Rehabilitation of Patients With Modic Changes in the Lumbar Spine

The Back Research Center, Denmark100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Low Back Pain

Interventions

ExerciseOTHER

Back exercise: At home every day. In groups once a week. Duration 10 weeks.

RestitutionOTHER

Restitution: At home 2 times one hour. Meetings every 2 weeks. Duration 10 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Spine Centre of Southern Denmark

Middelfart, Denmark

Outcomes

Primary Outcomes

The primary outcome measure is actual LBP, as measured with an "11 point box scale".

Time frame: 10 weeks and 12 months

Secondary Outcomes

General Health, as measured with the EQ-5D (EuroQol)

Time frame: 10 weeks and 12 months

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

Physical functions measured with "Roland Morris Disability Questionnaire"

Time frame: 10 weeks and 12 months

Data from ClinicalTrials.gov

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