NCT03924791

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jun 2019Jul 2026

First Submitted

Initial submission to the registry

April 10, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

6.5 years

First QC Date

April 10, 2019

Last Update Submit

October 18, 2023

Conditions

SciaticaSciatica Due to Intervertebral Disc DisorderSciatic Radiculopathy

Keywords

SciaticaAcute sciaticaTransforaminal epidural injectionLeg painLumbar spineBack painLumbar surgeryHerniated intervertebral lumbar diskCost-effectiveness

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 weeks after randomization

Secondary Outcomes (14)

  • Numerical Rating Scale (NRS) for leg pain

    Baseline, 1, 4, 10 and 21 weeks after randomization

  • Numerical Rating Scale (NRS) for back pain

    Baseline, 1, 2, 4, 10 and 21 weeks after randomization

  • Oswestry Disability Index (ODI)

    Baseline, 1, 2, 4, 10 and 21 weeks after randomization

  • EuroQoL Cost Utility (EQ-5D)

    Baseline, 2, 10 and 21 weeks after randomization

  • Quality of Life Visual Analogue Scale

    Baseline, 2, 10 and 21 weeks after randomization

  • +9 more secondary outcomes

Study Arms (2)

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

Drug: LidocaineDrug: Methylprednisolone AcetateDrug: Dexamethasone

Oral pain medication

NO INTERVENTION

Patients will receive oral pain medication according to general practitioner guidelines.

Interventions

LidocaineDRUG

In combination with dexamethasone or methylprednisolone acetate

Transforaminal Epidural Injection
Methylprednisolone AcetateDRUG

In combination with lidocaine

Also known as: Depo-Medrol
Transforaminal Epidural Injection
DexamethasoneDRUG

In combination with lidocaine

Transforaminal Epidural Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Spaarne Gasthuis

Haarlem, Netherlands

RECRUITING

Spaarne Gasthuis

Hoofddorp, Netherlands

RECRUITING

Related Publications (15)

  • 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.

    PMID: 17538084BACKGROUND

  • 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.

    PMID: 24710328BACKGROUND

  • 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.

    PMID: 28838872BACKGROUND

  • 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.

    PMID: 25448243BACKGROUND

  • 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.

    PMID: 1826546BACKGROUND

  • 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. doi: 10.1097/00007632-199601150-00011.

    PMID: 8720407BACKGROUND

  • El 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.

    PMID: 23874616BACKGROUND

  • 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.

    PMID: 24325881BACKGROUND

  • el 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.

    PMID: 24561397BACKGROUND

  • el 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.

    PMID: 24637890BACKGROUND

  • 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.

    PMID: 26842881BACKGROUND

  • El 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.

    PMID: 26871651BACKGROUND

  • 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.

    PMID: 25645576BACKGROUND

  • 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.

    PMID: 27641258BACKGROUND

  • 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.

    PMID: 31481010DERIVED

MeSH Terms

Conditions

SciaticaBack Pain

Interventions

LidocaineMethylprednisolone AcetateDexamethasone

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Carmen LA Vleggeert-Lankamp, MD Msc Ph.D

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen LA Vleggeert-Lankamp, MD Msc Ph.D

CONTACT

+31715262109cvleggeert@lumc.nl

Eduard JA Verheijen, Bsc

CONTACT

+31715262109e.j.a.verheijen@lumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomized to either treatment with transforaminal epidural injection or standard oral pain medication.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. C.L.A. Vleggeert-Lankamp

Study Record Dates

First Submitted

April 10, 2019

First Posted

April 23, 2019

Study Start

June 1, 2019

Primary Completion

December 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)