Low Back Pain Prevalence

Low Back Pain Clinical Trial

— LBP_TRA  

Official title:

Low Back Pain Prevalence in Young Adults.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05487729
• Other study ID #: LBP_TRA
• Status: Active, not recruiting
• Start date: February 8, 2021
• Est. completion date: May 8, 2024

Study information

• Verified date: August 2022
• Source: Szeged University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: May 8, 2024
• Est. primary completion date: August 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• ultrasonography and functional assessment and questionnaire survey
ultrasonography and functional assessment and questionnaire survey

Locations

Country	Name	City	State
Hungary	University of Szeged	Szeged	Csongrád-Csanád

Sponsors (1)

Lead Sponsor	Collaborator
Szeged University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 minutes
Primary	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.	20 minutes
Primary	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	5 minutes
Primary	ZEBRIS CMS-10 ULTRASOUND SYSTEM	ZEBRIS CMS10 computer-controlled, ultrasound-based motion analysis system located in the Biomechanical Laboratorium	10 minutes
Primary	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.	10 minutes
Primary	STABILITY LIMIT TESTS	LATERAL REACH, MODIFIED LATERAL REACH, REACH FORWARD, MODIFIED REACH FORWARD: special functional tests for stability limit.	12 minutes
Secondary	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.	1 minute
Secondary	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.	3 minutes
Secondary	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.	3 minutes
Secondary	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.	2 minutes
Secondary	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.	2 minutes
Secondary	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.	4 minutes
Secondary	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	4 minutes
Secondary	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.	2 minutes
Secondary	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.	4 minutes
Secondary	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.	2 minutes
Secondary	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.	2 minutes
Secondary	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).	1 minute
Secondary	PISQ-IR	PISQ-IR is a disease-specific questionnaire to assess sexual function in women with pelvic floor disorders.	2 minutes
Secondary	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.	3 minutes
Secondary	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.	2 minutes