NCT03924791

Transforaminal Epidural Injection in Acute Sciatica

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: C.L.A.Vleggeert-Lankamp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients 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.

Detailed description

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.

Conditions

• Sciatica
• Sciatica Due to Intervertebral Disc Disorder
• Sciatic Radiculopathy

Interventions

Type	Name	Description
DRUG	Lidocaine	In combination with dexamethasone or methylprednisolone acetate
DRUG	Methylprednisolone Acetate	In combination with lidocaine
DRUG	Dexamethasone	In combination with lidocaine

Timeline

• Start date: 2019-06-01
• Primary completion: 2025-12-01
• Completion: 2026-07-01
• First posted: 2019-04-23
• Last updated: 2023-10-19

Locations

2 sites across 1 country: Netherlands