The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Low Back Pain, Recurrent; Surgery; Physical Disability
• Intervention / Treatment: Behavioral: Control group; Behavioral: Rehabilitation with a biopsychosocial focus

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).

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • UZ/KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; usual care	Behavioral: Control group; usual care
Experimental: Intervention group; Rehabilitation with a biopsychosocial focus	Behavioral: Rehabilitation with a biopsychosocial focus; Rehabilitation with a biopsychosocial focus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating scale (NRS)	Severity of low back pain will be scored by the Numerical Rating Scale (NRS) from zero ('no pain') to ten ('worst pain imaginable') (Jensen, M.P., Karoly, P., Braver, S. (1986). The measurement of clinical pain intensity: a comparison of six methods. Pain 27, 117-126.)	Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Tampa scale for Kinesiophobia (TSK)	The Tampa Scale for Kinesiophobia (TSK), which ranges from 17 ('low') to 68 ('high'), was completed to identify fear of (re)injury following movements or activities in the participants with low back pain (Kori, K.S., Miller, R.P., Todd, D.D. (1990). Kinesiophobia: A new view of chronic pain behaviour. Pain 3, 35-43.)	Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
EuroQol five dimensions questionnaire (EQ-5D)	questionnaire measuring general health	Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Sit-to-stand	time to perform 5 times sit-to-stand-to-sit	Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Patient Specific Functional Scale (PSFS)	The PSFS is a questionnaire measuring disability related to low back pain. The Scale is developed by "Stratford, P., Gill, C., Westaway, M., & Binkley, J. (1995). Assessing disability and change on individual patients: a report of a patient specific measure. Physiotherapy Canada, 47, 258-263." Three to five activities are scored on a Visual Analogue Scale (VAS) from 0 ('not able to perform activity') to 10 ('can perform activity without any problems'). Lower scores indicate a worse outcome on function. The total score is the sum of the VAS scores of the 3 to 5 activities.	Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Return-to-work	questionnaire on work resumption	Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Pain Catastrophizing scale (PCS)	People are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness.	Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Depression Anxiety stress scale (DASS)	A higher score on the DASS indicates greater severity or frequency of negative emotional symptoms, ranging from 0-126.	Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: KU Leuven; UHasselt
• Investigators: Principal Investigator: Peter Van Wambeke, MD, Universitaire Ziekenhuizen KU Leuven; Principal Investigator: 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: 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

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 26, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Actual): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: KU/UZ Leuven S60109 - 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No