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Completed

NCT Number: NCT03913325

Early Identification of Risk for and Prevention of Sickness Absence Due to Musculoskeletal Pain - an RCT

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research and Development primary care Region Västra Götaland

Gothenburg, Västra Götalandregionen, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PREVSAM model

Other

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 (standard treatment)

Other

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

Primary outcomes

  1. Registered sickness absence

    Time frame: During 12 months from baseline

    Registered sickness absence at Swedish Social Insurance Agency

Secondary outcomes

  1. Short time sickness absence

    Time frame: Weekly for 12 months following baseline

    Self reported sickness absence by text messages

  2. Patient reported work ability

    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)

  3. Risk of sickness absence assessed by Örebro Musculoskeletal Pain Screening Questionnaire Short Form (ÖMPSQ-SF)

    Time frame: At 1, 3, 6 and 12 months following baseline

    Self reported risk of sickness absence using ÖMPSQ (NRS 0-10)

  4. Patient reported pain duration

    Time frame: At 1, 3, 6 and 12 months following baseline

    Self reported pain duration

  5. Patient reported pain intensity

    Time frame: At 1, 3, 6 and 12 months following baseline

    Self reported pain intensity

  6. Patient reported pain widespread

    Time frame: At 1, 3, 6 and 12 months following baseline

    Self reported pain widespread

  7. Health Related Quality of Life (HRQL) assessed by EuroQol 5 dimensions

    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)

  8. Health Related Quality of Life (HRQL) assessed by EuroQol VAS (0-100)

    Time frame: At 1, 3, 6 and 12 months following baseline

    Self reported HRQL using EQVAS

  9. Anxiety and Depression assessed by Hospital Anxiety and Depression Scale (HADS)

    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)

  10. Function/Disability assessed by Disability Rating Index (DRI)

    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)

  11. Drug use

    Time frame: 3 months before to 12 months after baseline

    Use of drugs/medication collected from "Läkemedelsregistret"

  12. General self-efficacy

    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.

  13. Pain Self-efficacy scale 2 items

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Swedish Council for Working Life and Social Research

Registry information

Official study title

Early Identification of Risk for and Prevention of Sickness Absence Due to Musculoskeletal Pain (PREVSAM) - a Randomized Controlled Trial

Acronym: PREVSAM

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2019
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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