Low Back PainNCT03403920
Validity of Profile Fitness Mapping Low Back Questionnaire
An observational study of Low Back Pain and 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
- Low Back Pain, Pain, Assessment, Self
- What is being tested?
- Questionnaire
- How many people
- 235 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Oct 2018to 15 Jan 2021
- 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 have neck pain more than six months
Who may be able to join
- low back pain for more than six months during activity or rest
- Having a problem with low back 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
Official title: Validity of the Turkish Version of the Profile Fitness Mapping Low Back Questionnaire for Patients With Low Back Pain
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 Low Back Questionnaire" in patients with low back pain.
Read the detailed description
The translation of the original version of "Profile Fitness Mapping Low Back 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 Low Back Questionnaire", "Oswestry Disability Index" and "SF-36 health related quality of life questionnaire".
Seven days after the questionnaire, the "Profile Fitness Mapping Low Back Questionnaire" will be completed again.
- Conditions
- Low Back Pain, Pain, Assessment, Self, Disability Physical
- Being tested
- Questionnaire
- Keywords
- validity, low back pain, functional, pain, questionnaire
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Profile Fitness Mapping Low Back Questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile Fitness Mapping Low Back Questionnaire
The Profile Fitness Mapping Low Back Questionnaire was developed between 1992 and 1994 at the Alfta Rehab Center and consists of two back specific scales, designed for the assessment of self-estimated symptoms and functional limitations. The symptom scale contains two indices of separate aspects of symptomatology. All items are given six response alternatives (how often: range from 1 = never/very seldom, to 6 = very often/always; how much: range from 7 = nothing/none at all, to 12 = almost unbearable/ unbearable, all/maximally).The functional limitation scale (one index) and the symptom scale (two indices) are presented in a self-administered form. All items were given six response alternatives (ranging from
1 = very good, no problem, very satisfying, very likely, to 6 = very bad, very difficult/impossible, very dissatisfying, very unlikely). Higher index scores reflect better function/better health.
Measured: Change from Baseline Profile Fitness Mapping Low Back Questionnaire score (functional limitation and symptom score) at 1 week.
Secondary outcomes (3)
Oswestry Disability Index
The Oswestry Disability Index assesses ten different aspects of disability (pain, personal care, lifting, sitting, standing, sleeping, sex life, social life, walking and travelling). Each parameter is scored from 0 to 5, with 0 indicating no functional limitation due to pain and 5 indicating a major functional disability due to low back pain. This questionnaire is scored using a global percentage score. The obtainable maximum score is 50, which corresponds to 100%. A score of 0%-20% means minimal disability, 21%-40% means moderate disability, 41%-60% means severe disability, 61%-80% means crippling back pain, and 81%-100% means bed-bound or exaggerated symptoms.
Measured: All of the participants will assess at baseline with this index.
SF-36 health related quality of life questionnaire
The SF-36 questionnaire consists of 36 items, which are used to calculate eight subscales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The first four scores can be summed to create the physical composite score, while the last four can be summed to create the mental composite score. Scores for the SF-36 scales range between 0 and 100, with higher scores indicating a better quality of life.
Measured: All of the participants will assess at baseline with this questionnaire.
Visual Analog Scale
The pain Visual Analog Scale is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]).
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 posted19 Jan 2018
- Study start24 Oct 2018
- Primary completion30 Dec 2020
- Study completion15 Jan 2021
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 Low Back 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
- NCT03403920
- Sponsor's protocol ID
- 7763482
- Status last verified
- Aug 2021
- First submitted
- 8 Jan 2018
- Last updated
- 25 Aug 2021
- 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 assessment of symptoms and functional limitations in low back pain patients: validity and reliability of a new questionnaire. Eur Spine J. 2007 Nov;16(11):1799-811. doi: 10.1007/s00586-007-0405-z. Epub 2007 Jun 22.
PubMed 17587068
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. 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 Low Back Questionnaire for Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT03403920
- Acronym / sponsor ID
- 7763482
- Conditions
- Low Back Pain, Pain, Assessment, Self, Disability Physical
- Keywords
- validity, low back pain, functional, pain, questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- HATİCE ÇETİNUniversity, hospital or other
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 19 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 Low Back Questionnaire" in patients with low back pain.
Detailed description
The translation of the original version of "Profile Fitness Mapping Low Back 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 Low Back Questionnaire", "Oswestry Disability Index" and "SF-36 health related quality of life questionnaire".
Seven days after the questionnaire, the "Profile Fitness Mapping Low Back 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 have neck pain more than six months
Key inclusion criteria (2 listed)
- low back pain for more than six months during activity or rest
- Having a problem with low back 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 Low Back Questionnaire | Other | – |
Primary outcome
Profile Fitness Mapping Low Back Questionnaire
Time frame: Change from Baseline Profile Fitness Mapping Low Back Questionnaire score (functional limitation and symptom score) at 1 week.
The Profile Fitness Mapping Low Back Questionnaire was developed between 1992 and 1994 at the Alfta Rehab Center and consists of two back specific scales, designed for the assessment of self-estimated symptoms and functional limitations. The symptom scale contains two indices of separate aspects of symptomatology. All items are given six response alternatives (how often: range from 1 = never/very seldom, to 6 = very often/always; how much: range from 7 = nothing/none at all, to 12 = almost unbearable/ unbearable, all/maximally).The functional limitation scale (one index) and the symptom scale (two indices) are presented in a self-administered form. All items were given six response alternatives (ranging from 1 = very good, no problem, very satisfying, very likely, to 6 = very bad, very difficult/impossible, very dissatisfying, very unlikely). Higher index scores reflect better function/better health.
3 secondary outcomes
Oswestry 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 25 Aug 2021.
- Background: PubMed 17587068Bjorklund M, Hamberg J, Heiden M, Barnekow-Bergkvist M. The assessment of symptoms and functional limitations in low back pain patients: validity and reliability of a new questionnaire. Eur Spine J. 2007 Nov;16(11):1799-811. doi: 10.1007/s00586-007-0405-z. Epub 2007 Jun 22.
- 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 Low Back Pain and 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 25 Aug 2021. 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 Low Back Questionnaire (time frame: Change from Baseline Profile Fitness Mapping Low Back 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 NCT03403920, 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 25 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.