NCT05530902

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

4 years

First QC Date

July 14, 2022

Last Update Submit

September 6, 2022

Conditions

Musculoskeletal Pain

Outcome Measures

Primary Outcomes (2)

  • Changes in perceived level of disability

    Measured with the Pain Disability Index (PDI) questionnaire

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

  • Changes in physical quality of life

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

    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)

  • Changes in health-related productivity losses

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

  • Changes in health care consumption

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

  • Changes in work ability

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

  • Changes in self efficacy

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

  • Changes in life participation

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

  • +4 more secondary outcomes

Study Arms (1)

Patients with musculoskeletal pain

EXPERIMENTAL

Patients with musculoskeletal pain

Other: Multidisciplinary Primary Rehabilitation Care

Interventions

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).

Patients with musculoskeletal pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

OCA

Eindhoven, 5652NP, Netherlands

RECRUITING

Activos

Goes, 4461LT, Netherlands

RECRUITING

Belife

Rotterdam, 3062MA, Netherlands

RECRUITING

Eenplus

Velp, 6881LD, Netherlands

RECRUITING

CIR

Zwolle, 8025AX, Netherlands

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Kirsty Musch, MSc

CONTACT

043-3882162kirsty.musch@maastrichtuniversity.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2022

First Posted

September 7, 2022

Study Start

February 1, 2022

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

September 7, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(5)