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

25 maja 2026 zaktualizowane przez: Vastra Gotaland Region

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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

87

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Szwecja
    • Sweden
      • Alingsås, Sweden, Szwecja
        • Närhälsan, Region Västra Götaland
      • Borås, Sweden, Szwecja
        • R&D primary care, Region Västra Götaland
      • Uddevalla, Sweden, Szwecja
        • Närhälsan, Region Västra Götaland

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 75 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant
  • Serious somatic disorders
  • Serious psychiatric disorders

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: Kohorta
  • Perspektywy czasowe: Spodziewany

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.
Inny: 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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Activity limitation
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Pain distribution
Ramy czasowe: 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.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Walking capacity
Ramy czasowe: 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
Ramy czasowe: 2019
The Chair Stand Test (CST) will be used.
2019
Hand grip strength
Ramy czasowe: 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
Ramy czasowe: 2019
The Jamar Hand Dynamometer®, will be used for measuring hand grip strength for each hand.
2019
Pain sensitivity/pain threshold
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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).

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Vastra Gotaland Region

Współpracownicy

Göteborg University

Śledczy

  • Główny śledczy: Lena Nordeman, PhD, R&D primary care Region Västra Götaland, University of Gothenburg Sweden

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

10 czerwca 2019

Zakończenie podstawowe (Rzeczywisty)

31 marca 2020

Ukończenie studiów (Rzeczywisty)

31 marca 2020

Daty rejestracji na studia

Pierwszy przesłany

27 maja 2019

Pierwszy przesłany, który spełnia kryteria kontroli jakości

31 maja 2019

Pierwszy wysłany (Rzeczywisty)

4 czerwca 2019

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

25 maja 2026

Ostatnia weryfikacja

1 marca 2025

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • VGFOUREG855601

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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