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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03974191
• Other study ID #: VGFOUREG855601
• Status: Active, not recruiting
• Start date: June 10, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2021
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 131
• Est. completion date: December 31, 2023
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant

• Serious somatic disorders

• Serious psychiatric disorders

Related Conditions & MeSH terms

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

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

Locations

Country	Name	City	State
Sweden	Närhälsan, Region Västra Götaland	Alingsås
Sweden	R&D primary care, Region Västra Götaland	Borås
Sweden	Närhälsan, Region Västra Götaland	Uddevalla

Sponsors (2)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Göteborg University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Walking capacity	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).
Other	Lower limb muscle endurance and muscle strength	The Chair Stand Test (CST) will be used.	2019
Other	Hand grip strength	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).
Other	Hand grip strength	The Jamar Hand Dynamometer®, will be used for measuring hand grip strength for each hand.	2019
Other	Pain sensitivity/pain threshold	Somedic algometer® will be used.	2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
Other	Fatigue	Multidimensional Fatigue Inventory (MFI-20) will be used.	2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
Other	General fatigue	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).
Other	Sleep quantity	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).
Other	Sleep quality	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)
Other	Social support	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).
Other	Stress	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).
Other	Physical function	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).
Other	Leisure Time Physical Activity	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).
Other	Experience of physical activity	Experience of physical activity questionnaire will be used.	2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).
Other	Risk for long-term disability and sick-leave	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).
Other	Health-related quality of life	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).
Other	Alcohol consumption	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).
Primary	Activity limitation	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
Primary	Pain intensity	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.
Primary	Work ability	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.
Secondary	Pain distribution	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.