Official Title
Transforaminal Epidural Injection in Acute Sciatica
Phase
N/ALead Sponsor
Leiden UniversityStudy Type
InterventionalStatus
RecruitingIndication/Condition
Sciatica Sciatica Due to Intervertebral Disc Disorder Sciatic RadiculopathyIntervention/Treatment
Lidocaine Methylprednisolone Acetate DexamethasoneStudy Participants
142Patients suffering from sciatica are treated conservatively for the first 8 weeks due to the favourable prognosis. This period is preferably extended up to 14-16 weeks after which patients may opt for surgery. However, patients may experience severe discomfort due to pain in the leg which can lead to decreased physical activity and socio-economic problems. An adequate therapy to alleviate symptoms during this period of 'wait-and-see' is lacking. In this study, patients will be randomized to treatment with transforaminal epidural injections or standard oral pain medication.
Sciatica is a condition of radicular pain in the leg and is usually caused by herniation of a lumbar intervertebral disc. The herniated disc compresses a lumbar nerve root that continues its route into the sciatic nerve. About 13% to 40% of all people will suffer from sciatica at least once during their lifetime. Sciatica can have severe socio-economic effects; patients are immobilised by the pain they experience and therefore cannot go to work or participate in social events. Most cases resolve spontaneously with conservative therapy using only standard analgesics and/or physiotherapy. In a large RCT it was demonstrated that outcome of conservative and surgical therapy was comparable after 26 weeks. With this knowledge the guidelines for surgical treatment of sciatica were adjusted and it is nowadays usual care to offer surgery only after at least 8 weeks of conservative care and preferably after 14-16 weeks of conservative care. This decision is made together with the patient in a process of Shared Decision making. Although this treatment regimen has been demonstrated to be efficacious and cost effective, the burden for a patient during these weeks of conservative care is usually high. The investigators seek to find a type of conservative care to reduce the discomfort due to the pain and to enable the patient to remain physically active. Not only will this add to the quality of life of the patient, but it will also prevent the patient from taking a sick-leave. In this study, patients will be randomized to either treatment with transforaminal epidural injections or to standard care consisting of oral pain medication.
In combination with dexamethasone or methylprednisolone acetate
In combination with lidocaine
Transforaminal Epidural Injection containing 1,5 mL lidocaine 2% and 40mg methylprednisolone acetate for injections L3 or below Transforaminal Epidural Injection containing 1,5 mL lidocaine 1% and 10mg dexamethasone for injections above L3
Patients will receive oral pain medication according to general practitioner guidelines.
Inclusion Criteria: Diagnosed with sciatica by GP NRS leg pain of 6 or more on a 10-point NRS scale Minimum duration of symptoms of 3 weeks and maximum duration of 8 weeks Exclusion Criteria: Age under 18 years Condition preventing to receive transforaminal epidural injection Severe scoliosis Transforaminal epidural injection received in 6 months before randomization date Surgery for sciatica at the same level Surgery for sciatica at another level within one year before inclusion Pregnancy
