Prognostic Factors of Importance on Who Develops Chronic Low Back Pain

Prognostic Factors of Importance on Who Develops Chronic Low Back Pain: a Protocol Update for an Inception Cohort with Focus on Prognostic Factors with 54 Years of Follow Up

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Life Style; Illness Perception
• Intervention / Treatment: Other: Questionnaire

Detailed Description

Despite massive efforts of trying to find predictors and prevention for LBP, it remains to be clarified, why some individuals develop severely disabling low back pain while others never experience noteworthy back pain. There is no evidence that numbers of chronically affected individuals have diminished; rather, the incidence of LBP has increased continuously over the last 20 years which is also reflected in rising numbers of lumbar surgical treatments. The prevalence and burden increase with age and prevention of LBP in an aging population seems more urgent than ever. As LBP is undoubtedly a multifaceted disorder that tends to fluctuate throughout life, there is a need for longitudinal research, exploring the effect of both life style and psychosocial factors on the development of chronic low back pain.

The aim of this study is to identify whether a history of low back pain during adolescence represents an increased risk of experiencing low back pain later in life.

• Study Type: Observational
• Enrollment (Actual): 607

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2000
    • The Parker Institute, Frederiksberg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 67 years to 69 years (Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

This is an inception cohort based on pupils from schools in Elsinore. There are no formal inclusion criteria other tan being part of this cohort

Exclusion Criteria:

• No formal exclusion criteria but inability to understand/answer our questionnaire is per se an exclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Questionnaire mainly focusing on low back pain, pain related disorders, psychosocial factors and the use of alternative treatments for pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of LBP	To estimate the prevalence of self-disclosed low back pain	measured once at study baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of LBP	To estimate the incidence of self-disclosed low back pain	measured once at study baseline
Brief illness perception questionnaire (IPQ-B)	Actual IPQ-B score. Generic questionnaire developed to measure illness perception. The IPQ-B contains eight items and one causal scale. Items 1-8 are rated using a 0-to-10 response scale, item 9 is a memo field. Five of the items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items assess emotional representations: concern (Item 6) and emotions (Item 8). One item assesses illness comprehensibility (Item 7). A low score on items number 1,2,5,6 and 8 indicates that the illness is perceived as benign while a low score on the items 3, 4 and 7 indicates that the illness is perceived as threatening. By reversing these three items it is possible to compute an overall score. A higher score reflects a more threatening view of the illness.	measured once at study baseline
EQ-5D (3 likert scale)	The EQ-5D-3L essentially consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS) (0-100). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' (100) and 'Worst imaginable health state' (0). This information can be used as a quantitative measure of health outcome as judged by the individual respondents. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	measured once at study baseline

Collaborators and Investigators

• Sponsor: Frederiksberg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2019
• Primary Completion (Actual): September 24, 2019
• Study Completion (Actual): September 24, 2019

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: May 5, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Low Back Pain; Cohort; Life Style; Illness perception
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Elsinore low back pain cohort

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No