The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis

December 28, 2023 updated by: Universitaire Ziekenhuizen KU Leuven
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index (ODI)
Time Frame: Postoperative: 1 week
questionnaire measuring disability related to low back pain
Postoperative: 1 week
Oswestry Disability Index (ODI)
Time Frame: Postoperative: 6 weeks
questionnaire measuring disability related to low back pain
Postoperative: 6 weeks
Oswestry Disability Index (ODI)
Time Frame: Postoperative: 3 months
questionnaire measuring disability related to low back pain
Postoperative: 3 months
Oswestry Disability Index (ODI)
Time Frame: Postoperative: 6 months
questionnaire measuring disability related to low back pain
Postoperative: 6 months
Oswestry Disability Index (ODI)
Time Frame: Postoperative: 1 year
questionnaire measuring disability related to low back pain
Postoperative: 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Numeric Rating scale (NRS)
Time Frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
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)
Time Frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
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)
Time Frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
questionnaire measuring general health
Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Sit-to-stand
Time Frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
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)
Time Frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
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
Time Frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
questionnaire on work resumption
Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Pain Catastrophizing scale (PCS)
Time Frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
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)
Time Frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
KU Leuven
UHasselt

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Low Back Pain, Recurrent

Clinical Trials on Control group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings