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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 January 2024 |
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Main ID: |
NCT03427099 |
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Date of registration:
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26/01/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis
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Scientific title:
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The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis |
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Date of first enrolment:
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January 3, 2018 |
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Target sample size:
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80 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03427099 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Thijs Swinnen, MSc, PT |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universitaire Ziekenhuizen KU Leuven |
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Name:
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Sebastiaan Schelfaut, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universitaire Ziekenhuizen KU Leuven |
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Name:
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Lotte Janssens, PhD, PT |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hasselt University |
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Name:
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Bart Depreitere, PhD, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universitaire Ziekenhuizen KU Leuven |
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Name:
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Peter Van Wambeke, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universitaire Ziekenhuizen KU Leuven |
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Name:
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Wim Dankaerts, PhD, PT |
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Address:
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Telephone:
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Email:
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Affiliation:
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KU Leuven |
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Name:
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Lieven Moke, PhD, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universitaire Ziekenhuizen KU Leuven |
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Name:
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Simon Brumagne, PhD, PT |
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Address:
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Telephone:
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Email:
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Affiliation:
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KU Leuven |
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Name:
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Ann Spriet, MSc, PT |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universitaire Ziekenhuizen KU Leuven |
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Name:
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Tinne Thys, MSc, PT |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universitaire Ziekenhuizen KU Leuven |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Low Back Pain, Recurrent
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Physical Disability
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Surgery
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Intervention(s)
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Behavioral: Rehabilitation with a biopsychosocial focus
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Behavioral: Control group
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Primary Outcome(s)
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Oswestry Disability Index (ODI)
[Time Frame: Postoperative: 3 months]
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Oswestry Disability Index (ODI)
[Time Frame: Postoperative: 6 months]
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Oswestry Disability Index (ODI)
[Time Frame: Postoperative: 1 year]
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Oswestry Disability Index (ODI)
[Time Frame: Postoperative: 1 week]
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Oswestry Disability Index (ODI)
[Time Frame: Postoperative: 6 weeks]
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Secondary Outcome(s)
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Depression Anxiety stress scale (DASS)
[Time Frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year]
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Tampa scale for Kinesiophobia (TSK)
[Time Frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year]
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Pain Catastrophizing scale (PCS)
[Time Frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year]
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Return-to-work
[Time Frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year]
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EuroQol five dimensions questionnaire (EQ-5D)
[Time Frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year]
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Patient Specific Functional Scale (PSFS)
[Time Frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year]
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Numeric Rating scale (NRS)
[Time Frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year]
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Sit-to-stand
[Time Frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year]
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Secondary ID(s)
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KU/UZ Leuven S60109 - 3
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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