Clinical trial NCT03427099: The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis
Official title: The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Physical Disability
Low Back Pain, Recurrent
Surgery
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: UHasselt
First posted: 2018-02-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Detailed description: This involves a prospective interventional study with a one year follow-up. The investigators will compare the outcomes of the current rehabilitation pathway with a newly developed (based on systematic review and delphi study) rehabilitation pathway for patients with a single and double level lumbar arthrodesis. The usual care group (n= 30) will be compared with the intervention group (n= 30).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: Postoperative: 1 week
measure: Oswestry Disability Index (ODI)
timeFrame: Postoperative: 6 weeks
measure: Oswestry Disability Index (ODI)
timeFrame: Postoperative: 3 months
measure: Oswestry Disability Index (ODI)
timeFrame: Postoperative: 6 months
measure: Oswestry Disability Index (ODI)
timeFrame: Postoperative: 1 year
Secondary outcomes:
measure: Numeric Rating scale (NRS)
timeFrame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
measure: Tampa scale for Kinesiophobia (TSK)
timeFrame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
measure: Pain Catastrophizing scale (PCS)
timeFrame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
measure: Depression Anxiety stress scale (DASS)
timeFrame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
measure: EuroQol five dimensions questionnaire (EQ-5D)
timeFrame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
measure: Sit-to-stand
timeFrame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
measure: Patient Specific Functional Scale (PSFS)
timeFrame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
measure: Return-to-work
timeFrame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ/KU Leuven
state: Vlaams Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Bart Depreitere, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Thijs Swinnen, MSc, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Tinne Thys, MSc, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Wim Dankaerts, PhD, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Simon Brumagne, PhD, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Peter Van Wambeke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Lieven Moke, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Sebastiaan Schelfaut, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Ann Spriet, MSc, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Lotte Janssens, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: