CClinicalTrials.gg
RecruitingNCT06030570PROGRESSUpdated Sep 23, 2025

Effect of an Interdisciplinary Spine Rehabilitation Program

An observational study in Low Back Pain and Spine Disease, sponsored by KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-23.

Sponsored by KU Leuven · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
90
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Low Back Pain
  • Spine Disease
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

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
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • Subjects with low back pain

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

    Other: Rehabilitation program (Revita)

Interventions

  • OtherRehabilitation 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.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline - 6 months - 1 year

  2. 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

    Time frame: baseline - 6 months - 1 year

Secondary outcomes

  1. 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

    Time frame: baseline - 6 months - 1 year

  2. 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

    Time frame: baseline - 6 months - 1 year

  3. 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

    Time frame: baseline - 6 months - 1 year

  4. 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

    Time frame: baseline - 6 months - 1 year

  5. 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

    Time frame: baseline - 6 months - 1 year

  6. 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

    Time frame: baseline - 6 months - 1 year

  7. Treatment experience

    Patient Global impression of change (PGIC) minimum score: 1 maximum score: 7 a higher score corresponds with less impression of change

    Time frame: 6 months - 1 year

  8. 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

    Time frame: baseline - 6 months - 1 year

  9. Return to work

    number of days to return to work

    Time frame: baseline - 6 months - 1 year

  10. 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

    Time frame: baseline - 6 months - 1 year

  11. Effect on medication use

    Change in Medication Quantification Scale (MQS) a higher score corresponds with a higher medication use

    Time frame: baseline - 6 months - 1 year

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06030570
Lead sponsor
KU Leuven
Responsible party
Sofie Rummens (Principal Investigator, Physical and Rehabilitation Medicine Specialist, PhD in Biomedical Sciences, Universitaire Ziekenhuizen KU Leuven) — Principal investigator
First posted
Sep 11, 2023
Start date
Aug 22, 2023
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Sep 23, 2025

Study contacts

Sofie Rummens, MD
Contact
sofie.rummens@uzleuven.be
003216338700

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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