Epidural Sacral Injection study: effect of volume and triamcinolone on chronic lumbosacral radiculopathy?

ISRCTN ISRCTN12574253
DOI https://doi.org/10.1186/ISRCTN12574253
Secondary identifying numbers 2137
Submission date
02/04/2005
Registration date
18/05/2005
Last edited
16/12/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Trond Iversen
Scientific

Gullveien 3
Terraak
7980
Norway

Email trondiv@online.no

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEpidural Sacral Injection study: effect of volume and triamcinolone on chronic lumbosacral radiculopathy?
Study acronymESI
Study objectivesESI (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(s)Regional Committee for Medical Research Ethics in Norway (P REK NORD), 09/01/2004, ref: 105/2003
Health condition(s) or problem(s) studiedLumbosacral radiculopathy
Sciatica
InterventionEpidural sacral injection with triamcinolone versus saline
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Triamcinolone
Primary outcome measureOswestry Disability Index (ODI)
Secondary outcome measures1. 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 study start date01/05/2005
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants124
Key inclusion criteriaAge: 20-60 years
Sex: Both
Symptoms: Sciatic pain >12 weeks
Objective: Radiculopathy L3-S1
Key exclusion criteria1. 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
Date of first enrolment01/05/2005
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • Norway

Study participating centre

Gullveien 3
Terraak
7980
Norway

Sponsor information

University Hospital of North Norway - Neurosurgery department
University/education

-
Tromsoe
9038
Norway

ROR logo "ROR" https://ror.org/030v5kp38

Funders

Funder type

University/education

Health North RHF (Norway)

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 13/09/2011 Yes No
Results article results 07/02/2015 Yes No

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.