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 |
| Protocol serial number | RS2001/02-026 (Workers Compensation Board of British Columbia Research Secretariat) |
| Sponsor | WorkSafeBC Research Secretariat (Canada) |
| Funder | Workers Compensation Board of British Columbia Research Secretariat (RS2001/02-026)(Canada) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Laurel Rheumatology Group
208 888 West 8th Ave
Vancouver, BC
V5Z 3Y1
Canada
| Phone | +1 604 731 3125 |
|---|---|
| mbadii@shaw.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective double-blind randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
Rate of progression to surgery |
| Completion date | 30/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
V5Z 3Y1
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
20/08/2021: Proactive update review. No publications found. Search options exhausted.
