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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03924791
Recruitment Status Recruiting
First Posted April 23, 2019
Last update posted August 19, 2019
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.
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.
|Experimental: Transforaminal Epidural Injection
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
In combination with dexamethasone or methylprednisolone acetate
Drug: Methylprednisolone Acetate
In combination with lidocaine
In combination with lidocaine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- 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
- 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
Contact: Carmen LA Vleggeert-Lankamp, MD Msc Ph.D +31715262109 firstname.lastname@example.org
Contact: Eduard JA Verheijen, Bsc +31715262109 email@example.com
Stichting Achmea Gezondheidszor
Posthumus Meyjes Fonds
Principal Investigator: Carmen LA Vleggeert-Lankamp, MD Msc Ph.D Leiden University Medical Center
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Hofstede SN, van Bodegom-Vos L, Wentink MM, Vleggeert-Lankamp CL, Vliet Vlieland TP, Marang-van de Mheen PJ; DISC study group. Most important factors for the implementation of shared decision making in sciatica care: ranking among professionals and patients. PLoS One. 2014 Apr 7;9(4):e94176. doi: 10.1371/journal.pone.0094176. eCollection 2014.
Joswig H, Neff A, Ruppert C, Hildebrandt G, Stienen MN. The Value of Short-Term Pain Relief in Predicting the Long-Term Outcome of Lumbar Transforaminal Epidural Steroid Injections. World Neurosurg. 2017 Nov;107:764-771. doi: 10.1016/j.wneu.2017.08.055. Epub 2017 Aug 23.
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Kuslich SD, Ulstrom CL, Michael CJ. The tissue origin of low back pain and sciatica: a report of pain response to tissue stimulation during operations on the lumbar spine using local anesthesia. Orthop Clin North Am. 1991 Apr;22(2):181-7.
El Barzouhi A, Vleggeert-Lankamp CL, Lycklama À Nijeholt GJ, Van der Kallen BF, van den Hout WB, Verwoerd AJ, Koes BW, Peul WC; Leiden–The Hague Spine Intervention Prognostic Study Group. Magnetic resonance imaging interpretation in patients with sciatica who are potential candidates for lumbar disc surgery. PLoS One. 2013 Jul 10;8(7):e68411. doi: 10.1371/journal.pone.0068411. Print 2013.
Verwoerd AJ, Peul WC, Willemsen SP, Koes BW, Vleggeert-Lankamp CL, el Barzouhi A, Luijsterburg PA, Verhagen AP. Diagnostic accuracy of history taking to assess lumbosacral nerve root compression. Spine J. 2014 Sep 1;14(9):2028-37. doi: 10.1016/j.spinee.2013.11.049. Epub 2013 Dec 8.
el Barzouhi A, Vleggeert-Lankamp CL, Lycklama à Nijeholt GJ, Van der Kallen BF, van den Hout WB, Koes BW, Peul WC; Leiden–The Hague Spine Intervention Prognostic Study Group. Reliability of gadolinium-enhanced magnetic resonance imaging findings and their correlation with clinical outcome in patients with sciatica. Spine J. 2014 Nov 1;14(11):2598-607. doi: 10.1016/j.spinee.2014.02.028. Epub 2014 Feb 21.
el Barzouhi A, Vleggeert-Lankamp CL, Lycklama à Nijeholt GJ, Van der Kallen BF, van den Hout WB, Koes BW, Peul WC; Leiden–The Hague Spine Intervention Prognostic Study Group. Influence of low back pain and prognostic value of MRI in sciatica patients in relation to back pain. PLoS One. 2014 Mar 17;9(3):e90800. doi: 10.1371/journal.pone.0090800. eCollection 2014.
Verwoerd AJH, Mens J, El Barzouhi A, Peul WC, Koes BW, Verhagen AP. A diagnostic study in patients with sciatica establishing the importance of localization of worsening of pain during coughing, sneezing and straining to assess nerve root compression on MRI. Eur Spine J. 2016 May;25(5):1389-1392. doi: 10.1007/s00586-016-4393-8. Epub 2016 Feb 2.
El Barzouhi A, Verwoerd AJ, Peul WC, Verhagen AP, Lycklama À Nijeholt GJ, Van der Kallen BF, Koes BW, Vleggeert-Lankamp CL; Leiden–The Hague Spine Intervention Prognostic Study Group. Prognostic value of magnetic resonance imaging findings in patients with sciatica. J Neurosurg Spine. 2016 Jun;24(6):978-85. doi: 10.3171/2015.10.SPINE15858. Epub 2016 Feb 12.
Katz NP, Paillard FC, Ekman E. Determining the clinical importance of treatment benefits for interventions for painful orthopedic conditions. J Orthop Surg Res. 2015 Feb 3;10:24. doi: 10.1186/s13018-014-0144-x. Review.
Joswig H, Neff A, Ruppert C, Hildebrandt G, Stienen MN. The Value of Short-Term Pain Relief in Predicting the One-Month Outcome of Lumbar Transforaminal Epidural Steroid Injections. World Neurosurg. 2016 Dec;96:323-333. doi: 10.1016/j.wneu.2016.09.016. Epub 2016 Sep 15.