- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05487729
Low Back Pain Prevalence (LBP_TRA)
Low Back Pain Prevalence in Young Adults.
Brief Summery: 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.
The aim of our current study is to assess the prevalence of low back pain among young adults, and we would like to examine the musculoskeletal and psychosocial factors associated with low back pain that can be justified as risk factors. Our further goal is to assess and compare lumbar sensorimotor control in young people without complaints and with low back pain.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Csongrád-Csanád
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Szeged, Csongrád-Csanád, Hungary, 6726
- University of Szeged
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Young adults
Young adults without neurological and serious structural condition.
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ultrasonography and functional assessment and questionnaire survey
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DIAGNOSTICAL ULTRASOUND - MUSCULOSKELETAL ULTRASOUND
Time Frame: 12 minutes
|
An imaging procedure that allows doctors, physiotherapist to see muscles, joints, and more.
For diagnosing muscle tears/strains, nerves, and arthritis.
Physical therapy or injection of medicine may be next step.
Involves radiology and center for musculoskeletal care.
|
12 minutes
|
|
NEUROCOM BASIC BALANCE MASTER
Time Frame: 20 minutes
|
Limits of Stability (LOS), Modified Clinical Test of Sensory Interaction on Balance (mCTSIB), Rhythmic Weight Shift (RWS) special tests for the balancing and motor control paremeters.
|
20 minutes
|
|
STABILIZER PRESSURE BIOFEEDBACK
Time Frame: 5 minutes
|
Stabilizer Pressure Biofeedback is an easy to use device that provides a visual indication of whether you are working the correct postural muscles, in the right manner, when performing specific exercises.
Intended for the prevention and treatment of back pain, neck pain, and to improve core stability
|
5 minutes
|
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ZEBRIS CMS-10 ULTRASOUND SYSTEM
Time Frame: 10 minutes
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ZEBRIS CMS10 computer-controlled, ultrasound-based motion analysis system located in the Biomechanical Laboratorium
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10 minutes
|
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The Functional Movement Screen (FMS)
Time Frame: 10 minutes
|
The Functional Movement Screen (FMS) is a screening tool used to evaluate seven fundamental movement patterns in individuals with no current pain complaint or musculoskeletal injury.
The FMS is not intended to diagnose orthopedic problems but rather to demonstrate opportunities for improved movement in individuals.
The screen is designed to place an individual in extreme positions where movement deficits become noticeable if appropriate stability and mobility are not used.
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10 minutes
|
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STABILITY LIMIT TESTS
Time Frame: 12 minutes
|
LATERAL REACH, MODIFIED LATERAL REACH, REACH FORWARD, MODIFIED REACH FORWARD: special functional tests for stability limit.
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12 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VISUAL ANALOG SCALE
Time Frame: 1 minute
|
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.
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1 minute
|
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MEDICAL HISTORY RECORD SHEET
Time Frame: 3 minutes
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We created an individual patient examination form, in which we could ask our subjects about their lifestyle habits and about their low back pain.
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3 minutes
|
|
OSWESTRY DISABILITY INDEX
Time Frame: 3 minutes
|
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability.
The test is considered the 'gold standard' of low back functional outcome tools.
|
3 minutes
|
|
ROLAND-MORRIS QUESTIONNAIRE
Time Frame: 2 minutes
|
The Roland-Morris Disability Questionnaire[1] is designed to assess self-rated physical disability caused by low back pain.
The Roland-Morris Disability Questionnaire is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain.
|
2 minutes
|
|
THE QUEBEC BACK PAIN DISABILITY SCALE (QBPDS)
Time Frame: 2 minutes
|
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.
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2 minutes
|
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SHORT FORM-36 HEALTH SURVEY
Time Frame: 4 minutes
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SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.
These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients.
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4 minutes
|
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THE STATE-TRAIT ANXIETY INVENTORY (STAI Y-1,2 form))
Time Frame: 4 minutes
|
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety.
It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes.
It also is often used in research as an indicator of caregiver distress
|
4 minutes
|
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THE PERCEIVED STRESS SCALE (PSS)
Time Frame: 2 minutes
|
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.
|
2 minutes
|
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THE BECK DEPRESSION INVENTORY (BDI, BDI-1A, BDI-II)
Time Frame: 4 minutes
|
It is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. Its development marked a shift among mental health professionals, who had until then, viewed depression from a psychodynamic perspective, instead of it being rooted in the patient's own thoughts. There are three versions of the BDI-the original BDI, first published in 1961 and later revised in 1978 as the BDI-1A, and the BDI-II, published in 1996. The BDI is widely used as an assessment tool by health care professionals and researchers in a variety of settings. |
4 minutes
|
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LOW BACK PAIN KNOWLEDGE QUESTIONNAIRE (LKQ)
Time Frame: 2 minutes
|
This instrument assesses knowledge about back pain.
Composed of 16 questions, divided into the following categories: general aspects, concepts and treatment.
The score ranges from 0 to 24 points, with a higher score denoting a better knowledge of low back pain.
|
2 minutes
|
|
COMI
Time Frame: 2 minutes
|
The COMI is a valid and sensitive questionnaire for the evaluation of patients with degenerative lumbar disease before and after treatment.
The COMI is a questionnaire composed of 8 questions that evaluates pain (2 items), function (1 item), well-being (1 item), disability (2 items) and satisfaction (2 items).
The scores of the questionnaire range from 1 to 5, with 1 being the best possible result.
The total COMI score is the average of the 5 dimensions.
It was designed for a simpler but effective standardized evaluation of outcome in patients with low back pain and would replace more cumbersome health-related questionnaires in daily practice.
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2 minutes
|
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ZUNG
Time Frame: 1 minute
|
The Zung Self-Rating Depression Scale was designed by W.W. Zung to assess the level of depression for patients diagnosed with depressive disorder.
The Zung Self-Rating Depression Scale is a short self-administered survey to quantify the depressed status of a patient.
There are 20 items on the scale that rate the four common characteristics of depression: the pervasive effect, the physiological equivalents, other disturbances, and psychomotor activities.
There are ten positively worded and ten negatively worded questions.
Each question is scored on a scale of 1-4 (a little of the time, some of the time, good part of the time, most of the time).
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1 minute
|
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PISQ-IR
Time Frame: 2 minutes
|
PISQ-IR is a disease-specific questionnaire to assess sexual function in women with pelvic floor disorders.
|
2 minutes
|
|
FSFI
Time Frame: 3 minutes
|
The Female Sexual Function Index (FSFI) is recognized as an excellent tool for assessing female sexuality and screening female sexual dysfunction, but it also has important venereological implications as sexually transmitted diseases result from human behaviour in the sexual sphere.
|
3 minutes
|
|
GAUDENZ
Time Frame: 2 minutes
|
The Gaudenz Incontinence Questionnaire has been used widely in Europe as a diagnostic tool to discriminate between SUI and UUI.
Initial studies demonstrated high validity.
|
2 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LBP_TRA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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