Pain Clinical Trial
Official title:
Validity of the Turkish Version of the Profile Fitness Mapping Low Back Questionnaire for Patients With Low Back Pain
NCT number | NCT03403920 |
Other study ID # | 7763482 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 24, 2018 |
Est. completion date | January 15, 2021 |
Verified date | August 2021 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 235 |
Est. completion date | January 15, 2021 |
Est. primary completion date | December 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Hacettepe University | Ankara |
Lead Sponsor | Collaborator |
---|---|
HATICE ÇETIN |
Turkey,
Björklund 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. Epub 2007 Jun 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Change from Baseline Profile Fitness Mapping Low Back Questionnaire score (functional limitation and symptom score) at 1 week. | |
Secondary | 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. | All of the participants will assess at baseline with this index. | |
Secondary | 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. | All of the participants will assess at baseline with this questionnaire. | |
Secondary | 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]). | All of the participants will assess at baseline with this scale. |
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