NCT03924791 Transforaminal Epidural Injection in Acute Sciatica
| NCT ID | NCT03924791 |
| Status | Recruiting |
| Phase | — |
| Sponsor | C.L.A.Vleggeert-Lankamp |
| Condition | Sciatica |
| Study Type | INTERVENTIONAL |
| Enrollment | 142 participants |
| Start Date | 2019-06-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 142 participants in total. It began in 2019-06-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Carmen LA Vleggeert-Lankamp, MD Msc Ph.D
PRINCIPAL INVESTIGATOR
Leiden University Medical Center
Frequently Asked Questions
Who can join the NCT03924791 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sciatica. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03924791 currently recruiting?
Yes, NCT03924791 is actively recruiting participants. Contact the research team at cvleggeert@lumc.nl for enrollment information.
Where is the NCT03924791 trial being conducted?
This trial is being conducted at Haarlem, Netherlands, Hoofddorp, Netherlands.
Who is sponsoring the NCT03924791 clinical trial?
NCT03924791 is sponsored by C.L.A.Vleggeert-Lankamp. The principal investigator is Carmen LA Vleggeert-Lankamp, MD Msc Ph.D at Leiden University Medical Center. The trial plans to enroll 142 participants.