Chronic Low Back PainPhase 3NCT00256373
Treatment of Chronic Low Back Pain: A Trial Comparing Traditional Back School and Individual Therapist-Assisted Exercise
A Phase 3 study testing Mod. functional restoration-Individ. dynamic back-muscle in people with Chronic Low Back Pain, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Mod. functional restoration-Individ. dynamic back-muscle
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Jan 2001to Nov 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Low Back Pain lasting more than 12 weeks with or with out pain radiating into the leg(s)
- Age 18 - 60 years
Who cannot join
- Serious spinal pathology
- Malignancy
- Osteoporosis,
- Fresh vertebral fracture
- Newly operation on the back
- Stenosis of the lumbar spine
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Mod. functional restoration-Individ. dynamic back-muscle
- Keywords
- Low Back Pain, Dynamic Back-Muscle exercise Treatment, Interdisciplinary Treatment, Roland Morris Disability Questionnaire, SF-36, Low Back Pain Rating Scale
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mod. functional restoration-Individ. dynamic back-muscleProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain VAS
Secondary outcomes (8)
Roland Morris Disability Questionnaire
SF-36
Low Back Pain Rating Scale
Medicine use
Work situation
Pension
Change in physical activity
Global assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startJan 2001
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Sygekassernes Helsefond, Apotekerfonden af 1991, Indenrigs- og sundhedsministeriet
- Investigators
- Charlotte Lundsgaard, MD, Study chairClaus Hellesen, MD, Study directorAlex Oefeldt, Therapist, Study directorGorm Thamsborg, Dr.Med.Sci., Study directorArne Astrup, Dr.Med.Sci., Study directorSteen Stender, Dr.Med.Sci., Study chairNinna Dufour, MD, Principal investigator, Unfilliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256373
- Sponsor's protocol ID
- KA 01011
- Status last verified
- Sep 2005
- First submitted
- 16 Nov 2005
- Last updated
- 19 Apr 2006
- Results posted
- No
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. doi: 10.1097/BRS.0b013e3181b8db2e.
PubMed 20147878
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Low Back Pain: A Trial Comparing Traditional Back School and Individual Therapist-Assisted Exercise
- ClinicalTrials.gov ID
- NCT00256373
- Acronym / sponsor ID
- KA 01011
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- Sygekassernes Helsefond, Apotekerfonden af 1991, Indenrigs- og sundhedsministeriet
- Study start
- Jan 2001
- Study completion
- Nov 2005
- First posted
- 21 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Low Back Pain lasting more than 12 weeks with or with out pain radiating into the leg(s)
- Age 18 - 60 years
Key exclusion criteria (13 listed)
- Serious spinal pathology
- Neurological dysfunction of the thoracic or abdominal muscles
- Pregnancy/breastfeeding
- Mental illness
- Health conditions which prohibit intensive training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mod. functional restoration-Individ. dynamic back-muscle | Procedure or surgery | – |
Primary outcome
Pain VAS
8 secondary outcomes
Roland Morris Disability Questionnaire
SF-36
Low Back Pain Rating Scale
Medicine use
Work situation
Pension
Change in physical activity
Global assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2006.
- Derived from this study: PubMed 20147878Dufour 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Lundsgaard, MD study chair
Claus Hellesen, MD study director
Alex Oefeldt, Therapist study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mod. functional restoration-Individ. dynamic back-muscle in people with Chronic Low Back Pain, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain VAS. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00256373, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2006.