Effect of an Interdisciplinary Spine Rehabilitation Program

Recruiting

• Conditions: Spine Disease; Low Back Pain
• Interventions: Other: Rehabilitation program (Revita)

• Registration Number: NCT06030570
• Lead Sponsor: KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-22
• Study First Submitted: 2023-08-24
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-07
• Last Update Submitted: 2023-09-07
• Study First Posted: 2023-09-11
• Last Update Posted: 2023-09-11
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with low back pain	Rehabilitation program (Revita)	Patients of University Hospitals Leuven participating in the interdisciplinary spine rehabilitation program (REVITA)

Primary Outcome Measures

Name	Time	Method
Change in pain	baseline - 6 months - 1 year	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
Change in Oswestry Disability Index (ODI)	baseline - 6 months - 1 year	Change in functional impairment (before vs. after rehabilitation program); minimum score: 0 maximum score: 100 a higher score corresponds with more functional impairment

Secondary Outcome Measures

Name	Time	Method
Effect on quality of life	baseline - 6 months - 1 year	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
Effect on kinesiophobia	baseline - 6 months - 1 year	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
Effect on anxiety and depression	baseline - 6 months - 1 year	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
Effect on body awareness	baseline - 6 months - 1 year	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
Return to Work self-efficacy	baseline - 6 months - 1 year	"the Return to Work Self-Efficacy" questionnaire; minimum score: 1 maximum score: 6 a higher score corresponds with a higher level of self-efficacy
Return to work	baseline - 6 months - 1 year	number of days to return to work
Effect on risk stratification tool	baseline - 6 months - 1 year	Change in Örebro score (before vs. after rehabilitation program); minimum score: 0 maximum score: 100 a higher score corresponds with a higher risk profile
Effect on functioning	baseline - 6 months - 1 year	Change in Patient Specific Functional scale (PSFS); minimum score: 0 maximum score: 10 a higher score corresponds with a better functional level
Effect on fear-avoidance beliefs	baseline - 6 months - 1 year	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
Treatment experience	6 months - 1 year	Patient Global impression of change (PGIC); minimum score: 1 maximum score: 7 a higher score corresponds with less impression of change
Effect on medication use	baseline - 6 months - 1 year	Change in Medication Quantification Scale (MQS); a higher score corresponds with a higher medication use

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium