Condition category
Musculoskeletal Diseases
Date applied
02/04/2005
Date assigned
18/05/2005
Last edited
16/12/2015
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 Trond Iversen

ORCID ID

Contact details

Gullveien 3
Terraak
7980
Norway
-
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

Sponsor information

Organisation

University Hospital of North Norway - Neurosurgery department

Sponsor details

-
Tromsoe
9038
Norway

Sponsor type

University/education

Website

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

  1. 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.

  2. 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.

Additional files

Editorial Notes

On 22/10/2007 the overall trial end date was changed from 31/12/2006 to 31/12/2008. On 25/01/2011 the target number of participant section was changed from 240 to 124.