NCT03427099

Brief Summary

To compare the current rehabilitation pathway with the implementation of a newly developed rehabilitation pathway for patients with a single and double level lumbar arthrodesis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2018

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

7 years

First QC Date

January 26, 2018

Last Update Submit

December 28, 2023

Conditions

Physical DisabilityLow Back Pain, RecurrentSurgery

Outcome Measures

Primary Outcomes (5)

  • Oswestry Disability Index (ODI)

    questionnaire measuring disability related to low back pain

    Postoperative: 1 week

  • Oswestry Disability Index (ODI)

    questionnaire measuring disability related to low back pain

    Postoperative: 6 weeks

  • Oswestry Disability Index (ODI)

    questionnaire measuring disability related to low back pain

    Postoperative: 3 months

  • Oswestry Disability Index (ODI)

    questionnaire measuring disability related to low back pain

    Postoperative: 6 months

  • Oswestry Disability Index (ODI)

    questionnaire measuring disability related to low back pain

    Postoperative: 1 year

Secondary Outcomes (8)

  • Numeric Rating scale (NRS)

    Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year

  • Tampa scale for Kinesiophobia (TSK)

    Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year

  • Pain Catastrophizing scale (PCS)

    Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year

  • Depression Anxiety stress scale (DASS)

    Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year

  • EuroQol five dimensions questionnaire (EQ-5D)

    Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year

  • +3 more secondary outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR

usual care

Behavioral: Control group

Intervention group

EXPERIMENTAL

Rehabilitation with a biopsychosocial focus

Behavioral: Rehabilitation with a biopsychosocial focus

Interventions

Rehabilitation with a biopsychosocial focusBEHAVIORAL

Rehabilitation with a biopsychosocial focus

Intervention group
Control groupBEHAVIORAL

usual care

Control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lumbar single and double level arthrodesis
  • Signed informed consent
  • Posterior Lumbar interbody fusion (PLIF), Posterolateral lumbar fusion (PLF) and Transforaminal lumbar interbody fusion (TLIF)

You may not qualify if:

  • Previous arthrodesis in the lumbar spine
  • Musculoskeletal disorders which interfere with functional outcome, f.e. severe lower limb problems not related to the lumbar surgery
  • Presence of one of the following pathologies:Parkinson Multiple sclerose (MS), Cerebral vascular accident (CVA), Peripheral neuropathies, Circulatory disorders, Gout, Rheumatoid disorders, Neoplasia, Septic arthritis, Pregnancy, Vestibular disorder, Infectious diseases
  • Accident at work or lawsuit
  • Low cognition
  • Not able to speak Dutch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ/KU Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

RehabilitationControl Groups

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Bart Depreitere, PhD, MD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • Thijs Swinnen, MSc, PT

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • Tinne Thys, MSc, PT

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • Wim Dankaerts, PhD, PT

    KU Leuven

    PRINCIPAL INVESTIGATOR

  • Simon Brumagne, PhD, PT

    KU Leuven

    PRINCIPAL INVESTIGATOR

  • Peter Van Wambeke, MD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • Lieven Moke, PhD, MD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • Sebastiaan Schelfaut, MD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • Ann Spriet, MSc, PT

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

  • Lotte Janssens, PhD, PT

    Hasselt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2018

First Posted

February 9, 2018

Study Start

January 3, 2018

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 3, 2024

Record last verified: 2023-12

Locations

BE(1)