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Personalized treatment for patients with musculoskeletal disorders in general practice

Stratified care for patients with musculoskeletal disorders in general practice - a cluster randomized controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14067965
Enrollment
748
Registered
2022-05-11
Start date
2022-05-18
Completion date
Unknown
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common musculoskeletal complaints, including pain in the neck, shoulder, low back, knee, hip and multisite pain Musculoskeletal Diseases

Interventions

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 Cen

Sponsors

Norwegian University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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 Admini

Countries

Norway

Contacts

Public ContactIngebrigt Meisingset
ingebrigt.meisingset@ntnu.no+47 (0)90066915

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026