NCT04739839

Brief Summary

The incidence of low back pain (LBP) is increasing and prognostic factors for developing LBP are unclear. Based on questionnaires, different prognostic factors are being explored over time.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

February 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

February 27, 2025

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

February 1, 2021

Last Update Submit

February 25, 2025

Conditions

Keywords

low back painprevalenceillness perceptionquality of lifecohort studysurvey

Outcome Measures

Primary Outcomes (1)

  • Incidence of low back pain

    Amount of respondents reporting low back pain within last month

    Measured once at study baseline

Secondary Outcomes (10)

  • Incidence of severe low back pain

    Measured once at study baseline

  • Actual low back pain

    Measured once at study baseline

  • The Brief Illness Perception Questionnaire

    Measured once at study baseline

  • Roland Morris Questionnaire

    Measured once at study baseline

  • Health related quality of life EQ-5D

    Measured once at study baseline

  • +5 more secondary outcomes

Study Arms (1)

Inception cohort, former pupils in different schools in Western Zealand

1327 former Western Zealand pupils (originally 1389). Aged 14-15 in 1997. This is the first follow up on this cohort.

Other: survey questionnaire

Interventions

Questionnaire focusing on low back pain in relation to life style, physical activity level, illness perception and quality of life.

Inception cohort, former pupils in different schools in Western Zealand

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This is an inception cohort where all participants will be around 38 years

You may qualify if:

  • Being a member of the original Western Zealand cohort
  • Ability to understand and write in Danish
  • Having access to the Danish digital mail system "e-Boks". (Access to e-Boks is mandatory in Denmark unless you have special needs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Claus Bomhoff

Copenhagen, DK, 2000, Denmark

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
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 5, 2021

Study Start

February 5, 2021

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

February 27, 2025

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Data will be available through request to study contact person

Locations