Prospective randomized controlled trial of selective nerve root blockade in patients with acute or subacute sciatica
| ISRCTN | ISRCTN94584126 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94584126 |
| Secondary identifying numbers | RS2001/02-026 (Workers Compensation Board of British Columbia Research Secretariat) |
- Submission date
- 10/02/2007
- Registration date
- 27/02/2007
- Last edited
- 20/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Maziar Badii
Scientific
Scientific
Laurel Rheumatology Group
208 888 West 8th Ave
Vancouver, BC
V5Z 3Y1
Canada
| Phone | +1 604 731 3125 |
|---|---|
| mbadii@shaw.ca |
Study information
| Study design | Prospective double-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | Prospective randomized controlled trial of selective nerve root blockade in patients with acute or subacute sciatica |
| Study acronym | Transforaminal epidural steroid injection in Acute Radicular Pain (TARP) |
| Study objectives | 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(s) | Univeristy of British Columbia Clinical Research Ethics Board Approval was obtained. Number C02-0365 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 30/05/2003 |
| Completion date | 30/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 88 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 30/05/2003 |
| Date of final enrolment | 30/04/2005 |
Locations
Countries of recruitment
- Canada
Study participating centre
Laurel Rheumatology Group
Vancouver, BC
V5Z 3Y1
Canada
V5Z 3Y1
Canada
Sponsor information
WorkSafeBC Research Secretariat (Canada)
Government
Government
6951 Westminster Highway
Richmond, BC
V7C 1C6
Canada
| Phone | +1 604 244 6300 |
|---|---|
| Penny.Lowe@worksafebc.com | |
| Website | http://worksafebc.com/contact_us/research/about_the_research_secretariat/contact_the_research_secretariat/default.asp |
Funders
Funder type
Government
Workers Compensation Board of British Columbia Research Secretariat (RS2001/02-026)(Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
20/08/2021: Proactive update review. No publications found. Search options exhausted.
