An observational study in Low Back Pain and Spine Disease, sponsored by KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by KU Leuven · Observational
The goal of this research project is to evaluate the effectiveness of the current interdisciplinary rehabilitation program (Revita) and follow-up trajectory for chronic lumbar spine disorders in the University Hospitals Leuven.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 90 is close to the median of 100 across 481 observational studies indexed under Low Back Pain.
Browse Low Back Pain studies →KU Leuven is the lead sponsor of 373 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with chronic spine problems in which a multidisciplinary approach is needed
Inclusion criteria
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients of University Hospitals Leuven participating in the interdisciplinary spine rehabilitation program (REVITA)
Other: Rehabilitation program (Revita)
Multidisciplinary programs in an outpatient hospital setting are coordinated by specialists in Physical and Rehabilitation Medicine. These programs combine a physical part (e.g., specific exercises, manual techniques) with at least one other element (psychological, social, educational or occupational intervention). In a multidisciplinary spine rehabilitation program, a maximum of 36 sessions over a maximum time period of 6 months is offered. Afterwards, a (monodisciplinary) follow-up trajectory (K15) is possible, consisting of maximum 104 sessions a year.
Change in Oswestry Disability Index (ODI)
Change in functional impairment (before vs. after rehabilitation program) minimum score: 0 maximum score: 100 a higher score corresponds with more functional impairment
Time frame: baseline - 6 months - 1 year
Change in pain
Change in numeric rating scale (NRS) for low back/leg pain (before vs. after rehabilitation program) minimum score: 0 maximum score: 10 a higher score corresponds with more pain
Time frame: baseline - 6 months - 1 year
Effect on quality of life
Change in EuroQoL 5D (before vs. after rehabilitation program) 5 items with 3 levels Scale to assess health: 0-100 a higher score corresponds with better health
Time frame: baseline - 6 months - 1 year
Effect on risk stratification tool
Change in Örebro score (before vs. after rehabilitation program) minimum score: 0 maximum score: 100 a higher score corresponds with a higher risk profile
Time frame: baseline - 6 months - 1 year
Effect on anxiety and depression
Change in Hospital Anxiety and Depression Scale (HADS) (before vs. after rehabilitation program) minimum score: 0 maximum score: 21 (anxiety) - 21 (depression) a higher score corresponds with a higher suspicion for anxiety/depression
Time frame: baseline - 6 months - 1 year
Effect on kinesiophobia
Change in Tampa scale for Kinesiophobia (TSK) score (before vs. after rehabilitation program) minimum score: 17 maximum score: 68 a higher score corresponds with an increasing degree of kinesiophobia
Time frame: baseline - 6 months - 1 year
Effect on fear-avoidance beliefs
Change in Fear Avoidance Beliefs Questionnaire (FABQ) score (before vs. after rehabilitation program) minimum score: 0 maximum score: 96 a higher score corresponds with stronger fear avoidance beliefs
Time frame: baseline - 6 months - 1 year
Effect on body awareness
Change in Fremantle Back Awareness Scale Questionnaire score (before vs. after rehabilitation program) minimum score: 0 maximum score: 36 a higher score corresponds with a worse back-specific body perception
Time frame: baseline - 6 months - 1 year
Treatment experience
Patient Global impression of change (PGIC) minimum score: 1 maximum score: 7 a higher score corresponds with less impression of change
Time frame: 6 months - 1 year
Return to Work self-efficacy
"the Return to Work Self-Efficacy" questionnaire minimum score: 1 maximum score: 6 a higher score corresponds with a higher level of self-efficacy
Time frame: baseline - 6 months - 1 year
Return to work
number of days to return to work
Time frame: baseline - 6 months - 1 year
Effect on functioning
Change in Patient Specific Functional scale (PSFS) minimum score: 0 maximum score: 10 a higher score corresponds with a better functional level
Time frame: baseline - 6 months - 1 year
Effect on medication use
Change in Medication Quantification Scale (MQS) a higher score corresponds with a higher medication use
Time frame: baseline - 6 months - 1 year
Plan to share: No
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