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

Primary Purpose

Musculoskeletal Disorder

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
PREVSAM model
Treatment as usual (standard treatment)
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Musculoskeletal Disorder

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research and Development primary care Region Västra Götaland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PREVSAM model

Treatment as usual

Arm Description

Outcomes

Primary Outcome Measures

Registered sickness absence
Registered sickness absence at Swedish Social Insurance Agency

Secondary Outcome Measures

Short time sickness absence
Self reported sickness absence by text messages
Patient reported work ability
Self reported work ability using single question of Work Ability Index (WAI) (NRS 0-10)
Risk of sickness absence assessed by Örebro Musculoskeletal Pain Screening Questionnaire Short Form (ÖMPSQ-SF)
Self reported risk of sickness absence using ÖMPSQ (NRS 0-10)
Patient reported pain duration
Self reported pain duration
Patient reported pain intensity
Self reported pain intensity
Patient reported pain widespread
Self reported pain widespread
Health Related Quality of Life (HRQL) assessed by EuroQol 5 dimensions
Self reported HRQL using EQ5D (5 dimensions with 3 answering options which form an index)
Health Related Quality of Life (HRQL) assessed by EuroQol VAS (0-100)
Self reported HRQL using EQVAS
Anxiety and Depression assessed by Hospital Anxiety and Depression Scale (HADS)
Self reported anxiety and depression using HADS (NRS 0-21 per Anxiety and depression respectively)
Function/Disability assessed by Disability Rating Index (DRI)
Self reported function/disability assessed by Disability Rating Index (DRI) (10 VAS summed range 0-100)
Drug use
Use of drugs/medication collected from "Läkemedelsregistret"
General self-efficacy
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.
Pain Self-efficacy scale 2 items
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.

Full Information

First Posted
April 9, 2019
Last Updated
July 3, 2023
Sponsor
Vastra Gotaland Region
Collaborators
Swedish Council for Working Life and Social Research
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1. Study Identification

Unique Protocol Identification Number
NCT03913325
Brief Title
Early Identification of Risk for and Prevention of Sickness Absence Due to Musculoskeletal Pain - an RCT
Acronym
PREVSAM
Official Title
Early Identification of Risk for and Prevention of Sickness Absence Due to Musculoskeletal Pain (PREVSAM) - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 14, 2019 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vastra Gotaland Region
Collaborators
Swedish Council for Working Life and Social Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PREVSAM model
Arm Type
Experimental
Arm Title
Treatment as usual
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
PREVSAM model
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Treatment as usual (standard treatment)
Intervention Description
Treatment as usual (ordinary/standard) treatment. Can include unimodal or multimodal treatment of physiotherapy solely and/or occupational therapy
Primary Outcome Measure Information:
Title
Registered sickness absence
Description
Registered sickness absence at Swedish Social Insurance Agency
Time Frame
During 12 months from baseline
Secondary Outcome Measure Information:
Title
Short time sickness absence
Description
Self reported sickness absence by text messages
Time Frame
Weekly for 12 months following baseline
Title
Patient reported work ability
Description
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
Title
Risk of sickness absence assessed by Örebro Musculoskeletal Pain Screening Questionnaire Short Form (ÖMPSQ-SF)
Description
Self reported risk of sickness absence using ÖMPSQ (NRS 0-10)
Time Frame
At 1, 3, 6 and 12 months following baseline
Title
Patient reported pain duration
Description
Self reported pain duration
Time Frame
At 1, 3, 6 and 12 months following baseline
Title
Patient reported pain intensity
Description
Self reported pain intensity
Time Frame
At 1, 3, 6 and 12 months following baseline
Title
Patient reported pain widespread
Description
Self reported pain widespread
Time Frame
At 1, 3, 6 and 12 months following baseline
Title
Health Related Quality of Life (HRQL) assessed by EuroQol 5 dimensions
Description
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
Title
Health Related Quality of Life (HRQL) assessed by EuroQol VAS (0-100)
Description
Self reported HRQL using EQVAS
Time Frame
At 1, 3, 6 and 12 months following baseline
Title
Anxiety and Depression assessed by Hospital Anxiety and Depression Scale (HADS)
Description
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
Title
Function/Disability assessed by Disability Rating Index (DRI)
Description
Self reported function/disability assessed by Disability Rating Index (DRI) (10 VAS summed range 0-100)
Time Frame
At 1, 3, 6 and 12 months following baseline
Title
Drug use
Description
Use of drugs/medication collected from "Läkemedelsregistret"
Time Frame
3 months before to 12 months after baseline
Title
General self-efficacy
Description
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
Title
Pain Self-efficacy scale 2 items
Description
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.
Time Frame
At 1, 3, 6 and 12 months following baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Research and Development primary care Region Västra Götaland
City
Göteborg
State/Province
Västra Götalandregionen
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
33248457
Citation
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.
Results Reference
derived

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

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