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Musculoskeletal PainMPRC_CMPNCT05530902

Multidisciplinary Primary Rehabilitation Care for Patients With Chronic Musculoskeletal Pain

A study testing Multidisciplinary Primary Rehabilitation Care in people with Musculoskeletal Pain, run by Maastricht University Medical Center at 5 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Rationale: A great variability in treatment contents, ways of collaboration between healthcare professionals, and evaluation methods for the treatment in chronic musculoskeletal pain (CMP), exists. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Musculoskeletal Pain
What is being tested?
Multidisciplinary Primary Rehabilitation Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,400 participants
Where
5 sitesNetherlands
Study dates
1 Feb 2022to 1 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age≥18 years
  • musculoskeletal pain
  • duration of musculoskeletal pain ≥ 3 months
  • monodisciplinary primary care is completed

Who cannot join

  • previous experiences with treatment in multidisciplinary secondary or tertiary care
  • Co-morbidities limiting to complete the treatment program within the preset time
  • BMI ≥ 35
  • present addiction or other psychiatric problems
  • inadequate understanding of the Dutch language.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Netherlands5 sites, 5 recruiting
  • OCA

    Eindhoven, 5652NP

    Recruiting
  • Activos

    Goes, 4461LT

    Recruiting
  • Belife

    Rotterdam, 3062MA

    Recruiting
  • Eenplus

    Velp, 6881LD

    Recruiting
  • CIR

    Zwolle, 8025AX

    Recruiting

Other trials in Netherlands

About this study

Rationale: A great variability in treatment contents, ways of collaboration between healthcare professionals, and evaluation methods for the treatment in chronic musculoskeletal pain (CMP), exists. Currently, multidisciplinary diagnostics, pain education and treatment in primary care, in collaboration with secondary care, especially with a biopsychosocial approach, is barely or not organized for patients having CMP. Objective: The aim of this study is to gain insight into the feasibility, health care and societal costs, effects regarding the patients' functioning and participation and perceived quality of care of the multidisciplinary primary rehabilitation care (MPRC) for different organization structures.

Read the detailed description

Chronic musculoskeletal pain (CMP) occurs in 18% of the Dutch population and may cause severe problems in daily functioning of patients. In 10% of the Dutch population, these problems are a leading cause of chronic disability, which leads to a high personal burden.

This will lead to high societal and health care costs. Most of these costs (80-90%) are the result of societal burden, such as work absenteeism, work productivity loss, social benefits and costs as a result of required (in)formal support from third parties (e.g. domestic help). According to the RIVM, the health care costs for neck and back pain are estimated at 937 million euro in 2017. This represents 14% of the total healthcare costs for musculoskeletal and tissue complaints and 1% of the total health care costs in The Netherlands.

The World Health Organization states that two-thirds of all conditions that need rehabilitation services comes from musculoskeletal disorders. With an ageing and growing population, the number people with musculoskeletal disorders increases fast, which will lead to a rapid increase of societal and health care costs. To decrease these costs, multidisciplinary rehabilitation workforce should be available. It is shown that multidisciplinary rehabilitation services in primary care and between primary care and secondary or tertiary care can be efficient. However, a great variability in treatment contents, ways of collaboration between healthcare professionals, and evaluation methods for the treatment in CMP exists.

The Dutch national care standard for CMP proposes an inventory of the factors contributing the causes and maintenance of pain and its associated limitations in daily functioning and participation. These factors can be divided in biomedical, psychological and societal factors: the biopsychosocial model. Since treatments focusing on this model have positive effects on patient outcomes, the standard recommends a biopsychosocial approach in designing a treatment plan. Thereby, the stepped care principles have to be taken into account for the treatment of CMP patient. In stepped care, the intensity of professional care is pre-defined. The stepped care principles contain the four following levels of care:

Step 1: prevention and self-management; Step 2: Monodisciplinary diagnostics, pain education and treatment in primary care; Step 3: Multidisciplinary diagnostics, pain education and treatment in primary care in collaboration with secondary care; Step 4: Multidisciplinary diagnostics, pain education and treatment in secondary or third care.

A great variability in treatment contents, ways of collaboration between healthcare professionals, and evaluation methods for the treatment in chronic musculoskeletal pain (CMP), exists. Currently, multidisciplinary diagnostics, pain education and treatment in primary care, in collaboration with secondary care (step 3), especially with a biopsychosocial approach, is barely or not organized for patients having CMP. Receival of the right health care treatment, at the right moment can therefore be restricted.

Presently, only restricted evidence exists, concerning the effectiveness of multidisciplinary primary care for CMP patients. Therefore, the Dutch Healthcare Authority (NZa) initiated an Policy Regulation 'Innovation' for multidisciplinary primary care. This study aims to gain insight into the feasibility, health care and societal costs, effects regarding the patients' functioning and participation and perceived quality of care of the multidisciplinary primary rehabilitation care (MPRC) for different organization structures.

Aims and hypotheses

The aim of this study is to gain insight into the feasibility, health care and societal costs, effects regarding the patients' functioning and participation and perceived quality of care of the multidisciplinary primary rehabilitation care (MPRC) for different organization structures. The research aims of this study are:

  1. To evaluate the changes in functioning and participation of patients with CMP receiving MPRC, directly after the treatment, after six months follow-up and after 12 months follow-up as compared to baseline.
  2. To evaluate the clinical relevance changes in functioning and participation of patients with CMP receiving MPRC, directly after the treatment, after six months follow-up and after 12 months follow-up.
  3. To evaluate whether the changes in functioning and participation of patients with CMP receiving MPRC, directly after the treatment, after six months follow-up and after 12 months follow-up, differs between the different regions where the treatment is received.
  4. To evaluate which prognostic factors may predict the level of changes in functioning and/or participation in CMP patients receiving MPRC after six months follow-up and after 12 months follow-up.
  5. To evaluate the changes in (direct and indirect) costs for CMP patients receiving MPRC, post treatment compared to pretreatment.
  6. To evaluate the feasibility of MPRC for patients with CMP.
  7. To study the experiences of patients with CMP receiving MPRC.
  8. To study the experiences of the healthcare professionals participating in the MPRC program for CMP patients.

Methodological approach

This study is a mixed-methods, multicenter study that will be conducted five local networks / health care settings in the Netherlands. The study will be conducted from May 2022 until August 2024. The health care settings participating this study offer their own developed treatment program to patients in its region. An independent research team will evaluate the effect of programs.

Study 1

Study design

  1. The main field of study is a quantitative longitudinal cohort study whereby participating patients are asked to fill in a set of eight questionnaires. The set of questionnaires will be partly sent by the health care organizations and partly by the research group Study parameters Main study parameters are the perceived disability, measured with the Pain Disability Index (PDI) and the physical quality of life, measured with the Physical Component Scale (PCS) of the SF-12. Secondary study parameters are the mental quality of life (SF-12), health-related productivity losses (iPCQ), health care consumption (iMCQ), work ability (WAS), self efficacy (PSEQ), life participation: (USER-P ggz), anxiety and depression (HADS), catastrophizing (PCS-6), satisfaction with care (PREM) and complexity of musculoskeletal problems (STarT MSK tool). Study procedures The patients participating the study will be asked to complete a set of eight questionnaires at the start of the treatment, the diagnostic phase/intake (T0), after the intensive treatment phase, three months after T0 (T1); after the intensive treatment phase, nine months after T0 (T2) and after the intensive treatment phase, fifteen months after T0 (T3). The set of questionnaires will partly be sent by the health care settings and partly by the research group. These questionnaires are provided electronically (the EPD-system of the health care setting, Castor EDC and LDOT). On request, a paper-version of the set of questionnaires can be provided. The results will be used by the health care professional to determine the treatment plan, to assess the effect of the treatment and a adjust the treatment plan based on the patients' current needs. Study 2 and 3 Study design
  2. Evaluation on the feasibility of the treatment and the organization of the MER will be executed. Data on this subject will be collected via the Electronic Patient Dossier of the health care settings
  3. Two qualitative focus group studies will be performed on the experiences and satisfaction with the MER from both the perspective of the health care professionals and the participating patients Study parameters The following prognostic data and patient selection data will be collected: patient characteristics, physical and psychiatric co-morbidity, duration of current complaint episodes, complicating physical or social factors, perceived social support, treatment received in the last year, recidivism and received help when filling in the questionnaires

Study procedures Qualitative research Three months after the intensive treatment phase a random selection of participating patients will be invited to participate in a phone interview. Topics that will be addressed are related to the content of the treatment, satisfaction with the treatment, history of the pain complaints, history of health care consumption and improvement recommendations. Furthermore, participating health care professionals will be invited to participate in an online focus group interview per health care setting. The focus group interviews will take place at the start of the project, after six months after the start of the project and after 18 months after the start of the project. Topics that will be addressed are related to the professionals satisfaction with the M, the process of the MPRC and the feasibility of the MPRC.

Feasibility The participating health care professionals will be asked to collect and deliver the following patient data to the research team, which will be used for the process evaluation: healthcare professionals' disciplines that are involved in the treatment program, the amount of treatment sessions, frequency and content of healthcare professionals' collaboration, (frequency of) coordination, communication and collaboration with general practitioners, patients' adherence and planning, executing and declaring the MPRC. Besides that, the following data will be collected and analyzed: compliance, feasibility and duration of the treatment.

Being tested
Multidisciplinary Primary Rehabilitation Care
Medical subject headings
Musculoskeletal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multidisciplinary Primary Rehabilitation CareOther

    As described by the Policy Regulation 'Innovation' (NZa). The MPRC is a structured treatment program following the biopsychosocial approach, aiming to optimize functioning and participation in CMP patients. The treatment program is provided by paramedical specialists and, in cases that are more complex, a rehabilitation physician will be involved. The program has a diagnostic phase, a treatment phase (6-12 weeks) and a follow-up (12 months).

Study groups in NCT05530902
Study groupRoleWhat they receive
Patients with musculoskeletal painExperimentalPatients with musculoskeletal pain
Receives: Other: Multidisciplinary Primary Rehabilitation Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in perceived level of disability

    Measured with the Pain Disability Index (PDI) questionnaire

    Measured: At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).

  2. Changes in physical quality of life

    Measured with the Physical Component Scale (PCS) of the SF-12 questionnaire

    Measured: At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).

Secondary outcomes (9)
  1. Changes in health-related productivity losses

    Measured with the iMTA Productivity Cost Questionnaire (iPCQ) Questionnaire (iPC)

    Measured: At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).

  2. Changes in health care consumption

    Measured with the iMTA Medical Consumption Questionnaire (iMCQ)

    Measured: At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).

  3. Changes in work ability

    Measured with the Work Ability score (WAS) questionnaire.

    Measured: At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).

  4. Changes in self efficacy

    Measured with the Pain Self Efficacy Questionnaire (PSEQ)

    Measured: At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).

  5. Changes in life participation

    Measured with the USER-Participation (USER-P)

    Measured: At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).

  6. Changes in anxiety and depression

    Measured with the Hospital Anxiety and Depression Scale (HADS)

    Measured: At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).

  7. Changes in catastrophizing

    Measured with the Pain Catastrophizing Scale (PCS)

    Measured: At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).

  8. Changes in satisfaction with care

    Measured with the Patient Reported Experience Measure' (PREM)

    Measured: At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).

  9. Changes in complexity of musculoskeletal problems

    STarT MSK tool

    Measured: At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2022
  2. Study start1 Feb 2022
  3. Primary completion1 Feb 2026 (estimated)
  4. Study completion1 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Cohort study
Masking
None (open label)
Enrolment
1,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05530902
Sponsor's protocol ID
MEC-2022-0289
Acronym
MPRC_CMP
Status last verified
Sep 2022
First submitted
14 Jul 2022
Last updated
7 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Multidisciplinary Primary Rehabilitation Care in people with Musculoskeletal Pain, run by Maastricht University Medical Center at 5 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kirsty Musch, MSc (043-3882162, kirsty.musch@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in perceived level of disability (time frame: At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.

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