NCT05486845

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Jul 2022

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

August 3, 2022

Last Update Submit

August 3, 2022

Conditions

Keywords

LBPspecial pillowlower back pillow

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

adults

EXPERIMENTAL

People who use the lower back pillow.

Other: survey

Interventions

surveyOTHER

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.

adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • in case of patients with low back pain: chronic pain
  • in case of asymptomatic individuals: no symptomes

You may not qualify if:

  • serious neurologycal symptomes
  • serious scoliosis
  • previous surgery which affected the local stabilizers
  • serious pulmonar disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Szeged

Szeged, Csongrád-Csanád, 6726, Hungary

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2022

First Posted

August 4, 2022

Study Start

July 1, 2022

Primary Completion

July 1, 2023

Study Completion

July 1, 2025

Last Updated

August 4, 2022

Record last verified: 2022-08

Locations