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NCT Number: NCT03924791

Transforaminal Epidural Injection in Acute Sciatica

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.

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Key information

Conditions

Sciatica Back Pain Mononeuropathies Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sciatic Neuropathy Sciatic Radiculopathy Sciatica Due to Intervertebral Disc Disorder Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaarne Gasthuis, Haarlem, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

In combination with dexamethasone or methylprednisolone acetate

Methylprednisolone Acetate

Drug

In combination with lidocaine

Other names: Depo-Medrol

Dexamethasone

Drug

In combination with lidocaine

Primary outcomes

  1. 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.

Secondary outcomes

  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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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'.

  7. 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).

  8. 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.

  9. 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

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carmen LA Vleggeert-Lankamp, MD Msc Ph.D

CONTACT

[email protected]

+31715262109

Eduard JA Verheijen, Bsc

CONTACT

[email protected]

+31715262109

Sponsors and collaborators

Lead sponsor

C.L.A.Vleggeert-Lankamp

Other

Collaborators

  • Posthumus Meyjes Fonds
  • Spaarne Gasthuis
  • Stichting Achmea Gezondheidszor

Registry information

Acronym: TEIAS

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Apr 23, 2019
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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