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Clinical Trials/NCT03403920
NCT03403920CompletedNot Applicable

Validity of the Turkish Version of the Profile Fitness Mapping Low Back Questionnaire for Patients With Low Back Pain

HATİCE ÇETİN1 site in 1 country235 target enrollmentStarted: October 24, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
235
Locations
1
Primary Endpoint
Profile Fitness Mapping Low Back Questionnaire

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • SF-36 health related quality of life questionnaire(All of the participants will assess at baseline with this questionnaire.)
  • Oswestry Disability Index(All of the participants will assess at baseline with this index.)
  • Visual Analog Scale(All of the participants will assess at baseline with this scale.)

Investigators

Sponsor
HATİCE ÇETİN
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

HATİCE ÇETİN

Research Assistant

Hacettepe University

Study Sites (1)

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