Rehabilitation of Patients With Modic Changes in the Lumbar Spine

• ClinicalTrials.gov Identifier: NCT00454792
• Recruitment Status: Completed
• First Posted: April 2, 2007
• Last Update Posted: September 26, 2011
• Sponsor: The Back Research Center, Denmark
• Collaborator: Velux Fonden
• Information provided by (Responsible Party): Rikke Krüger Jensen, The Back Research Center, Denmark

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Other: Exercise; Other: Restitution	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Rehabilitation of Patients With Modic Changes in the Lumbar Spine - a Randomized Controlled Trial
• Study Start Date: March 2007
• Actual Primary Completion Date: September 2011
• Actual Study Completion Date: September 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. General Health, as measured with the EQ-5D (EuroQol) [ Time Frame: 10 weeks and 12 months ]
2. 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 ]
3. Physical functions measured with "Roland Morris Disability Questionnaire" [ Time Frame: 10 weeks and 12 months ]

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Denmark

Spine Centre of Southern Denmark

Middelfart, Denmark, 5500

Sponsors and Collaborators

The Back Research Center, Denmark

Velux Fonden

Investigators

• Study Chair: Claus Manniche, Prof.Dr.Med.; Spine Centre of Southern Denmark

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Rikke Krüger Jensen, MSc, The Back Research Center, Denmark
• ClinicalTrials.gov Identifier: NCT00454792
• Other Study ID Numbers: VF-20060111
• First Posted: April 2, 2007
• Last Update Posted: September 26, 2011
• Last Verified: September 2011

Keywords provided by Rikke Krüger Jensen, The Back Research Center, Denmark:

Low back pain; Modic changes

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations