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The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis

Primary Purpose

Physical Disability, Low Back Pain, Recurrent, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Rehabilitation with a biopsychosocial focus
Control group
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physical Disability

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Lumbar single level arthrodesis
  • Signed informed consent
  • Posterior Lumbar interbody fusion (PLIF)

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

Sites / Locations

  • UZ/KU LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Intervention group

Arm Description

usual care

Rehabilitation with a biopsychosocial focus

Outcomes

Primary Outcome Measures

Oswestry Disability Index (ODI)
questionnaire measuring disability related to low back pain
Oswestry Disability Index (ODI)
questionnaire measuring disability related to low back pain
Oswestry Disability Index (ODI)
questionnaire measuring disability related to low back pain
Oswestry Disability Index (ODI)
questionnaire measuring disability related to low back pain
Oswestry Disability Index (ODI)
questionnaire measuring disability related to low back pain

Secondary Outcome Measures

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.)
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.)
Pain Catastrophizing scale (PCS)
questionnaire measuring catastrophizing
Depression Anxiety stress scale (DASS)
questionnaire measuring depression
EuroQol five dimensions questionnaire (EQ-5D)
questionnaire measuring general health
Sit-to-stand
time to perform 5 times sit-to-stand-to-sit
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.
Return-to-work
questionnaire on work resumption

Full Information

First Posted
January 26, 2018
Last Updated
January 26, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven, UHasselt
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1. Study Identification

Unique Protocol Identification Number
NCT03427099
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven, UHasselt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Disability, Low Back Pain, Recurrent, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
usual care
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Rehabilitation with a biopsychosocial focus
Intervention Type
Behavioral
Intervention Name(s)
Rehabilitation with a biopsychosocial focus
Intervention Description
Rehabilitation with a biopsychosocial focus
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
usual care
Primary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
questionnaire measuring disability related to low back pain
Time Frame
Postoperative: 1 week
Title
Oswestry Disability Index (ODI)
Description
questionnaire measuring disability related to low back pain
Time Frame
Postoperative: 6 weeks
Title
Oswestry Disability Index (ODI)
Description
questionnaire measuring disability related to low back pain
Time Frame
Postoperative: 3 months
Title
Oswestry Disability Index (ODI)
Description
questionnaire measuring disability related to low back pain
Time Frame
Postoperative: 6 months
Title
Oswestry Disability Index (ODI)
Description
questionnaire measuring disability related to low back pain
Time Frame
Postoperative: 1 year
Secondary Outcome Measure Information:
Title
Numeric Rating scale (NRS)
Description
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.)
Time Frame
Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Title
Tampa scale for Kinesiophobia (TSK)
Description
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.)
Time Frame
Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Title
Pain Catastrophizing scale (PCS)
Description
questionnaire measuring catastrophizing
Time Frame
Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Title
Depression Anxiety stress scale (DASS)
Description
questionnaire measuring depression
Time Frame
Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Title
EuroQol five dimensions questionnaire (EQ-5D)
Description
questionnaire measuring general health
Time Frame
Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Title
Sit-to-stand
Description
time to perform 5 times sit-to-stand-to-sit
Time Frame
Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Title
Patient Specific Functional Scale (PSFS)
Description
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.
Time Frame
Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Title
Return-to-work
Description
questionnaire on work resumption
Time Frame
Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tinne Thys, Msc, PT
Phone
+3216338721
Email
tinne.thys@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Bart Depreitere, PhD, MD
Email
bart.depreitere@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bart Depreitere, PhD, MD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thijs Swinnen, MSc, PT
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tinne Thys, MSc, PT
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wim Dankaerts, PhD, PT
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simon Brumagne, PhD, PT
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Van Wambeke, MD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lieven Moke, PhD, MD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sebastiaan Schelfaut, MD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ann Spriet, MSc, PT
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lotte Janssens, PhD, PT
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ/KU Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lotte Janssens
Phone
+32474435639
Email
lotte.janssens@uhasselt.be

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis

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