Low Back Pain
Conditions
Keywords
pulsed radiofrequency, gelified ethanol
Brief summary
Many different minimally invasive techniques have been used for the treatment of chronic discogenic low back pain refractory to conservative treatments, with various results. The aim of this study is to assess the efficacy of the combination of intradiscal pulsed radiofrequency and gelified ethanol versus gelified ethanol alone, on pain and quality of life of patients sufferring from chronic discogenic low back pain.
Interventions
DRUGGelified ethanol combined to pulsed radiofrequency
Gelified ethanol (Discogel) is a sterile, implantable medical solution which is administered within the affected intervertebral disc nucleus pulposus, via a fine needle which is guided into the center of the disc, transdermally. Pulsed radiofrequency treatment is performed intradiscally for the management of chronic discogenic low back pain. The intradiscal pulsed radiofrequency is first applied and then combined to gelified ethanol injection via the same radiofrequency needle.
DRUGGelified ethanol
Gelified ethanol is a sterile, implantable medical solution which is administered within the affected intervertebral disc nucleus pulposus, via a fine needle which is guided into the center of the disc, transdermally.
Sponsors
Attikon Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Numeric Rating Scale (NRS) | One, three, six and twelve months after the procedure. | Mean pain intensity assessed by VAS 1, 3, 6 and 12 months after the procedure. |
| Change in Rolland Morris questionnaire | One, three, six and twelve months after the procedure. | Functional status of patient assessed by Rolland Morris questionnaire 1, 3, 6 and 12 months after the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of life (EQ 5D) | One, three, six and twelve months after the procedure. | Quality of life assessed via EQ 5D questionnaire 1, 3, 6 and 12 months after the procedure |
| Change in Satisfaction from therapy ( assessed via NRS 0-10) | One, three, six and twelve months after the procedure. | Satisfaction from therapy assessed via NRS 0-10 1, 3, 6 and 12 months after the procedure |
Countries
Greece
Outcome results
None listed