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Rehabilitation of Patients With Modic Changes in the Lumbar Spine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00454792
Recruitment Status : Completed
First Posted : April 2, 2007
Last Update Posted : September 26, 2011
Sponsor:
Collaborator:
Velux Fonden
Information provided by (Responsible Party):
Rikke Krüger Jensen, The Back Research Center, Denmark

Tracking Information
First Submitted Date  ICMJE March 30, 2007
First Posted Date  ICMJE April 2, 2007
Last Update Posted Date September 26, 2011
Study Start Date  ICMJE March 2007
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2011)
The primary outcome measure is actual LBP, as measured with an "11 point box scale". [ Time Frame: 10 weeks and 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2007)
  • The primary outcome measure is actual LBP, as measured with an "11 point box scale".
  • The secondary outcome measure is disability, as measured with the "Roland Morris" and the "Low Back Pain Rating Scale".
Change History Complete list of historical versions of study NCT00454792 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2007)
  • Change in individual functional limitation, as measured with the "Patient Specific Function Scale"
  • General Health, as measured with the EQ-5D (EuroQol)
  • General improvement, as measured with two global instruments a 7-point transition question and an assessment score consisting of a "bothersomeness index"
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Rehabilitation of Patients With Modic Changes in the Lumbar Spine
Official Title  ICMJE Rehabilitation of Patients With Modic Changes in the Lumbar Spine - a Randomized Controlled Trial
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.
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  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Other: Exercise
    Back exercise: At home every day. In groups once a week. Duration 10 weeks.
  • Other: Restitution
    Restitution: At home 2 times one hour. Meetings every 2 weeks. Duration 10 weeks.
Study Arms
  • 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.
    Intervention: Other: Exercise
  • 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
    Intervention: Other: Restitution
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2007)
100
Original Enrollment  ICMJE
 (submitted: March 30, 2007)
210
Actual Study Completion Date September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00454792
Other Study ID Numbers  ICMJE VF-20060111
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Rikke Krüger Jensen, The Back Research Center, Denmark
Study Sponsor  ICMJE The Back Research Center, Denmark
Collaborators  ICMJE Velux Fonden
Investigators  ICMJE
Study Chair: Claus Manniche, Prof.Dr.Med. Spine Centre of Southern Denmark
PRS Account The Back Research Center, Denmark
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP