Rehabilitation of Patients With Modic Changes in the Lumbar Spine
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Exercise
Restitution
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Modic changes
Eligibility Criteria
Inclusion Criteria:
Primary inclusion criteria for receiving MRI
- The patient must have LBP with a current duration of 3 - 12 month.
- The patient must have an actual pain intensity ≥4 on numerical pain rating scale from 0-10.
Secondary inclusion criteria for receiving MRI
- The patient must speak and understand Danish.
- The patient must be between 18-60 years of age.
- The patient must be willing to participate in the project. Inclusions criterium for the project
- There must be an MRI showing MC in the lumbar spine.
Exclusion Criteria:
- The patient is unable to go through with the project because of other physical or mental disorder.
- The patient is pregnant.
- The patient is referred to operation.
Sites / Locations
- Spine Centre of Southern Denmark
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Exercise and advise to stay active
Rest and use of flexible lumbar belt
Arm Description
The exercise group received exercises for the stabilising muscles in the low back and abdomen together with dynamic exercises, exercises for postural instability and light physical fitness training.
The rest group was instructed to avoid hard physical activity and to rest twice daily for one hour, by lying down
Outcomes
Primary Outcome Measures
The primary outcome measure is actual LBP, as measured with an "11 point box scale".
Secondary Outcome Measures
General Health, as measured with the EQ-5D (EuroQol)
General improvement, as measured with two global instruments a 7-point transition question and an assessment score consisting of a "bothersomeness index"
Physical functions measured with "Roland Morris Disability Questionnaire"
Full Information
NCT ID
NCT00454792
First Posted
March 30, 2007
Last Updated
September 23, 2011
Sponsor
The Back Research Center, Denmark
Collaborators
Velux Fonden
1. Study Identification
Unique Protocol Identification Number
NCT00454792
Brief Title
Rehabilitation of Patients With Modic Changes in the Lumbar Spine
Official Title
Rehabilitation of Patients With Modic Changes in the Lumbar Spine - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Back Research Center, Denmark
Collaborators
Velux Fonden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare patients with low back pain (LBP) and Modic Changes from The Backcenter Funen, Ringe:
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Modic changes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise and advise to stay active
Arm Type
Active Comparator
Arm Description
The exercise group received exercises for the stabilising muscles in the low back and abdomen together with dynamic exercises, exercises for postural instability and light physical fitness training.
Arm Title
Rest and use of flexible lumbar belt
Arm Type
Experimental
Arm Description
The rest group was instructed to avoid hard physical activity and to rest twice daily for one hour, by lying down
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Back exercise: At home every day. In groups once a week. Duration 10 weeks.
Intervention Type
Other
Intervention Name(s)
Restitution
Intervention Description
Restitution: At home 2 times one hour. Meetings every 2 weeks. Duration 10 weeks.
Primary Outcome Measure Information:
Title
The primary outcome measure is actual LBP, as measured with an "11 point box scale".
Time Frame
10 weeks and 12 months
Secondary Outcome Measure Information:
Title
General Health, as measured with the EQ-5D (EuroQol)
Time Frame
10 weeks and 12 months
Title
General improvement, as measured with two global instruments a 7-point transition question and an assessment score consisting of a "bothersomeness index"
Time Frame
10 weeks and 12 months
Title
Physical functions measured with "Roland Morris Disability Questionnaire"
Time Frame
10 weeks and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary inclusion criteria for receiving MRI
The patient must have LBP with a current duration of 3 - 12 month.
The patient must have an actual pain intensity ≥4 on numerical pain rating scale from 0-10.
Secondary inclusion criteria for receiving MRI
The patient must speak and understand Danish.
The patient must be between 18-60 years of age.
The patient must be willing to participate in the project. Inclusions criterium for the project
There must be an MRI showing MC in the lumbar spine.
Exclusion Criteria:
The patient is unable to go through with the project because of other physical or mental disorder.
The patient is pregnant.
The patient is referred to operation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Manniche, Prof.Dr.Med.
Organizational Affiliation
Spine Centre of Southern Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Spine Centre of Southern Denmark
City
Middelfart
ZIP/Postal Code
5500
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
22376791
Citation
Jensen RK, Leboeuf-Yde C, Wedderkopp N, Sorensen JS, Manniche C. Rest versus exercise as treatment for patients with low back pain and Modic changes. A randomized controlled clinical trial. BMC Med. 2012 Feb 29;10:22. doi: 10.1186/1741-7015-10-22.
Results Reference
derived
Learn more about this trial
Rehabilitation of Patients With Modic Changes in the Lumbar Spine
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