent professional translators. Afterwards, a person without a medical history and a native English speaker will be translated into English again. Once the translation stages are complete, the translators will be brought together to discuss the two versions of the questionnaire. Then the final state will be translated into the main language of the questionnaire and the compliance will be checked.
First of all, people who have been suffering from low back pain for at least six months will complete the "Profile Fitness Mapping NeckQuestionnaire", "Neck Disability Index", "SF-36 health related quality of life questionnaire" and "Visual Analog Scale".
Seven days after the questionnaire, the "Profile Fitness Mapping Neck Questionnaire" will be completed again.
- Conditions
- Pain, Neck Pain, Evaluations, Diagnostic Self, Assessment, Self
- Being tested
- Questionnaire
- Medical subject headings
- Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Profile Fitness Mapping Neck Questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile Fitness Mapping Neck Questionnaire
This questionnaire measures symptoms and functional limitations about neck pain.
Measured: Change from Baseline Profile Fitness Mapping Neck Questionnaire score (functional limitation and symptom score) at 1 week.
Secondary outcomes (3)
Neck Disability Index
This questionnaire evaluates disability related with neck pain.
Measured: All of the participants will assess at baseline with this index.
SF-36 health related quality of life questionnaire
This questionnaire evaluates quality of life.
Measured: All of the participants will assess at baseline with this questionnaire.
Visual Analog Scale
This scale evaluates severity of pain.
Measured: All of the participants will assess at baseline with this scale.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start30 Oct 2018
- Primary completion20 Dec 2018
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 235 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- HATİCE ÇETİN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, HATİCE ÇETİN, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415737
- Sponsor's protocol ID
- 776348
- Status last verified
- May 2019
- First submitted
- 8 Jan 2018
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bjorklund M, Hamberg J, Heiden M, Barnekow-Bergkvist M. The ProFitMap-neck--reliability and validity of a questionnaire for measuring symptoms and functional limitations in neck pain. Disabil Rehabil. 2012;34(13):1096-107. doi: 10.3109/09638288.2011.635747. Epub 2011 Dec 12.
PubMed 22149067
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of the Turkish Version of the Profile Fitness Mapping Neck Questionnaire for Patients With Neck Pain
- ClinicalTrials.gov ID
- NCT03415737
- Acronym / sponsor ID
- 776348
- Conditions
- Pain, Neck Pain, Evaluations, Diagnostic Self, Assessment, Self
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- HATİCE ÇETİNUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 30 Jan 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.
As patients improve on one parametric result, the results on the other parametric may worsen, but the total score may not be affected. For this reason, it would be useful to make measurements that evaluate all the parameters of the patients. Thus, it would be more advantageous to score both pain and symptoms separately, as well as activity limitations. Therefore, neck specific surveys are needed to meet this need.
For this reason, this study was planned to determine the validity of the questionnaire named "Profile Fitness Mapping Neck Questionnaire" in patients with neck pain.
Detailed description
The translation of the original version of "Profile Fitness Mapping Neck Questionnaire" to Turkish will be translated by two independent professional translators. Afterwards, a person without a medical history and a native English speaker will be translated into English again. Once the translation stages are complete, the translators will be brought together to discuss the two versions of the questionnaire. Then the final state will be translated into the main language of the questionnaire and the compliance will be checked.
First of all, people who have been suffering from low back pain for at least six months will complete the "Profile Fitness Mapping NeckQuestionnaire", "Neck Disability Index", "SF-36 health related quality of life questionnaire" and "Visual Analog Scale".
Seven days after the questionnaire, the "Profile Fitness Mapping Neck Questionnaire" will be completed again.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with neck pain
Key inclusion criteria (2 listed)
- Neck pain for more than six months during activity or rest
- Having a problem with the neck based on clinical examination and story
Key exclusion criteria (2 listed)
- Having neurological problems
- Having vestibular or cerebellar problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireProfile Fitness Mapping Neck Questionnaire | Other | – |
Primary outcome
Profile Fitness Mapping Neck Questionnaire
Time frame: Change from Baseline Profile Fitness Mapping Neck Questionnaire score (functional limitation and symptom score) at 1 week.
This questionnaire measures symptoms and functional limitations about neck pain.
3 secondary outcomes
Neck Disability Index
Time frame: All of the participants will assess at baseline with this index.
SF-36 health related quality of life questionnaire
Time frame: All of the participants will assess at baseline with this questionnaire.
Visual Analog Scale
Time frame: All of the participants will assess at baseline with this scale.
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 24 May 2019.
- Background: PubMed 22149067Bjorklund M, Hamberg J, Heiden M, Barnekow-Bergkvist M. The ProFitMap-neck--reliability and validity of a questionnaire for measuring symptoms and functional limitations in neck pain. Disabil Rehabil. 2012;34(13):1096-107. doi: 10.3109/09638288.2011.635747. Epub 2011 Dec 12.
- 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 Pain and Neck Pain, run by HATİCE ÇETİN at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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 24 May 2019. 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 Turkey (Türkiye). 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?
Profile Fitness Mapping Neck Questionnaire (time frame: Change from Baseline Profile Fitness Mapping Neck Questionnaire score (functional limitation and symptom score) at 1 week.). 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 NCT03415737, which also lists 1 linked publication.
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 24 May 2019.