PainPhase 2NCT00533286
Do Benzodiazepines Improve the Outcome of Mechanical Physiotherapy for Lumbar Disk Prolapse
A Phase 2 study testing benzodiacepine in people with Pain and Disability, run by University Hospital Tuebingen.
Trial summary
Sixty patients were randomized to receive either placebo or diazepam in addition to mechanical physiotherapy and analgesics for the first 7 days of conservative treatment of clinically and radiologically confirmed lumbar disk prolapse Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Disability, Paresis
- What is being tested?
- benzodiacepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 2002to Apr 2007
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sciatica without or with neurological deficit attributable to lumbar disc prolapse
- CT or MRI confirmation of lumbar disc prolapse
- informed consent
Who cannot join
- bladder or bowel disturbance
- acute (< 24 h) development of paresis grade 1 or plegia
- taken benzodiazepines for more than 2 weeks
- history of benzodiazepine intolerance
- prior surgery for disc prolapse, or prior trauma to the vertrebral column
About this study
Official title: Do Benzodiazepines Improve the Outcome of Mechanical Physiotherapy for Lumbar Disk Prolapse: a Prospective Randomized Clinical Trial
Sixty patients were randomized to receive either placebo or diazepam in addition to mechanical physiotherapy and analgesics for the first 7 days of conservative treatment of clinically and radiologically confirmed lumbar disk prolapse
- Conditions
- Pain, Disability, Paresis
- Being tested
- benzodiacepine
- Keywords
- physiotherapy, Tuebingen concept, benzodiazepines, muscle relaxants, disc herniation
- Medical subject headings
- Pain, Paresis, Muscle Hypotonia, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benzodiacepineDrug
diazepam (2 x 5 mg/ die)
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | placebo (2 tablets daily) Receives: Drug: benzodiacepine |
| B | Experimental | diazepam (2 x 5 mg) Receives: Drug: benzodiacepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
(i) median extent of reduction of referred pain
Measured: 7 days
Secondary outcomes (1)
median duration of inability to work after discharge
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startAug 2002
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Michael Weller, Prof., Principal investigator, Department of General Neurology, University of Tuebingen Medical School, Tuebingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533286
- Sponsor's protocol ID
- AKF 57-0-0
- Status last verified
- Sep 2007
- First submitted
- 20 Sep 2007
- Last updated
- 21 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Benzodiazepines Improve the Outcome of Mechanical Physiotherapy for Lumbar Disk Prolapse: a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00533286
- Acronym / sponsor ID
- AKF 57-0-0
- Conditions
- Pain, Disability, Paresis
- Keywords
- physiotherapy, Tuebingen concept, benzodiazepines, muscle relaxants, disc herniation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Aug 2002
- Study completion
- Apr 2007 (actual)
- First posted
- 21 Sep 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.
Sixty patients were randomized to receive either placebo or diazepam in addition to mechanical physiotherapy and analgesics for the first 7 days of conservative treatment of clinically and radiologically confirmed lumbar disk prolapse
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: benzodiacepineplacebo (2 tablets daily) |
| B | Experimental | Drug: benzodiacepinediazepam (2 x 5 mg) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- sciatica without or with neurological deficit attributable to lumbar disc prolapse
- CT or MRI confirmation of lumbar disc prolapse
- informed consent
Key exclusion criteria (5 listed)
- bladder or bowel disturbance
- acute (< 24 h) development of paresis grade 1 or plegia
- taken benzodiazepines for more than 2 weeks
- history of benzodiazepine intolerance
- prior surgery for disc prolapse, or prior trauma to the vertrebral column
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 |
|---|---|---|
| benzodiacepinediazepam (2 x 5 mg/ die) | Drug | A, B |
Primary outcome
(i) median extent of reduction of referred pain
Time frame: 7 days
1 secondary outcome
median duration of inability to work after discharge
Time frame: one year
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 21 Sep 2007.
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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.
Michael Weller, Prof. principal investigator
Department of General Neurology, University of Tuebingen Medical School, Tuebingen, Germany
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing benzodiacepine in people with Pain and Disability, run by University Hospital Tuebingen.
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 3 inclusion and 5 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 21 Sep 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
(i) median extent of reduction of referred pain (time frame: 7 days). 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 21 Sep 2007.