Rehabilitation of Patients With Modic Changes in the Lumbar Spine

NCT00454792 | Completed

• 1 other identifier: VF-20060111
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.To compare the effect of two types of non-operative treatments:
2. 2.To investigate if the results of the treatment are influenced by gender, age, smoking, and physical load.

Conditions

Low Back Pain

Keywords

Low back pain; Modic changes

Outcome Measures

Primary Outcomes (1)

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

  10 weeks and 12 months

Secondary Outcomes (3)

• General Health, as measured with the EQ-5D (EuroQol)

  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"

  10 weeks and 12 months

• Physical functions measured with "Roland Morris Disability Questionnaire"

  10 weeks and 12 months

Study Arms (2)

Exercise and advise to stay active

ACTIVE COMPARATOR

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

Rest and use of flexible lumbar belt

EXPERIMENTAL

The rest group was instructed to avoid hard physical activity and to rest twice daily for one hour, by lying down

Other: Restitution

Interventions

Exercise OTHER

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

Exercise and advise to stay active

Restitution OTHER

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

Rest and use of flexible lumbar belt

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• There must be an MRI showing MC in the lumbar spine.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Back Research Center, Denmark: lead
• Velux Fonden: collaborator

Study Sites (1)

Spine Centre of Southern Denmark

Middelfart, 5500, Denmark

Location

Related Publications (1)

• 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.

  PMID: 22376791 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Claus Manniche, Prof.Dr.Med.

  Spine Centre of Southern Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: March 30, 2007
• First Posted: April 2, 2007
• Study Start: March 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 26, 2011

Record last verified: 2011-09

Locations

DK (1)