Rehabilitation of Patients With Modic Changes in the Lumbar Spine

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00454792
• Other study ID #: VF-20060111
• Status: Completed
• Phase: N/A
• First received: March 30, 2007
• Last updated: September 23, 2011
• Start date: March 2007
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: The Back Research Center, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Back Pain

Intervention

Other:
• Exercise
Back exercise: At home every day. In groups once a week. Duration 10 weeks.
• Restitution
Restitution: At home 2 times one hour. Meetings every 2 weeks. Duration 10 weeks.

Locations

Country	Name	City	State
Denmark	Spine Centre of Southern Denmark	Middelfart

Sponsors (2)

Lead Sponsor	Collaborator
The Back Research Center, Denmark	Velux Fonden

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is actual LBP, as measured with an "11 point box scale".		10 weeks and 12 months	No
Secondary	General Health, as measured with the EQ-5D (EuroQol)		10 weeks and 12 months	No
Secondary	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	No
Secondary	Physical functions measured with "Roland Morris Disability Questionnaire"		10 weeks and 12 months	No