An interventional study of Lidocaine and Methylprednisolone Acetate in Sciatica, Sciatica Due to Intervertebral Disc Disorder and Sciatic Radiculopathy, sponsored by C.L.A.Vleggeert-Lankamp. Recruiting at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by C.L.A.Vleggeert-Lankamp · Not applicable, Interventional, and Treatment
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.
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.
149 studies on the registry are indexed under Sciatica; 31 are open to participants now.
This study's planned enrollment of 142 is above the median of 68 across 122 interventional studies indexed under Sciatica.
Browse Sciatica studies →This is the only study on the registry with C.L.A.Vleggeert-Lankamp as lead sponsor.
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Exclusion Criteria:
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 · Drug: Methylprednisolone Acetate · Drug: Dexamethasone
Patients will receive oral pain medication according to general practitioner guidelines.
In combination with dexamethasone or methylprednisolone acetate
In combination with lidocaine
Also known as: Depo-Medrol
In combination with lidocaine
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.
Time frame: 2 weeks after randomization
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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'.
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 21 weeks after randomization
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drugs tested here: Lidocaine · Methylprednisolone Acetate · Dexamethasone