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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 January 2022 |
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Main ID: |
NCT02459392 |
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Date of registration:
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26/05/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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EuroPainClinics® Study II (Prospective Trial)
EPCSII |
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Scientific title:
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EuroPainClinics® Study II (Prospective Randomized Double Blinded Trial) |
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Date of first enrolment:
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December 31, 2021 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02459392 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Czech Republic
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Czechia
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Contacts
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Name:
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Juraj Mláka, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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R-Clinic |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lumbar Spinal Stenosis
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Intervention(s)
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Drug: Hyaluronic Acid
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Other: Epiduroscopy
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Drug: DepoMedrol
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Primary Outcome(s)
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Pain as assessed by the Visual analogue scale
[Time Frame: 3 years]
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Secondary Outcome(s)
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Pain localization as assessed by note of radiating dermatome as neurologic examination
[Time Frame: 3 years]
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Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids
[Time Frame: 3 years]
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Pain progress as assessed by global pain scale
[Time Frame: 3 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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