Treatment of Chronic Low Back Pain: A Trial Comparing Traditional Back School and Individual Therapist-Assisted Exercise
Recruitment status was Active, not recruiting
| Tracking Information | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | November 16, 2005 | ||||||||||||||||||||||||||||
| Last Updated Date | April 18, 2006 | ||||||||||||||||||||||||||||
| Start Date ICMJE | January 2001 | ||||||||||||||||||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Pain VAS | ||||||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00256373 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||||||
| Brief Title ICMJE | Treatment of Chronic Low Back Pain: A Trial Comparing Traditional Back School and Individual Therapist-Assisted Exercise | ||||||||||||||||||||||||||||
| Official Title ICMJE | Not Provided | ||||||||||||||||||||||||||||
| 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) |
||||||||||||||||||||||||||||
| Detailed Description | Not Provided | ||||||||||||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||||||||||||
| Study Phase | Phase 3 | ||||||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
||||||||||||||||||||||||||||
| Condition ICMJE | Chronic Low Back Pain | ||||||||||||||||||||||||||||
| Intervention ICMJE | Procedure: Mod. functional restoration-Individ. dynamic back-muscle | ||||||||||||||||||||||||||||
| Study Arm (s) | Not Provided | ||||||||||||||||||||||||||||
| Publications * | 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. | ||||||||||||||||||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||||||||||||||||||
| Recruitment Information | |||||||||||||||||||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||||||||||||||
| Enrollment ICMJE | Not Provided | ||||||||||||||||||||||||||||
| Completion Date | November 2005 | ||||||||||||||||||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||||||||||||||||||
| Gender | Both | ||||||||||||||||||||||||||||
| Ages | 18 Years to 60 Years | ||||||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||
| Location Countries ICMJE | Denmark | ||||||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||||||
| NCT Number ICMJE | NCT00256373 | ||||||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | KA 01011 | ||||||||||||||||||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||||||||||||||||||
| Responsible Party | Not Provided | ||||||||||||||||||||||||||||
| Study Sponsor ICMJE | University Hospital, Gentofte, Copenhagen | ||||||||||||||||||||||||||||
| Collaborators ICMJE |
|
||||||||||||||||||||||||||||
| Investigators ICMJE |
|
||||||||||||||||||||||||||||
| Information Provided By | University Hospital, Gentofte, Copenhagen | ||||||||||||||||||||||||||||
| Verification Date | September 2005 | ||||||||||||||||||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||||||||||||||||||