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Treatment of Chronic Low Back Pain: A Trial Comparing Traditional Back School and Individual Therapist-Assisted Exercise

NCT ID: NCT00256373

Last Updated: 2006-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2005-11-30

Brief Summary

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Rheumatologists are discussing, whether rehabilitation of patients with low back pain (LBP) can be improved. At present patients with LBP start treatment as soon as possible, this also applies for patients with chronic low back pain (CLBP) - pain lasting over 12 weeks. At Glostrup University Hospital department of Physical Medicine/rheumatology we use a method (method A) where an interdisciplinary team gives the patients a treatment composed of various topics. This includes among other things education, physical team training, exercises in swimming pool, stretching exercises, and occupational therapy. A different method (method B) originates from the Rehabilitation centre in Karlslunde led by Teddy Oefeldt. Here they focus strictly on dynamic training of muscles in the back and the buttocks. A therapist, who in the beginning partly carries the patient through the exercises, assists this training.

In both methods, individually considerations are taken, but to a greater extend in method B. The treatment will extend over a three months period.

A few earlier investigations have compared these two methods, but they have not been systematized to such a degree, that they gave any final conclusions. Therefore, we initialized an investigation including a larger number of patients, where the two methods are compared from the results the patients achieve after 3, 6, 12 and 24 months.

286 consecutive patients were included and randomized to one of the two methods. Those, who did not wish to participate in the investigation, were treated according to the department's normal procedure (Method A)

Detailed Description

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Conditions

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Chronic Low Back Pain

Keywords

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Low Back Pain Dynamic Back-Muscle exercise Treatment Interdisciplinary Treatment Roland Morris Disability Questionnaire SF-36 Low Back Pain Rating Scale

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Mod. functional restoration-Individ. dynamic back-muscle

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Low Back Pain lasting more than 12 weeks with or with out pain radiating into the leg(s)
2. Age 18 - 60 years

Exclusion Criteria

1. Serious spinal pathology

1. Malignancy
2. Osteoporosis,
3. Fresh vertebral fracture
4. Newly operation on the back
5. Stenosis of the lumbar spine
6. Unstable spondylolistesis
7. Infections in the back
2. Neurological dysfunction of the thoracic or abdominal muscles
3. Pregnancy/breastfeeding
4. Mental illness
5. Health conditions which prohibit intensive training.
6. Languish problems/ dyslexia
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sygekassernes Helsefond

OTHER

Sponsor Role collaborator

Apotekerfonden af 1991

OTHER

Sponsor Role collaborator

Indenrigs- og sundhedsministeriet

UNKNOWN

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Principal Investigators

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Charlotte Lundsgaard, MD

Role: STUDY_CHAIR

Claus Hellesen, MD

Role: STUDY_DIRECTOR

Alex Oefeldt, Therapist

Role: STUDY_DIRECTOR

Gorm Thamsborg, Dr.Med.Sci.

Role: STUDY_DIRECTOR

Arne Astrup, Dr.Med.Sci.

Role: STUDY_DIRECTOR

Steen Stender, Dr.Med.Sci.

Role: STUDY_CHAIR

Ninna Dufour, MD

Role: PRINCIPAL_INVESTIGATOR

Unfilliated

Locations

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Glostrup University Hospital

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

References

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Dufour N, Thamsborg G, Oefeldt A, Lundsgaard C, Stender S. Treatment of chronic low back pain: a randomized, clinical trial comparing group-based multidisciplinary biopsychosocial rehabilitation and intensive individual therapist-assisted back muscle strengthening exercises. Spine (Phila Pa 1976). 2010 Mar 1;35(5):469-76. doi: 10.1097/BRS.0b013e3181b8db2e.

Reference Type DERIVED
PMID: 20147878 (View on PubMed)

Other Identifiers

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KA 01011

Identifier Type: -

Identifier Source: org_study_id