NCT03940456

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

87
On Track

Trial Health Score

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

Enrollment
607

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 29, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

May 8, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2019

Completed
Last Updated

February 27, 2025

Status Verified

September 1, 2020

Enrollment Period

5 months

First QC Date

April 29, 2019

Last Update Submit

February 25, 2025

Conditions

Low Back PainLife StyleIllness Perception

Keywords

CohortLow Back PainIllness perceptionLife Style

Outcome Measures

Primary Outcomes (1)

  • prevalence of LBP

    To estimate the prevalence of self-disclosed low back pain

    measured once at study baseline

Secondary Outcomes (3)

  • Incidence of LBP

    measured once at study baseline

  • Brief illness perception questionnaire (IPQ-B)

    measured once at study baseline

  • EQ-5D (3 likert scale)

    measured once at study baseline

Study Arms (1)

Inception cohort, former Elsinore pupils

640 former Elsinore pupils (330 female, 310 male). Aged 14 in 1965. Two earlier cross-sectional studies have been done in this group (in 1990 and 2000).

Other: Questionnaire

Interventions

QuestionnaireOTHER

Questionnaire mainly focusing on low back pain, pain related disorders, psychosocial factors and the use of alternative treatments for pain

Inception cohort, former Elsinore pupils

Eligibility Criteria

Age67 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population will comprise all available subjects who have been part of the Elsinore cohort since 1965

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Parker Institute, Frederiksberg Hospital

Copenhagen, 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
Professor

Study Record Dates

First Submitted

April 29, 2019

First Posted

May 7, 2019

Study Start

May 8, 2019

Primary Completion

September 24, 2019

Study Completion

September 24, 2019

Last Updated

February 27, 2025

Record last verified: 2020-09

Locations

DK(1)