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Anna DE LUCA 1, Maddalena CASTELLANO 2, Carla ROERO 1, Maria CLEMENTE 1, Anna CASTIGLIONE 3, Giovannino CICCONE 3, 4, Aldo VERRI 4, Sergio ZEME 1
1 Pain Therapy and Palliative Care SCDO, AOU Città della Salute e della Scienza, Turin, Italy; 2 Pain Therapy Unit, St. Louis University Hospital, Orbassano, Turin, Italy; 3 Clinical Epidemiology Unit, AOU Città della Salute e della Scienza, Turin; 4 CPO Piemonte, Turin, Italy; 5 Vascular Surgery SCDO, AOU Città della Salute e della Scienza, Turin, Italy
BACKGROUND: Chronic ischemic leg pain is a mixed nociceptive-neuropathic pain affecting patients with critical chronic leg ischemia (CCLI). When mini-invasive techniques are indicated, pulse dose radiofrequency (PDRF) could be useful in controlling pain. Our study is aimed to evaluate: 1) short term results of a single initial PDRF treatment versus placebo; 2) efficacy and tolerability of repeated PDRF treatments.
METHODS: We enrolled in a randomized, double-blinded, controlled trial 25 patients, affected by severe ischemic pain due to CCLI, not responsive to other medical and/or surgical treatments. Pain was measured by Brief Pain Inventory (BPI) and Numeric Rating Scale (NRS). At the first visit they were randomly assigned to receive either an active PDRF or a sham treatment. Active treatment was delivered by applying 1,200 pulse doses to the sciatic and femoral nerves. Control visits were scheduled during the next 24 weeks. At each control all patients with NRS≥5 received another session of PDRF. A statistical analysis of the results was applied.
RESULTS: After the first treatment no significant differences of BPI and NRS score between active and sham treatment patients groups were recorded. A significant improvement of pain was noted as far as the number of treatments applied increased, with a final mean reduction from baseline of 49 points in BPI and of 5 points in NRS scores.
CONCLUSIONS: In patients with ischemic pain from CCLI a single PDRF treatment has no significant benefit on pain, but repeated treatments did allow to control the pain in most patients.