Condition category
Musculoskeletal Diseases
Date applied
10/02/2007
Date assigned
27/02/2007
Last edited
27/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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 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

http://worksafebc.com/contact_us/research/about_the_research_secretariat/contact_the_research_secretariat/default.asp

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

Publication citations

Additional files

Editorial Notes