NCT00454792

Rehabilitation of Patients With Modic Changes in the Lumbar Spine

Rehabilitation of Patients With Modic Changes in the Lumbar Spine - a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: The Back Research Center, Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
OTHER	Exercise	Back exercise: At home every day. In groups once a week. Duration 10 weeks.
OTHER	Restitution	Restitution: At home 2 times one hour. Meetings every 2 weeks. Duration 10 weeks.

Timeline

• Start date: 2007-03-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2007-04-02
• Last updated: 2011-09-26

Locations

1 site across 1 country: Denmark