Personalized treatment for patients with musculoskeletal disorders in general practice

ISRCTN	ISRCTN14067965
DOI	https://doi.org/10.1186/ISRCTN14067965
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Project number NRC: 303331
Sponsor	Norwegian University of Science and Technology
Funder	Norges Forskningsråd

Submission date: 09/05/2022
Registration date: 11/05/2022
Last edited: 21/10/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Musculoskeletal disorders pain complaints (MSK) represent every fourth patient in primary healthcare services in Norway. Common interventions for patients either lack documentation or at best have modest or short-term effects. Large inter-individual variations in symptoms, signs and patient histories make it difficult to adopt evidence-based guidelines in the clinical setting since they are based on one-size-fits-all evidence from clinical trials. Researchers have therefore developed a system to classify patients into five different groups, called phenotypes, based on scoring on patient characteristics related to biological, psychological and social aspects important for the prognosis of MSK pain complaints. The phenotypes separate patients clearly according to patient characteristics, expected clinical course and treatment outcome. Further, the researchers have developed matched treatment options for the five phenotypes which will be provided to the GPs and the patients in a digital decision support system. The aim of this study is to evaluate the effect of the decision-support system against usual care.

Who can participate?
Adults aged over 18 years presenting to a General Practitioner (GP) with musculoskeletal pain disorder in any of these areas; shoulder, neck, upper/low back, hip, knee or with multisite pain as primary contact reason.

What does the study involve?
The GPs will be randomly allocated to receive access to the decision support system to aid their decision making or to continue giving treatment as usual. The treatment recommendations are provided in four main categories: advice and guidance, work and employment, medications, and referrals. Patients will be treated by the GPs and data will be regularly collected for 12 months to assess if the decision-support system is contributing to improved outcomes for patients.

What are the possible benefits and risks of participating?
Benefits for those in the intervention group are access to a comprehensive overview of the patient's characteristics and reported symptoms at the initiation of treatment, as well as the matched treatment options. Other possible benefits are that the patients will receive more adequate care, better outcome and reduced health care spending. There are no anticipated risks of participating as the matched treatment options are a part of already established treatment options in general practice.

Where is the study run from?
Norwegian University of Science and Technology (Norway)

When is the study starting and how long is it expected to run for?
January 2021 to June 2025

Who is funding the study?
Norwegian Research Council (Norway)

Who is the main contact?
Ingebrigt Meisingset
ingebrigt.meisingset@ntnu.no

Contact information

Dr Ingebrigt Meisingset
Principal investigator

Norwegian University of Science and Technology
Faculty of Medicine and Health Sciences
Department of Public Health and Nursing
PO Box 8905
Trondheim
N-7491
Norway

ORCID ID	0000-0002-3228-1236
Phone	+47 (0)90066915
Email	ingebrigt.meisingset@ntnu.no

Dr Ingebrigt Meisingset
Public

Norwegian University of Science and Technology
Faculty of Medicine and Health Sciences
Department of Public Health and Nursing
PO Box 8905
Trondheim
N-7491
Norway

ORCID ID	0000-0002-3228-1236
Phone	+47 (0)90066915
Email	ingebrigt.meisingset@ntnu.no

Dr Ingebrigt Meisingset
Scientific

Norwegian University of Science and Technology
Faculty of Medicine and Health Sciences
Department of Public Health and Nursing
PO Box 8905
Trondheim
7350
Norway

ORCID ID	0000-0002-3228-1236
Phone	+47 (0)90066915
Email	ingebrigt.meisingset@ntnu.no

Study information

Primary study design	Interventional
Study design	Multicentre cluster randomized controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Stratified care for patients with musculoskeletal disorders in general practice - a cluster randomized controlled study
Study acronym	SupportPrim
Study objectives	Relative to usual care, it is hypothesized that stratified care provided by a clinical decision support system results in better globally perceived effects and improved function among patients with common musculoskeletal disorders in general practice
Ethics approval(s)	The Regional Committee for Medical Research Ethics Northern Norway defined the project as outside the Health Research Act and the project therefore does not need an ethical approval, application number 376060, date 07/12/2021
Health condition(s) or problem(s) studied	Common musculoskeletal complaints, including pain in the neck, shoulder, low back, knee, hip and multisite pain
Intervention	General practitioners are randomized to the intervention group or the control group in a 1 to 1 ratio. The randomisation procedure will be performed by a third party, the Clinical Research Unit in Central Norway. The GPs and their patients in the intervention group will get access to a clinician dashboard where the stratified care intervention will be provided. The stratified care intervention consists of three main steps. First, based on the pre-completion of various questionnaires by the patient, the patient profile in the clinician dashboard summarizes the patient characteristics and the patient's phenotype from 1-5 is calculated based on 11 established prognostic factors. Next, the GPs can fill in the diagnostic code (International Classification of Primary Care [ICPC]-2 code) and decide the patient's main problem. Third, the GP and the patient can view what treatment is recommended based on the patient's phenotype and other specific factors. The patient and the GP decide a treatment plan together trough a shared decision-making process. The treatment recommendations are provided in four main categories: advice and guidance, work and employment, medications, and referrals. The GPs in the control group will receive usual care without access to the patient profile and treatment recommendations in the clinician dashboard. Patients will be treated by the GPs and data will be regularly collected for 12 months to assess if the decision-support system is contributing to improved outcomes for patients.
Intervention type	Other
Primary outcome measure(s)	This study has two primary outcomes: 1. Global perceived effect at 3 months. Global perceived effect is assessed with the question "Since treatment started, I am:" with 7 different response option: very much better, much better, little better, not better nor worse, little worse, much worse, very much worse. The response options are dichotomized into improved = very much better and much better, and not improved = the other response options. The primary outcome is the proportion reporting improved at 3 months. 2. Clinically important improvement in function at 3 months, measured by the Patient-Specific Function Scale (PSFS; 0-10), where a 30% change is defined as a minimal clinically important difference (MCID). The primary outcome is the proportion reporting MCID at 3 months.
Key secondary outcome measure(s)	Measured at baseline and 3, 6 and 12 month follow-up: 1. Pain intensity measured using a Numerical Rating Scale (NRS; 0-10) 2. Pain drawing: number of pain sites measured using the Nordic Pain questionnaire and the pain mannequin with 10 possible pain sites 3. Frequency of pain measured using the question “Is the pain continuous? With the response option “yes, I have pain all the time” and “no, the pain is on and off” 4. Quality of life measured using EQ-5D-5L, five items 5. Health-related quality of life (sleep and vitality) measured using 15D 6. General musculoskeletal health measured using the Musculoskeletal Health Questionnaire (MSK-HQ) 7. Number of treatments by 3 months measured using patient records 8. Patient-reported function measured using the Patient-specific functional scale (PSFS; 0-10) (only 6 and 12 months) 9. Work ability measured using a single item from Work Ability Index; current work ability compared with lifetime best 10. Work status/sick leave measured using patient records 11. Medication measured using patient records 12. Patient-GP relationship measured using three questions (overall satisfaction, belief in GP's competency, and communication) 13. Patient Acceptable Symptom State (PASS) measured by the question: "Considering your pain complaint, do you consider your current state as satisfactory?", with the response option yes/no. 14. Adherence to the treatment plan assessed using five alternatives 15. Goal achievement (not, partly, or fully achieved) measured using patient records 16. Most important reason for success/non-success (text) at 3 months only 18. Physical activity measured using three questions (frequency, intensity and duration) 19. Emotional distress measured using the Hopkins Symptom Check List (HSCL-10) 20. Pain self-efficacy measured using two questions from Pain Self-Efficacy Questionnaire (PSEQ) 2-item 21. Cost-effectiveness analysed based on patients' deductibles and costs covered by the Norwegian Health Economics Administration (HELFO) and utility measured by EQ-5D 22. GP's compliance with the treatment advice from the decision support system measured using information from the GPs' medical records and the treatment plan decided by the GPs and patients 23. Compliance between treatment advice from the decision support system, treatment plan decided at the first consultation and the actual treatment provided according to the medical record Measured at 2, 4 and 8 weeks by SMS (text messages). These will be analyzed as time to event: 1. Patient-specific functional scale (PSFS) 2. Work ability 3. Global perceived effect 4. Pain intensity at 2 and 8 weeks only 5. Pain self-efficacy at 2 and 8 weeks only
Completion date	01/06/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	748
Total final enrolment	299
Key inclusion criteria	1. Patients presenting to a primary care general practitioner with musculoskeletal pain disorder in any of these areas: shoulder, neck, upper/low back, hip, knee or with multisite pain as primary contact reason 2. Age above 18 years 3. Understand written and oral Norwegian, and can write Norwegian
Key exclusion criteria	1. Neurological diagnosis, such as (multiple sclerosis, stroke, amyotrophic lateral sclerosis, Parkinson's, dementia) 2. Ongoing cancer disease 3. Planned surgery related to the MSK complaint for seeking treatment, or have had surgery or fracture related to the MSK complaint in the last 6 months. 4. Pregnancy or complaints related to pregnancy
Date of first enrolment	18/05/2022
Date of final enrolment	01/04/2023

Locations

Countries of recruitment

Norway

Study participating centre

Norwegian University of Science and Technology

Trondheim
N-7491
Norway

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request (Prof. Ottar Vasseljen, ottar.vasseljen@ntnu.no). Anonymized clustered and participant-level data can be shared after acceptance of publications of main results, providing a relevant research question and ethical approval of the study protocol is documented, including whether data sharing is covered by the current, approved consent from participants. Collaborative research efforts and work is appreciated.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		11/04/2023	12/04/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Statistical Analysis Plan	SAP preprint	06/10/2023	15/03/2024	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/10/2024: The overall end date was changed from 31/12/2024 to 01/06/2025.
18/03/2024: The following changes were made to the study record:
1. The overall study end date was changed from 01/09/2023 to 31/12/2024.
2. The intention to publish date was changed from 31/12/2024 to 01/10/2024.
15/03/2024: A statistical analysis plan was added.
13/07/2023: Total final enrolment added.
11/07/2023: The overall study end date was changed from 01/07/2023 to 01/09/2023.
12/04/2023: Publication reference added.
15/02/2023: The recruitment end date was changed from 31/12/2022 to 01/04/2023.
10/05/2022: Trial's existence confirmed by the Regional Committee for Medical Research Ethics Northern Norway.