The discTRODE probe applies radiofrequency (RF) current, heating the annulus to treat chronic discogenic low back pain. Randomized controlled studies have not been published. We assessed the long-term effect and safety aspects of percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) with the discTRODE probe in a prospective parallel, randomized and gender stratified, double-blind placebo-controlled study. Twenty selected patients with chronic low back pain and a positive one-level pressure-controlled provocation discography were randomized to either intra-annular PIRFT or intra-annular sham treatment. A blinded interim analysis was performed when 20 patients had been followed for six months. The 6-month analysis did not reveal any trend towards overall effect or difference between active and sham treatment for the primary endpoint: change in pain intensity (0-10). The inclusion of patients was therefore discontinued. After 12 months the overall reduction from baseline pain had reached statistical significance, but there was no significant difference between the groups. The functional outcome measures (Oswestry Disability Index, and SF 36 subscales and the relative change in pain) appeared more promising, but did not reach statistical significance when compared with sham treatment. Two actively treated and two sham-treated patients reported increased pain levels, and in both groups a higher number was unemployed after 12 months. The study did not find evidence for a benefit of PIRFT, although it cannot rule out a moderate effect. Considering the high number, reporting increased pain in our study, we would not recommend intra-annular thermal therapy with the discTRODE probe.
IntroductionThere is limited evidence for effect of interventional treatment, and pragmatic studies are needed to assess these interventions within a clinical setting. The aim of this study was to describe patients referred to an interventional pain clinic and investigate responses after spinal intervention in general and for radiofrequency ablation (RFA) and transforaminal epidural corticosteroid administration (TECA), specifically.MethodsThis is a prospective, non-controlled study of patients with chronic spinal pain. The procedures were performed in accordance with the Spine Intervention Society recommendations. Outcome data after a median of 4.5 months are presented, and for those treated with RFA also after 6 and 12 months.ResultsAmong 815 patients, 190 patients underwent diagnostic blocks only and 625 interventional treatment, of these 94 RFA and 246 TECA. Of the whole sample 70% reported pain reduction, for 49% ≥ 50%, while 9% were pain free (p < 0.001). Highest pain intensity decreased from 7.1 to 5.4 [95% Confidence Interval of the Difference (95%-CI): 1.4–1.9] (p < 0.001), while Euroqual – visual analogue scale for general health (EQ-VAS) improved from 48 to 58 (95%-CI: 7.6–11.9) (p < 0.001), and Euroqual-5 Dimensions-5 Levels Index for health related quality of life (EQ-5D-5L Index) from 0.489 to 0.628 (95%-CI: 0.123–0.157) (p < 0.001). The proportions, not taking analgesics, increased from 16% to 30%, and proportion taking strong opioids decreased from 14% to 9% (p < 0.001). We found no significant change in proportion receiving physiotherapy/other treatment nor occupational status. No complications were reported. Among patients treated with RFA, 77% reported pain reduction, for 56% ≥ 50%, while 9% were pain free (p < 0.001). Highest pain intensity decreased from 6.9 to 4.6 (95%-CI: 1.6–3.0) (p < 0.001), while EQ-VAS improved from 47 to 57 (95%-CI: 4.8–13.6 (p < 0.001), and EQ-5D-5L Index from 0.489 to 0.643 (95%-CI: 0.117–0.191) (p < 0.001). The proportion not taking analgesics, increased from 7% to 23% and proportion taking strong opioids decreased from 16% to 10%. Among patients who responded at 6- and 12-month follow up, the proportions reporting pain reduction, EQ-VAS, and EQ-5D-5L Index remained significantly improved from baseline, and the change in proportions taking analgesic and opioids achieved statistical significance. We found no significant change in proportion receiving physiotherapy/other treatment nor occupational status. Among patients treated with TECA, 58% reported pain reduction, for 36% ≥ 50%, while 5% were pain free (p < 0.001). Highest pain intensity decreased from 7.2 to 6.2 (95%-CI 0.5–1.4) (p < 0.001), while EQ-VAS improved from 46 to 52 (95%-CI: 2.0–3.6) (p < 0.001), and EQ-5D-5L Index from 0.456 to 0.571 (95%-CI: 0.077–0.138) (p < 0.001). The proportions, not taking analgesics, increased from 17% to 27% and proportion taking strong opioids decreased from 15% to 10%, but the changes did not reach statistical significance. We found no significant changes in the proportion who recieved physiotherapy/other treatment nor occupational status.ConclusionThe study demonstrates substantial short-term responses after spinal intervention and long-lasting improvement for a subsample of the RFA treated patients. We observed larger proportions reporting pain reduction among those treated with cervical RFA.ImplementationQuality assessment should be implemented in interventional pain clinics to improve treatment quality.
AimsTo evaluate the effect of spinal interventions following ISIS guidelines [1].MethodsData from all patients from April 2012 until February 2014 have been registered and followed up after 4–6 months. Patients were mainly referred from surgeons at the regional hospitals. Employment status, medication, VAS, EQ-5D-5L, EQ-VAS and pain reduction were gathered before and at the follow-up. Only patients receiving any kind of treatment were included.ResultsSo far 419/823 patients have been followed-up. Here we present levels of medication and total pain reduction for all patients and, separately, for patients treated with radio frequency facet joint medial branch neurotomy (n = 76).Opioids were reduced from 33% to 26% and no use of analgesics increased from 15% to 31% (p < 0.0159). Opioids in the RF group fell from 31% to 21%, and no use went from 2% to 31%. Of all the patients, 46% had pain reduction >50% and 9% were pain free. In the RF group the figures were 57% and 11%, respectively. No one in the RF group got worse.ConclusionIt is important to follow-up your results, even if complete scientific RCT rigour cannot be upheld Our stringent, long-term follow-up can presumably deliver reasonably reliable effect information, a majority of our patients have reduced their medication significantly (p < 0.001) and more than 50% experience a greater than 50% pain reduction, indicating a significant effect.
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