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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Prognostic Factors of Importance on Who Develops Chronic Low Back Pain

Clinicaltrials.gov identifier NCT03940456

Recruitment Status Completed

First Posted May 7, 2019

Last update posted September 30, 2020

Study Description

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.

  • Condition or Disease:Low Back Pain
    Life Style
    Illness Perception
  • Intervention/Treatment: Other: Questionnaire
  • Phase: N/A
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 Design
  • Study Type: Observational
  • Actual Enrollment: 607 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official 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
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: September 2019
  • Actual Study Completion Date: September 2019
Groups and Cohorts
Groups/Cohorts 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
Outcome Measures
  • Primary Outcome Measures: 1. prevalence of LBP [ Time Frame: measured once at study baseline ]
    To estimate the prevalence of self-disclosed low back pain
  • Secondary Outcome Measures: 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.
Eligibility Criteria
  • Ages Eligible for Study: 67 to 69 Years (Older Adult)
  • Sexes Eligible for Study: All
  • 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
Criteria

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

Contacts and Locations
Contacts
Locations

Denmark
The Parker Institute, Frederiksberg Hospital
Copenhagen

Sponsors and Collaborators

Frederiksberg University Hospital

More Information
  • Responsible Party: Frederiksberg University Hospital
  • ClinicalTrials.gov Identifier: NCT03940456 History of Changes
  • Other Study ID Numbers: Elsinore low back pain cohort
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: September 30, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Frederiksberg University Hospital: Cohort
    Low Back Pain
    Illness perception
    Life Style
  • Additional relevant MeSH terms: Back Pain Low Back Pain