13-year Follow-up of Women With Chronic Low Back Pain in Primary Care - a Prospective Longitudinal Cohort Study
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Alingsås, Suecia
- Närhälsan, Region Västra Götaland
-
Borås, Suecia
- R&D primary care, Region Västra Götaland
-
Uddevalla, Suecia
- Närhälsan, Region Västra Götaland
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- All participants (n=131) included in the Cross Sectional Study in 2006
Exclusion Criteria:
- Pregnant
- Serious somatic disorders
- Serious psychiatric disorders
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
13-year prospective longitudinal cohort study
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Activity limitation
Periodo de tiempo: 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.
|
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
|
|
Pain intensity
Periodo de tiempo: 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.
|
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.
|
|
Work ability
Periodo de tiempo: 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.
|
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.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain distribution
Periodo de tiempo: 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
|
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.
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Walking capacity
Periodo de tiempo: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
The 6-minute walk test (6MWT) will be used.
The person walks back and forth in a measured distance of 30 meters for 6 minutes.
The number of meters achieved is recorded.
|
2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
|
Lower limb muscle endurance and muscle strength
Periodo de tiempo: 2019
|
The Chair Stand Test (CST) will be used.
|
2019
|
|
Hand grip strength
Periodo de tiempo: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
The Grippit®, electronic hand strength measurement will be used.
Sustained hand grip strength will be measured during 10 seconds for each hand.
|
2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
|
Hand grip strength
Periodo de tiempo: 2019
|
The Jamar Hand Dynamometer®, will be used for measuring hand grip strength for each hand.
|
2019
|
|
Pain sensitivity/pain threshold
Periodo de tiempo: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
Somedic algometer® will be used.
|
2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
|
Fatigue
Periodo de tiempo: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
Multidimensional Fatigue Inventory (MFI-20) will be used.
|
2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
|
General fatigue
Periodo de tiempo: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
A Visual Analogue Scale (VAS), ranging 0 to 100 mm will be used for general fatigue during the last week.
0 mm indicates no tiredness and 100 mm indicates very tired.
Higher score indicates more severe general fatigue.
|
2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
|
Sleep quantity
Periodo de tiempo: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
One question will be used: "Do you think you get enough sleep?" (Range 1-4).
Higher score indicate better sleep quantity.
|
2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
|
Sleep quality
Periodo de tiempo: Time frame: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019)
|
One questions will be used: "On the whole, how do you think you sleep?" (Range 1-4).
Higher score indicate better sleep quality.
|
Time frame: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019)
|
|
Social support
Periodo de tiempo: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
The 4-item version of Medical Outcome Study Social Support Survey will be used.
|
2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
|
Stress
Periodo de tiempo: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
Stress and Crisis Inventory (SCI-93) will be used for measuring clinical symptoms of stress.
|
2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
|
Physical function
Periodo de tiempo: 2019, Comparison from the first assessment (2006) to the present 13-year follow-up (2019).
|
The Patient Specific Functional Scale (PSFS), will be used for the participant´s self-identified activities that are difficult to perform due to low back pain.
Then the participant rates the level of difficulty for each identified activity on an 11-point numeric scale ranging from 0 ("unable to perform activity") to 10 ("able to perform activity unhindered or at pre-injury level").
|
2019, Comparison from the first assessment (2006) to the present 13-year follow-up (2019).
|
|
Leisure Time Physical Activity
Periodo de tiempo: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
Leisure Time Physical Activity Instrument (LTPAI) will be used to assess the amount of self-rated physical activity in free time during a typical week
|
2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
|
Experience of physical activity
Periodo de tiempo: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
Experience of physical activity questionnaire will be used.
|
2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
|
Risk for long-term disability and sick-leave
Periodo de tiempo: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ), estimate the risk for long-term disability and sick-leave.
The sum score of 21 items will be used.
|
2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
|
Health-related quality of life
Periodo de tiempo: Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
Short Form-36 (SF-36) will be used to measure health-related quality of life.
|
Change from the first assessment (2006) to the present 13-year follow-up (2019).
|
|
Alcohol consumption
Periodo de tiempo: Comparison from the first assessment (2006) to the present 13-year follow-up (2019).
|
The Alcohol Use Disorders Identification Test (Audit-C) will be used.
|
Comparison from the first assessment (2006) to the present 13-year follow-up (2019).
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lena Nordeman, PhD, R&D primary care Region Västra Götaland, University of Gothenburg Sweden
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- VGFOUREG855601
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .