Do Benzodiazepines Improve the Outcome of Mechanical Physiotherapy for Lumbar Disk Prolapse

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

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Key information

Conditions

Pain Bone Diseases Disability Hernia Intervertebral Disc Displacement Muscle Hypotonia Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Paresis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

sciatica without or with neurological deficit attributable to lumbar disc prolapse
CT or MRI confirmation of lumbar disc prolapse
informed consent

Exclusion criteria

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

Treatment and study plan

benzodiacepine

Drug

diazepam (2 x 5 mg/ die)

Primary outcomes

(i) median extent of reduction of referred pain

Time frame: 7 days

Secondary outcomes

median duration of inability to work after discharge

Time frame: one year

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Do Benzodiazepines Improve the Outcome of Mechanical Physiotherapy for Lumbar Disk Prolapse: a Prospective Randomized Clinical Trial

Important dates

Study start: 2002
Study completion: 2007
First posted: Sep 21, 2007
Registry last updated: Sep 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed