Contact information
Type
Scientific
Primary contact
Dr Maziar Badii
ORCID ID
Contact details
Laurel Rheumatology Group
208 888 West 8th Ave
Vancouver
BC
V5Z 3Y1
Canada
+1 604 731 3125
mbadii@shaw.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RS2001/02-026 (Workers Compensation Board of British Columbia Research Secretariat)
Study information
Scientific title
Acronym
Transforaminal epidural steroid injection in Acute Radicular Pain (TARP)
Study hypothesis
Fluoroscopically guided transforaminal epidural steroid injection (TFESI) into the immediate vicinity of the affected nerve root in patients with acute lumbar disc herniation and radicular pain is associated with:
1. Improvement in pain and functional status and
2. Reduction in rate of progression to surgery
Ethics approval
Univeristy of British Columbia Clinical Research Ethics Board Approval was obtained.
Number C02-0365
Study design
Prospective double-blind randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Acute lumbar intervertebral disc herniation
Intervention
Patients were randomized to either 1.0 cc Celestone (40 mg/mL) plus 1.0 cc 0.5% bupivicaine (treatment), or 1.0 cc sterile saline plus 1.0 cc 0.5% bupivicaine (control).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. LegPain40: LegPain40 is a 0 to 40 aggregate pain score based on severity of pain/discomfort in the leg (sciatica) over the past week when it was i) most severe, ii) least severe, iii) average, and iv) at present time, with 0 being no pain and 10 being pain as bad as it can be.
2. BackPain10: BackPain10 is a 0 to 10 scale of severity of back pain/discomfort over the past week when it was most severe.
3. Modified Roland-Morris Disability Questionnaire (RDQ): RDQ measures the degree to which a patients functional capacity is limited by back pain. The modified RDQ is a 23-item questionnaire developed specifically for patients with sciatica, and has good internal consistency, validity, and responsiveness in this population of patients.
Secondary outcome measures
Rate of progression to surgery
Overall trial start date
30/05/2003
Overall trial end date
30/04/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 19 years or older
2. Pain in a single lower extremity below the level of the knee of less than 18 week duration
3. Presence of at least one of the following on physical examination - positive straight leg test, motor deficit, or reflex abnormality
4. Presence of a herniated nucleus pulposus (HNP) demonstrated by CT or MRI at a level and side corresponding to symptoms and signs
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
88
Participant exclusion criteria
1. History of an adverse reaction to local anaesthetic or steroids
2. Any spinal injection within the last 6 months
3. Cauda equina syndrome, progressive neurological deficit, or lower extremity weakness of less than 3/5
Recruitment start date
30/05/2003
Recruitment end date
30/04/2005
Locations
Countries of recruitment
Canada
Trial participating centre
Laurel Rheumatology Group
Vancouver, BC
V5Z 3Y1
Canada
Sponsor information
Organisation
WorkSafeBC Research Secretariat (Canada)
Sponsor details
6951 Westminster Highway
Richmond
BC
V7C 1C6
Canada
+1 604 244 6300
Penny.Lowe@worksafebc.com
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Workers Compensation Board of British Columbia Research Secretariat (RS2001/02-026)(Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary