Special Lower Back Pillow Examination (LBP PILLOW)
Primary Purpose
Low Back Pain
Status
Active
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
survey
Sponsored by
About this trial
This is an interventional screening trial for Low Back Pain focused on measuring LBP, special pillow, lower back pillow
Eligibility Criteria
Inclusion Criteria:
- in case of patients with low back pain: chronic pain
- in case of asymptomatic individuals: no symptomes
Exclusion Criteria:
- serious neurologycal symptomes
- serious scoliosis
- previous surgery which affected the local stabilizers
- serious pulmonar disease
Sites / Locations
- University of Szeged
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
adults
Arm Description
People who use the lower back pillow.
Outcomes
Primary Outcome Measures
MEDICAL HISTORY RECORD SHEET
We created an individual patient examination form, in which we could ask our subjects about their lifestyle habits and about their low back pain.
THE QUEBEC BACK PAIN DISABILITY SCALE (QBPDS)
The Quebec back pain disability scale is a condition-specific questionnaire developed to measure the level of functional disability for patients with low back pain (LBP) is a condition-specific questionnaire developed to measure the level of functional disability for patients with low back pain (LBP). The original purpose of the questionnaire is to take into account the functional limitations related to pain, to monitor the progress of individual patients and to compare the evolution of LBP subjects incorporated in rehabilitation programs.
THE PERCEIVED STRESS SCALE (PSS)
The Perceived Stress Scale is a classic stress assessment instrument. The tool remains a popular choice for helping us understand how different situations affect our feelings and our perceived stress. The questions in this scale ask about your feelings and thoughts during the last month. In each case, you will be asked to indicate how often you felt or thought a certainn way.
VISUAL ANALOG SCALE
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. VAS is the most common pain scale.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05486845
Brief Title
Special Lower Back Pillow Examination
Acronym
LBP PILLOW
Official Title
The Effect of the Use of Lower Back Pillow.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Szeged University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Low back pain is a significant, serious and widespread problem in our world today, both in terms of social and economic burdens. It should be emphasized that even the young adult age group is very often affected by non-specific, low back pain without proven pathoanatomical changes.
Detailed Description
We plan to examine the use of a special lower back pillow and the time period of the sitting position. We would like to know how it helps to prevent and treat low back pain. We would like to know more about the people's pillow usage habits.
We are planning a questionnaire survey. We combine our own questions with validated, official questionnaires. Validated forms ask for an assessment of the extent of low back pain and the quality of experienced stress.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
LBP, special pillow, lower back pillow
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
adults
Arm Type
Experimental
Arm Description
People who use the lower back pillow.
Intervention Type
Other
Intervention Name(s)
survey
Intervention Description
We are planning a questionnaire survey. We combine our own questions with validated, official questionnaires. Validated forms ask for an assessment of the extent of low back pain and the quality of experienced stress.
Primary Outcome Measure Information:
Title
MEDICAL HISTORY RECORD SHEET
Description
We created an individual patient examination form, in which we could ask our subjects about their lifestyle habits and about their low back pain.
Time Frame
3 minutes
Title
THE QUEBEC BACK PAIN DISABILITY SCALE (QBPDS)
Description
The Quebec back pain disability scale is a condition-specific questionnaire developed to measure the level of functional disability for patients with low back pain (LBP) is a condition-specific questionnaire developed to measure the level of functional disability for patients with low back pain (LBP). The original purpose of the questionnaire is to take into account the functional limitations related to pain, to monitor the progress of individual patients and to compare the evolution of LBP subjects incorporated in rehabilitation programs.
Time Frame
2 minutes
Title
THE PERCEIVED STRESS SCALE (PSS)
Description
The Perceived Stress Scale is a classic stress assessment instrument. The tool remains a popular choice for helping us understand how different situations affect our feelings and our perceived stress. The questions in this scale ask about your feelings and thoughts during the last month. In each case, you will be asked to indicate how often you felt or thought a certainn way.
Time Frame
2 minutes
Title
VISUAL ANALOG SCALE
Description
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. VAS is the most common pain scale.
Time Frame
1 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
in case of patients with low back pain: chronic pain
in case of asymptomatic individuals: no symptomes
Exclusion Criteria:
serious neurologycal symptomes
serious scoliosis
previous surgery which affected the local stabilizers
serious pulmonar disease
Facility Information:
Facility Name
University of Szeged
City
Szeged
State/Province
Csongrád-Csanád
ZIP/Postal Code
6726
Country
Hungary
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Special Lower Back Pillow Examination
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