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.
Condition or disease | Intervention/treatment |
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Low Back Pain Chronic Widespread Pain Predictors Pain Physical Activity Work Ability | 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. |
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.
Study Type : | Observational |
Estimated Enrollment : | 131 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | 13-year Follow-up of Women With Chronic Low Back Pain in Primary Care - a Prospective Longitudinal Cohort Study |
Actual Study Start Date : | June 10, 2019 |
Estimated Primary Completion Date : | June 30, 2020 |
Estimated Study Completion Date : | December 31, 2023 |
Group/Cohort | Intervention/treatment |
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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.
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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
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | This study will follow up all women (n=131) included in the cross sectional study in 2006. |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lena Nordeman, PhD | +46701714463 | lena.nordeman@vgregion.se |
Sweden | |
Närhälsan, Region Västra Götaland | Recruiting |
Alingsås, Sweden | |
Contact: Lena Nordeman, PhD +46701714463 lena.nordeman@vgregion.se | |
R&D primary care, Region Västra Götaland | Recruiting |
Borås, Sweden | |
Contact: Lena Nordeman, PhD +46701714463 lena.nordeman@vgregion.se | |
Närhälsan, Region Västra Götaland | Recruiting |
Uddevalla, Sweden | |
Contact: Lena Nordeman, PhD +46701714463 lena.nordeman@vgregion.se |
Principal Investigator: | Lena Nordeman, PhD | R&D primary care Region Västra Götaland, University of Gothenburg Sweden |
Tracking Information | |||||||
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First Submitted Date | May 27, 2019 | ||||||
First Posted Date | June 4, 2019 | ||||||
Last Update Posted Date | June 27, 2019 | ||||||
Actual Study Start Date | June 10, 2019 | ||||||
Estimated Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome 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
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Original Secondary Outcome Measures | Same as current | ||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||
Descriptive Information | |||||||
Brief Title | 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 | ||||||
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. |
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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. |
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Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
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. | ||||||
Condition |
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Intervention | 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
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Study Groups/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.
Intervention: 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.
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Publications * | 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. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Recruiting | ||||||
Estimated Enrollment |
131 | ||||||
Original Estimated Enrollment | Same as current | ||||||
Estimated Study Completion Date | December 31, 2023 | ||||||
Estimated Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts |
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Listed Location Countries | Sweden | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT03974191 | ||||||
Other Study ID Numbers | VGFOUREG855601 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Vastra Gotaland Region | ||||||
Study Sponsor | Vastra Gotaland Region | ||||||
Collaborators | Göteborg University | ||||||
Investigators |
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PRS Account | Vastra Gotaland Region | ||||||
Verification Date | June 2019 |