MedDataX Logo

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

NCT ID: NCT00533286

Last Updated: 2007-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2007-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Disability Paresis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

physiotherapy Tuebingen concept benzodiazepines muscle relaxants disc herniation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

placebo (2 tablets daily)

Group Type PLACEBO_COMPARATOR

benzodiacepine

Intervention Type DRUG

diazepam (2 x 5 mg/ die)

B

diazepam (2 x 5 mg)

Group Type EXPERIMENTAL

benzodiacepine

Intervention Type DRUG

diazepam (2 x 5 mg/ die)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

benzodiacepine

diazepam (2 x 5 mg/ die)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital Tuebingen

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Weller, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of General Neurology, University of Tuebingen Medical School, Tuebingen, Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AKF 57-0-0

Identifier Type: -

Identifier Source: org_study_id