Pain Clinical Trial
Official title:
13-year Follow-up of Women With Chronic Low Back Pain in Primary Care - a Prospective Longitudinal Cohort Study
Verified date | August 2021 |
Source | Vastra Gotaland Region |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Vastra Gotaland Region | Göteborg University |
Sweden,
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
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. |
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