Low Back PainLBP_TRANCT05487729
Low Back Pain Prevalence
An observational study of Low Back Pain and Local Stabilizers, run by Szeged University at 1 site in Hungary.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Local Stabilizers, ODI
- What is being tested?
- ultrasonography and functional assessment and questionnaire survey
- How many people
- 250 participants
- Where
- 1 siteHungary
- Study dates
- 8 Feb 2021to 8 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: community sample
Who may be able to join
- in case of patients with low back pain: chronic pain
- in case of asymptomatic individuals: no symptomes
Who cannot join
- serious neurologycal symptomes
- serious scoliosis
- previous surgery which affected the local stabilizers
- serious pulmonar disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Low Back Pain, Local Stabilizers, ODI
- Being tested
- ultrasonography and functional assessment and questionnaire survey
- Keywords
- low back pain, local stabilizers, ODI
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonography and functional assessment and questionnaire surveyOther
ultrasonography and functional assessment and questionnaire survey
| Study group | Role | What they receive |
|---|---|---|
| Young adults | Young adults without neurological and serious structural condition. Receives: Other: ultrasonography and functional assessment and questionnaire survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
DIAGNOSTICAL ULTRASOUND - MUSCULOSKELETAL ULTRASOUND
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.
Measured: 12 minutes
NEUROCOM BASIC BALANCE MASTER
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.
Measured: 20 minutes
STABILIZER PRESSURE BIOFEEDBACK
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
Measured: 5 minutes
ZEBRIS CMS-10 ULTRASOUND SYSTEM
ZEBRIS CMS10 computer-controlled, ultrasound-based motion analysis system located in the Biomechanical Laboratorium
Measured: 10 minutes
The Functional Movement Screen (FMS)
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.
Measured: 10 minutes
STABILITY LIMIT TESTS
LATERAL REACH, MODIFIED LATERAL REACH, REACH FORWARD, MODIFIED REACH FORWARD: special functional tests for stability limit.
Measured: 12 minutes
Secondary outcomes (15)
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.
Measured: 1 minute
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.
Measured: 3 minutes
OSWESTRY DISABILITY INDEX
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.
Measured: 3 minutes
ROLAND-MORRIS QUESTIONNAIRE
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.
Measured: 2 minutes
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.
Measured: 2 minutes
SHORT FORM-36 HEALTH SURVEY
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.
Measured: 4 minutes
THE STATE-TRAIT ANXIETY INVENTORY (STAI Y-1,2 form))
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
Measured: 4 minutes
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.
Measured: 2 minutes
THE BECK DEPRESSION INVENTORY (BDI, BDI-1A, BDI-II)
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.
Measured: 4 minutes
LOW BACK PAIN KNOWLEDGE QUESTIONNAIRE (LKQ)
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.
Measured: 2 minutes
COMI
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.
Measured: 2 minutes
ZUNG
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).
Measured: 1 minute
PISQ-IR
PISQ-IR is a disease-specific questionnaire to assess sexual function in women with pelvic floor disorders.
Measured: 2 minutes
FSFI
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.
Measured: 3 minutes
GAUDENZ
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.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start8 Feb 2021
- Primary completion8 Aug 2022 (estimated)
- Study completion8 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487729
- Sponsor's protocol ID
- LBP_TRA
- Acronym
- LBP_TRA
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kasza BB, Nakity K, Finta R, Pasztor N, Kurokawa T, Sapi M, Domjan A. Investigating the impact of perceived stress and anxiety on nonspecific low back pain among future health care professionals in Hungary: a cross-sectional study. Front Psychol. 2025 May 19;16:1463414. doi: 10.3389/fpsyg.2025.1463414. eCollection 2025.
PubMed 40458634
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Back Pain Prevalence in Young Adults.
- ClinicalTrials.gov ID
- NCT05487729
- Acronym / sponsor ID
- LBP_TRA / LBP_TRA
- Conditions
- Low Back Pain, Local Stabilizers, ODI
- Keywords
- low back pain, local stabilizers, ODI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 8 Aug 2022 (estimated)
- Study completion
- 8 May 2024 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young adults | – | Other: ultrasonography and functional assessment and questionnaire surveyYoung adults without neurological and serious structural condition. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- community sample
Key inclusion criteria (2 listed)
- in case of patients with low back pain: chronic pain
- in case of asymptomatic individuals: no symptomes
Key exclusion criteria (4 listed)
- serious neurologycal symptomes
- serious scoliosis
- previous surgery which affected the local stabilizers
- serious pulmonar disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonography and functional assessment and questionnaire surveyultrasonography and functional assessment and questionnaire survey | Other | Young adults |
Primary outcome
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.
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.
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
ZEBRIS CMS-10 ULTRASOUND SYSTEM
Time frame: 10 minutes
ZEBRIS CMS10 computer-controlled, ultrasound-based motion analysis system located in the Biomechanical Laboratorium
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.
STABILITY LIMIT TESTS
Time frame: 12 minutes
LATERAL REACH, MODIFIED LATERAL REACH, REACH FORWARD, MODIFIED REACH FORWARD: special functional tests for stability limit.
15 secondary outcomes
VISUAL ANALOG SCALE
Time frame: 1 minute
MEDICAL HISTORY RECORD SHEET
Time frame: 3 minutes
OSWESTRY DISABILITY INDEX
Time frame: 3 minutes
ROLAND-MORRIS QUESTIONNAIRE
Time frame: 2 minutes
THE QUEBEC BACK PAIN DISABILITY SCALE (QBPDS)
Time frame: 2 minutes
SHORT FORM-36 HEALTH SURVEY
Time frame: 4 minutes
THE STATE-TRAIT ANXIETY INVENTORY (STAI Y-1,2 form))
Time frame: 4 minutes
THE PERCEIVED STRESS SCALE (PSS)
Time frame: 2 minutes
THE BECK DEPRESSION INVENTORY (BDI, BDI-1A, BDI-II)
Time frame: 4 minutes
LOW BACK PAIN KNOWLEDGE QUESTIONNAIRE (LKQ)
Time frame: 2 minutes
COMI
Time frame: 2 minutes
ZUNG
Time frame: 1 minute
PISQ-IR
Time frame: 2 minutes
FSFI
Time frame: 3 minutes
GAUDENZ
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Derived from this study: PubMed 40458634Kasza BB, Nakity K, Finta R, Pasztor N, Kurokawa T, Sapi M, Domjan A. Investigating the impact of perceived stress and anxiety on nonspecific low back pain among future health care professionals in Hungary: a cross-sectional study. Front Psychol. 2025 May 19;16:1463414. doi: 10.3389/fpsyg.2025.1463414. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Local Stabilizers, run by Szeged University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DIAGNOSTICAL ULTRASOUND - MUSCULOSKELETAL ULTRASOUND (time frame: 12 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05487729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.