Transforaminal Epidural Injection in Acute Sciatica

TEIAS

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.

2019-06-01

2025-12-01

2026-07-01

Recruiting

142

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized to either treatment with transforaminal epidural injection or standard oral pain medication.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Since masking is not possible for treatment with injections and oral pain medication, this is an open-label study. Outcomes are assessed by patients through online questionnaires and therefore the outcome assessor is not masked as well.'}}, 'enrollmentInfo': {'count': 142, 'type': 'ESTIMATED'}}

2023-10-19