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临床试验/NCT03403920
NCT03403920已完成不适用

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

HATİCE ÇETİN1 个研究点 分布在 1 个国家目标入组 235 人开始时间: 2018年10月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
235
试验地点
1
主要终点
Profile Fitness Mapping Low Back Questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Having neurological problems
  • Having vestibular or cerebellar problems

结局指标

主要结局

Profile Fitness Mapping Low Back Questionnaire

时间窗: 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.

次要结局

  • 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.)

研究者

发起方
HATİCE ÇETİN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

HATİCE ÇETİN

Research Assistant

Hacettepe University

研究点 (1)

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