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

NCT00256373 | Unknown Phase 3

• 1 other identifier: KA 01011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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)

Conditions

Chronic Low Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pain VAS

Secondary Outcomes (8)

• Roland Morris Disability Questionnaire

• SF-36

• Low Back Pain Rating Scale

• Medicine use

• Work situation

Interventions

Mod. functional restoration-Individ. dynamic back-muscle PROCEDURE

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Serious spinal pathology
• Malignancy
• Osteoporosis,
• Fresh vertebral fracture
• Newly operation on the back
• Stenosis of the lumbar spine
• Unstable spondylolistesis
• Infections in the back
• Neurological dysfunction of the thoracic or abdominal muscles
• Pregnancy/breastfeeding
• Mental illness
• Health conditions which prohibit intensive training.
• Languish problems/ dyslexia

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• Sygekassernes Helsefond: collaborator
• Apotekerfonden af 1991: collaborator
• Indenrigs- og sundhedsministeriet: collaborator

Study Sites (1)

Glostrup University Hospital

Glostrup Municipality, 2600, Denmark

Location

Related Publications (1)

• 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.

  PMID: 20147878 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Charlotte Lundsgaard, MD

  STUDY CHAIR

• Claus Hellesen, MD

  STUDY DIRECTOR

• Alex Oefeldt, Therapist

  STUDY DIRECTOR

• Gorm Thamsborg, Dr.Med.Sci.

  STUDY DIRECTOR

• Arne Astrup, Dr.Med.Sci.

  STUDY DIRECTOR

• Steen Stender, Dr.Med.Sci.

  STUDY CHAIR

• Ninna Dufour, MD

  Unfilliated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 16, 2005
• First Posted: November 21, 2005
• Study Start: January 1, 2001
• Study Completion: November 1, 2005
• Last Updated: April 19, 2006

Record last verified: 2005-09

Locations

DK (1)