Precision Based Primary Care for Patients With Musculoskeletal Disorders

NCT07603674 | Recruiting

• 1 other identifier: 2024-05078-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

In this research project, the researchers will implement the Start-MSK tool, which is a screening instrument to support and facilitate the work of directing the right treatment to the right patient with musculoskeletal pain to promote recovery and improve health outcomes. The screening tool aims to identify prognostic factors to stratify patients into groups with different risks for long-term pain and disability. A total of 300 patients, 18 years and older, with musculoskeletal pain who seek primary care rehabilitation and a physiotherapist will be recruited. For this project, the investigaters are in contact with 10-15 primary care units in the Stockholm, Västra Götaland, Uppsala and Skåne Regions. Patients who are recruited will receive care from a physiotherapist and with a follow-up for 6 months. The primary aim is to investigate whether Start-MSK can predict the outcome (pain, quality of life) of the treatment at 3 months, and at long-term follow-up 6 months. The investigators will also conduct interview studies using focus groups with the physiotherapists and individual interviews with included patients who are part of the study to capture their experiences of using the Start-MSK; about how the participants feel the use has affected treatment and the measures they have received. Through Start-MSK, which is a step towards precision-based treatment for musculoskeletal pain, some of the long-term pain should be preventable.

Conditions

Musculoskeletal Disorders (MSDs)

Keywords

Start MSK; rehabilitation; musculoskeletal pain; stratification

Outcome Measures

Primary Outcomes (1)

• The Start Musculoskeletal (MSK) tool

  Start-MSK comprise 10 questions that measure different constructs of functional and psychosocial pain-related factors to predict persistent disabling pain. The first question is about the severity of pain, and the score of this question is determined by a number from 0-10, with 10 representing the worst pain. Questions 2-10 are answered by yes or no. A total score of 0 and 12 is obtained, where 12 represents the worst. The patient is stratified based on the total score to a subgroup with low (0-4), medium (5-8), or high (9-12) risk of persistent disabling pain.

  The Start MSK will be used at baseline and at followed up at 8 weeks, 3 and 6 months

Secondary Outcomes (3)

• The modified Örebro Musculoskeletal Pain Questionnaire

  The ÖMPSQ will be used at baseline, and follow up at 8 weeks, 3 and 6 months

• EQ-5-D-5L

  The EQ-5D-5L will be used at baseline and at follow-up at 8 weeks, 3 and 6 months

• The Musculoskeletal health questionnaire (MSK-HQ)

  The MSK-HQ is used at baseline, at follow up at 8 weeks and 3 and 6 months

Study Arms (1)

Patients with musculoskeltal disorders seeking primary care

Patients seeking physiotherapy primary care with a primary reason of a musculoskeletal disorder; neck pain, low-back pain, shoulder, hip, knee and multisite pain.

Other: No intervention

Interventions

No intervention OTHER

The patients are followed over 6 month through patient reported outcome measures. No intervention other than the regular treatment that the physiotherapists give. In this project the participating physiotherapists are not instructed to treat the participating patients according to the recommended treatment level based on the risk group. The physiotherapists are instructed to use the Start MSK the first visit and to use the results in the dialogue with the patients. The investigators will follow up on what treatment that is given with a short survey at 8 weeks. This survey comprises questions on how many treatment sessions were given, and include a multiple choice question with a list of possible treatments (exercise, information, home exercise, mobilisation, manipulation, stretching, modalities etc). The physiotherapists report treatment given by checking boxes of the different treatments. This information will later be analysed in relation to risk group (low, medium and high risk).

Patients with musculoskeltal disorders seeking primary care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People, more than 18 years, with musculoskeletal pain seeking physiotherapist in primary care.

You may qualify if:

• adults with musculoskeletal pain (neck, back, shoulder, hip, knee, multisite pain)
• recruited from primary care, aged 18 and above

You may not qualify if:

• malignant and inflammatory diseases
• inability to understand spoken and written Swedish

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philip von Rosen, Associate professor, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Rasmussen Barr, Associate professor PhD

CONTACT

0046707400045; eva.rasmussen.barr@ki.se

Philip von Rosen, Associate professor, PhD

CONTACT

philip.von.rosen@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: May 22, 2026
• Study Start: April 16, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

SE (1)