Sciatica, Sciatica Due to Intervertebral Disc Disorder, Sciatic Radiculopathy
Conditions
Keywords
Sciatica, Acute sciatica, Transforaminal epidural injection, Leg pain, Lumbar spine, Back pain, Lumbar surgery, Herniated intervertebral lumbar disk, Cost-effectiveness
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.
Interventions
DRUGLidocaine
In combination with dexamethasone or methylprednisolone acetate
In combination with lidocaine
DRUGDexamethasone
In combination with lidocaine
Sponsors
Spaarne Gasthuis
Stichting Achmea Gezondheidszor
Posthumus Meyjes Fonds
C.L.A.Vleggeert-Lankamp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Intervention model description
Patients will be randomized to either treatment with transforaminal epidural injection or standard oral pain medication.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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'. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
Countries
Netherlands
Contacts
Primary ContactCarmen LA Vleggeert-Lankamp, MD Msc Ph.D
Backup ContactEduard JA Verheijen, Bsc
Outcome results
None listed