Effect of an Interdisciplinary Spine Rehabilitation Program

NCT06030570 | Recruiting

• 1 other identifier: S67679
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Spine Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Effect on quality of life

  baseline - 6 months - 1 year

• Effect on risk stratification tool

  baseline - 6 months - 1 year

• Effect on anxiety and depression

  baseline - 6 months - 1 year

• Effect on kinesiophobia

  baseline - 6 months - 1 year

• Effect on fear-avoidance beliefs

  baseline - 6 months - 1 year

Study Arms (1)

Subjects with low back pain

Patients of University Hospitals Leuven participating in the interdisciplinary spine rehabilitation program (REVITA)

Other: Rehabilitation program (Revita)

Interventions

Rehabilitation program (Revita) OTHER

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.

Subjects with low back pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic spine problems in which a multidisciplinary approach is needed

You may qualify if:

• Adults, age \> 18 years
• Spine problem for \> 6 weeks, needing interdisciplinary care (risk factors, failure of first line treatment, etc)
• Informed consent to participate

You may not qualify if:

• Patients without sufficient understanding of the Dutch language
• Unable to participate in 2h rehabilitation sessions with exercises

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Spinal Diseases

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Sofie Rummens, MD

CONTACT

003216338700; sofie.rummens@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Physical and Rehabilitation Medicine Specialist, PhD in Biomedical Sciences

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 11, 2023
• Study Start: August 22, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)