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Tidlig identifikation af risiko for og forebyggelse af sygefravær på grund af muskel- og skeletsmerter - en RCT (PREVSAM)

23. september 2026 opdateret af: Maria Larsson, Vastra Gotaland Region

Tidlig identifikation af risiko for og forebyggelse af sygefravær på grund af muskel- og skeletsmerter (PREVSAM) - et randomiseret kontrolleret forsøg

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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

254

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Västra Götalandregionen
      • Gothenburg, Västra Götalandregionen, Sverige
        • Research and Development primary care Region Västra Götaland

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Behandling som sædvanlig

Treatment as usual (ordinary/standard) treatment. Can include unimodal or multimodal treatment of physiotherapy solely and/or occupational therapy

Eksperimentel: PREVSAM model

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Registered sickness absence
Tidsramme: During 12 months from baseline

Registered sickness absence at Swedish Social Insurance Agency

During 12 months from baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Short time sickness absence
Tidsramme: Weekly for 12 months following baseline

Self reported sickness absence by text messages

Weekly for 12 months following baseline
Patient reported work ability
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: At 1, 3, 6 and 12 months following baseline

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)
Tidsramme: 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
Drug use
Tidsramme: 3 months before to 12 months after baseline

Use of drugs/medication collected from "Läkemedelsregistret"

3 months before to 12 months after baseline
General self-efficacy
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. maj 2019

Primær færdiggørelse (Faktiske)

22. december 2023

Studieafslutning (Faktiske)

22. december 2023

Datoer for studieregistrering

Først indsendt

9. april 2019

Først indsendt, der opfyldte QC-kriterier

10. april 2019

Først opslået (Faktiske)

12. april 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FORTE 2018-01250

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