Precision Based Primary Care for Patients With Musculoskeletal Disorders
ConditionMusculoskeletal Disorders (MSDs)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adults with musculoskeletal pain (neck, back, shoulder, hip, knee, multisite pain)
recruited from primary care, aged 18 and above
Disqualifiers
malignant and inflammatory diseases
inability to understand spoken and written Swedish
Trial population
People, more than 18 years, with musculoskeletal pain seeking physiotherapist in primary care.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionThe 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).
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Patients with musculoskeltal disorders seeking primary care1 intervention
Trial outcomes
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.
Time frame
The Start MSK will be used at baseline and at followed up at 8 weeks, 3 and 6 monthsSecondary outcomes
1
The modified Örebro Musculoskeletal Pain Questionnaire
The modified Örebro Musculoskeletal Pain Questionnaire (ÖMPSQ) includes 10 questions, comprising the duration of the pain period and questions related to psycho-social risk factors in musculoskeletal pain; self-perceived function, pain experience, fear-avoidance beliefs, distress and return to work expectancy. The questions are scored on a scale from 0-10, 10 being worst. A cutoff of ≥50 has been suggested to indicate a higher-risk group. The Swedish version of the short version ÖMPSQ has been validated for non-acute musculoskeletal pain.
Time frame
The ÖMPSQ will be used at baseline, and follow up at 8 weeks, 3 and 6 months2
EQ-5-D-5L
The EQ-5D-5L measures the quality of life and comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and is scored from 1 (worst imaginable health) to 5 (best imaginable health) (11). The scores are transformed into an index value ranging from -0.59 to 1, indicating perfect health
Time frame
The EQ-5D-5L will be used at baseline and at follow-up at 8 weeks, 3 and 6 months3
The Musculoskeletal health questionnaire (MSK-HQ)
The MSK-HQ comprises 14 items aimed to assess the musculoskeletal health status in patients suffering from MSK disorders. It is a formative instrument including aspects shown to be relevant in musculoskeletal health, including questions on pain, fatigue, physical function, sleep, self-efficacy, and psychological well-being. The MSK-HQ includes 14 questions that are scored between 0 and 56, with a higher score representing better health. In addition, the MSK-HQ includes a question on the number of physically active days per week (0-7). The MSK-HQ has shown good reliability and validity in subjects with a range of musculoskeletal disorders. The instrument is translated and validated in a Swedish primary health care context with good test-retest reliability (total score ICC2.1 0.90) and moderate to high construct validity (r \> 0.30) (in manuscript to be published by the investigators of this project)
Time frame
The MSK-HQ is used at baseline, at follow up at 8 weeks and 3 and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov