13-year Follow-up of Women With Chronic Low Back Pain in Primary Care - a Prospective Longitudinal Cohort Study

NCT ID: NCT03974191

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 131 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-10
• Study Completion Date: 2023-12-31

Brief Summary

Background: Low back pain (LBP) is among the main causes of long-term sickness absence and is associated with considerable costs for both the individual and society. LBP affects 60-80% of the population and most individuals recover, while about 10-20% develop persistent pain and disability. Women have a higher risk of developing chronic LBP (CLBP) and widespread pain.

Purpose: To investigate change in body function, activity, participation and other health related factors in women with CLBP after 13 years and to identify prognostic factors for pain, activity limitation and work ability.

Methods: In the present study, all women (n = 131) who were included in the cross-sectional study in 2006 and who were followed-up after 2 years are now invited to the same study-protocol 13 years after the first examination in 2006.

The Swedish Ethical Review Authority approved the study. Dnr: 2019-01944, 2019-05-21.

Detailed Description

Background: Low back pain (LBP) is among the main causes of long-term sickness absence and is associated with considerable costs for both the individual and society. LBP affects 60-80% of the population and most individuals recover, while about 10-20% develop persistent pain and disability. Women have a higher risk of developing chronic LBP (CLBP) and widespread pain.

How LBP develops into recurrent and or more persistent pain with disability is not fully understood. Prognostic factors for pain development, work ability and self-rated activity limitation in 1 and 2-year follow-ups of persons with CLBP who sought primary care are described. Performance on physical capacity tests (6-min walking test), limitations on self-rated activity and participation and psycho-social factors play a role in unfavorable pain and function development. However, there are patients with CLBP who have no anatomical, demographic or psychosocial explanation of their symptoms. Some people with CLBP also have widespread pain and show altered pain sensitivity as fibromyalgia.

Purpose:To investigate change in body function, activity, participation and other health related factors in women with CLBP after 13 years and to identify prognostic factors for pain, activity limitation and work ability.

Methods: In the present study, all women (n = 131) who were included in the cross-sectional study in 2006 and who were followed-up after 2 years are now invited to the same study-protocol 13 years after the first examination in 2006.

Participants will be assessed by a registered physiotherapist at one occasion. Demographic data are collected, Questions about social support, sleep quality and sleep quantity, smoking and alcohol consumption. Self-reported questionnaires, pain and function performance tests will be assessed.

Data Analysis: Descriptive analysis based on data level; mean value (standard deviation), median (25th; 75th percentile), number and proportion will be used to present the group's characteristics. For analysis of change between the first assessment and after 13 years, Wilcoxon's signed rank test will be used for continuous variables and Teckentest / McNemar's test will be used for nominal data.

Multivariable regression analysis will be performed to calculate predictors of pain intensity (VAS), number of pain locations/pain distribution, self-rated activity limitation (RMDQ) and work ability after 13 years. Independent variables will be variables at the first assessment within the domains; body function (pain intensity, pain distribution, pain sensitivity, anxiety, depression, function test and stress), activity (RMDQ) and participation (work ability), as well as other health-related factors (Health-Related Quality of Life (SF-36), Leisure Time Physical Activity Instrument, Experience of Physical Activity). Multivariable regression models will be adjusted for age, level of education and social status. P-value is set to 0.05.

Ethical approval: The Swedish Ethical Review Authority approved the study. Dnr: 2019-01944, 2019-05-21.

Expected Results: The results is expected to provide knowledge about long-term clinical course (13 years) and prognostic factors for a positive pain and function development of CLBP in women seeking primary care.

Conditions

Low Back Pain; Chronic Widespread Pain; Predictors; Pain; Physical Activity; Work Ability

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

131 participants with chronic low back pain

All the participants (n=131) with chronic low back pain (CLBP) from the cross-sectional study in 2006 are invited to participate in the present 13-year follow-up. The same examination battery used in the cross-sectional study plus a supplementary Chair Stand Test will be used.

Change in function, activity, participation and other health related factors in CLBP and to identify predictors for pain, activity and work ability after 13 years.

Intervention Type: OTHER

13-year prospective longitudinal cohort study

Interventions

Change in function, activity, participation and other health related factors in CLBP and to identify predictors for pain, activity and work ability after 13 years.

13-year prospective longitudinal cohort study

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All participants (n=131) included in the Cross Sectional Study in 2006

Exclusion Criteria

• Pregnant
• Serious somatic disorders
• Serious psychiatric disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lena Nordeman, PhD

Role: PRINCIPAL_INVESTIGATOR

R&D primary care Region Västra Götaland, University of Gothenburg Sweden

Locations

Närhälsan, Region Västra Götaland

Alingsås, , Sweden

R&D primary care, Region Västra Götaland

Borås, , Sweden

Närhälsan, Region Västra Götaland

Uddevalla, , Sweden

Countries

Sweden

References

Nordeman L, Gunnarsson R, Mannerkorpi K. Prevalence and characteristics of widespread pain in female primary health care patients with chronic low back pain. Clin J Pain. 2012 Jan;28(1):65-72. doi: 10.1097/AJP.0b013e318223622c.

Reference Type: BACKGROUND

PMID: 21677567 (View on PubMed)

Other Identifiers

VGFOUREG855601

Identifier Type: -

Identifier Source: org_study_id