Lumbar Spinal Stenosis Clinical Trial
— EPCSIIOfficial title:
EuroPainClinics® Study II (Prospective Randomized Double Blinded Trial)
Verified date | December 2021 |
Source | Europainclinics z.ú. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this prospective multi-centre double-blind trial the effect of the epiduroscopy will be examined in (approximately 300) adult patients with low back pain pain caused by failed back surgery syndrome (FBSS).
Status | Completed |
Enrollment | 300 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age of 18 years or older - Written informed consent - Patients with FBSS - Magnetic resonance examination evidence of intervertebral disc herniation - Permanent pain radiating to lower limbs despite previous periradicular therapy or caudal block - Actual Magnetic resonance imaging: lesion without serious spinal stenosis, lesion without serious radicular compression, lesion without serious intervertebral disc herniation Exclusion Criteria: - Patients not capable of consenting - Pregnant women or women of child-bearing potential - Cauda equine syndrome |
Country | Name | City | State |
---|---|---|---|
Czechia | Czech republic | Praha |
Lead Sponsor | Collaborator |
---|---|
Europainclinics z.ú. |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain as assessed by the Visual analogue scale | All acquired information will be noted in to the special anonymous protocol | 3 years | |
Secondary | Pain progress as assessed by global pain scale | All acquired information will be noted in to the special anonymous protocol | 3 years | |
Secondary | Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids | All acquired information will be noted in to the special anonymous protocol | 3 years | |
Secondary | Pain localization as assessed by note of radiating dermatome as neurologic examination | All acquired information will be noted in to the special anonymous protocol | 3 years |
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