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

Primary Purpose

Chronic Low Back Pain

Status
Unknown status
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Mod. functional restoration-Individ. dynamic back-muscle
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Low Back Pain, Dynamic Back-Muscle exercise Treatment, Interdisciplinary Treatment, Roland Morris Disability Questionnaire, SF-36, Low Back Pain Rating Scale

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Glostrup University Hospital

Outcomes

Primary Outcome Measures

Pain VAS

Secondary Outcome Measures

Roland Morris Disability Questionnaire
SF-36
Low Back Pain Rating Scale
Medicine use
Work situation
Pension
Change in physical activity
Global assessment

Full Information

First Posted
November 16, 2005
Last Updated
April 18, 2006
Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Sygekassernes Helsefond, Apotekerfonden af 1991, Indenrigs- og sundhedsministeriet
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1. Study Identification

Unique Protocol Identification Number
NCT00256373
Brief Title
Treatment of Chronic Low Back Pain: A Trial Comparing Traditional Back School and Individual Therapist-Assisted Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Sygekassernes Helsefond, Apotekerfonden af 1991, Indenrigs- og sundhedsministeriet

4. Oversight

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Mod. functional restoration-Individ. dynamic back-muscle
Primary Outcome Measure Information:
Title
Pain VAS
Secondary Outcome Measure Information:
Title
Roland Morris Disability Questionnaire
Title
SF-36
Title
Low Back Pain Rating Scale
Title
Medicine use
Title
Work situation
Title
Pension
Title
Change in physical activity
Title
Global assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte Lundsgaard, MD
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Claus Hellesen, MD
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alex Oefeldt, Therapist
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gorm Thamsborg, Dr.Med.Sci.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Arne Astrup, Dr.Med.Sci.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Steen Stender, Dr.Med.Sci.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ninna Dufour, MD
Organizational Affiliation
Unfilliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glostrup University Hospital
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
20147878
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.
Results Reference
derived

Learn more about this trial

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

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