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Sponsored by: |
University Hospital Tuebingen |
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Information provided by: | University Hospital Tuebingen |
ClinicalTrials.gov Identifier: | NCT00533286 |
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
Condition | Intervention | Phase |
---|---|---|
Pain Disability Paresis |
Drug: benzodiacepine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Do Benzodiazepines Improve the Outcome of Mechanical Physiotherapy for Lumbar Disk Prolapse: a Prospective Randomized Clinical Trial |
Study Start Date: | August 2002 |
Study Completion Date: | April 2007 |
Arms | Assigned Interventions |
---|---|
A: Placebo Comparator
placebo (2 tablets daily)
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Drug: benzodiacepine
diazepam (2 x 5 mg/ die)
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B: Experimental
diazepam (2 x 5 mg)
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Drug: benzodiacepine
diazepam (2 x 5 mg/ die)
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | AKF 57-0-0 |
Study First Received: | September 20, 2007 |
Last Updated: | September 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00533286 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
physiotherapy Tuebingen concept benzodiazepines muscle relaxants disc herniation |
Spinal Diseases Paresis Musculoskeletal Diseases Diazepam Hernia |
Muscle Hypotonia Pain Intervertebral Disk Displacement Bone Diseases Prolapse |