Contact information
Type
Scientific
Primary contact
Dr Trond Iversen
ORCID ID
Contact details
Gullveien 3
Terraak
7980
Norway
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trondiv@online.no
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2137
Study information
Scientific title
Epidural Sacral Injection study: effect of volume and triamcinolone on chronic lumbosacral radiculopathy?
Acronym
ESI
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.
Ethics approval
Regional Committee for Medical Research Ethics in Norway (P REK NORD), 09/01/2004, ref: 105/2003
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Lumbosacral radiculopathy
Sciatica
Intervention
Epidural sacral injection with triamcinolone versus saline
Intervention type
Drug
Phase
Not Applicable
Drug names
Triamcinolone
Primary outcome measures
Oswestry Disability Index (ODI)
Secondary outcome measures
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
Overall trial start date
01/05/2005
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Age: 20-60 years
Sex: Both
Symptoms: Sciatic pain >12 weeks
Objective: Radiculopathy L3-S1
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
124
Participant 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
Recruitment start date
01/05/2005
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Norway
Trial participating centre
Gullveien 3
Terraak
7980
Norway
Funders
Funder type
University/education
Funder name
Health North RHF (Norway)
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
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21914755
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25887469
Publication citations
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Results
Iversen T, Solberg TK, Romner B, Wilsgaard T, Twisk J, Anke A, Nygaard O, Hasvold T, Ingebrigtsen T, Effect of caudal epidural steroid or saline injection in chronic lumbar radiculopathy: multicentre, blinded, randomised controlled trial., BMJ, 2011, 343, d5278.
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Results
Iversen T, Solberg TK, Wilsgaard T, Waterloo K, Brox JI, Ingebrigtsen T, Outcome prediction in chronic unilateral lumbar radiculopathy: prospective cohort study, BMC Musculoskelet Disord, 2015, 16, 17, doi: 10.1186/s12891-015-0474-9.