COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Rehabilitation of Patients With Modic Changes in the Lumbar Spine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00454792
Recruitment Status : Completed
First Posted : April 2, 2007
Last Update Posted : September 26, 2011
Velux Fonden
Information provided by (Responsible Party):
Rikke Krüger Jensen, The Back Research Center, Denmark

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Exercise Other: Restitution Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rehabilitation of Patients With Modic Changes in the Lumbar Spine - a Randomized Controlled Trial
Study Start Date : March 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Exercise and advise to stay active
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.
Other: Exercise
Back exercise: At home every day. In groups once a week. Duration 10 weeks.

Experimental: Rest and use of flexible lumbar belt
The rest group was instructed to avoid hard physical activity and to rest twice daily for one hour, by lying down
Other: Restitution
Restitution: At home 2 times one hour. Meetings every 2 weeks. Duration 10 weeks.

Primary Outcome Measures :
  1. The primary outcome measure is actual LBP, as measured with an "11 point box scale". [ Time Frame: 10 weeks and 12 months ]

Secondary Outcome Measures :
  1. General Health, as measured with the EQ-5D (EuroQol) [ Time Frame: 10 weeks and 12 months ]
  2. 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 ]
  3. Physical functions measured with "Roland Morris Disability Questionnaire" [ Time Frame: 10 weeks and 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00454792

Layout table for location information
Spine Centre of Southern Denmark
Middelfart, Denmark, 5500
Sponsors and Collaborators
The Back Research Center, Denmark
Velux Fonden
Layout table for investigator information
Study Chair: Claus Manniche, Prof.Dr.Med. Spine Centre of Southern Denmark
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Rikke Krüger Jensen, MSc, The Back Research Center, Denmark Identifier: NCT00454792    
Other Study ID Numbers: VF-20060111
First Posted: April 2, 2007    Key Record Dates
Last Update Posted: September 26, 2011
Last Verified: September 2011
Keywords provided by Rikke Krüger Jensen, The Back Research Center, Denmark:
Low back pain
Modic changes
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Neurologic Manifestations