Transforaminal Epidural Injection in Acute Sciatica (TEIAS)

• ClinicalTrials.gov Identifier: NCT03924791
• Recruitment Status: Unknown
• First Posted: April 23, 2019
• Last Update Posted: August 19, 2019
• Sponsor: C.L.A.Vleggeert-Lankamp
• Collaborators: Spaarne Gasthuis; Stichting Achmea Gezondheidszor; Posthumus Meyjes Fonds
• Information provided by (Responsible Party): C.L.A.Vleggeert-Lankamp, Leiden University Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sciatica; Sciatica Due to Intervertebral Disc Disorder; Sciatic Radiculopathy	Drug: Lidocaine; Drug: Methylprednisolone Acetate; Drug: Dexamethasone	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 142 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients will be randomized to either treatment with transforaminal epidural injection or standard oral pain medication.
• Masking: None (Open Label)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Transforaminal Epidural Injection in Acute Sciatica
• Actual Study Start Date: June 1, 2019
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

Arm	Intervention/treatment
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	Drug: Lidocaine; In combination with dexamethasone or methylprednisolone acetate; Drug: Methylprednisolone Acetate; In combination with lidocaine; Other Name: Depo-Medrol; Drug: Dexamethasone; In combination with lidocaine
No Intervention: Oral pain medication; Patients will receive oral pain medication according to general practitioner guidelines.

Outcome Measures

Primary Outcome Measures :

1. Numerical Rating Scale (NRS) for leg pain [ Time Frame: 2 weeks after randomization ]
   Pain intensity in the leg using the NRS. 0 is the minimal score indicating no pain, 10 is the maximum indicating the worst imaginable pain. Scale increases with increments of 1.

Secondary Outcome Measures :

1. Numerical Rating Scale (NRS) for leg pain [ Time Frame: Baseline, 1, 4, 10 and 21 weeks after randomization ]
   Pain intensity in the leg using the NRS. 0 is the minimal score indicating no pain, 10 is the maximum indicating the worst imaginable pain. Scale increases with increments of 1.
2. Numerical Rating Scale (NRS) for back pain [ Time Frame: Baseline, 1, 2, 4, 10 and 21 weeks after randomization ]
   Pain intensity in the back using the NRS. 0 is the minimal score indicating no pain, 10 is the maximum indicating the worst imaginable pain. Scale increases with increments of 1.
3. Oswestry Disability Index (ODI) [ Time Frame: Baseline, 1, 2, 4, 10 and 21 weeks after randomization ]
   Assessment of functionality using the ODI. 0 is the minimal score indicating no disability, 50 is the maximum indicating the worst disability possible. This questionnaire is based on 10 questions with answers corresponding to values of 0-5 points.
4. EuroQoL Cost Utility (EQ-5D) [ Time Frame: Baseline, 2, 10 and 21 weeks after randomization ]
   Assessment of cost utility using the EuroQoL EQ-5D analysis tool. The tool measures five dimensions: mobility, self-care, daily activities, pain/discomfort and anxiety/depression.
5. Quality of Life Visual Analogue Scale [ Time Frame: Baseline, 2, 10 and 21 weeks after randomization ]
   Assessment of the utility by valuation of the patient's health state representing the patient's perspective. 0 is the minimal score indicating 'as bad as death', 100 is the maximum indicating 'perfect health'. Scale increases with increments of 1.
6. Likert scale [ Time Frame: Baseline, 1, 2, 4, 10 and 21 weeks after randomization ]
   Perceived recovery by the patient using the Likert scale. This is a 7-point scoring scale that ranges from 'completely recovered' to 'worse than ever'.
7. Cost diary [ Time Frame: 10 and 21 weeks after randomization ]
   Determination of medical expenses due to health care utilization (costs of medication, physiotherapy, treatment by a medical specialist), patient costs (mobility aid, nursing care, domestic help), and absenteeism from work (amount of hours of absenteeism, hourly wage).
8. Complications from treatment with transforaminal epidural injection (TEI) [ Time Frame: Throughout the follow-up of 21 weeks ]
   The occurrence and incidence of complications caused by treatment with TEI will be reported.
9. Level and shape of disc herniation from MRI data [ Time Frame: 21 weeks after randomization ]
   The lumbar intervertebral level and shape of the herniated disc will be described based on MRI data
10. Size of disc herniation from MRI data [ Time Frame: 21 weeks after randomization ]
    The size of the herniated disc will be reported in millimetres based on MRI data
11. Pfirrmann scale for disc degeneration on MRI [ Time Frame: 21 weeks after randomization ]
    Disc degeneration on MRI will be assessed using the Pfirrmann scale which distinguishes 5 degrees of disc degeneration. Grade 1 indicates a normal disc. Higher grades indicate a more severe degenerative state of the intervertebral disc.
12. Histology of disc material obtained during surgery [ Time Frame: 21 weeks after randomization ]
    Identification of immunological cells, macrophages and bacteria in disk material obtained during discectomy using staining, cell culture and polymerase chain reaction techniques.
13. Modic scale for end plate changes on MRI [ Time Frame: 21 weeks after randomization ]
    The degree of end plate changes on MRI will be assessed using the Modic scale which distinguishes 3 degrees of end plate changes. All three Modic degrees indicate a certain type of underlying pathology in the vertebra. When the vertebra is normal, Modic changes are absent.
14. Weishaupt scale for facet degeneration on MRI [ Time Frame: 21 weeks after randomization ]
    The degree of facet degeneration on MRI will be assessed using the Weishaupt scale which distinguishes 4 degrees of facet degeneration. Grade 0 indicates normal facet joint space. Higher grades indicate a more severe degenerative state of the facet joint.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Carmen LA Vleggeert-Lankamp, MD Msc Ph.D; +31715262109; cvleggeert@lumc.nl

Contact: Eduard JA Verheijen, Bsc; +31715262109; e.j.a.verheijen@lumc.nl

Locations

Netherlands

Spaarne Gasthuis; Recruiting

Haarlem, Netherlands

Contact: Carmen Vleggeert-Lankamp, M.D. Ph.D

Spaarne Gasthuis; Recruiting

Hoofddorp, Netherlands

Contact: Carmen Vleggeert-Lankamp, M.D. Ph.D

Sponsors and Collaborators

C.L.A.Vleggeert-Lankamp

Spaarne Gasthuis

Stichting Achmea Gezondheidszor

Posthumus Meyjes Fonds

Investigators

• Principal Investigator: Carmen LA Vleggeert-Lankamp, MD Msc Ph.D; Leiden University Medical Center

  Study Documents (Full-Text)

Documents provided by C.L.A.Vleggeert-Lankamp, Leiden University Medical Center:

Study Protocol and Statistical Analysis Plan  [PDF] March 25, 2019

More Information

Publications:

Peul WC, van Houwelingen HC, van den Hout WB, Brand R, Eekhof JA, Tans JT, Thomeer RT, Koes BW; Leiden-The Hague Spine Intervention Prognostic Study Group. Surgery versus prolonged conservative treatment for sciatica. N Engl J Med. 2007 May 31;356(22):2245-56.

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.

Spijker-Huiges A, Vermeulen K, Winters JC, van Wijhe M, van der Meer K. Epidural steroids for lumbosacral radicular syndrome compared to usual care: quality of life and cost utility in general practice. Arch Phys Med Rehabil. 2015 Mar;96(3):381-7. doi: 10.1016/j.apmr.2014.10.017. Epub 2014 Nov 8.

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.

Takahashi H, Suguro T, Okazima Y, Motegi M, Okada Y, Kakiuchi T. Inflammatory cytokines in the herniated disc of the lumbar spine. Spine (Phila Pa 1976). 1996 Jan 15;21(2):218-24.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Verheijen E, Munts AG, van Haagen O, de Vries D, Dekkers O, van den Hout W, Vleggeert-Lankamp C. Transforaminal epidural injection versus continued conservative care in acute sciatica (TEIAS trial): study protocol for a randomized controlled trial. BMC Neurol. 2019 Sep 3;19(1):216. doi: 10.1186/s12883-019-1445-9.

• Responsible Party: C.L.A.Vleggeert-Lankamp, Dr. C.L.A. Vleggeert-Lankamp, Leiden University Medical Center
• ClinicalTrials.gov Identifier: NCT03924791
• Other Study ID Numbers: TEIAS
• First Posted: April 23, 2019
• Last Update Posted: August 19, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by C.L.A.Vleggeert-Lankamp, Leiden University Medical Center:

Sciatica; Acute sciatica; Transforaminal epidural injection; Leg pain; Lumbar spine; Back pain; Lumbar surgery; Herniated intervertebral lumbar disk; Cost-effectiveness

Additional relevant MeSH terms:

Radiculopathy; Sciatica; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Sciatic Neuropathy; Mononeuropathies; Neuralgia; Pain; Neurologic Manifestations; Dexamethasone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Lidocaine; Prednisolone hemisuccinate; Prednisolone phosphate; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents