Transforaminal Epidural Injection in Acute Sciatica (TEIAS)
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ClinicalTrials.gov Identifier: NCT03924791 |
Recruitment Status :
Recruiting
First Posted : April 23, 2019
Last Update Posted : April 7, 2022
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Condition or disease | Intervention/treatment | Phase |
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Sciatica Sciatica Due to Intervertebral Disc Disorder Sciatic Radiculopathy | Drug: Lidocaine Drug: Methylprednisolone Acetate Drug: Dexamethasone | Not Applicable |
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 2023 |
Estimated Study Completion Date : | December 2024 |

Arm | Intervention/treatment |
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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
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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.
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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'.
- 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).
- 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.
- 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
- 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
- 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.
- 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.
- 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.
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03924791
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 |
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 |
Principal Investigator: | Carmen LA Vleggeert-Lankamp, MD Msc Ph.D | Leiden University Medical Center |
Documents provided by C.L.A.Vleggeert-Lankamp, Leiden University Medical Center:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
Last Update Posted: | April 7, 2022 |
Last Verified: | April 2022 |
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 |
Sciatica Acute sciatica Transforaminal epidural injection Leg pain Lumbar spine |
Back pain Lumbar surgery Herniated intervertebral lumbar disk Cost-effectiveness |
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 |