Effect of an Interdisciplinary Spine Rehabilitation Program

Recruiting

• Conditions: Spine Disease; Low Back Pain

• 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

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