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

Laurel Rheumatology Group
208 – 888 West 8th Ave
Vancouver, BC
V5Z 3Y1
Canada

Phone +1 604 731 3125
Email mbadii@shaw.ca

Study information

Study designProspective double-blind randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleProspective randomized controlled trial of selective nerve root blockade in patients with acute or subacute sciatica
Study acronymTransforaminal epidural steroid injection in Acute Radicular Pain (TARP)
Study objectivesFluoroscopically 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) studiedAcute lumbar intervertebral disc herniation
InterventionPatients 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 typeOther
Primary outcome measure1. 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 patient’s 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 measuresRate of progression to surgery
Overall study start date30/05/2003
Completion date30/04/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants88
Key inclusion criteria1. 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 criteria1. 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 enrolment30/05/2003
Date of final enrolment30/04/2005

Locations

Countries of recruitment

  • Canada

Study participating centre

Laurel Rheumatology Group
Vancouver, BC
V5Z 3Y1
Canada

Sponsor information

WorkSafeBC Research Secretariat (Canada)
Government

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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

20/08/2021: Proactive update review. No publications found. Search options exhausted.