Transforaminal Epidural Injection in Acute Sciatica

NCT03924791 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2023-10-19

No results posted yet for this study

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.

Conditions

  • Sciatica
  • Sciatica Due to Intervertebral Disc Disorder
  • Sciatic Radiculopathy

Interventions

DRUG

Lidocaine

In combination with dexamethasone or methylprednisolone acetate

DRUG

Methylprednisolone Acetate

In combination with lidocaine

DRUG

Dexamethasone

In combination with lidocaine

Sponsors & Collaborators

  • Spaarne Gasthuis

    collaborator OTHER
  • Stichting Achmea Gezondheidszor

    collaborator OTHER
  • Posthumus Meyjes Fonds

    collaborator UNKNOWN
  • C.L.A.Vleggeert-Lankamp

    lead OTHER

Principal Investigators

  • Carmen LA Vleggeert-Lankamp, MD Msc Ph.D · Leiden University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2025-12-31
Completion
2026-07-31

Countries

  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03924791 on ClinicalTrials.gov