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Journal Journal of pain research
Year 2014
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Background: No proof of efficacy, in the form of a randomized controlled trial (RCT), exists to support pulsed radiofrequency (PRF) treatment of the dorsal root ganglion (DRG) for chronic lumbar radicular (CLR) pain. We determined the feasibility of a larger trial (primary objective), and also explored the efficacy of PRF in decreasing pain on a visual analog scale (VAS) and improving the Oswestry Disability Index. Methods: This was a single-center, placebo-controlled, triple-blinded RCT. Patients were randomized to a placebo group (needle placement) or a treatment group (PRF at 42°C for 120 seconds to the DRG). Patients were followed up for 3 months post procedure. Outcomes with regard to pain, Oswestry Disability Index score, and side effects were analyzed on an intention-to-treat basis. Results: Over 15 months, 350 potential patients were identified and 56 were assessed for eligibility. Fifteen of them did not meet the selection criteria. Of the 41 eligible patients, 32 (78%) were recruited. One patient opted out before intervention. Three patients were lost to follow-up at 3 months. Mean VAS differences were not significantly different at 4 weeks (-0.36, 95% confidence interval [CI], -2.29, 1.57) or at 3 months (-0.76, 95% CI, -3.14, 1.61). The difference in mean Oswestry Disability Index score was also not significantly different at 4 weeks (-2%, 95% CI, -14%, 10%) or 3 months (-7%, 95% CI, -21%, 6%). There were no major side effects. Six of 16 patients in the PRF group and three of 15 in the placebo group showed a >50% decrease in VAS score. Conclusion: The recruitment rate was partially successful. At 3 months, the relative success of PRF-DRG was small. A large-scale trial to establish efficacy is not practically feasible considering the small effect size, which would necessitate recruitment of a challengingly large number of participants over a number of years. Until clear parameters for application of PRF are established, clinicians will need to use their individual judgment regarding its clinical applicability, given the present evidence. © 2014 Shanthanna et al.

Primary study

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Journal The Clinical journal of pain
Year 2013
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OBJECTIVES: Sacroiliac joint pain is a common cause of low back pain (LBP). Cooled radiofrequency ablation (c-RFA) of the lateral branches was recently introduced with the hypothesis that it creates larger lesions to overcome the anatomic variability of the lateral branches and achieve better outcomes as compared with the traditional radiofrequency approach (t-RFA). The objective of this comparative study is to determine if c-RFA is superior over t-RFA in providing longer pain relief. METHODS: Data on 88 patients were retrospectively collected between January 2006 and June 2009. Patients' pain relief was registered as <50%, 50% to 80%, or >80% at 1, 3, 6, and 12 months after procedure. The duration of pain relief, defined as the time until the patient reported <50% pain relief, served as our primary outcome. Demographic, morphometric, and procedural characteristics were analyzed using standard descriptive statistics and univariable tests. The relationship between RFA technique and duration of pain relief was evaluated using multivariable Cox regression. RESULTS: Among the 88 patients, 30 received t-RFA and 58 received c-RFA. We did not find a significant univariable relationship between RFA technique and duration of pain relief either before (P=0.76, Sun test) or after (P=0.95, Wald test) adjusting for the potentially confounding variables. Both cooled and traditional RFAs provided >50% pain reduction for 3 to 6 months in majority of the patients. DISCUSSION: This study did not reveal evidence that c-RFA of the lateral branches provides longer relief of sacroiliac joint pain as compared with t-RFA.

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Journal Pain medicine (Malden, Mass.)
Year 2013
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BACKGROUND.: The sacroiliac joint (SIJ) complex has been identified as a common source of chronic low back pain. Radiofrequency (RF) neurotomy has been investigated in recent years as a minimally invasive treatment option for SIJ-mediated low back pain. A number of RF neurotomy methodologies have been investigated, including the use of cooled RF. OBJECTIVE.: To retrospectively evaluate the use of cooled RF lateral branch neurotomy (LBN) to treat chronic SIJ-mediated low back pain in a large European study population. STUDY DESIGN.: The electronic records of 126 patients with chronic low back pain who underwent treatment with cooled RF LBN were identified. Subjects were selected for treatment based on physical examination and positive response (≥50% pain relief) to an intra-articular SIJ block. Cooled RF LBN involved lesioning the L5 dorsal ramus and lateral to the S1, S2, and S3 posterior sacral foraminal apertures. Visual analog scale (VAS) pain scores, quality of life, medication usage, and satisfaction were collected before the procedure, at 3-4 weeks postprocedure (N = 97), and once again between 4 and 20 months postprocedure (N = 105). RESULTS.: When stratified by time to final follow-up (4-6, 6-12, and >12 months, respectively): 86%, 71%, and 48% of subjects experienced ≥50% reduction in VAS pain scores, 96%, 93%, and 85% reported their quality of life as much improved or improved, and 100%, 62%, and 67% of opioid users stopped or decreased use of opioids. CONCLUSIONS.: The current results show promising, durable improvements in pain, quality of life, and medication usage in a large European study population, with benefits persisting in some subjects at 20 months after treatment. These results are consistent with previous study findings on the use of cooled RF to treat SIJ-mediated low back pain.

Primary study

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Journal Anesthesia and analgesia
Year 2013
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BACKGROUND: Lumbar facet joint degeneration is a source of chronic low back pain, with an incidence of 15% to 45% among patients with low back pain. Various therapeutic techniques in the treatment of facet-related pain have been described in the literature, including intraarticular lumbar facet joint steroid injections and radiofrequency denervation. In this study, we compared the effectiveness of intraarticular facet joint steroid injections and radiofrequency denervation. METHODS: Our randomized, double-blind, controlled study included patients who received intraarticular steroid infiltrations in the lumbar facet joints (L3/L4-L5/S1) and patients who underwent radiofrequency denervation of L3/L4-L5/S1 segments. The inclusion criteria were based first on magnetic resonance imaging findings showing hypertrophy of the facet joints L3/L4-L5/S1 and a positive response to an intraarticular test infiltration of the facet joints L3/L4-L5/S1 with local anesthetics. The primary end point was the Roland-Morris Questionnaire. Secondary end points were the visual analog scale and the Oswestry Disability Index. All outcome assessments were performed at baseline and at 6 months. RESULTS: Fifty-six patients were randomized; 24 of 29 patients in the steroid injection group and 26 of 27 patients in the denervation group completed the 6-month follow-up. Pain relief and functional improvement were observed in both groups. There were no significant differences between the 2 groups for the primary end point (95% confidence interval [CI], -3 to 4) and for both secondary end points (95% CI for visual analog scale, -2 to 1; 95% CI for Oswestry Disability Index, -18 to 0). CONCLUSIONS: Intraarticular steroid infiltration or radiofrequency denervation appear to be a managing option for chronic function-limiting low back pain of facet origin with favorable short- and midterm results in terms of pain relief and function improvement, but improvements were similar in both groups.

Primary study

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Journal Pain medicine (Malden, Mass.)
Year 2013
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OBJECTIVE: The aim was to compare the efficacy of intradiscal biacuplasty (IDB) with that of placebo treatment for discogenic low back pain. DESIGN: This is a randomized, placebo-controlled trial. Subjects were randomized on a 1:1 basis to IDB and sham groups. Follow-ups were conducted at 1, 3, and 6 months. Subjects and coordinators were blinded to randomization until 6 months. Of the 1,894 subjects screened, 64 subjects were enrolled, and 59 were treated: 29 randomized to IDB and 30 to sham. All subjects had a history of chronic low back pain for longer than 6 months. INTERVENTIONS: Two cooled radiofrequency (RF) electrodes placed in a bipolar manner in affected discs to lesion the nociceptive fibers of the annulus fibrosus. The sham procedure was identical to the active treatment except that probes were not directly inserted into the disc space, and RF energy was not actively delivered. RESULTS: The principal outcome measures were physical function, pain, disability, and opioid usage. Patients in the IDB group exhibited statistically significant improvements in physical function (P = 0.029), pain (P = 0.006), and disability (P = 0.037) at 6-month follow-up as compared to patients who received sham treatment. Treatment patients reported a reduction of 16 mg daily intake of opioids at 6 months; however, the results were not statistically different from sham patients. CONCLUSIONS: The results suggest that the clinical benefits observed in this study are the result of non-placebo treatment effects afforded by IDB. IDB should be recommended to select the patients with chronic discogenic low back pain. (Clinicaltrials.gov number, NCT00750191.).

Primary study

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Authors Moon JY , Lee PB , Kim YC , Choi SP , Sim WS
Journal Anesthesia and analgesia
Year 2013
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BACKGROUND: An alternative technique involving a "distal approach" can be used for lumbar medial branch radiofrequency denervation (LMBRFD). We described and assessed this technique by comparing it with a conventional tunnel vision approach in a prospective randomized trial. METHODS: Eighty-two patients underwent LMBRFD by a distal (n = 41) or a tunnel vision approach (n = 41). The primary end point was a comparison of the mean difference in the change of 11-point numeric rating scale (NRS) scores of low back pain from entry to the scores at 1 month (NRS at baseline--NRS at 1 month) and at 6 months (NRS at baseline--NRS at 6 months) between the distal approach group and the tunnel vision approach group. The secondary end points were a change of NRS and the Oswestry disability index over time. RESULTS: Thirty-four patients in each group had complete time courses. There were no statistically significant differences in the change of NRS scores between the groups at 1 month (corrected P = 0.19; 97.5% 2-sided confidence interval [CI], -1.37 to 0.37) and 6 months (corrected P = 0.53; 97.5% CI, -1.36 to 0.77). Patients in both groups showed a statistically significant reduction in NRS and Oswestry disability index scores from baseline to that of the scores at 1 and 6 months (all P < 0.0001, Bonferroni corrected). The procedure-related pain score was significantly lower in the distal approach group (P = 0.001; 99% CI, -2.00 to -0.23). CONCLUSIONS: Patients who underwent LMBRFD by the tunnel vision or distal approaches showed significant pain relief at the 6-month follow-up. Less periprocedural pain was reported in the distal approach group. We consider that the distal approach provides an improved option for LMBRFD.

Primary study

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Journal Turkish neurosurgery
Year 2012
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AIM: The study was conducted to compare the clinical effectiveness of FJ injections (FJI) and FJ radiofrequency (FJRF) denervation in patients with chronic low back pain. MATERIAL AND METHODS: This study included 100 patients; 50 in FJI 50 in FJRF group. VNS, NASS and EQ-5D were used to evaluate the outcomes. All outcome assessments were performed at baseline, 3 months, 6 months and 12 months. RESULTS: FJI in early post-op but FJRF in 1st, 6th and 12th month VNS showed better results (p < 0.001). There was no significant difference in the 1st (p=1) and 6th month (p=0.13) but in 12th month (p=0.04) in NASS. Increase in level number showed positive effect in NASS in FJRF group (p=0.018) but no effect in FJI group (p=0.823) in the 12th month follow-up. There was no significant difference with respect to 1st month (p=0.17), 6th month (p=0.22) and 12th month (p=0.11) post-procedure follow-ups in EQ-5D. At the short term FJI was more effective than FJRF however in midterm follow-up FJRF had more satisfying results than FJRF. CONCLUSION: To our knowledge, the first choice should be the FJI and if pain reoccurs after a period of time or injection is not effective, RF procedure should be used for the treatment of chronic lumbar pain.

Primary study

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Authors Patel N , Gross A , Brown L , Gekht G
Journal Pain medicine (Malden, Mass.)
Year 2012
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OBJECTIVE: The objective of this study was to compare the efficacy of lateral branch neurotomy using cooled radiofrequency to a sham intervention for sacroiliac joint pain. DESIGN: Fifty-one subjects were randomized on a 2:1 basis to lateral branch neurotomy and sham groups, respectively. Follow-ups were conducted at 1, 3, 6, and 9 months. Subjects and coordinators were blinded to randomization until 3 months. Sham subjects were allowed to crossover to lateral branch neurotomy after 3 months. SUBJECTS: Subjects 18-88 years of age had chronic (>6 months) axial back pain and positive response to dual lateral branch blocks. INTERVENTIONS: Lateral branch neurotomy involved the use of cooled radiofrequency electrodes to ablate the S1-S3 lateral branches and the L5 dorsal ramus. The sham procedure was identical to the active treatment, except that radiofrequency energy was not delivered. OUTCOME MEASURES: The principal outcome measures were pain (numerical rating scale, SF-36BP), physical function (SF-36PF), disability (Oswestry disability index), quality of life (assessment of quality of life), and treatment success. RESULTS: Statistically significant changes in pain, physical function, disability, and quality of life were found at 3-month follow-up, with all changes favoring the lateral branch neurotomy group. At 3-month follow-up, 47% of treated patients and 12% of sham subjects achieved treatment success. At 6 and 9 months, respectively, 38% and 59% of treated subjects achieved treatment success. CONCLUSIONS: The treatment group showed significant improvements in pain, disability, physical function, and quality of life as compared with the sham group. The duration and magnitude of relief was consistent with previous studies, with current results showing benefits extending beyond 9 months.

Primary study

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Journal HealthMED
Year 2012
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Primary study

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Authors Speldewinde GC
Journal Pain medicine (Malden, Mass.)
Year 2011
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OBJECTIVE: To evaluate the analgesic, physical, and psychological outcomes of percutaneous radiofrequency neurotomy for persistent zygapophysial and sacroiliac joint pain in a community setting. DESIGN: A prospective evaluation of 379 consecutive neurotomies in a single specialist practice over an extended period 2001-2010. SETTING: A provincial community environment in Australia. PATIENTS: All patients who had positive responses to diagnostic blocks, performed according to the guidelines of the International Spine Intervention Society by three trained specialists, underwent percutaneous radiofrequency thermal neurotomies performed by the author. INTERVENTIONS: Radiofrequency neurotomies to denervate the zygapophysial or sacroiliac joints according to the standards of the International Spine Intervention Society. OUTCOME MEASURES: Numerical Rating Scale for Pain, Functional Rating Index, 4-Activities of Daily Living Scale, General Health Questionnaire, Depression Anxiety Stress Scale, duration of pain relief, "whether they would do it again," and overall amount of pain relief. RESULTS: Of 379 procedures, 272 (72%) were regarded as successful by the patients. Irrespective of region treated. The results were highly significant by t-test, and the effect size was large as determined by the Cohen's d. Adverse events were infrequent and relatively minor. Repetitions of the procedure were highly successful. CONCLUSIONS: Neurotomy of the cervical, thoracic, lumbar, and sacroiliac joints were uniformly successful with 72% recipients obtaining an average of 86% reduction in pain for a period of 12 months.