- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00256373
Treatment of Chronic Low Back Pain: A Trial Comparing Traditional Back School and Individual Therapist-Assisted Exercise
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)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
-
Glostrup, Danmark, 2600
- Glostrup University Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Low Back Pain lasting more than 12 weeks with or with out pain radiating into the leg(s)
- Age 18 - 60 years
Exclusion Criteria:
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
|---|
|
Smerte VAS
|
Sekundære resultatmål
Resultatmål |
|---|
|
SF-36
|
|
Global vurdering
|
|
Roland Morris Disability Questionnaire
|
|
Low Back Pain Rating Scale
|
|
Medicine use
|
|
Work situation
|
|
Pension
|
|
Change in physical activity
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Charlotte Lundsgaard, MD
- Studieleder: Claus Hellesen, MD
- Studieleder: Alex Oefeldt, Therapist
- Studieleder: Gorm Thamsborg, Dr.Med.Sci.
- Studieleder: Arne Astrup, Dr.Med.Sci.
- Studiestol: Steen Stender, Dr.Med.Sci.
- Ledende efterforsker: Ninna Dufour, MD, Unfilliated
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KA 01011
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .