The goal is to find answer to the question: do epidural injections with corticosteroids in patients with sciatica have a positive effect on pain, absenteeism from work and number of operations compared to standard care (pain medication only).
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures:
1. Roland Disability Questionaire
2. Visual Analogue Scale (VAS) for back pain
3. Visual Analogue Scale (VAS) for leg pain
4. Global Perceived effect
Secondary outcome
Secondary outomce measures:
1. satisfaction
2. use of medication
3. absenteism from work (yes- no)
4. number of operations
Background summary
Sciatica is characterized by radiating pain in an area of the leg typically
served by one nerve root in the lumbar or sacral spine/. The most common cause
of sciatica is a herniated disk. The estimated annual incidence of sciatica in
The Netherlands is 9 cases per 1000 adults (95%BI 8,4-10,2).
The natural history of sciatica is favorable, with resolution of leg pain
within 2-3 months from onset in the majority of patients. The international
consensus has been that surgery should be offered only if symptoms persist
after a period of conservative treatment. Exceptions are patients with severe
pain refractory to medication or patients with neurological deficits (cauda
equine syndrome, weakness MRC gr 3 or more). These patients are operated
regardless of the duration of symptoms.
There are several non-surgical treatment options in patients with sciatica
including pain medication, physiotherapy or epidural injections with
corticosteroids. The latter is performed by an anesthesiologist under
radiological guidance. In the national Dutch treatment guideline for sciatica
(2008) the injections are recommended if pain medication fails.
What is meant by *failing*? It*s not always clear when to refer patients for
an injection. Many Hospitals in The Netherlands have their own Pain Department
where injections are carried out easily, without different forms of pain
medication having been tried. This asks for new research: what is the role of
epidural injections with steroids within the treatment protocol for sciatica?
Study objective
The goal is to find answer to the question: do epidural injections with
corticosteroids in patients with sciatica have a positive effect on pain,
absenteeism from work and number of operations compared to standard care (pain
medication only).
Study design
a partly blinded*, randomized, controlled trial.
There are3 groups:
1) pain medication only
2) pain medication + epidural injection with corticosteroids and local
anesthetic
3) pain medication + epidural injection with local aneshetic
* partly blinded refers to: patients and investigators of course know when they
are injected. The injected substance is unknown however.
Intervention
Intervention group 1:
transforaminal epidural injection with 60 mg Depomedrol and 1,5 ml
Levobupivacaine. The injection is given under radiological guidance with
administration of contrast agent.
Intervention group 2:
transforaminal epidural injection with 1,5 ml Levobupivacaine only. The
injection is given under radiological guidance with administration of contrast
agent.
Study burden and risks
For all 3 groups:
4 visits to hospital (20 mins max.) During each visit questionnaires are filled
in.
For the injected groups there minor risks related to the injections: temporary
headache, infection (rare). The risks of radiogical procedures and contrast
fluid are negliglible.
Jan Tooropstraat 164
Amsterdam 1061 AE
NL
Jan Tooropstraat 164
Amsterdam 1061 AE
NL
Listed location countries
Age
Inclusion criteria
18- 65 years old;sciatica; 8 weeks;radiologically confirmed discus;correlation between symptoms and MRI abnormalities;VAS 40 or more despite NSAIDs, PCM, of opioids
Exclusion criteria
paresis MRC gr 3 or more, caudasyndrome;spinal surgery at the same level within 1 year ;lumbar stenosis, spondylolistesis;pregnancy;severe co morbidity (for example cancer)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2014-003096-37-NL |
CCMO | NL45805.100.15 |