Low Back PainNCT00410319
Information or Physical Activity for Chronic LBP
A study testing Fear-reducing Information and Symptom-based exercise in people with Low Back Pain, run by University of Southern Denmark.
Trial summary
The purpose of this study is to compare a specific fear-reducing information with symptom-based exercise Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Fear-reducing Information and Symptom-based exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 60 years
- All sexes
- Adult
Who may be able to join
- Daily LBP, dominating over possible pain in leg or other joints/muscles
- Pain og > 4 (scale 0-10) for more than 4 months
Who cannot join
- Cancer, inflammatory disease, previous back surgery, pregnancy
About this study
The purpose of this study is to compare a specific fear-reducing information with symptom-based exercise
- Conditions
- Low Back Pain
- Being tested
- Fear-reducing Information, Symptom-based exercise
- 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.
Fear-reducing InformationBehavioural
Symptom-based exerciseBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2006 (estimated)
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 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
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Investigators
- Tom Bendix, dr.med prof, Study director, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410319
- Sponsor's protocol ID
- VF 20040016
- Status last verified
- Apr 2007
- First submitted
- 11 Dec 2006
- Last updated
- 27 Apr 2007
- Results posted
- No
Publications
Sorensen PH, Bendix T, Manniche C, Korsholm L, Lemvigh D, Indahl A. An educational approach based on a non-injury model compared with individual symptom-based physical training in chronic LBP. A pragmatic, randomised trial with a one-year follow-up. BMC Musculoskelet Disord. 2010 Sep 17;11:212. doi: 10.1186/1471-2474-11-212.
PubMed 20849601
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Information or Physical Activity for Chronic LBP
- ClinicalTrials.gov ID
- NCT00410319
- Acronym / sponsor ID
- VF 20040016
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- First posted
- 12 Dec 2006 (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.
The purpose of this study is to compare a specific fear-reducing information with symptom-based exercise
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Daily LBP, dominating over possible pain in leg or other joints/muscles
- Pain og > 4 (scale 0-10) for more than 4 months
Key exclusion criteria (1 listed)
- Cancer, inflammatory disease, previous back surgery, pregnancy
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 |
|---|---|---|
| Fear-reducing Information | Behavioural | – |
| Symptom-based exercise | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2007.
- Derived from this study: PubMed 20849601Sorensen PH, Bendix T, Manniche C, Korsholm L, Lemvigh D, Indahl A. An educational approach based on a non-injury model compared with individual symptom-based physical training in chronic LBP. A pragmatic, randomised trial with a one-year follow-up. BMC Musculoskelet Disord. 2010 Sep 17;11:212. doi: 10.1186/1471-2474-11-212.
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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.
Tom Bendix, dr.med prof study director
University of Southern Denmark
Questions about this trial
What is this clinical trial studying?
A study testing Fear-reducing Information and Symptom-based exercise in people with Low Back Pain, run by University of Southern 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 1 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 27 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00410319, 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 27 Apr 2007.