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Completed

NCT Number: NCT03940456

Prognostic Factors of Importance on Who Develops Chronic Low Back Pain

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.

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Key information

Conditions

Low Back Pain Back Pain Illness Perception Life Style Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

67 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Parker Institute, Frederiksberg Hospital

Copenhagen, 2000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

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

Primary outcomes

  1. prevalence of LBP

    Time frame: measured once at study baseline

    To estimate the prevalence of self-disclosed low back pain

Secondary outcomes

  1. Incidence of LBP

    Time frame: measured once at study baseline

    To estimate the incidence of self-disclosed low back pain

  2. Brief illness perception questionnaire (IPQ-B)

    Time frame: 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.

  3. EQ-5D (3 likert scale)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Frederiksberg University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 7, 2019
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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