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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00533286

Enrollment

Unknown

Registered

2007-09-21

Start date

2002-08-31

Completion date

2007-04-30

Last updated

2007-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disability, Pain, Paresis

Keywords

physiotherapy, Tuebingen concept, benzodiazepines, muscle relaxants, disc herniation

Brief 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

Interventions

DRUGbenzodiacepine

diazepam (2 x 5 mg/ die)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
(i) median extent of reduction of referred pain	7 days

Secondary

Measure	Time frame
median duration of inability to work after discharge	one year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026