Musculoskeletal DisorderPREVSAMNCT03913325
Early Identification of Risk for and Prevention of Sickness Absence Due to Musculoskeletal Pain - an RCT
A study testing PREVSAM model and Treatment as usual (standard treatment) in people with Musculoskeletal Disorder, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Musculoskeletal Disorder
- What is being tested?
- PREVSAM model and Treatment as usual (standard treatment)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteSweden
- Study dates
- 14 May 2019to 22 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Research and Development primary care Region Västra Götaland
Gothenburg, Västra Götalandregionen
About this study
Official title: Early Identification of Risk for and Prevention of Sickness Absence Due to Musculoskeletal Pain (PREVSAM) - a Randomized Controlled Trial
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.
- Conditions
- Musculoskeletal Disorder
- Being tested
- PREVSAM model, Treatment as usual (standard treatment)
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREVSAM modelOther
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
| Study group | Role | What they receive |
|---|---|---|
| PREVSAM model | Experimental | Not described Receives: Other: PREVSAM model |
| Treatment as usual | Active comparator | Not described Receives: Other: Treatment as usual (standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Registered sickness absence
Registered sickness absence at Swedish Social Insurance Agency
Measured: During 12 months from baseline
Secondary outcomes (13)
Short time sickness absence
Self reported sickness absence by text messages
Measured: Weekly for 12 months following baseline
Patient reported work ability
Self reported work ability using single question of Work Ability Index (WAI) (NRS 0-10)
Measured: At 1, 3, 6 and 12 months following baseline
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)
Measured: At 1, 3, 6 and 12 months following baseline
Patient reported pain duration
Self reported pain duration
Measured: At 1, 3, 6 and 12 months following baseline
Patient reported pain intensity
Self reported pain intensity
Measured: At 1, 3, 6 and 12 months following baseline
Patient reported pain widespread
Self reported pain widespread
Measured: At 1, 3, 6 and 12 months following baseline
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)
Measured: At 1, 3, 6 and 12 months following baseline
Health Related Quality of Life (HRQL) assessed by EuroQol VAS (0-100)
Self reported HRQL using EQVAS
Measured: At 1, 3, 6 and 12 months following baseline
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)
Measured: At 1, 3, 6 and 12 months following baseline
Function/Disability assessed by Disability Rating Index (DRI)
Self reported function/disability assessed by Disability Rating Index (DRI) (10 VAS summed range 0-100)
Measured: At 1, 3, 6 and 12 months following baseline
Drug use
Use of drugs/medication collected from "Läkemedelsregistret"
Measured: 3 months before to 12 months after baseline
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.
Measured: At 1, 3, 6 and 12 months following baseline
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.
Measured: At 1, 3, 6 and 12 months following baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start14 May 2019
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DisorderStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Swedish Council for Working Life and Social Research
- Responsible party
- Principal investigator, Maria Larsson, Vastra Gotaland Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913325
- Sponsor's protocol ID
- FORTE 2018-01250
- Acronym
- PREVSAM
- Status last verified
- Sep 2026
- First submitted
- 9 Apr 2019
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bornhoft L, Ekhammar A, Svensson M, Dottori M, Larsson MEH. Prevention of sickness absence through early identification and rehabilitation of at-risk patients with musculoskeletal disorders (PREVSAM): a cost-effectiveness analysis comparing team-based rehabilitation in primary care vs treatment as usual. BMC Health Serv Res. 2026 Sep 26;26(1):1319. doi: 10.1186/s12913-026-15652-2.
PubMed 42806350Larsson ME, Ekhammar A, Gronkvist R, Bornhoft L, Nordeman L, Holmgren K, Grimby-Ekman A, Hensing G, Bjorkelund C, Bergman S, Dottori M, Bernhardsson S. Prevention of sickness absence through early identification and rehabilitation of at-risk patients with musculoskeletal disorders (PREVSAM): 12-month follow-up of a randomised controlled trial. BMC Musculoskelet Disord. 2026 Apr 27;27(1):360. doi: 10.1186/s12891-026-09859-x.
PubMed 42046075Larsson 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.
PubMed 33248457
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Identification of Risk for and Prevention of Sickness Absence Due to Musculoskeletal Pain (PREVSAM) - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03913325
- Acronym / sponsor ID
- PREVSAM / FORTE 2018-01250
- Conditions
- Musculoskeletal Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Swedish Council for Working Life and Social Research
- Study start
- 14 May 2019 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 12 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PREVSAM model | Experimental | Other: PREVSAM model |
| Treatment as usual | Active comparator | Other: Treatment as usual (standard treatment) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PREVSAM modelA 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 | Other | PREVSAM model |
| Treatment as usual (standard treatment)Treatment as usual (ordinary/standard) treatment. Can include unimodal or multimodal treatment of physiotherapy solely and/or occupational therapy | Other | Treatment as usual |
Primary outcome
Registered sickness absence
Time frame: During 12 months from baseline
Registered sickness absence at Swedish Social Insurance Agency
13 secondary outcomes
Short time sickness absence
Time frame: Weekly for 12 months following baseline
Patient reported work ability
Time frame: At 1, 3, 6 and 12 months following baseline
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
Patient reported pain duration
Time frame: At 1, 3, 6 and 12 months following baseline
Patient reported pain intensity
Time frame: At 1, 3, 6 and 12 months following baseline
Patient reported pain widespread
Time frame: At 1, 3, 6 and 12 months following baseline
Health Related Quality of Life (HRQL) assessed by EuroQol 5 dimensions
Time frame: At 1, 3, 6 and 12 months following baseline
Health Related Quality of Life (HRQL) assessed by EuroQol VAS (0-100)
Time frame: At 1, 3, 6 and 12 months following baseline
Anxiety and Depression assessed by Hospital Anxiety and Depression Scale (HADS)
Time frame: At 1, 3, 6 and 12 months following baseline
Function/Disability assessed by Disability Rating Index (DRI)
Time frame: At 1, 3, 6 and 12 months following baseline
Drug use
Time frame: 3 months before to 12 months after baseline
General self-efficacy
Time frame: At 1, 3, 6 and 12 months following baseline
Pain Self-efficacy scale 2 items
Time frame: At 1, 3, 6 and 12 months following baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Derived from this study: PubMed 42806350Bornhoft L, Ekhammar A, Svensson M, Dottori M, Larsson MEH. Prevention of sickness absence through early identification and rehabilitation of at-risk patients with musculoskeletal disorders (PREVSAM): a cost-effectiveness analysis comparing team-based rehabilitation in primary care vs treatment as usual. BMC Health Serv Res. 2026 Sep 26;26(1):1319. doi: 10.1186/s12913-026-15652-2.
- Derived from this study: PubMed 42046075Larsson ME, Ekhammar A, Gronkvist R, Bornhoft L, Nordeman L, Holmgren K, Grimby-Ekman A, Hensing G, Bjorkelund C, Bergman S, Dottori M, Bernhardsson S. Prevention of sickness absence through early identification and rehabilitation of at-risk patients with musculoskeletal disorders (PREVSAM): 12-month follow-up of a randomised controlled trial. BMC Musculoskelet Disord. 2026 Apr 27;27(1):360. doi: 10.1186/s12891-026-09859-x.
- Derived from this study: PubMed 33248457Larsson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREVSAM model and Treatment as usual (standard treatment) in people with Musculoskeletal Disorder, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Registered sickness absence (time frame: During 12 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03913325, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.