Transforaminal Epidural Injection in Acute Sciatica (TEIAS)

October 18, 2023 updated by: C.L.A.Vleggeert-Lankamp
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Carmen LA Vleggeert-Lankamp, MD Msc Ph.D
  • Phone Number: +31715262109
  • Email: cvleggeert@lumc.nl

Study Contact Backup

Study Locations

  • Netherlands
      • Haarlem, Netherlands
        • Recruiting
        • Spaarne Gasthuis
        • Contact:
          • Carmen Vleggeert-Lankamp, M.D. Ph.D
      • Hoofddorp, Netherlands
        • Recruiting
        • Spaarne Gasthuis
        • Contact:
          • Carmen Vleggeert-Lankamp, M.D. Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Depo-Medrol
Drug: Dexamethasone
In combination with lidocaine
No Intervention: Oral pain medication
Patients will receive oral pain medication according to general practitioner guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
Baseline, 2, 10 and 21 weeks after randomization
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.
Baseline, 2, 10 and 21 weeks after randomization
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'.
Baseline, 1, 2, 4, 10 and 21 weeks after randomization
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).
10 and 21 weeks after randomization
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.
Throughout the follow-up of 21 weeks
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
21 weeks after randomization
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
21 weeks after randomization
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.
21 weeks after randomization
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.
21 weeks after randomization
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.
21 weeks after randomization
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.
21 weeks after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

C.L.A.Vleggeert-Lankamp

Collaborators

Spaarne Gasthuis
Stichting Achmea Gezondheidszor
Posthumus Meyjes Fonds

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 10, 2019

First Submitted That Met QC Criteria

April 18, 2019

First Posted (Actual)

April 23, 2019

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEIAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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