Transforaminal Epidural Injection in Acute Sciatica

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Transforaminal Epidural Injection in Acute Sciatica

Conditions
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Sciatica, Sciatica Due to Intervertebral Disc Disorder, Sciatic Radiculopathy

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Methylprednisolone Acetate
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized to either treatment with transforaminal epidural injection or standard oral pain medication.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transforaminal Epidural Injection<br>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<br>* In combination with dexamethasone or methylprednisolone acetate<br>Drug: Methylprednisolone Acetate<br>* In combination with lidocaine<br>* Other names: Depo-Medrol;Drug: Dexamethasone<br>* In combination with lidocaine<br>|
| No Intervention: Oral pain medication<br>Patients will receive oral pain medication according to general practitioner guidelines. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale (NRS) for leg pain | 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 | 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 | 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) | 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) | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sciatica, Acute sciatica, Transforaminal epidural injection, Leg pain, Lumbar spine, Back pain, Lumbar surgery, Herniated intervertebral lumbar disk, Cost-effectiveness