Prognostic Factors of Importance on Who Develops Chronic Low Back Pain

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03940456
• Other study ID #: Elsinore low back pain cohort
• Status: Completed
• Start date: May 8, 2019
• Est. completion date: September 24, 2019

Study information

• Verified date: September 2020
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 607
• Est. completion date: September 24, 2019
• Est. primary completion date: September 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 67 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Illness Perception
• Life Style
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
Denmark	The Parker Institute, Frederiksberg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Frederiksberg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of LBP	To estimate the prevalence of self-disclosed low back pain	measured once at study baseline
Secondary	Incidence of LBP	To estimate the incidence of self-disclosed low back pain	measured once at study baseline
Secondary	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
Secondary	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