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

NCT03974191 | Unknown

• 1 other identifier: VGFOUREG855601
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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.

• 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 Outcomes (1)

• Pain distribution

  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 (17)

• Walking capacity

  2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).

• Lower limb muscle endurance and muscle strength

  2019

• Hand grip strength

  2019, Change from the first assessment (2006) to the present 13-year follow-up (2019).

Study Arms (1)

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.

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.

Interventions

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. OTHER

13-year prospective longitudinal cohort study

131 participants with chronic low back pain

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: This study will follow up all women (n=131) included in the cross sectional study in 2006.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Pregnant
• Serious somatic disorders
• Serious psychiatric disorders

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Study Sites (3)

Närhälsan, Region Västra Götaland

Alingsås, Sweden

Location

R&D primary care, Region Västra Götaland

Borås, Sweden

Location

Närhälsan, Region Västra Götaland

Uddevalla, Sweden

Location

Related 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.

  PMID: 21677567 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Chronic Pain; Pain; Motor Activity

Interventions

Functional Status; Exercise

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lena Nordeman, PhD

  R&D primary care Region Västra Götaland, University of Gothenburg Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: June 4, 2019
• Study Start: June 10, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 31, 2023
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)