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Transforaminal Epidural Injection in Acute Sciatica (TEIAS)

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ClinicalTrials.gov Identifier: NCT03924791
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : August 19, 2019
Sponsor:
Collaborators:
Spaarne Gasthuis
Stichting Achmea Gezondheidszor
Posthumus Meyjes Fonds
Information provided by (Responsible Party):
C.L.A.Vleggeert-Lankamp, Leiden University Medical Center

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 Intervention/treatment Phase
Sciatica Sciatica Due to Intervertebral Disc Disorder Sciatic Radiculopathy Drug: Lidocaine Drug: Methylprednisolone Acetate Drug: Dexamethasone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Transforaminal Epidural Injection in Acute Sciatica
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


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 Name: Depo-Medrol

Drug: Dexamethasone
In combination with lidocaine

No Intervention: Oral pain medication
Patients will receive oral pain medication according to general practitioner guidelines.



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. 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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03924791


Contacts
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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
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Netherlands
Spaarne Gasthuis Recruiting
Haarlem, Netherlands
Contact: Carmen Vleggeert-Lankamp, M.D. Ph.D         
Spaarne Gasthuis Recruiting
Hoofddorp, Netherlands
Contact: Carmen Vleggeert-Lankamp, M.D. Ph.D         
Sponsors and Collaborators
C.L.A.Vleggeert-Lankamp
Spaarne Gasthuis
Stichting Achmea Gezondheidszor
Posthumus Meyjes Fonds
Investigators
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Principal Investigator: Carmen LA Vleggeert-Lankamp, MD Msc Ph.D Leiden University Medical Center
  Study Documents (Full-Text)

Documents provided by C.L.A.Vleggeert-Lankamp, Leiden University Medical Center:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: C.L.A.Vleggeert-Lankamp, Dr. C.L.A. Vleggeert-Lankamp, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT03924791     History of Changes
Other Study ID Numbers: TEIAS
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by C.L.A.Vleggeert-Lankamp, Leiden University Medical Center:
Sciatica
Acute sciatica
Transforaminal epidural injection
Leg pain
Lumbar spine
Back pain
Lumbar surgery
Herniated intervertebral lumbar disk
Cost-effectiveness
Additional relevant MeSH terms:
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Neuromuscular Diseases
Lidocaine
Radiculopathy
Sciatica
Peripheral Nervous System Diseases
Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Neuralgia
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones