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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Musculoskeletal Disorder
• Intervention / Treatment: Other: PREVSAM model; Other: Treatment as usual (standard treatment)

• Study Type: Interventional
• Enrollment (Actual): 254
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Västra Götalandregionen
    • Göteborg, Västra Götalandregionen, Sweden
      • Research and Development primary care Region Västra Götaland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Registered sickness absence	Registered sickness absence at Swedish Social Insurance Agency	During 12 months from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported work ability	Self reported work ability using single question of Work Ability Index (WAI) (NRS 0-10)	At 1, 3, 6 and 12 months following baseline
Patient reported pain duration	Self reported pain duration	At 1, 3, 6 and 12 months following baseline
Patient reported pain intensity	Self reported pain intensity	At 1, 3, 6 and 12 months following baseline
Patient reported pain widespread	Self reported pain widespread	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)	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	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)	At 1, 3, 6 and 12 months following baseline
Short time sickness absence	Self reported sickness absence by text messages	Weekly for 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)	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)	At 1, 3, 6 and 12 months following baseline
Drug use	Use of drugs/medication collected from "Läkemedelsregistret"	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.	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.	At 1, 3, 6 and 12 months following baseline

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Collaborators: Swedish Council for Working Life and Social Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2019
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 12, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Muscular Diseases; Musculoskeletal Pain; Musculoskeletal Diseases
• Other Study ID Numbers: FORTE 2018-01250

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No