Clinical trial NCT03403920: Validity of Profile Fitness Mapping Low Back Questionnaire
Official title: Validity of the Turkish Version of the Profile Fitness Mapping Low Back Questionnaire for Patients With Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Pain
Assessment, Self
Disability Physical
Keywords: validity
low back pain
functional
pain
questionnaire
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients have neck pain more than six months

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* low back pain for more than six months during activity or rest
* Having a problem with low back based on clinical examination and story

Exclusion Criteria:

* Having neurological problems
* Having vestibular or cerebellar problems

Primary outcomes:
measure: Profile Fitness Mapping Low Back Questionnaire
timeFrame: Change from Baseline Profile Fitness Mapping Low Back Questionnaire score (functional limitation and symptom score) at 1 week.
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: All of the participants will assess at baseline with this index.
measure: SF-36 health related quality of life questionnaire
timeFrame: All of the participants will assess at baseline with this questionnaire.
measure: Visual Analog Scale
timeFrame: All of the participants will assess at baseline with this scale.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
citation: 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.