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

NCT ID: NCT03913325

Last Updated: 2023-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-14
• Study Completion Date: 2024-12-30

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.

Conditions

Musculoskeletal Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

PREVSAM model

Group Type: EXPERIMENTAL

PREVSAM model

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Treatment as usual (standard treatment)

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swedish Council for Working Life and Social Research

OTHER

Sponsor Role: collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Maria Larsson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Research and Development primary care Region Västra Götaland

Gothenburg, Västra Götalandregionen, Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 33248457 (View on PubMed)

Other Identifiers

FORTE 2018-01250

Identifier Type: -

Identifier Source: org_study_id