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

• ClinicalTrials.gov Identifier: NCT00256373
• Recruitment Status: Unknown
• First Posted: November 21, 2005
• Last Update Posted: April 19, 2006
• Sponsor: University Hospital, Gentofte, Copenhagen
• Collaborators: Sygekassernes Helsefond; Apotekerfonden af 1991; Indenrigs- og sundhedsministeriet
• Information provided by: University Hospital, Gentofte, Copenhagen

Study Description

Brief Summary:

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)

Condition or disease	Intervention/treatment	Phase
Chronic Low Back Pain	Procedure: Mod. functional restoration-Individ. dynamic back-muscle	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Study Start Date: January 2001
• Study Completion Date: November 2005

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Pain VAS

Secondary Outcome Measures :

1. Roland Morris Disability Questionnaire
2. SF-36
3. Low Back Pain Rating Scale
4. Medicine use
5. Work situation
6. Pension
7. Change in physical activity
8. Global assessment

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Denmark

Glostrup University Hospital

Glostrup, Denmark, 2600

Sponsors and Collaborators

University Hospital, Gentofte, Copenhagen

Sygekassernes Helsefond

Apotekerfonden af 1991

Indenrigs- og sundhedsministeriet

Investigators

• Study Chair: Charlotte Lundsgaard, MD
• Study Director: Claus Hellesen, MD
• Study Director: Alex Oefeldt, Therapist
• Study Director: Gorm Thamsborg, Dr.Med.Sci.
• Study Director: Arne Astrup, Dr.Med.Sci.
• Study Chair: Steen Stender, Dr.Med.Sci.
• Principal Investigator: Ninna Dufour, MD; Unfilliated

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• ClinicalTrials.gov Identifier: NCT00256373
• Other Study ID Numbers: KA 01011
• First Posted: November 21, 2005
• Last Update Posted: April 19, 2006
• Last Verified: September 2005

Keywords provided by University Hospital, Gentofte, Copenhagen:

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

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations