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Completed

NCT Number: NCT00454792

Rehabilitation of Patients With Modic Changes in the Lumbar Spine

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spine Centre of Southern Denmark

Middelfart, 5500, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

Back exercise: At home every day. In groups once a week. Duration 10 weeks.

Restitution

Other

Restitution: At home 2 times one hour. Meetings every 2 weeks. Duration 10 weeks.

Primary outcomes

  1. The primary outcome measure is actual LBP, as measured with an "11 point box scale".

    Time frame: 10 weeks and 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The Back Research Center, Denmark

Other

Collaborators

  • Velux Fonden

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Apr 2, 2007
Registry last updated
Sep 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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