Preoperative Rehabilitation for Patients Undergoing Surgery for Lumbar Spinal Stenosis

March 24, 2020 updated by: Martin Descarreaux, Université du Québec à Trois-Rivières

Effects of a Preoperative Rehabilitation Program on the Recovery of Patients Undergoing Surgery for Lumbar Spinal Stenosis: a Feasibility Study.

The purpose of the present study is to evaluate the effectiveness of a prehabilitation program on the recovery of patients undergoing a minimally invasive surgery for degenerative lumbar spinal stenosis. To do so, 40 participants will be recruited and randomized into two groups; intervention or control group. Participants in the intervention group will take part in a physical training program, three times a week for six weeks before undergoing surgery. The exercise program will be supervised and will aim at improving core muscles strength and endurance as well as spine stability. It is hypothesized that the prehabilitation program will significantly improve disability and pain intensity reported by patients after surgery. Ultimately, this study aims to improve health care of patients awaiting lumbar surgery but its results may also impact the management of patients awaiting spine surgery for various conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • 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 Locations

  • Canada
    • Quebec
      • Trois-Rivières, Quebec, Canada, G9A 5H7
        • Université du Québec à Trois-Rivières

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

To be affected by degenerative lumbar spinal stenosis and to be awaiting minimally invasive surgery for the lumbar spinal stenosis

Exclusion Criteria:

Non-degenerative spinal stenosis, arthritic conditions (except for facet arthrosis), impaired cognitive function, spinal instability and disagreement from the treating neurosurgeon for the patient to take part in the preadaptation programme.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prehabilitation program
Participants will be physically trained before undergoing surgery
Other: Prehabilitation program
Progressive and individualized physical training aimed at improving core muscles strength and endurance as well as spinal stability.
No Intervention: Control
Patients will follow the normal course of care provided by the hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in disability
Time Frame: baseline, week 6, week 10, week 18, week 30
Oswestry Disability Index
baseline, week 6, week 10, week 18, week 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in pain intensity
Time Frame: baseline, week 6, week 10, week 18, week 30
Visual Analog Scale
baseline, week 6, week 10, week 18, week 30

Collaborators and Investigators

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

Sponsor

Université du Québec à Trois-Rivières

Collaborators

Fonds de soutien au démarrage de projets en collaboration (CSSSTR)
Fonds pour la Recherche Clinique de l'UQTR

Investigators

  • Study Director: Martin Descarreaux, DC, PhD, Université du Québec à Trois-Rivières

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 1, 2014

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

October 2, 2014

First Submitted That Met QC Criteria

October 2, 2014

First Posted (Estimate)

October 7, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UQTR-CSSSTR 2014

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.

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