Clinical trial NCT03974191: 13-year Follow-up of Women With Chronic Low Back Pain in Primary Care - a Prospective Longitudinal Cohort Study
Official title: 13-year Follow-up of Women With Chronic Low Back Pain in Primary Care - a Prospective Longitudinal Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Back Pain
Chronic Widespread Pain
Predictors
Pain
Physical Activity
Work Ability
Keywords: Low Back Pain
Pain
Physical Activity
Physical Capacity
Work Ability
Primary Health Care
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Göteborg University
First posted: 2019-06-04
Enrollment: 131
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The 183 women who fulfilled the inclusion criteria were invited to participate in the cross-sectional study in 2006 and 131 accepted participation. All 131 from the cross-sectional study are now invited to participate in the present 13-year follow-up.The inclusion criteria at the first assessment in 2006 were: female patient, age between 18 and 60 years, low back pain (pain between costal margins and gluteal folds) with or without referred leg pain. Further criteria were; greater than 12-week's duration of symptoms, not pregnant, no known spinal disorders, no other severe somatic or psychiatric disorders, understanding in Swedish.

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.

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

Primary outcomes:
measure: Activity limitation
timeFrame: 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
measure: Pain intensity
timeFrame: 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.
measure: Work ability
timeFrame: 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.
Secondary outcomes:
measure: Pain distribution
timeFrame: 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.
Other outcomes:
measure: Walking capacity
timeFrame: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
measure: Lower limb muscle endurance and muscle strength
timeFrame: 2019
measure: Hand grip strength
timeFrame: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
measure: Hand grip strength
timeFrame: 2019
measure: Pain sensitivity/pain threshold
timeFrame: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
measure: Fatigue
timeFrame: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
measure: General fatigue
timeFrame: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
measure: Sleep quantity
timeFrame: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
measure: Sleep quality
timeFrame: Time frame: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019)
measure: Social support
timeFrame: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
measure: Stress
timeFrame: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
measure: Physical function
timeFrame: 2019, Comparison from the first assessment (2006) to the present 13-year follow-up (2019).
measure: Leisure Time Physical Activity
timeFrame: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
measure: Experience of physical activity
timeFrame: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
measure: Risk for long-term disability and sick-leave
timeFrame: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
measure: Health-related quality of life
timeFrame: Change from the first assessment (2006) to the present 13-year follow-up (2019).
measure: Alcohol consumption
timeFrame: Comparison from the first assessment (2006) to the present 13-year follow-up (2019).
Locations:
city: Alingsås
country: Sweden
facility: Närhälsan, Region Västra Götaland
city: Borås
country: Sweden
facility: R&D primary care, Region Västra Götaland
city: Uddevalla
country: Sweden
facility: Närhälsan, Region Västra Götaland
Study officials:
affiliation: R&D primary care Region Västra Götaland, University of Gothenburg Sweden
name: Lena Nordeman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.