Transforaminal Epidural Injection in Acute Sciatica (TEIAS)

C.L.A.Vleggeert-Lankamp

Status: Enrolling

Conditions: Sciatic Radiculopathy; Sciatica; Sciatica Due to Intervertebral Disc Disorder

Treatments: Drug: Dexamethasone; Drug: Methylprednisolone Acetate; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03924791

TEIAS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

142 participants in 2 patient groups

Transforaminal Epidural Injection

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone

Drug: Lidocaine

Drug: Methylprednisolone Acetate

Oral pain medication

No Intervention group

Description:

Patients will receive oral pain medication according to general practitioner guidelines.