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Rehabilitation of Patients With Modic Changes in the Lumbar Spine

This study has been completed.
Sponsor:
Collaborator:
Velux Fonden
Information provided by (Responsible Party):
Rikke Krüger Jensen, The Back Research Center, Denmark
ClinicalTrials.gov Identifier:
NCT00454792
First received: March 30, 2007
Last updated: September 23, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention
Low Back Pain
 Other: Exercise
Other: Restitution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rehabilitation of Patients With Modic Changes in the Lumbar Spine - a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Back Research Center, Denmark:

Primary Outcome Measures:
  • The primary outcome measure is actual LBP, as measured with an "11 point box scale". [ Time Frame: 10 weeks and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • General Health, as measured with the EQ-5D (EuroQol) [ Time Frame: 10 weeks and 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Physical functions measured with "Roland Morris Disability Questionnaire" [ Time Frame: 10 weeks and 12 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: March 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454792

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

No publications provided by The Back Research Center, Denmark

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

Responsible Party: Rikke Krüger Jensen, MSc, The Back Research Center, Denmark
ClinicalTrials.gov Identifier: NCT00454792     History of Changes
Other Study ID Numbers: VF-20060111
Study First Received: March 30, 2007
Last Updated: September 23, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by The Back Research Center, Denmark:
Low back pain
Modic changes

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013