Effect of an Interdisciplinary Spine Rehabilitation Program
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKU Leuven
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults, age > 18 years
Spine problem for > 6 weeks, needing interdisciplinary care (risk factors, failure of first line treatment, etc)
Inclusion in Revita program
Informed consent to participate
Disqualifiers
Patients without sufficient understanding of the Dutch language
Unable to participate in 2h rehabilitation sessions with exercises
Trial population
Patients with chronic spine problems in which a multidisciplinary approach is needed
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Rehabilitation program (Revita)
Other interventionMultidisciplinary 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.
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: Subjects with low back pain1 intervention
Trial outcomes
Primary outcomes
1
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 year2
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 yearSecondary outcomes
1
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 year2
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 year3
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 year4
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
KU Leuven
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Sponsor institution
Source ClinicalTrials.gov