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Clinical Trials/NCT03913325
NCT03913325
Active, not recruiting
Not Applicable

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

Vastra Gotaland Region1 site in 1 country254 target enrollmentMay 14, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Musculoskeletal Disorder
Sponsor
Vastra Gotaland Region
Enrollment
254
Locations
1
Primary Endpoint
Registered sickness absence
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 14, 2019
End Date
December 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Vastra Gotaland Region
Responsible Party
Principal Investigator
Principal Investigator

Maria Larsson

Associate Professor

Vastra Gotaland Region

Eligibility Criteria

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

Outcomes

Primary Outcomes

Registered sickness absence

Time Frame: During 12 months from baseline

Registered sickness absence at Swedish Social Insurance Agency

Secondary Outcomes

  • Drug use(3 months before to 12 months after baseline)
  • Patient reported pain duration(At 1, 3, 6 and 12 months following baseline)
  • Patient reported pain widespread(At 1, 3, 6 and 12 months following baseline)
  • Health Related Quality of Life (HRQL) assessed by EuroQol 5 dimensions(At 1, 3, 6 and 12 months following baseline)
  • Function/Disability assessed by Disability Rating Index (DRI)(At 1, 3, 6 and 12 months following baseline)
  • General self-efficacy(At 1, 3, 6 and 12 months following baseline)
  • Pain Self-efficacy scale 2 items(At 1, 3, 6 and 12 months following baseline)
  • Short time sickness absence(Weekly for 12 months following baseline)
  • Risk of sickness absence assessed by Örebro Musculoskeletal Pain Screening Questionnaire Short Form (ÖMPSQ-SF)(At 1, 3, 6 and 12 months following baseline)
  • Patient reported pain intensity(At 1, 3, 6 and 12 months following baseline)
  • Anxiety and Depression assessed by Hospital Anxiety and Depression Scale (HADS)(At 1, 3, 6 and 12 months following baseline)
  • Patient reported work ability(At 1, 3, 6 and 12 months following baseline)
  • Health Related Quality of Life (HRQL) assessed by EuroQol VAS (0-100)(At 1, 3, 6 and 12 months following baseline)

Study Sites (1)

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