Effect of an Interdisciplinary Spine Rehabilitation Program

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
PROGRESS: The Effect of an Interdisciplinary Program for Rehabilitation for Spinal Disorders

Conditions
-----------------
Low Back Pain, Spine Disease

Intervention / Treatment
-----------------
* Other: Rehabilitation program (Revita)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria 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 Exclusion criteria Patients without sufficient understanding of the Dutch language Unable to participate in 2h rehabilitation sessions with exercises

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with low back pain<br>Patients of University Hospitals Leuven participating in the interdisciplinary spine rehabilitation program (REVITA) | Other: Rehabilitation program (Revita)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | baseline - 6 months - 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | baseline - 6 months - 1 year | 
| Return to work | number of days to return to work | 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 | baseline - 6 months - 1 year | 
| Effect on medication use | Change in Medication Quantification Scale (MQS) a higher score corresponds with a higher medication use | baseline - 6 months - 1 year |