Low Back PainNCT00459433
The Right Intervention for the Right Patient
A study testing Biopsychosocial intervention in people with Low Back Pain, run by The Back Research Center, Denmark at 1 site in Denmark.
Trial summary
Complicated and expensive interventions are used to treat unspecific low back pain and the intervention is not always targeted the patients specific problems.It is therefore not surprising that a large fraction of unspecific low back pain patients do not respond very well to the usual biopsychosocial intervention. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Biopsychosocial intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2006to May 2009
- Phase
- Interventional
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Unspecific low back pain
- Level of low back pain must be at least equal to leg pain
- Patients must have been sick listed during the past 12 months
- Age > 17 years and < than 60
Who cannot join
- Modic changes as seen on MRI
- Direct or progressive paresis or Cauda equina syndrome
- Known MB Bechterew or Sacroiliitis
- Suspicion of other serious malignancy
- Alcohol or medicine abuse
- A screening result of more than 30 in the Beck Depression Inventory
Trial locations and contacts
1 site in 1 country.
About this study
Complicated and expensive interventions are used to treat unspecific low back pain and the intervention is not always targeted the patients specific problems.It is therefore not surprising that a large fraction of unspecific low back pain patients do not respond very well to the usual biopsychosocial intervention.
We would therefore like to identify the patients specific problems regarding the patients biomedical, psychological, and social needs.
Read the detailed description
Two quality assurance investigations are performed in the The Back Research Center Clinic, where one is published in The Spine. The systematics of Health Technology Assessment was used to throw light on important indicators in relation to Health Technology aspects, patient aspects, organisational aspects and economical aspects. At 12 months follow up in 1999, approximately one third of the patients stated that their low back pain was unchanged or worse. In 2004 in a new investigation this fraction was larger. Therefore it seems relevant to be able to identify the patients early in their course in the back ambulatory.
A Norwegian project has shown that when one divides the patients into 3 levels of severity, then the interdisciplinary biopsychosocial intervention had best effect in the intermediary and severe groups. Conversely the mono disciplinary intervention had best effect on the least severe patient group.
Therefore we would like to combine elements from the typical clinical investigation with a screening for psychosocial factors in order to sort patients according to their individual needs.
Even though the bio-psycho-social elements are a coherent continuum one can arbitrarily combine them in 4 groups of increasing complexity.
- mainly biological
- both biological and psychological
- both biological and social
- both biological, psychological and social It is probably not good enough to give more or less the same type of somatic treatment to all unspecific low back pain patients. It is important to take into account all three elements, the severity of the elements, and the combination of elements. To be able to do this it is important to use a combination of screening instruments that can isolate and quantify the manifestations of the three elements in the patients.
- Conditions
- Low Back Pain
- Being tested
- Biopsychosocial intervention
- Keywords
- Low back pain, Return to work, Biopsychosocial, Screening, SMS, Non specific low back pain
- 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.
Biopsychosocial interventionProcedure or surgery
Psychosocial versus usual care
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | psychosocial intervention Receives: Procedure: Biopsychosocial intervention |
| 2 | Active comparator | Usual care Receives: Procedure: Biopsychosocial intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days on sick leave and days with low back pain problems measured every week by SMS questionnaire
Measured: 12 months
Secondary outcomes (2)
Pain level
Measured: 12 months
Activity of daily living
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2007 (estimated)
- Study startOct 2006
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Back Research Center, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Investigators
- Bendt Johansen, MHS, Principal investigator, Affiliated with University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459433
- Sponsor's protocol ID
- 258
- Status last verified
- May 2009
- First submitted
- 10 Apr 2007
- Last updated
- 29 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Johansen B, Mainz J, Sabroe S, Manniche C, Leboeuf-Yde C. Quality improvement in an outpatient department for subacute low back pain patients: prospective surveillance by outcome and performance measures in a health technology assessment perspective. Spine (Phila Pa 1976). 2004 Apr 15;29(8):925-31. doi: 10.1097/00007632-200404150-00021.
PubMed 15082998Haldorsen EM, Grasdal AL, Skouen JS, Risa AE, Kronholm K, Ursin H. Is there a right treatment for a particular patient group? Comparison of ordinary treatment, light multidisciplinary treatment, and extensive multidisciplinary treatment for long-term sick-listed employees with musculoskeletal pain. Pain. 2002 Jan;95(1-2):49-63. doi: 10.1016/s0304-3959(01)00374-8.
PubMed 11790467
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Right Intervention for the Right Patient
- ClinicalTrials.gov ID
- NCT00459433
- Acronym / sponsor ID
- 258
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Return to work, Biopsychosocial, Screening, SMS, Non specific low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Back Research Center, DenmarkUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- Oct 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 12 Apr 2007 (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.
Complicated and expensive interventions are used to treat unspecific low back pain and the intervention is not always targeted the patients specific problems.It is therefore not surprising that a large fraction of unspecific low back pain patients do not respond very well to the usual biopsychosocial intervention.
We would therefore like to identify the patients specific problems regarding the patients biomedical, psychological, and social needs.
Detailed description
Two quality assurance investigations are performed in the The Back Research Center Clinic, where one is published in The Spine. The systematics of Health Technology Assessment was used to throw light on important indicators in relation to Health Technology aspects, patient aspects, organisational aspects and economical aspects. At 12 months follow up in 1999, approximately one third of the patients stated that their low back pain was unchanged or worse. In 2004 in a new investigation this fraction was larger. Therefore it seems relevant to be able to identify the patients early in their course in the back ambulatory.
A Norwegian project has shown that when one divides the patients into 3 levels of severity, then the interdisciplinary biopsychosocial intervention had best effect in the intermediary and severe groups. Conversely the mono disciplinary intervention had best effect on the least severe patient group.
Therefore we would like to combine elements from the typical clinical investigation with a screening for psychosocial factors in order to sort patients according to their individual needs.
Even though the bio-psycho-social elements are a coherent continuum one can arbitrarily combine them in 4 groups of increasing complexity.
- mainly biological
- both biological and psychological
- both biological and social
- both biological, psychological and social It is probably not good enough to give more or less the same type of somatic treatment to all unspecific low back pain patients. It is important to take into account all three elements, the severity of the elements, and the combination of elements. To be able to do this it is important to use a combination of screening instruments that can isolate and quantify the manifestations of the three elements in the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Biopsychosocial interventionpsychosocial intervention |
| 2 | Active comparator | Procedure: Biopsychosocial interventionUsual care |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Unspecific low back pain
- Level of low back pain must be at least equal to leg pain
- Patients must have been sick listed during the past 12 months
- Age > 17 years and < than 60
Key exclusion criteria (6 listed)
- Modic changes as seen on MRI
- Direct or progressive paresis or Cauda equina syndrome
- Known MB Bechterew or Sacroiliitis
- Suspicion of other serious malignancy
- Alcohol or medicine abuse
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 |
|---|---|---|
| Biopsychosocial interventionPsychosocial versus usual care | Procedure or surgery | 1, 2 |
Primary outcome
Days on sick leave and days with low back pain problems measured every week by SMS questionnaire
Time frame: 12 months
2 secondary outcomes
Pain level
Time frame: 12 months
Activity of daily living
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2009.
- Background: PubMed 15082998Johansen B, Mainz J, Sabroe S, Manniche C, Leboeuf-Yde C. Quality improvement in an outpatient department for subacute low back pain patients: prospective surveillance by outcome and performance measures in a health technology assessment perspective. Spine (Phila Pa 1976). 2004 Apr 15;29(8):925-31. doi: 10.1097/00007632-200404150-00021.
- Background: PubMed 11790467Haldorsen EM, Grasdal AL, Skouen JS, Risa AE, Kronholm K, Ursin H. Is there a right treatment for a particular patient group? Comparison of ordinary treatment, light multidisciplinary treatment, and extensive multidisciplinary treatment for long-term sick-listed employees with musculoskeletal pain. Pain. 2002 Jan;95(1-2):49-63. doi: 10.1016/s0304-3959(01)00374-8.
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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.
Bendt Johansen, MHS principal investigator
Affiliated with University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsychosocial intervention in people with Low Back Pain, run by The Back Research Center, Denmark 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 29 May 2009. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Days on sick leave and days with low back pain problems measured every week by SMS questionnaire (time frame: 12 months). 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 NCT00459433, which also lists 2 linked publications.
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 29 May 2009.