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Clinical Trials/NCT06030570
NCT06030570
Recruiting
Not Applicable

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

KU Leuven1 site in 1 country90 target enrollmentAugust 22, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
KU Leuven
Enrollment
90
Locations
1
Primary Endpoint
Change in pain
Status
Recruiting
Last Updated
7 months ago

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.

Registry
clinicaltrials.gov
Start Date
August 22, 2023
End Date
December 1, 2025
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
KU Leuven
Responsible Party
Principal Investigator
Principal Investigator

Sofie Rummens

Principal Investigator, Physical and Rehabilitation Medicine Specialist, PhD in Biomedical Sciences

Universitaire Ziekenhuizen KU Leuven

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in pain

Time Frame: 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)

Time Frame: 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 Outcomes

  • Effect on quality of life(baseline - 6 months - 1 year)
  • Effect on kinesiophobia(baseline - 6 months - 1 year)
  • Effect on anxiety and depression(baseline - 6 months - 1 year)
  • Effect on body awareness(baseline - 6 months - 1 year)
  • Return to Work self-efficacy(baseline - 6 months - 1 year)
  • Return to work(baseline - 6 months - 1 year)
  • Effect on risk stratification tool(baseline - 6 months - 1 year)
  • Effect on functioning(baseline - 6 months - 1 year)
  • Effect on fear-avoidance beliefs(baseline - 6 months - 1 year)
  • Treatment experience(6 months - 1 year)
  • Effect on medication use(baseline - 6 months - 1 year)

Study Sites (1)

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