Transforaminal Epidural Injection in Acute Sciatica
- Conditions
- SciaticaSciatica Due to Intervertebral Disc DisorderSciatic Radiculopathy
- Interventions
- Registration Number
- NCT03924791
- Lead Sponsor
- C.L.A.Vleggeert-Lankamp
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 142
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transforaminal Epidural Injection Lidocaine 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 Transforaminal Epidural Injection Methylprednisolone Acetate 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 Transforaminal Epidural Injection Dexamethasone 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
- Primary Outcome Measures
Name Time Method Numerical Rating Scale (NRS) for leg pain 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
Name Time Method Likert scale 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'.
Cost diary 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).
Numerical Rating Scale (NRS) for leg pain 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.
Numerical Rating Scale (NRS) for back pain 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.
Oswestry Disability Index (ODI) 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.
EuroQoL Cost Utility (EQ-5D) 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.
Level and shape of disc herniation from MRI data 21 weeks after randomization The lumbar intervertebral level and shape of the herniated disc will be described based on MRI data
Quality of Life Visual Analogue Scale 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.
Complications from treatment with transforaminal epidural injection (TEI) Throughout the follow-up of 21 weeks The occurrence and incidence of complications caused by treatment with TEI will be reported.
Size of disc herniation from MRI data 21 weeks after randomization The size of the herniated disc will be reported in millimetres based on MRI data
Pfirrmann scale for disc degeneration on MRI 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.
Histology of disc material obtained during surgery 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.
Modic scale for end plate changes on MRI 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.
Weishaupt scale for facet degeneration on MRI 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.
Trial Locations
- Locations (1)
Spaarne Gasthuis
🇳🇱Hoofddorp, Netherlands