- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03913325
Včasná identifikace rizika a prevence nepřítomnosti nemoci v důsledku muskuloskeletální bolesti – RCT (PREVSAM)
Včasná identifikace rizika a prevence nepřítomnosti nemoci v důsledku muskuloskeletální bolesti (PREVSAM) – randomizovaná kontrolovaná studie
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
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Västra Götalandregionen
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Gothenburg, Västra Götalandregionen, Švédsko
- Research and Development primary care Region Västra Götaland
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Léčba jako obvykle
|
Treatment as usual (ordinary/standard) treatment. Can include unimodal or multimodal treatment of physiotherapy solely and/or occupational therapy |
|
Experimentální: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Registered sickness absence
Časové okno: During 12 months from baseline
|
Registered sickness absence at Swedish Social Insurance Agency |
During 12 months from baseline
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Short time sickness absence
Časové okno: Weekly for 12 months following baseline
|
Self reported sickness absence by text messages |
Weekly for 12 months following baseline
|
|
Patient reported work ability
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 3 months before to 12 months after baseline
|
Use of drugs/medication collected from "Läkemedelsregistret" |
3 months before to 12 months after baseline
|
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General self-efficacy
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- FORTE 2018-01250
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