Research and Development primary care Region Västra Götaland
Gothenburg, Västra Götalandregionen, Sweden
NCT Number: NCT03913325
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.
Looking for future studies?
Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Gothenburg, Västra Götalandregionen, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Treatment as usual (ordinary/standard) treatment. Can include unimodal or multimodal treatment of physiotherapy solely and/or occupational therapy
Time frame: During 12 months from baseline
Registered sickness absence at Swedish Social Insurance Agency
Time frame: Weekly for 12 months following baseline
Self reported sickness absence by text messages
Time frame: At 1, 3, 6 and 12 months following baseline
Self reported work ability using single question of Work Ability Index (WAI) (NRS 0-10)
Time frame: At 1, 3, 6 and 12 months following baseline
Self reported risk of sickness absence using ÖMPSQ (NRS 0-10)
Time frame: At 1, 3, 6 and 12 months following baseline
Self reported pain duration
Time frame: At 1, 3, 6 and 12 months following baseline
Self reported pain intensity
Time frame: At 1, 3, 6 and 12 months following baseline
Self reported pain widespread
Time frame: At 1, 3, 6 and 12 months following baseline
Self reported HRQL using EQ5D (5 dimensions with 3 answering options which form an index)
Time frame: At 1, 3, 6 and 12 months following baseline
Self reported HRQL using EQVAS
Time frame: At 1, 3, 6 and 12 months following baseline
Self reported anxiety and depression using HADS (NRS 0-21 per Anxiety and depression respectively)
Time frame: 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)
Time frame: 3 months before to 12 months after baseline
Use of drugs/medication collected from "Läkemedelsregistret"
Time frame: 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.
Time frame: 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.
Looking for future studies?
Notify MeVastra Gotaland Region
Other Gov
Early Identification of Risk for and Prevention of Sickness Absence Due to Musculoskeletal Pain (PREVSAM) - a Randomized Controlled Trial
Acronym: PREVSAM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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