Risk Factors for Low Back Pain in Adults A 23-year Prospective Cohort Study of 14-15-year-old Schoolchildren.

Low Back Pain Clinical Trial

Official title:

Risk Factors for Low Back Pain in Adults A 23-year Prospective Cohort Study of 14-15-year-old Schoolchildren.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04739839
• Other study ID #: Western Zealand Cohort
• Status: Terminated
• Start date: February 5, 2021
• Est. completion date: March 30, 2021

Study information

• Verified date: January 2022
• 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 the 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 and rising costs due to health care expenses and sick leave. Hence, prevention of LBP in the working 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 lifestyle and psychosocial factors on the development of chronic low back pain.

The main aims of this study is to identify the prevalence of low back pain and 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: Terminated
• Enrollment: 1400
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 45 Years

Eligibility

Inclusion Criteria:

• Being a member of the original Western Zealand cohort

• Ability to understand and write in Danish

• Having access to the Danish digital mail system "e-Boks". (Access to e-Boks is mandatory in Denmark unless you have special needs)

Exclusion Criteria:

We have no formal exclusion criterias

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• survey questionnaire
Questionnaire focusing on low back pain in relation to life style, physical activity level, illness perception and quality of life.

Locations

Country	Name	City	State
Denmark	Claus Bomhoff	Copenhagen	DK

Sponsors (1)

Lead Sponsor	Collaborator
Frederiksberg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of low back pain	Amount of respondents reporting low back pain within last month	Measured once at study baseline
Secondary	Incidence of severe low back pain	Amount of respondents reporting low back pain more than thirty days within last year	Measured once at study baseline
Secondary	Actual low back pain	Current low back pain, defined as "the level of pain in your lower back today"	Measured once at study baseline
Secondary	The Brief Illness Perception Questionnaire	We use the Danish version of The Brief illness perception questionnaire (B-IPQ). B-IPQ is a generic 9-item questionnaire developed to rapidly assess the cognitive and emotional representations in a variety of illnesses. The first 8 items are scored on a 1-10 numeric rating scale with descriptors (none or extreme) at either end. B-IPQ assesses perceptions on the following five dimensions: Identity, Cause, Timeline, Consequences and Cure-Control. Five of the items assess cognitive illness representations: consequences, timeline, personal control, treatment control, and identity. Two of the items assess emotional representations: concern and emotions. One item assesses illness comprehensibility. Item 9 is a free text field in which the respondent can formulate their beliefs about their condition (cause). We will not use this field in our study. In all questions we replace the word "illness" with "low back pain".; In this study we explore each B-IPQ item score and not an overall score.	Measured once at study baseline
Secondary	Roland Morris Questionnaire	The Roland Morris Questionnaire (RMQ) is designed to assess self-rated physical disability caused by low back pain. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. It is easy to administer and correlates well with other physical disability measures. We used the Danish version (RMQ-Patrick). It has 23 questions with yes/no options and is translated in 2003. A clinically meaningful change on the RMQ ranges from a 2.5- to a 5.0-point improvement (reduction) from baseline has been suggested.	Measured once at study baseline
Secondary	Health related quality of life EQ-5D	To assess health related quality of life we apply the Danish version of the EuroQoL 5 dimensions (EQ-5D) questionnaire. EQ-5D is a standardised measure of health status that provides a simple, generic measure of health. It is applicable to a wide range of health conditions and is ideally suited for use in surveys. The EQ-5D consists of a descriptive system comprising 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Standardized answer options are given (3 Likert boxes) and each question is assigned a score from 1 to 3. From the responses an EQ-5D index is calculated. Further a EQ visual analogue scale (EQ VAS) is used to record the respondent's self-rated health on a 0-100 vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine' used as a quantitative measure of health as judged by the individual respondents.	Measured once at study baseline
Secondary	Health related quality of life EQ-5D VAS	A visual analogue scale (EQ VAS) is used to record the respondent's self-rated health on a 0-100 vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine' used as a quantitative measure of health as judged by the individual respondents.	Measured once at study baseline
Secondary	Use of CAMs for low back pain	Amount of respondents reporting regular use of complementary or alternative treatments (CAMs) for low back pain	Measured once at study baseline
Secondary	Use of exercise for low back pain	Amount of respondents doing regular exercise for low back pain	Measured once at study baseline
Secondary	Use of recommended non-pharmacological treatments for low back pain	Amount of respondents reporting regular use of recommended non-pharmacological treatments for low back pain	Measured once at study baseline
Secondary	Use of recommended pharmacological treatments for low back pain	Amount of respondents reporting regular use of recommended pharmacological treatments for low back pain	Measured once at study baseline