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Transforaminal Epidural Injection in Acute Sciatica

  • Clinicaltrials.gov identifier

    NCT03924791

  • Recruitment Status

    Recruiting

  • First Posted

    April 23, 2019

  • Last update posted

    August 19, 2019

Study Description

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.

  • Condition or Disease:Sciatic Radiculopathy
    Sciatica Due to Intervertebral Disc Disorder
    Sciatica
  • Intervention/Treatment: Drug: Lidocaine
    Drug: Methylprednisolone Acetate
    Drug: Dexamethasone
  • Phase: N/A

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

  • Study Type: Interventional
  • Estimated Enrollment: 142 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Patients will be randomized to either treatment with transforaminal epidural injection or standard oral pain medication.
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Transforaminal Epidural Injection in Acute Sciatica
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020

Arms and interventions

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

Drug: Dexamethasone
In combination with lidocaine

Outcome Measures

  • Primary Outcome Measures: 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 Outcome Measures: 1. 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.
  • 2. 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.
  • 3. 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.
  • 4. 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.
  • 5. 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.
  • 6. 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.
  • 7. 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'.
  • 8. 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).
  • 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.

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Carmen LA Vleggeert-Lankamp, MD Msc Ph.D +31715262109 cvleggeert@lumc.nl

Contact: Eduard JA Verheijen, Bsc +31715262109 e.j.a.verheijen@lumc.nl

Locations

Netherlands
Spaarne Gasthuis
Haarlem

Netherlands
Spaarne Gasthuis
Hoofddorp

Sponsors and Collaborators

C.L.A.Vleggeert-Lankamp

Spaarne Gasthuis

Stichting Achmea Gezondheidszor

Posthumus Meyjes Fonds

Investigators

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

More Information