Chronic Pain Clinical Trial
— BetaDexaCaudalOfficial title:
Efficacy and Safety of Dexamethasone Versus Betamethasone Epidural Caudal Administration for Treatment of Lumbosacral Radiculalgia: Randomized Clinical Trial
This study evaluate the administration of epidural betamethasone versus dexamethasone for pain reduction, consumption of analgesic and quality of life. Half of the patient will receive dexametasone and the other half betametasone.
Status | Recruiting |
Enrollment | 320 |
Est. completion date | June 2020 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Unilateral leg pain secondary to lateral stenosis, disc protrusion or herniated disc. - Age between 18 and 80 years. - Moderate to severe pain (NVS>4). - Right proficient oral and written language. Exclusion Criteria: - Patients with high intracranial pressure. - Patients with Multiple Sclerosis. - Patients with Guillain-Barré syndrome radiculopathy of vascular origin. - Patients with previous lumbar surgery. - Patients pregnant or lactating. - Patients with allergy or intolerance to any of the drugs used. - Patients with severe cognitive impairment. - Patients with intrathecal injectio radiculalgia. - Patients with poorly controlled major psychiatric pathology. - Patients with type I diabetes or poorly controlled type II diabetes (Hb1Ac>8.5). - Patients with glaucoma. - Patients with caudal equine syndrome. - Patients with pre-treatment with steroid injections/or local anesthetics. - Patients with central canal stenosis. - patients with chronic treatment with oral corticosteroids without stabilized pattern. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Enrique Barez | Vitoria-Gasteiz | Álava |
Lead Sponsor | Collaborator |
---|---|
Basque Health Service |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain. | Pain according to numerical visual pain scale. | 3 months. | No |
Secondary | Quality of life. | Quality of life according to SF-36. | 7 days, 1, 3 and 6 months. | No |
Secondary | Pain. | Pain according to numerical visual pain scale. | 7 days, 1, 3 and 6 months. | No |
Secondary | Adverse events. | Adverse events. | 7 days, 1, 3 and 6 months. | Yes |
Status | Clinical Trial | Phase | |
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