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

University Hospital Tuebingen

Status and phase: Completed; Phase 2

Conditions: Disability; Pain; Paresis

Treatments: Drug: benzodiacepine

Study type: Interventional

Funder types: Other

Identifiers

NCT00533286

AKF 57-0-0

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

A

Placebo Comparator group

Description:

placebo (2 tablets daily)

Treatment:

Drug: benzodiacepine

B

Experimental group

Description:

diazepam (2 x 5 mg)

Treatment:

Drug: benzodiacepine