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Trial registered on ANZCTR


Registration number
ACTRN12608000401358
Ethics application status
Approved
Date submitted
10/07/2008
Date registered
12/08/2008
Date last updated
12/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised controlled trial of transforaminal injections for sciatica
Scientific title
Randomised controlled trial of transforaminal injections for the relief of lumbar radicular pain caused by lumbar disc herniation
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lower limb pain caused by lumbar disc herniation 3390 0
Condition category
Condition code
Musculoskeletal 3539 3539 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients are randomised by random number allocation to one of five treatment groups. Each receives an injection under fluoroscopic guidance. In three groups the needle is placed in the intervertebral foramen that lodges the affected nerve. Respectively those groups are randomly injected with (1) 0.75ml of a local anaesthetic (0.5% bupivacaine) followed by a steroid preparation (1.75 ml triamcinolone 40mg/ml) or (2) 2ml bupivacaine 0.5% or (3) 2ml normal saline. In two other groups the needle is placed deeply in the back muscles opposite the segment affected by the disc herniation. They receive either 1.75 ml triamcinolone 40mg/ml or 2 ml normal saline. All patients receive at least one therapeutic injection, but are entitled to have one or two repeats of the allocated agent if their response is favourable but partial, and they wish to boost their response.
Intervention code [1] 3115 0
Treatment: Other
Comparator / control treatment
There are no explicit control groups. Each of the tratments to which patients might be allocated has been regarded as effective. EVen intramuscular normal saline is purported to be effective in 48% of patients. The intervention for which there is no quantiative data is transforaminal injection of normal saline, also known as "washout". Of all the interventions, this most closely approximates a control group or placebo.
Control group
Placebo

Outcomes
Primary outcome [1] 4443 0
relief of radicular pain. as measured by a numerical pain rating scale, and quantified as percentage relief of pain.
Timepoint [1] 4443 0
1 month, 3 months, 6 months, 12 months
Secondary outcome [1] 7501 0
restoration of function, as measured by (1) restoration of Patient Specified Functional Outcomes, (2) SF-36, and (AQoL).
Timepoint [1] 7501 0
1 month, 3 months, 6 months, 12 months

Eligibility
Key inclusion criteria
radicular pain and disc herniation demonstrated on computerised tomography (CT) or magnetic resonance imaging (MRI)
Minimum age
18 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
anatomical barriers to safe executaion of injection, preganancy, allergy to local anaesthetic or contrast medium

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential patients identified by Neurosurgeons. Research team confirms eligibility. Patient consents. Treatment allocated by random numbers on day of procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random numbers table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3712 0
Charities/Societies/Foundations
Name [1] 3712 0
International Spine Intervention Society
Country [1] 3712 0
United States of America
Primary sponsor type
Individual
Name
Professor Nikolai Bogduk
Address
Newcatle Bone and Joint Institute
Royal Newcastle Centre
PO Box 664J Newcastle NSW 2300
Country
Australia
Secondary sponsor category [1] 3329 0
Hospital
Name [1] 3329 0
Newcastle Bone and Joint institute
Address [1] 3329 0
Royal Newcastle Centre
PO Box 664J
Newcastle NSW 2300
Country [1] 3329 0
Australia
Other collaborator category [1] 365 0
Individual
Name [1] 365 0
Dr Jay Govind
Address [1] 365 0
Pain Management
Canberra Hospital
Woden ACT 2601
Country [1] 365 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5767 0
Hunter New england Area Health Service Human Research Ethics Committee
Ethics committee address [1] 5767 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 5767 0
Australia
Date submitted for ethics approval [1] 5767 0
Approval date [1] 5767 0
20/12/2006
Ethics approval number [1] 5767 0
06/12/13/3/01

Summary
Brief summary
Five different injections are purported to be effective for lumbar radicular pain. Each has its advocates but each lacks convincing scientific data. This study is designed to test which of these injections is effective, for relieving pain and restoring function, in the greatest proportion of patients and for the longest duration.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28738 0
Address 28738 0
Country 28738 0
Phone 28738 0
Fax 28738 0
Email 28738 0
Contact person for public queries
Name 11895 0
Professor Nikolai Bogduk
Address 11895 0
PO Box 664J
Newcastle NSW 2300
Country 11895 0
Australia
Phone 11895 0
02 49 223505
Fax 11895 0
02 49 223559
Email 11895 0
[email protected]
Contact person for scientific queries
Name 2823 0
Professor Nikolai Bogduk
Address 2823 0
PO Box 664J
Newcastle NSW 2300
Country 2823 0
Australia
Phone 2823 0
02 49 223505
Fax 2823 0
02 49 223559
Email 2823 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.