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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02343484 |
Date of registration:
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13/01/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Intradiscal Gelified Ethanol and Pulsed Radiofrequency Versus Gelified Ethanol Injection for Discogenic Low Back Pain
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Scientific title:
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Intradiscal Combination of Gelified Ethanol and Pulsed Radiofrequency Versus Gelified Ethanol Injection for the Treatment of Chronic Discogenic Low Back Pain. A Randomized Controlled Trial. |
Date of first enrolment:
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March 2013 |
Target sample size:
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40 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02343484 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Greece
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Discogenic low back pain > 6 months,
- pain refractory to conservative treatment,
- no other aetiology for pain,
- pain reported during provocative discography according to standard criteria,
- MRI imaging indicating disk degenarative disease
Exclusion Criteria:
- Red flags for low back pain,
- lumbosacral radiculopathy,
- extruded or sequestered lumbar disc,
- severe spinal stenosis,
- facet joint syndrome,
- sacroiliac joint pain,
- neurological disorders,
- psychiatric disorders,
- rheumatoid arhtritis, ancylosing spondylitis, other autoimmune arthritis,
- coagulation disorders,
- pregnancy
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Low Back Pain
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Intervention(s)
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Drug: Gelified ethanol
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Drug: Gelified ethanol combined to pulsed radiofrequency
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Primary Outcome(s)
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Change in Numeric Rating Scale (NRS)
[Time Frame: One, three, six and twelve months after the procedure.]
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Change in Rolland Morris questionnaire
[Time Frame: One, three, six and twelve months after the procedure.]
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Secondary Outcome(s)
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Change in Quality of life (EQ 5D)
[Time Frame: One, three, six and twelve months after the procedure.]
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Change in Satisfaction from therapy ( assessed via NRS 0-10)
[Time Frame: One, three, six and twelve months after the procedure.]
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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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