Radiofrequency denervation of lumbar facet joints in the treatment of chronic low back pain : a randomized, double-blind, sham lesion-controlled trial

Departments of Anaesthesia, Royal Adelaide Hospital & Queen Elizabeth Hospital, Adelaide, Australia. [corrected]
Clinical Journal of Pain (Impact Factor: 2.7). 11/2004; 21(4):335-44.
Source: PubMed

ABSTRACT Radiofrequency facet joint denervation procedures have been common practice for 2 decades in treatment of chronic low back pain. We designed this multicenter, randomized, double-blind, sham treatment controlled trial to determine the efficacy of radiofrequency facet joint denervation, as it is routinely performed.
Inclusion criteria were low back pain, duration more than 6 months, and >or=50% Visual Analog Scale (VAS) reduction on diagnostic block. Exclusion criteria were prior radiofrequency treatment, radicular syndrome, coagulopathies, specific allergies, cancer, and pregnancy. A total of 81 out of 462 patients were randomized to undergo radiofrequency facet joint denervation or sham treatment. The first evaluation was carried out 3 months after treatment. Primary outcome was determined with a combined outcome measure comprising VAS, physical activities, and analgesic intake, from a twice-weekly recorded diary. Secondary outcome measures were the separate diary parameters, global perceived effect (complete relief, >50% relief, no effect, pain increase), and SF-36 Quality of Life Questionnaire.
There were no dropouts before the first evaluation. The combined outcome measure showed no differences between radio- frequency facet joint denervation (n=40; success 27.5%) and sham (n=41; success 29.3%) (P=0.86). The VAS in both groups improved (P<0.001). Global perceived effect improved after radiofrequency facet joint denervation (P<0.05). The other secondary outcome parameters showed no significant differences. Relevant costs were evaluated.
The combined outcome measure and VAS showed no difference between radiofrequency and sham, though in both groups, significant VAS improvement occurred. The global perceived effect was in favor of radiofrequency. In selected patients, radiofrequency facet joint denervation appears to be more effective than sham treatment.

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    • "A single item (Appendix F, item 17) was used to assess the participants' perceived level of global improvement. The Global Perceived Effect (GPE) is a subjective, single-item report of the person's level of improvement and is widely used within the pain management literature (a 6-point scale; Nath, Nath, & Pettersson, 2008; Stewart, Maher, Refshauge, Bogduk, & Nicholas, 2007; van Kleef et al., 1999; van Wijk et al., 2005). Participants were given a choice of four responses on a Likert scale to answer the question of " compared to when this episode first started, how would you describe your shoulder these days? "
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    ABSTRACT: Clinical guidelines are a constructive response to the reality that practicing physicians require assistance in assimilating and applying the exponentially expanding, often contradictory, body of medical knowledge. They attempt to define practices that meet the needs of most patients under most circumstances. Ideally, specific clinical recommendations contained within practice guidelines are systematically developed by expert panels who have access to all the available evidence, have an understanding of the clinical problem, and have clinical experience with the procedure being assessed, as well as knowledge of relevant research methods. The recent development of American Pain Society (APS) guidelines has created substantial controversy because of their perceived lack of objective analysis and recommendations perceived to be biased due to conflicts of interest. To formally and carefully assess the APS guidelines' evidence synthesis for low back pain for therapeutic interventions using the same methodology utilized by the APS authors. The interventions examined were therapeutic interventions for managing low back pain, including epidural injections, adhesiolysis, facet joint interventions, and spinal cord stimulation. A literature search by 2 authors was carried out utilizing appropriate databases from 1966 through July 2008. Articles in which conflicts arose were reviewed and mediated by a third author to arrive at a consensus. Selections of manuscripts and methodologic quality assessment was also performed by at least 2 authors utilizing the same criteria applied in the APS guidelines. The guideline reassessment process included the evaluation of individual studies and systematic reviews and their translation into practice recommendations. The conclusions of APS and our critical assessment based on grading of good, fair, and poor, agreed that there is fair evidence for spinal cord stimulation in post lumbar surgery syndrome, and poor evidence for lumbar intraarticular facet joint injections, lumbar interlaminar epidural injections, caudal epidural steroids for conditions other than disc herniation or radiculitis, sacroiliac joint injections, intradiscal electrothermal therapy, endoscopic adhesiolysis, and intrathecal therapy. However, our assessment of APS guidelines for other interventional techniques, utilizing their own criteria, showed fair evidence for therapeutic lumbar facet joint nerve blocks, caudal epidural injections in disc herniation or radiculitis, percutaneous adhesiolysis in post lumbar surgery syndrome, radiofrequency neurotomy, and transforaminal epidural injections in radiculitis. Also it is illustrated that inclusion of latest literature will change the conclusions, with improved grading - caudal epidural, adhesiolysis, and lumbar facet joint nerve blocks from fair to good or poor to fair. The present critical assessment review illustrates that APS guidelines have utilized multiple studies inappropriately and have excluded appropriate studies. Our integrity assessment shows deep concerns that the APS guidelines illustrating significant methodologic failures which raise concerns about transparency, accountability, consistency, and independence. The current reassessment, using appropriate methodology, shows evidence similar to APS guidelines for several procedures, but differs extensively from published APS guidelines for multiple other procedures including caudal epidural injections, lumbar facet joint nerve blocks, lumbar radiofrequency neurotomy, and percutaneous adhesiolysis.
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