Clinical trial NCT00256373: Treatment of Chronic Low Back Pain: A Trial Comparing Traditional Back School and Individual Therapist-Assisted Exercise
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
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
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: Sygekassernes Helsefond
name: Apotekerfonden af 1991
name: Indenrigs- og sundhedsministeriet
First posted: 2005-11-21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility 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

Primary outcomes:
measure: Pain VAS
Secondary outcomes:
measure: Roland Morris Disability Questionnaire
measure: SF-36
measure: Low Back Pain Rating Scale
measure: Medicine use
measure: Work situation
measure: Pension
measure: Change in physical activity
measure: Global assessment
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup University Hospital
Study officials:
name: Charlotte Lundsgaard, MD
role: STUDY_CHAIR
name: Claus Hellesen, MD
role: STUDY_DIRECTOR
name: Alex Oefeldt, Therapist
role: STUDY_DIRECTOR
name: Gorm Thamsborg, Dr.Med.Sci.
role: STUDY_DIRECTOR
name: Arne Astrup, Dr.Med.Sci.
role: STUDY_DIRECTOR
name: Steen Stender, Dr.Med.Sci.
role: STUDY_CHAIR
affiliation: Unfilliated
name: Ninna Dufour, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.