Transforaminal epidural injection for treating acute sciatica
Transforaminal Epidural Injection in Acute Sciatica
This study tests if a special injection can help people with severe leg pain from sciatica feel better and move more easily compared to taking regular pain pills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 2 sites (Haarlem and 1 other locations) |
| Trial ID | NCT03924791 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of transforaminal epidural injections compared to standard oral pain medication in patients suffering from acute sciatica. Patients diagnosed with sciatica will be randomized to receive either the injection or oral medication after a conservative treatment period of 8 weeks. The goal is to alleviate severe leg pain and improve physical activity during the waiting period before potential surgical intervention. The study aims to enhance the quality of life for patients and reduce socio-economic impacts associated with sciatica.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with sciatica experiencing leg pain rated 6 or higher on a 10-point scale, with symptoms lasting between 3 to 8 weeks.
Not a fit: Patients under 18, those with conditions preventing the injection, or those who have had recent surgeries for sciatica may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain and improve the quality of life for patients suffering from acute sciatica.
How similar studies have performed: Previous studies have shown that conservative treatments for sciatica can be effective, but the specific use of transforaminal epidural injections in this context is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Haarlem and 1 other locations
- Spaarne Gasthuis — Haarlem, Netherlands (Recruiting)
- Spaarne Gasthuis — Hoofddorp, Netherlands (Recruiting)
Study contacts
- Principal investigator: Carmen LA Vleggeert-Lankamp, MD Msc Ph.D — Leiden University Medical Center
- Study coordinator: Carmen LA Vleggeert-Lankamp, MD Msc Ph.D
- Email: cvleggeert@lumc.nl
- Phone: +31715262109
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.