Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454792
Status:
COMPLETED
Last Update Posted:
2011-09-26
First Post:
2007-03-30
Brief Title:
Rehabilitation of Patients With Modic Changes in the Lumbar Spine
Sponsor:
The Back Research Center Denmark
Organization:
The Back Research Center Denmark
Study Overview
Official Title:
Rehabilitation of Patients With Modic Changes in the Lumbar Spine - a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare patients with low back pain LBP and Modic Changes from The Backcenter Funen Ringe
1 To compare the effect of two types of non-operative treatments
A exercise and advice to be physically active
B restitution and advice not to overload the spine
2 To investigate if the results of the treatment are influenced by gender age smoking and physical load
1 To compare the effect of two types of non-operative treatments
A exercise and advice to be physically active
B restitution and advice not to overload the spine
2 To investigate if the results of the treatment are influenced by gender age smoking and physical load
Detailed Description:
The clinical experience is that many patients with Modic changes have relatively severe and persistent LBP which typically appears to be resistant to treatment Furthermore a retrospective study at The Backcenter Funen Ringe shows that patients with MC fail to improve engaging physical activity This is unfortunate because the typical rehabilitation for patients with persistent LBP is back exercises and information about keeping physically active This means that this relatively large subgroup of patients with Modic changes probably does not improve with the rehabilitation tools used today
A randomised controlled trial has therefore been designed to study the specific subgroup of patients with Modic changes In this study we will compare the present state-of-the art rehabilitation approach to persistent LBP namely to exercise and keep active with a new concept restitution The justification for this is that restitution reduces mechanical stress on the vertebrae and therefore would allow heeling of the possible micro fractures in Modic changes
A randomised controlled trial has therefore been designed to study the specific subgroup of patients with Modic changes In this study we will compare the present state-of-the art rehabilitation approach to persistent LBP namely to exercise and keep active with a new concept restitution The justification for this is that restitution reduces mechanical stress on the vertebrae and therefore would allow heeling of the possible micro fractures in Modic changes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None