Back to resultsPreoperative Rehabilitation for Patients Undergoing Surgery for Lumbar Spinal Stenosis
Primary Purpose
Lumbar Spinal Stenosis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Prehabilitation program
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring Preoperative rehabilitation, Minimally invasive surgery, Functional capacity
Eligibility Criteria
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.
Sites / Locations
- Université du Québec à Trois-Rivières
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Prehabilitation program
Control
Arm Description
Participants will be physically trained before undergoing surgery
Patients will follow the normal course of care provided by the hospital
Outcomes
Primary Outcome Measures
Change from Baseline in disability
Oswestry Disability Index
Secondary Outcome Measures
Change from Baseline in pain intensity
Visual Analog Scale
Full Information
NCT ID
NCT02258672
First Posted
October 2, 2014
Last Updated
March 24, 2020
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
1. Study Identification
Unique Protocol Identification Number
NCT02258672
Brief Title
Preoperative Rehabilitation for Patients Undergoing Surgery for Lumbar Spinal Stenosis
Official Title
Effects of a Preoperative Rehabilitation Program on the Recovery of Patients Undergoing Surgery for Lumbar Spinal Stenosis: a Feasibility Study.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the 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
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis
Keywords
Preoperative rehabilitation, Minimally invasive surgery, Functional capacity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prehabilitation program
Arm Type
Experimental
Arm Description
Participants will be physically trained before undergoing surgery
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will follow the normal course of care provided by the hospital
Intervention Type
Other
Intervention Name(s)
Prehabilitation program
Intervention Description
Progressive and individualized physical training aimed at improving core muscles strength and endurance as well as spinal stability.
Primary Outcome Measure Information:
Title
Change from Baseline in disability
Description
Oswestry Disability Index
Time Frame
baseline, week 6, week 10, week 18, week 30
Secondary Outcome Measure Information:
Title
Change from Baseline in pain intensity
Description
Visual Analog Scale
Time Frame
baseline, week 6, week 10, week 18, week 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Descarreaux, DC, PhD
Organizational Affiliation
Université du Québec à Trois-Rivières
Official's Role
Study Director
Facility Information:
Facility Name
Université du Québec à Trois-Rivières
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G9A 5H7
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
26507388
Citation
Marchand AA, Suitner M, O'Shaughnessy J, Chatillon CE, Cantin V, Descarreaux M. Effects of a prehabilitation program on patients' recovery following spinal stenosis surgery: study protocol for a randomized controlled trial. Trials. 2015 Oct 27;16:483. doi: 10.1186/s13063-015-1009-2.
Results Reference
derived
Learn more about this trial
Preoperative Rehabilitation for Patients Undergoing Surgery for Lumbar Spinal Stenosis
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