Back PainPhase 4NCT00302796
Antibiotic Treatment to Patients With Low Back Pain
A Phase 4 study testing Bioclavid in people with Back Pain, run by The Back Research Center, Denmark at 1 site in Denmark.
Trial summary
A large proportion of patients with Low Back Pain (LBP) (80 %) are classified as "non-specific", due to the lack of a patho-anatomical diagnosis. This term is not satisfactory, since it implies uncertainty for both the patient and the clinician. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Bioclavid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2006to Oct 2009
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-65 years
- Previous lumbar herniated disc confirmed by MRI
- Time since lumbar disc herniation more than 6 months less than 2 years
- LBP in the area of L1 to L5, with an added Low Back Pain Rating Scale of 6 or more
- The present MRI shows Modic changes
- Positive Springing test (SPT) at the level of Modic changes
Who cannot join
- Allergy against antibiotics
- The Beck Depression Inventory >7,
- Pregnancy
- Breast feeding
- All Kidney diseases
- Pending workers litigation or pension
Show all 10Show fewer
- Danish as second language
- Fertile women who do not user safe anti conseption
- Reduced liver functions
- Reduced liver function due to previous treatment wiht amoxicillin/clavulanasid.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antibiotic Treatment to Patients With Low Back Pain Associated With Modic Changes Following Disc Herniation. A Randomized Clinical Controlled Trial
A large proportion of patients with Low Back Pain (LBP) (80 %) are classified as "non-specific", due to the lack of a patho-anatomical diagnosis. This term is not satisfactory, since it implies uncertainty for both the patient and the clinician. Modic changes have recently been identified as a pain giving patho-anatomical diagnosis for a considerable percentage (20-30 %) of LBP patients. The causes of these Modic changes have not been determined conclusively but bacterial infection is among the plausible causes for those following a disc herniation.
Purpose The aim of this study is to assess the clinical effect of antibiotic treatment compared to placebo, in patients with LBP and Modic changes following a lumbar herniated disc.
Read more
Design A double blind prospective clinically controlled trial. Patients will be randomized by a blinded observer to either Group A: 1 antibiotic tablet 45 patients Group B: 1 placebo tablet 36 patients Group C: 2 antibiotic tablets 45 patients Group D: 2 placebo tablets 36 patients
The patients will take the drug three times a day for 100 days.
- Conditions
- Back Pain
- Being tested
- Bioclavid, Placebo
- Keywords
- Low Back Pain,
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioclavidDrug
500 + 125 mg times 3 or 6
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Group A, Antibiotic | Experimental | 1 antibiotic tablet 45 patients Group Receives: Drug: Bioclavid |
| Group B: 1 placebo | Placebo comparator | 1 placebo tablet Receives: Drug: Placebo |
| Group C: Antibiotics | Experimental | 2 antibiotic tablets 45 patients Receives: Drug: Bioclavid |
| Group D, Placebo | Placebo comparator | 2 placebo tablets 36 patients Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Back Pain Roland Morris Questionaire
Measured: One year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Back Research Center, Denmark
- Sponsor type
- University, hospital or other
- Investigators
- Hanne B Albert, Ph.D, Principal investigator, The Back Research Center, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302796
- Sponsor's protocol ID
- 2005-005500-17
- Other IDs
- 2005
- Status last verified
- Jul 2009
- First submitted
- 14 Mar 2006
- Last updated
- 27 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Treatment to Patients With Low Back Pain Associated With Modic Changes Following Disc Herniation. A Randomized Clinical Controlled Trial
- ClinicalTrials.gov ID
- NCT00302796
- Acronym / sponsor ID
- 2005-005500-17
- Conditions
- Back Pain
- Keywords
- Low Back Pain,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- The Back Research Center, DenmarkUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 15 Mar 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.
A large proportion of patients with Low Back Pain (LBP) (80 %) are classified as "non-specific", due to the lack of a patho-anatomical diagnosis. This term is not satisfactory, since it implies uncertainty for both the patient and the clinician. Modic changes have recently been identified as a pain giving patho-anatomical diagnosis for a considerable percentage (20-30 %) of LBP patients. The causes of these Modic changes have not been determined conclusively but bacterial infection is among the plausible causes for those following a disc herniation.
Purpose The aim of this study is to assess the clinical effect of antibiotic treatment compared to placebo, in patients with LBP and Modic changes following a lumbar herniated disc.
Design A double blind prospective clinically controlled trial. Patients will be randomized by a blinded observer to either Group A: 1 antibiotic tablet 45 patients Group B: 1 placebo tablet 36 patients Group C: 2 antibiotic tablets 45 patients Group D: 2 placebo tablets 36 patients
The patients will take the drug three times a day for 100 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A, Antibiotic | Experimental | Drug: Bioclavid1 antibiotic tablet 45 patients Group |
| Group B: 1 placebo | Placebo comparator | Drug: Placebo1 placebo tablet |
| Group C: Antibiotics | Experimental | Drug: Bioclavid2 antibiotic tablets 45 patients |
| Group D, Placebo | Placebo comparator | Drug: Placebo2 placebo tablets 36 patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18-65 years
- Previous lumbar herniated disc confirmed by MRI
- Time since lumbar disc herniation more than 6 months less than 2 years
- LBP in the area of L1 to L5, with an added Low Back Pain Rating Scale of 6 or more
- The present MRI shows Modic changes
Key exclusion criteria (10 listed)
- Allergy against antibiotics
- The Beck Depression Inventory >7,
- Pregnancy
- Breast feeding
- All Kidney diseases
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 |
|---|---|---|
| Bioclavid500 + 125 mg times 3 or 6 | Drug | Group A, Antibiotic, Group C: Antibiotics |
| Placebo | Drug | Group B: 1 placebo, Group D, Placebo |
Primary outcome
Low Back Pain Roland Morris Questionaire
Time frame: One year follow-up
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 27 May 2010.
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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.
Hanne B Albert, Ph.D principal investigator
The Back Research Center, 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 Phase 4 study testing Bioclavid in people with 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 6 inclusion and 10 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 27 May 2010. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Low Back Pain Roland Morris Questionaire (time frame: One year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2010.