Effect of an Interdisciplinary Spine Rehabilitation Program (PROGRESS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain; Spine Disease
• Intervention / Treatment: Other: Rehabilitation program (Revita)

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Sofie Rummens, MD; Phone Number: 003216338700; Email: sofie.rummens@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • University Hospitals Leuven
    • Contact: Sofie Rummens, MD; Email: sofie.rummens@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Subjects with low back pain; Patients of University Hospitals Leuven participating in the interdisciplinary spine rehabilitation program (REVITA)

Other: Rehabilitation program (Revita); 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.

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

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain; Spinal Diseases; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Aftercare; Continuity of Patient Care; Rehabilitation
• Other Study ID Numbers: S67679

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No