Rehabilitation of Patients With Modic Changes in the Lumbar Spine

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Exercise; Other: Restitution

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Middelfart, Denmark, 5500
    • Spine Centre of Southern Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome measure is actual LBP, as measured with an "11 point box scale".	10 weeks and 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
General Health, as measured with the EQ-5D (EuroQol)	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"	10 weeks and 12 months
Physical functions measured with "Roland Morris Disability Questionnaire"	10 weeks and 12 months

Collaborators and Investigators

• Sponsor: The Back Research Center, Denmark
• Collaborators: Velux Fonden
• Investigators: Study Chair: Claus Manniche, Prof.Dr.Med., Spine Centre of Southern Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: March 30, 2007
• First Submitted That Met QC Criteria: March 30, 2007
• First Posted (Estimate): April 2, 2007

Study Record Updates

• Last Update Posted (Estimate): September 26, 2011
• Last Update Submitted That Met QC Criteria: September 23, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Low back pain; Modic changes
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: VF-20060111