Rehabilitation of Patients With Modic Changes in the Lumbar Spine

The Back Research Center, Denmark

Status: Completed

Conditions: Low Back Pain

Treatments: Other: Restitution; Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT00454792

VF-20060111

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Exercise and advise to stay active

Active Comparator group

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.

Treatment:

Other: Exercise

Rest and use of flexible lumbar belt

Experimental group

Description:

The rest group was instructed to avoid hard physical activity and to rest twice daily for one hour, by lying down

Treatment:

Other: Restitution