Rehabilitation of Patients With Modic Changes in the Lumbar Spine

NCT ID: NCT00454792

Last Updated: 2011-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2011-09-30

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

Restitution

Intervention Type: OTHER

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

Interventions

Exercise

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

Intervention Type: OTHER

Restitution

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Velux Fonden

OTHER

Sponsor Role: collaborator

The Back Research Center, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Rikke Krüger Jensen

MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claus Manniche, Prof.Dr.Med.

Role: STUDY_CHAIR

Spine Centre of Southern Denmark

Locations

Spine Centre of Southern Denmark

Middelfart, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 22376791 (View on PubMed)

Other Identifiers

VF-20060111

Identifier Type: -

Identifier Source: org_study_id