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NCT Number: NCT06030570

Effect of an Interdisciplinary Spine Rehabilitation Program

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.

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Key information

Conditions

Low Back Pain Back Pain Bone Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases Spine Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Leuven

Leuven, 3000, Belgium

Location status: Recruiting

Location contact

Sofie Rummens, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Effect on quality of life

    Time frame: 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

  2. Effect on risk stratification tool

    Time frame: 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

  3. Effect on anxiety and depression

    Time frame: 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

  4. Effect on kinesiophobia

    Time frame: 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

  5. Effect on fear-avoidance beliefs

    Time frame: 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

  6. Effect on body awareness

    Time frame: 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

  7. Treatment experience

    Time frame: 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

  8. Return to Work self-efficacy

    Time frame: 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

  9. Return to work

    Time frame: baseline - 6 months - 1 year

    number of days to return to work

  10. Effect on functioning

    Time frame: 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

  11. Effect on medication use

    Time frame: baseline - 6 months - 1 year

    Change in Medication Quantification Scale (MQS)

    a higher score corresponds with a higher medication use

Study contacts

Contact information is provided by the study sponsor or research team.

Sofie Rummens, MD

CONTACT

[email protected]

003216338700

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Acronym: PROGRESS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 11, 2023
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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