Welcome
Support Centre
20 April 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Epidural Sacral Injection study: effect of volume and triamcinolone on chronic lumbosacral radiculopathy?
ISRCTN ISRCTN12574253
DOI 10.1186/ISRCTN12574253
ClinicalTrials.gov identifier
EudraCT number
Public title Epidural Sacral Injection study: effect of volume and triamcinolone on chronic lumbosacral radiculopathy?
Scientific title
Acronym ESI
Serial number at source 2137
Study hypothesis ESI (Epidural Sacral Injection) is a method of treating low back pain and radiculopathy that is the subject of considerable discussion. Although the method has been in existence for nearly 100 years, there are only a few good randomised controlled studies. In Nelemans et al (2000), evidence for the method is given as weak, and studies of a high scientific quality are sought. To investigate these factors in greater detail, randomised controlled studies are needed to clarify the effect of volume and steroids versus placebo.

Many patients with chronic low back pain and sciatica feel that they have few good therapeutic options besides surgery. Only a few patients with sciatica are suitable for surgical treatment. The surgeon needs a correspondence between the clinical level of radiculopathy and Magnetic Resonance (MR) diagnosis of disc protrusion. Many patients lack this correspondence. We therefore want to conduct the study on patients with clinical signs of lumbosacral radiculopathy, where the pain has lasted for more than 12 weeks (chronic) and where surgical treatment is not indicated at the time of inclusion due either to lack of correspondence between clinical and MR finding or low Oswestry Disability Index (ODI).

In our study, we wish to use a corticosteroid preparation with a weak anti-inflammatory effect. Triamcinolone acetonide in a strength of 40 mg/ml and a quantity of 1 ml meets this requirement. The effect is to be compared with placebo (2 ml NaCl 0.9% subcutaneously) and volume (30 ml NaCL 0.9% epidural). In many studies, injections have been used with a small volume (less than 10 ml). We will use a volume of 30 ml to be sure that the medicinal product is distributed throughout the epidural space in the lumbosacral column up to level L2. If our study can demonstrate a significant therapeutic effect for ESI of steroid, the method could become an important tool in the treatment of patients with low back pain and radiculopathy. We could also clarify in the study whether there are special subgroups of patients with radiculopathy (Signal changes in the disc, Covered prolapse, Free prolapse, Thickened nerve root, Disclosed nerve root) that respond better to steroid injection.

If the method can also be proven to be easy to perform, and associated with few serious complications and adverse drug reactions, it could become useful in both the treatment and rehabilitation of sciatica patients. At present, we do not know enough about the risk associated with use of the method, the incidence of side-effects and what should be regarded as adequate follow-up of patients. Hopefully, a study could yield valuable information on this. Given a good effect from the treatment and a low incidence of side-effects, we will probably be able to substantiate a positive gain in the form of reduced suffering for the individual in addition to a socioeconomic gain from patients recovering their health and being able to return to work more quickly.

Please note that the anticipated end date of this trial has been extended from 31/12/2006 to 31/12/2008 (information updated as of 22/10/2007).

As of 25/01/2011 the target number of participant section has been updated. Previous target number was 240.
Lay summary Not provided at time of registration
Ethics approval Added as of 30/10/2007: Regional Committee for Medical Research Ethics in Norway (P REK NORD). Approved on 09/01/2004 (ref: 105/2003)
Study design Randomised controlled trial
Countries of recruitment Norway
Disease/condition/study domain Lumbosacral radiculopathy
Sciatica
Participants - inclusion criteria Age: 20-60 years
Sex: Both
Symptoms: Sciatic pain >12 weeks
Objective: Radiculopathy L3-S1
Participants - exclusion criteria 1. Indication of acute back surgery at the time of inclusion
2. Previous back surgery
3. Previous epidural or nerve root injection for low back pain or sciatica
4. Red flags
5. Yellow flags
6. The patient must not have noticed an improvement in symptoms or certralisation of pain from leg to back for the previous two weeks before inclusion
7. Pregnancy
8. Anticlotting therapy with Warfarin
9. Ongoing treatment with Non-Steroidal Anti-Inflammatory Drug (NSAID)
10. Magnetic Resonance Imaging (MRI) findings showing lateral recess stenosis of osteogenic aetiology, tumor, bleeding, dural fistula, synovial cyst, dysraphia conditions
Anticipated start date 01/05/2005
Anticipated end date 31/12/2008
Status of trial Completed
Patient information material
Target number of participants RCT with multilevel longitudinal design with 4 follow-up measurements. Sample size n=124.
Interventions Epidural sacral injection with triamcinolone versus saline
Primary outcome measure(s) Oswestry Disability Index (ODI)
Secondary outcome measure(s) 1. European Quality of life measure (EQ5-D)
2. Fear-Avoidance Beliefs (FABQ)
3. Visual Analog Scale (VAS) back pain, leg pain, general health
4. Number of patients referred to all types of Back Surgery during follow-up
Sources of funding Health North RHF (Norway)
Trial website
Publications 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21914755
Contact name Dr  Trond  Iversen
  Address Gullveien 3
  City/town Terraak
  Zip/Postcode 7980
  Country Norway
  Email trondiv@online.no
Sponsor University Hospital of North Norway - Neurosurgery department
  Address -
  City/town Tromsoe
  Zip/Postcode 9038
  Country Norway
Date applied 02/04/2005
Last edited 27/09/2011
Date ISRCTN assigned 18/05/2005
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.