- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03913325
Wczesna identyfikacja ryzyka i zapobieganie absencji chorobowej spowodowanej bólem mięśniowo-szkieletowym – RCT (PREVSAM)
Wczesna identyfikacja ryzyka i zapobieganie absencji chorobowej spowodowanej bólem mięśniowo-szkieletowym (PREVSAM) — randomizowana, kontrolowana próba
Background: Musculoskeletal pain is a leading cause of disability in the world. Although the majority of musculoskeletal-related pain conditions, such as low back pain, often resolves spontaneously, pain may recur or persist over a long time, potentially leading to disability and subsequent reduced work capacity and long-term sickness absence. There is a need for early identification of individuals in which this may occur, to prevent or reduce the risk of long-term musculoskeletal pain and long-term sickness absence. The aim of the trial described in this protocol is to evaluate a primary care rehabilitation model, PREVSAM, including early identification of patients at risk for long-term musculoskeletal pain and related sickness absence and a coordinated interdisciplinary rehabilitation programme based on individual and organizational resources.
Methods: Eligible individuals will be recruited from primary care rehabilitation centres, health care centres, and include those who seek care for musculoskeletal pain and who are at risk of developing persistent pain, disability and sickness absence. Participants will be randomized to either treatment according to the PREVSAM model (intervention group) or treatment as usual (TAU) within primary care (control group). The PREVSAM model will comprise a person-centred rehabilitation plan, including coordinated measures within primary health care as well as in collaboration with participants' employers, and when relevant the Swedish Public Employment Agency. The primary outcome sickness absence will be measured at 3 and12 months from the Swedish Social Insurance Agency regarding: the number and proportion of individuals who remain in full- or part-time work, the number of gross and net days of sickness during the follow-up period, and time to first sickness absence spell. Secondary outcomes are patient-reported work ability, pain, health-related quality of life, risk for sickness absence, anxiety/depression, general and pain self-efficacy and disability at 3 months after inclusion (short-term follow-up), and at 6 and 12 months (long-term follow-up). Follow-up of drug consumption and cost-effectiveness analyes will be performed at 12 months.
Discussion: This study is expected to provide new knowledge on how to best identify individuals at risk for long-term disability and sick leave due to musculoskeletal pain, and whether rehabilitation according to the PREVSAM model is effective. The study findings may contribute to more effective primary care rehabilitation processes of this large patient population, and potentially reduce sick leave and costs for healthcare and society.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Västra Götalandregionen
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Gothenburg, Västra Götalandregionen, Szwecja
- Research and Development primary care Region Västra Götaland
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Aged over 18
- Musculoskeletal pain, preferably less than 3 months
- Risk for development of persistent musculoskeletal pain and disability ≥ 40 p on ÖMPSQ-SF
- Independently mobile (with or without aids), to be capable of participating in intervention
Exclusion Criteria:
- Pain not primarily generated from the musculoskeletal system
- Sickness cash benefit more than 30 days during the last 12 months due to pain from the musculoskeletal system
- Full disability pension
- Pregnancy
- Red flag disorders such as malignancy/cancer, acute traumas such as fracture (less than 6 months ago) or infection, spinal cord compression/cauda equina
- Severe mental illness
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Leczenie jak zwykle
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Treatment as usual (ordinary/standard) treatment. Can include unimodal or multimodal treatment of physiotherapy solely and/or occupational therapy |
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Eksperymentalny: Model PREVSAM
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A person-centred rehabilitation plan, including coordinated measures within primary health care as well as in collaboration with participants' employers, and when relevant the Swedish Public Employment Agency |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Registered sickness absence
Ramy czasowe: During 12 months from baseline
|
Registered sickness absence at Swedish Social Insurance Agency |
During 12 months from baseline
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Short time sickness absence
Ramy czasowe: Weekly for 12 months following baseline
|
Self reported sickness absence by text messages |
Weekly for 12 months following baseline
|
|
Patient reported work ability
Ramy czasowe: At 1, 3, 6 and 12 months following baseline
|
Self reported work ability using single question of Work Ability Index (WAI) (NRS 0-10) |
At 1, 3, 6 and 12 months following baseline
|
|
Risk of sickness absence assessed by Örebro Musculoskeletal Pain Screening Questionnaire Short Form (ÖMPSQ-SF)
Ramy czasowe: At 1, 3, 6 and 12 months following baseline
|
Self reported risk of sickness absence using ÖMPSQ (NRS 0-10) |
At 1, 3, 6 and 12 months following baseline
|
|
Patient reported pain duration
Ramy czasowe: At 1, 3, 6 and 12 months following baseline
|
Self reported pain duration |
At 1, 3, 6 and 12 months following baseline
|
|
Patient reported pain intensity
Ramy czasowe: At 1, 3, 6 and 12 months following baseline
|
Self reported pain intensity |
At 1, 3, 6 and 12 months following baseline
|
|
Patient reported pain widespread
Ramy czasowe: At 1, 3, 6 and 12 months following baseline
|
Self reported pain widespread |
At 1, 3, 6 and 12 months following baseline
|
|
Health Related Quality of Life (HRQL) assessed by EuroQol 5 dimensions
Ramy czasowe: At 1, 3, 6 and 12 months following baseline
|
Self reported HRQL using EQ5D (5 dimensions with 3 answering options which form an index) |
At 1, 3, 6 and 12 months following baseline
|
|
Health Related Quality of Life (HRQL) assessed by EuroQol VAS (0-100)
Ramy czasowe: At 1, 3, 6 and 12 months following baseline
|
Self reported HRQL using EQVAS |
At 1, 3, 6 and 12 months following baseline
|
|
Anxiety and Depression assessed by Hospital Anxiety and Depression Scale (HADS)
Ramy czasowe: At 1, 3, 6 and 12 months following baseline
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Self reported anxiety and depression using HADS (NRS 0-21 per Anxiety and depression respectively) |
At 1, 3, 6 and 12 months following baseline
|
|
Function/Disability assessed by Disability Rating Index (DRI)
Ramy czasowe: At 1, 3, 6 and 12 months following baseline
|
Self reported function/disability assessed by Disability Rating Index (DRI) (10 VAS summed range 0-100) |
At 1, 3, 6 and 12 months following baseline
|
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Drug use
Ramy czasowe: 3 months before to 12 months after baseline
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Use of drugs/medication collected from "Läkemedelsregistret" |
3 months before to 12 months after baseline
|
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General self-efficacy
Ramy czasowe: At 1, 3, 6 and 12 months following baseline
|
Self reported general self efficacy assessed by General self-efficacy scale; the total score ranges between 10 and 40, with a higher score indicating more self-efficacy. |
At 1, 3, 6 and 12 months following baseline
|
|
Pain Self-efficacy scale 2 items
Ramy czasowe: At 1, 3, 6 and 12 months following baseline
|
Self reported pain self efficacy assessed by PSEQ-2SV; the total score ranges between 0 and 12, with a higher score indicating more pain self-efficacy. |
At 1, 3, 6 and 12 months following baseline
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Publikacje i pomocne linki
Publikacje ogólne
- Larsson M, Nordeman L, Holmgren K, Grimby-Ekman A, Hensing G, Bjorkelund C, Bergman S, Ekhammar A, Dottori M, Bernhardsson S. Prevention of sickness absence through early identification and rehabilitation of at-risk patients with musculoskeletal pain (PREVSAM): a randomised controlled trial protocol. BMC Musculoskelet Disord. 2020 Nov 28;21(1):790. doi: 10.1186/s12891-020-03790-5.
- Bornhoft L, Ekhammar A, Svensson M, Dottori M, Larsson MEH. Prevention of sickness absence through early identification and rehabilitation of at-risk patients with musculoskeletal disorders (PREVSAM): a cost-effectiveness analysis comparing team-based rehabilitation in primary care vs treatment as usual. BMC Health Serv Res. 2026 Sep 26;26(1):1319. doi: 10.1186/s12913-026-15652-2.
- Larsson ME, Ekhammar A, Gronkvist R, Bornhoft L, Nordeman L, Holmgren K, Grimby-Ekman A, Hensing G, Bjorkelund C, Bergman S, Dottori M, Bernhardsson S. Prevention of sickness absence through early identification and rehabilitation of at-risk patients with musculoskeletal disorders (PREVSAM): 12-month follow-up of a randomised controlled trial. BMC Musculoskelet Disord. 2026 Apr 27;27(1):360. doi: 10.1186/s12891-026-09859-x.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- FORTE 2018-01250
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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