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

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ClinicalTrials.gov Identifier: NCT03913325
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
Swedish research council for health, working life and welfare
Information provided by (Responsible Party):
Maria Larsson, Vastra Gotaland Region

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 occupational health 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 12 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, disability and drug consumption at 1 and 3 months after inclusion (short-term follow-up), and at 6 and 12 months (long-term follow-up).

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.


Condition or disease Intervention/treatment Phase
Musculoskeletal Disorder Other: PREVSAM model Other: Treatment as usual (standard treatment) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Early Identification of Risk for and Prevention of Sickness Absence Due to Musculoskeletal Pain (PREVSAM) - a Randomized Controlled Trial
Actual Study Start Date : May 14, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Experimental: PREVSAM model Other: 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

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




Primary Outcome Measures :
  1. Registered sickness absence [ Time Frame: During 12 months from baseline ]
    Registered sickness absence at Swedish Social Insurance Agency


Secondary Outcome Measures :
  1. 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)

  2. Patient reported pain duration [ Time Frame: At 1, 3, 6 and 12 months following baseline ]
    Self reported pain duration

  3. Patient reported pain intensity [ Time Frame: At 1, 3, 6 and 12 months following baseline ]
    Self reported pain intensity

  4. Patient reported pain widespread [ Time Frame: At 1, 3, 6 and 12 months following baseline ]
    Self reported pain widespread

  5. 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)

  6. 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

  7. 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)

  8. Short time sickness absence [ Time Frame: Weekly for 12 months following baseline ]
    Self reported sickness absence by text messages

  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"



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 or part-time 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913325


Locations
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Sweden
Research and Development primary care Region Västra Götaland Recruiting
Göteborg, Västra Götalandregionen, Sweden
Contact: Maria Larsson, Associate Professor    +46767905400    Maria.eh.larsson@vgregion.se   
Contact: Susanne Bernhardsson, Associate Professor       susanne.bernhardsson@vgregion.se   
Sponsors and Collaborators
Vastra Gotaland Region
Swedish research council for health, working life and welfare

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Responsible Party: Maria Larsson, Associate Professor, Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT03913325     History of Changes
Other Study ID Numbers: FORTE 2018-01250
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Musculoskeletal Pain
Musculoskeletal Diseases
Muscular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms