Chronic PainCIR-predictNCT05661760
Predicting Successful Outcome of Interdisciplinary Biopsychosocial Rehabilitation in Osteoarthritis
An observational study of Chronic Pain and Osteoarthritis, run by Maastricht University at 1 site in Netherlands.
Trial summary
The goal of this prospective study is to identify variables that can predict whether an interdisciplinary biopsychosocial intervention for patients with osteoarthritis will be successful. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Pain, Osteoarthritis, Disability Physical
- What is being tested?
- interdisciplinary multimodal pain treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,309 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2019to 31 Dec 2023
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Referred by GP, medical specialist or occupation physician to reduce level of disability and improve quality of life of patients fulfilling the eligibility criteria and not having one or more of the exclusion criteria:
Who may be able to join
- Chronic musculoskeletal pain > 3 months and osteoarthritis
- Large personal and social dysfunction
- Interplay of biological, social and psychological factors maintaining pain and/or disability
Who cannot join
- Inability to actively participate in treatment (insufficient motivation, limited Dutch language skills, environmental factors, other pending treatments)
- Disagreement between patient and care providers on content of treatment
- Pending legal procedures that hinder full cooperation
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Centrum voor Integrale Revalidatie
Zwolle, Overijssel, 8025 AX
About this study
Official title: Development of a Clinical Prediction Model to Facilitate Decision Making in Interdisciplinary Biopsychosocial Rehabilitation in Patients With Osteoarthritis (OA)
The goal of this prospective study is to identify variables that can predict whether an interdisciplinary biopsychosocial intervention for patients with osteoarthritis will be successful.
Using an observational design, patients admitted to this program during the 3-year period (2019-2021) will be included and data gathered during routine clinical practice at baseline and end of treatment of patients who gave informed consent, will be used.
With these data a prediction model will be build and internal validation with bootstrapping will be done.
Read the detailed description
Rationale: To predict the probability of a positive outcome of interdisciplinary biopsychosocial intervention in individual patients with osteoarthritis (OA), a prediction model is needed.
Research Question/Objective: The overall goal is to develop a clinical prediction model to facilitate decision making in interdisciplinary biopsychosocial rehabilitation in patients with OA. The model will predict the individual probability (in percentage) of a positive response to the treatment (treatment success).
Design: A retrospective cohort design. Setting: A Dutch rehabilitation facility. Participants: Patients with OA diagnosed by a medical specialist and consisting at least three months.
Intervention and procedures: The intervention of interest is interdisciplinary biopsychosocial rehabilitation. The procedures include the development of a clinical prediction model and assessment of its performance and internal validity.
Measurements: Candidate predictors will be carefully selected. The outcome of the model will be treatment success, defined by the change on the Pain Disability Index (PDI). The model will be built with data gathered as part of routine practice.
Expected outcome of the research: The deliverable will be a clinical predication model, which can be used in follow-up research.
- Conditions
- Chronic Pain, Osteoarthritis, Disability Physical
- Being tested
- interdisciplinary multimodal pain treatment
- Keywords
- multimodal treatment, interdisciplinary, rehabilitation medicine, prediction model, treatment outcome
- Medical subject headings
- Chronic Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interdisciplinary multimodal pain treatmentBehavioural
Also called biopsychosocial treatment
A combination of physical and psychosocial treatment methods is employed, including Emotional Awareness and Expression Therapy (EAET), Pain Neuroscience Education (PNE), Acceptance and Commitment Therapy (ACT), graded activity, exposure in vivo, and experiential learning through physical training.
| Study group | Role | What they receive |
|---|---|---|
| chronic pain osteoarthritis | Patients with chronic pain and disability with osteoarthritis Receives: Behavioral: interdisciplinary multimodal pain treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Disability Index
Measures to which degree pain prevents the patient from participating in daily activities. Improvement equal or higher than Minimal Clinically Important Change (MCID; which is 9 points) is defined as successful treatment, and all others as not successful treatment Population will be dichotomized into successful or non-successful treatment and this will be the dependent variable for the logistic regression analysis used to build the prediction model
Measured: baseline (start of treatment) and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Jan 2019
- Primary completion17 Jan 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Centrum voor Integrale Revalidatie (CIR), Pfizer
- Responsible party
- Sponsor
- Investigators
- Rob J Smeets, MD PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661760
- Sponsor's protocol ID
- CIR-001
- Other IDs
- 41150323011N
- Acronym
- CIR-predict
- Status last verified
- Nov 2022
- First submitted
- 24 Nov 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: As data are gathered as routine practice, data are owned by and stored by CIR. In case of any request the PI can be contacted and he will ask CIR whether specific data will be made available
Publications
Breugelmans L, Scheffer E, Beckers LWME, Oosterwijk RFA, Nijland G, Smeets RJEM. Systematic description of an interdisciplinary multimodal pain treatment programme for patients with chronic musculoskeletal pain, using the TIDieR checklist. BMC Res Notes. 2022 Oct 11;15(1):320. doi: 10.1186/s13104-022-06211-z.
PubMed 36221116
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Clinical Prediction Model to Facilitate Decision Making in Interdisciplinary Biopsychosocial Rehabilitation in Patients With Osteoarthritis (OA)
- ClinicalTrials.gov ID
- NCT05661760
- Acronym / sponsor ID
- CIR-predict / CIR-001
- Conditions
- Chronic Pain, Osteoarthritis, Disability Physical
- Keywords
- multimodal treatment, interdisciplinary, rehabilitation medicine, prediction model, treatment outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,309 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Centrum voor Integrale Revalidatie (CIR), Pfizer
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective study is to identify variables that can predict whether an interdisciplinary biopsychosocial intervention for patients with osteoarthritis will be successful.
Using an observational design, patients admitted to this program during the 3-year period (2019-2021) will be included and data gathered during routine clinical practice at baseline and end of treatment of patients who gave informed consent, will be used.
With these data a prediction model will be build and internal validation with bootstrapping will be done.
Detailed description
Rationale: To predict the probability of a positive outcome of interdisciplinary biopsychosocial intervention in individual patients with osteoarthritis (OA), a prediction model is needed.
Research Question/Objective: The overall goal is to develop a clinical prediction model to facilitate decision making in interdisciplinary biopsychosocial rehabilitation in patients with OA. The model will predict the individual probability (in percentage) of a positive response to the treatment (treatment success).
Design: A retrospective cohort design. Setting: A Dutch rehabilitation facility. Participants: Patients with OA diagnosed by a medical specialist and consisting at least three months.
Intervention and procedures: The intervention of interest is interdisciplinary biopsychosocial rehabilitation. The procedures include the development of a clinical prediction model and assessment of its performance and internal validity.
Measurements: Candidate predictors will be carefully selected. The outcome of the model will be treatment success, defined by the change on the Pain Disability Index (PDI). The model will be built with data gathered as part of routine practice.
Expected outcome of the research: The deliverable will be a clinical predication model, which can be used in follow-up research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic pain osteoarthritis | – | Behavioral: interdisciplinary multimodal pain treatmentPatients with chronic pain and disability with osteoarthritis |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Referred by GP, medical specialist or occupation physician to reduce level of disability and improve quality of life of patients fulfilling the eligibility criteria and not having one or more of the exclusion criteria:
Key inclusion criteria (3 listed)
- Chronic musculoskeletal pain > 3 months and osteoarthritis
- Large personal and social dysfunction
- Interplay of biological, social and psychological factors maintaining pain and/or disability
Key exclusion criteria (3 listed)
- Inability to actively participate in treatment (insufficient motivation, limited Dutch language skills, environmental factors, other pending treatments)
- Disagreement between patient and care providers on content of treatment
- Pending legal procedures that hinder full cooperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interdisciplinary multimodal pain treatmentAlso: biopsychosocial treatmentA combination of physical and psychosocial treatment methods is employed, including Emotional Awareness and Expression Therapy (EAET), Pain Neuroscience Education (PNE), Acceptance and Commitment Therapy (ACT), graded activity, exposure in vivo, and experiential learning through physical training. | Behavioural | chronic pain osteoarthritis |
Primary outcome
Pain Disability Index
Time frame: baseline (start of treatment) and 10 weeks
Measures to which degree pain prevents the patient from participating in daily activities. Improvement equal or higher than Minimal Clinically Important Change (MCID; which is 9 points) is defined as successful treatment, and all others as not successful treatment Population will be dichotomized into successful or non-successful treatment and this will be the dependent variable for the logistic regression analysis used to build the prediction model
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Background: PubMed 36221116Breugelmans L, Scheffer E, Beckers LWME, Oosterwijk RFA, Nijland G, Smeets RJEM. Systematic description of an interdisciplinary multimodal pain treatment programme for patients with chronic musculoskeletal pain, using the TIDieR checklist. BMC Res Notes. 2022 Oct 11;15(1):320. doi: 10.1186/s13104-022-06211-z.
- Individual participant dataSharing planned: Undecided. As data are gathered as routine practice, data are owned by and stored by CIR. In case of any request the PI can be contacted and he will ask CIR whether specific data will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob J Smeets, MD PhD principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Osteoarthritis, run by Maastricht University at 1 site 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 3 inclusion and 3 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 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Disability Index (time frame: baseline (start of treatment) and 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05661760, which also lists 1 linked publication.
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 22 Dec 2022.