SciaticaTEIASNCT03924791
Transforaminal Epidural Injection in Acute Sciatica
A study testing Lidocaine, Methylprednisolone Acetate and Dexamethasone in people with Sciatica and Sciatica Due to Intervertebral Disc Disorder, run by C.L.A.Vleggeert-Lankamp at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sciatica, Sciatica Due to Intervertebral Disc Disorder, Sciatic Radiculopathy
- What is being tested?
- Lidocaine, Methylprednisolone Acetate and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Jun 2019to Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Spaarne Gasthuis
Haarlem
Carmen Vleggeert-Lankamp, M.D. Ph.D
- Recruiting
Spaarne Gasthuis
Hoofddorp
Carmen Vleggeert-Lankamp, M.D. Ph.D
About this study
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.
Read the 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.
- Being tested
- Lidocaine, Methylprednisolone Acetate, Dexamethasone
- Keywords
- Sciatica, Acute sciatica, Transforaminal epidural injection, Leg pain, Lumbar spine, Back pain, Lumbar surgery, Herniated intervertebral lumbar disk, Cost-effectiveness
- Medical subject headings
- Sciatica, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
In combination with dexamethasone or methylprednisolone acetate
Methylprednisolone AcetateDrug
Also called Depo-Medrol
In combination with lidocaine
DexamethasoneDrug
In combination with lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Transforaminal Epidural Injection | Experimental | 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 Receives: Drug: Lidocaine; Drug: Methylprednisolone Acetate; Drug: Dexamethasone |
| Oral pain medication | No intervention | Patients will receive oral pain medication according to general practitioner guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS) for leg pain
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.
Measured: 2 weeks after randomization
Secondary outcomes (14)
Numerical Rating Scale (NRS) for leg pain
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.
Measured: Baseline, 1, 4, 10 and 21 weeks after randomization
Numerical Rating Scale (NRS) for back pain
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.
Measured: Baseline, 1, 2, 4, 10 and 21 weeks after randomization
Oswestry Disability Index (ODI)
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.
Measured: Baseline, 1, 2, 4, 10 and 21 weeks after randomization
EuroQoL Cost Utility (EQ-5D)
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.
Measured: Baseline, 2, 10 and 21 weeks after randomization
Quality of Life Visual Analogue Scale
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.
Measured: Baseline, 2, 10 and 21 weeks after randomization
Likert scale
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'.
Measured: Baseline, 1, 2, 4, 10 and 21 weeks after randomization
Cost diary
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).
Measured: 10 and 21 weeks after randomization
Complications from treatment with transforaminal epidural injection (TEI)
The occurrence and incidence of complications caused by treatment with TEI will be reported.
Measured: Throughout the follow-up of 21 weeks
Level and shape of disc herniation from MRI data
The lumbar intervertebral level and shape of the herniated disc will be described based on MRI data
Measured: 21 weeks after randomization
Size of disc herniation from MRI data
The size of the herniated disc will be reported in millimetres based on MRI data
Measured: 21 weeks after randomization
Pfirrmann scale for disc degeneration on MRI
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.
Measured: 21 weeks after randomization
Histology of disc material obtained during surgery
Identification of immunological cells, macrophages and bacteria in disk material obtained during discectomy using staining, cell culture and polymerase chain reaction techniques.
Measured: 21 weeks after randomization
Modic scale for end plate changes on MRI
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.
Measured: 21 weeks after randomization
Weishaupt scale for facet degeneration on MRI
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.
Measured: 21 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start1 Jun 2019
- Primary completionDec 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for SciaticaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to either treatment with transforaminal epidural injection or standard oral pain medication.
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- C.L.A.Vleggeert-Lankamp
- Sponsor type
- University, hospital or other
- Collaborators
- Spaarne Gasthuis, Stichting Achmea Gezondheidszor, Posthumus Meyjes Fonds
- Responsible party
- Sponsor-investigator, C.L.A.Vleggeert-Lankamp, Leiden University Medical Center
- Investigators
- Carmen LA Vleggeert-Lankamp, MD Msc Ph.D, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924791
- Sponsor's protocol ID
- TEIAS
- Acronym
- TEIAS
- Status last verified
- Oct 2023
- First submitted
- 10 Apr 2019
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. doi: 10.1056/NEJMoa064039.
PubMed 17538084Hofstede 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.
PubMed 24710328Joswig 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.
PubMed 28838872Spijker-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.
PubMed 25448243Kuslich 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.
PubMed 1826546Takahashi 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. doi: 10.1097/00007632-199601150-00011.
PubMed 8720407El Barzouhi A, Vleggeert-Lankamp CL, Lycklama A 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.
PubMed 23874616Verwoerd 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.
PubMed 24325881el Barzouhi A, Vleggeert-Lankamp CL, Lycklama a 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.
PubMed 24561397el Barzouhi A, Vleggeert-Lankamp CL, Lycklama a 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.
PubMed 24637890Verwoerd 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.
PubMed 26842881El Barzouhi A, Verwoerd AJ, Peul WC, Verhagen AP, Lycklama A 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.
PubMed 26871651Katz 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.
PubMed 25645576Joswig 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.
PubMed 27641258Verheijen 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.
PubMed 31481010
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforaminal Epidural Injection in Acute Sciatica
- ClinicalTrials.gov ID
- NCT03924791
- Acronym / sponsor ID
- TEIAS / TEIAS
- Keywords
- Sciatica, Acute sciatica, Transforaminal epidural injection, Leg pain, Lumbar spine, Back pain, Lumbar surgery, Herniated intervertebral lumbar disk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- C.L.A.Vleggeert-LankampUniversity, hospital or other
- Collaborators
- Spaarne Gasthuis, Stichting Achmea Gezondheidszor, Posthumus Meyjes Fonds
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to either treatment with transforaminal epidural injection or standard oral pain medication.
| Arm | Type | Receives |
|---|---|---|
| Transforaminal Epidural Injection | Experimental | Drug: Lidocaine, Drug: Methylprednisolone Acetate, Drug: DexamethasoneTransforaminal 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 |
| Oral pain medication | No intervention | –Patients will receive oral pain medication according to general practitioner guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineIn combination with dexamethasone or methylprednisolone acetate | Drug | Transforaminal Epidural Injection |
| Methylprednisolone AcetateAlso: Depo-MedrolIn combination with lidocaine | Drug | Transforaminal Epidural Injection |
| DexamethasoneIn combination with lidocaine | Drug | Transforaminal Epidural Injection |
Primary outcome
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.
14 secondary outcomes
Numerical Rating Scale (NRS) for leg pain
Time frame: Baseline, 1, 4, 10 and 21 weeks after randomization
Numerical Rating Scale (NRS) for back pain
Time frame: Baseline, 1, 2, 4, 10 and 21 weeks after randomization
Oswestry Disability Index (ODI)
Time frame: Baseline, 1, 2, 4, 10 and 21 weeks after randomization
EuroQoL Cost Utility (EQ-5D)
Time frame: Baseline, 2, 10 and 21 weeks after randomization
Quality of Life Visual Analogue Scale
Time frame: Baseline, 2, 10 and 21 weeks after randomization
Likert scale
Time frame: Baseline, 1, 2, 4, 10 and 21 weeks after randomization
Cost diary
Time frame: 10 and 21 weeks after randomization
Complications from treatment with transforaminal epidural injection (TEI)
Time frame: Throughout the follow-up of 21 weeks
Level and shape of disc herniation from MRI data
Time frame: 21 weeks after randomization
Size of disc herniation from MRI data
Time frame: 21 weeks after randomization
Pfirrmann scale for disc degeneration on MRI
Time frame: 21 weeks after randomization
Histology of disc material obtained during surgery
Time frame: 21 weeks after randomization
Modic scale for end plate changes on MRI
Time frame: 21 weeks after randomization
Weishaupt scale for facet degeneration on MRI
Time frame: 21 weeks after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Background: PubMed 17538084Peul 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. doi: 10.1056/NEJMoa064039.
- Background: PubMed 24710328Hofstede 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.
- Background: PubMed 28838872Joswig 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.
- Background: PubMed 25448243Spijker-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.
- Background: PubMed 1826546Kuslich 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.
- Background: PubMed 8720407Takahashi 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. doi: 10.1097/00007632-199601150-00011.
- Background: PubMed 23874616El Barzouhi A, Vleggeert-Lankamp CL, Lycklama A 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.
- Background: PubMed 24325881Verwoerd 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.
- Background: PubMed 24561397el Barzouhi A, Vleggeert-Lankamp CL, Lycklama a 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.
- Background: PubMed 24637890el Barzouhi A, Vleggeert-Lankamp CL, Lycklama a 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.
- Background: PubMed 26842881Verwoerd 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.
- Background: PubMed 26871651El Barzouhi A, Verwoerd AJ, Peul WC, Verhagen AP, Lycklama A 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen LA Vleggeert-Lankamp, MD Msc Ph.D principal investigator
Leiden University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine, Methylprednisolone Acetate and Dexamethasone in people with Sciatica and Sciatica Due to Intervertebral Disc Disorder, run by C.L.A.Vleggeert-Lankamp at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carmen LA Vleggeert-Lankamp, MD Msc Ph.D (+31715262109, cvleggeert@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) for leg pain (time frame: 2 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03924791, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.