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

Overview

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.

Full Title of Study: “13-year Follow-up of Women With Chronic Low Back Pain in Primary Care – a Prospective Longitudinal Cohort Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 30, 2021

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.

Interventions

  • Other: 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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Activity limitation
    • Time Frame: 2019, change from the first assessment (2006) to the present 13-year follow-up (2019), identify predictors (2006) for activity limitation (RMDQ) at the 13-year follow-up
    • Roland and Morris Disability Questionnaire (RMDQ) will be used.
  • Pain intensity
    • Time Frame: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019), identify predictors (2006) for pain intensity (VAS) at the 13-year follow-up.
    • A Visual Analogue Scale (VAS), ranging 0 to 100 mm will be used for pain intensity during the last week. 0 mm indicates no pain and 100 mm indicates very severe pain. Higher score indicates more severe pain.
  • Work ability
    • Time Frame: 2019, Comparison from the first assessment (2006) to the present 13-year follow-up (2019), identify predictors (2006) for work ability at the 13-year follow-up.
    • Sick-leave periods, and sickness and activity compensation is obtained from the Swedish Social Insurance Agency’s MiDAS database. Self-reported work status dichotomized into two categories, work ability or not will be used.

Secondary Measures

  • Pain distribution
    • Time Frame: 2019, Comparison from the first assessment (2006) to the present 13-year follow-up (2019), identify predictors (2006) for pain distribution at the 13-year follow-up.
    • A drawing of the body will be used for assessing distribution of pain

Participating in This Clinical Trial

Inclusion Criteria

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

  • Pregnant – Serious somatic disorders – Serious psychiatric disorders

Gender Eligibility: Female

This study will follow up all women (n=131) included in the cross sectional study in 2006.

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vastra Gotaland Region
  • Collaborator
    • Göteborg University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lena Nordeman, PhD, Principal Investigator, R&D primary care Region Västra Götaland, University of Gothenburg 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.

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