Prognostic Factors of Importance on Who Develops Chronic Low Back Pain

Completed

• Conditions: Low Back Pain; Life Style; Illness Perception
• Interventions: Other: Questionnaire

• Registration Number: NCT03940456
• Lead Sponsor: Frederiksberg University Hospital

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.

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 Timeline

• Study First Submitted: 2019-04-29
• Study First Submitted QC: 2019-05-05
• Study First Posted: 2019-05-07
• Study Start: 2019-05-08
• Primary Completion: 2019-09-24
• Study Completion: 2019-09-24
• Status Verified: 2020-09
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 607

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Inception cohort, former Elsinore pupils	Questionnaire	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).

Primary Outcome Measures

Name	Time	Method
prevalence of LBP	measured once at study baseline	To estimate the prevalence of self-disclosed low back pain

Secondary Outcome Measures

Name	Time	Method
Incidence of LBP	measured once at study baseline	To estimate the incidence of self-disclosed low back pain
Brief illness perception questionnaire (IPQ-B)	measured once at study baseline	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.
EQ-5D (3 likert scale)	measured once at study baseline	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.

Trial Locations

Locations (1)

The Parker Institute, Frederiksberg Hospital; 🇩🇰 Copenhagen, Denmark