Clinical trial NCT03913325: Early Identification of Risk for and Prevention of Sickness Absence Due to Musculoskeletal Pain - an RCT
Official title: Early Identification of Risk for and Prevention of Sickness Absence Due to Musculoskeletal Pain (PREVSAM) - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Musculoskeletal Disorder
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Swedish Council for Working Life and Social Research
First posted: 2019-04-12
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Registered sickness absence
timeFrame: During 12 months from baseline
Secondary outcomes:
measure: Short time sickness absence
timeFrame: Weekly for 12 months following baseline
measure: Patient reported work ability
timeFrame: At 1, 3, 6 and 12 months following baseline
measure: Risk of sickness absence assessed by Örebro Musculoskeletal Pain Screening Questionnaire Short Form (ÖMPSQ-SF)
timeFrame: At 1, 3, 6 and 12 months following baseline
measure: Patient reported pain duration
timeFrame: At 1, 3, 6 and 12 months following baseline
measure: Patient reported pain intensity
timeFrame: At 1, 3, 6 and 12 months following baseline
measure: Patient reported pain widespread
timeFrame: At 1, 3, 6 and 12 months following baseline
measure: Health Related Quality of Life (HRQL) assessed by EuroQol 5 dimensions
timeFrame: At 1, 3, 6 and 12 months following baseline
measure: Health Related Quality of Life (HRQL) assessed by EuroQol VAS (0-100)
timeFrame: At 1, 3, 6 and 12 months following baseline
measure: Anxiety and Depression assessed by Hospital Anxiety and Depression Scale (HADS)
timeFrame: At 1, 3, 6 and 12 months following baseline
measure: Function/Disability assessed by Disability Rating Index (DRI)
timeFrame: At 1, 3, 6 and 12 months following baseline
measure: Drug use
timeFrame: 3 months before to 12 months after baseline
measure: General self-efficacy
timeFrame: At 1, 3, 6 and 12 months following baseline
measure: Pain Self-efficacy scale 2 items
timeFrame: At 1, 3, 6 and 12 months following baseline
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Research and Development primary care Region Västra Götaland
state: Västra Götalandregionen
Study officials:
References:
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.