Clinical trial NCT00454792: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Modic changes
Lead sponsor: The Back Research Center, Denmark
Sponsor class: OTHER
Collaborators: name: Velux Fonden
First posted: 2007-04-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: The primary outcome measure is actual LBP, as measured with an "11 point box scale".
timeFrame: 10 weeks and 12 months
Secondary outcomes:
measure: General Health, as measured with the EQ-5D (EuroQol)
timeFrame: 10 weeks and 12 months
measure: General improvement, as measured with two global instruments a 7-point transition question and an assessment score consisting of a "bothersomeness index"
timeFrame: 10 weeks and 12 months
measure: Physical functions measured with "Roland Morris Disability Questionnaire"
timeFrame: 10 weeks and 12 months
Other outcomes:
Locations:
city: Middelfart
country: Denmark
facility: Spine Centre of Southern Denmark
Study officials:
affiliation: Spine Centre of Southern Denmark
name: Claus Manniche, Prof.Dr.Med.
role: STUDY_CHAIR
References:
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.