2010 May Efficacy and Safety of Pulsed Radiofrequency Treatment in Chronic Pain Syndromes Barreto J, Carrington M, Correia-Pinto J, Monteiro P, Oliveira L, Paula Pinto M, Pinto I, Pinto Faria A, Rey-Formoso J, Silvério T, Teixeira P, Soares J, Valente M ABSTRACT BACKGROUND Pulsed radiofrequency (PRF) is a growing method for treating chronic pain, defined as an unpleasing sensory experience associated with actual or potential tissue damage with duration of more than six months. AIM Our primary aim is to systematically review the evidence about efficacy and safety of pulsed radiofrequency in patients with chronic pain syndromes. METHODS We used four different databases (Pubmed, ISI Web of Knowledge, SCOPUS and Central) using the following key words: chronic, pain, pulsed and radiofrequency, applying no limits and in all languages. We included all type of articles (except meta-analyses, case series, reviews, letters and case reports of single patients) that mention the methods and results used to test the effectiveness and safety of PRF on treatment of a variety of chronic pain syndromes in humans. RESULTS Our search of literature for pulsed radiofrequency yielded 78 citations. After reviewing the abstracts and excluding the ones that didn’t match our criteria, we found 13 relevant articles. INTRODUCTION The importance of this treatment consists on its apparent lack of side effects which is appealing for those who suffer from chronic pain which has detrimental effects on physical and mental health. [1] Although it presents a growing popularity, its efficacy and safety still remains a controversial issue. It is important to notice that it is not uncommon for therapies with uncertain efficacies to become established before reliable experiments. [2] Thus, our primary aim is to systematically review the evidence about efficacy and safety of pulsed radiofrequency in patients with chronic pain syndromes. METHODS Study design A systematic review and meta-analysis of primary studies focusing on the efficacy and safety of pulsed radiofrequency in the treatment of chronic pain syndromes is being undertaken. The methodological approach includes the development of selection criteria, definition of search strategies, quality assessment of the studies, data abstraction and statistical data analysis. [3] Chronic pain is an unpleasing sensory experience associated with actual or potential tissue damage with duration of more than six months. It is the most underestimated healthcare problem impacting quality of life. [1] Pulsed radiofrequency is a recently developed treatment modality for pain syndromes such as chronic pain. It uses brief pulses of high voltage to produce controlled tissue destruction, reducing pain by modulating its transmission. Search strategy The MEDLINE database, ISI Web of Knowledge, SCOPUS and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched for identification of primary studies focusing on efficacy and safety of pulsed radiofrequency in the treatment of chronic pain syndromes. The queries used were: “pulsed[All Fields] AND radiofrequency[All Fields] AND (("pain"[MeSH Terms] OR "pain"[All Fields]) AND chronic[All Fields])” for MEDLINE, “TS=(Radiofrequency SAME pulsed) AND TS=pain AND TS=chronic” for ISI Web of knowledge, “TITLE-ABSKEY(radiofrequency) AND TITLE-ABSKEY(pulsed) AND TITLE-ABSKEY(pain) AND TITLE-ABSKEY(chronic)” for SCOPUS and “ #1 MeSH descriptor Pain explode all trees, #2 (Chronic): ti, ab, kw, #3 (Radiofrequency Near Pulsed): ti, ab, kw” for CENTRAL. Selection criteria and selection process Articles identified through the database searches were included in this review if the purpose of it was to study efficacy and safety of pulsed radiofrequency as a treatment for chronic pain syndromes. Articles that have, at least, two comparative groups - a group submitted to pulsed radiofrequency and a control group (experimental and observational studies – clinical trials, cohort studies and casecontrol studies) were included in the present review. Meta-analyses, case series, reviews, letters and case reports of single patients were excluded. Studies which were not conducted in humans were excluded as well. Studies were not excluded on the basis of quality assessment or language of publication. The studies selection process includes two phases. In the first phase of selection, the titles and abstracts of the retrieved studies were screened for relevance by at least two reviewers. In the second phase, two reviewers are independently analyzing the full-papers of articles identified as potentially relevant. Selection criteria were applied; exclusions were decided and recorded and disagreements were settled by a third reviewer. Study quality abstraction assessment and data The quality assessment of the included articles will be performed by using criteria based on CONSORT Statement (for clinical trials) [4] or STROBE Statement (for observational studies). [5] Quality of articles described as randomized controlled trials (RCT’s) will be scored by using the Jadad Scale, a three item quality scale [6]. The scale takes into account randomization, double-blinding and reporting of drop-outs and withdrawals. For observational studies we will use a selection of methodological criteria based on STROBE checklist.[7] Statistical analysis Summary presentation of general characteristics of included studies was performed applying appropriate descriptive statistics. For this descriptive analysis the statistical analysis software PASW 18th version was used. [8] Pooled analysis of efficacy and safety measures will be performed with appropriate meta-analysis methods if the available primary studies data allows it. We will calculate pooled efficacy and safety measures, present forest plots, perform heterogeneity analysis, present subgroup analysis and test for publication bias. The software RevMan version 5.0 will be used for this pooled analysis. [9] RESULTS The following are the results we have at this point of our work. These are not the final results, but the results of our search for primary studies selection. and their posterior Search for primary studies In our search we identified a total of seventy-eight articles. The MEDLINE search identified forty-eight articles. Of those forty-eight articles, four were exclusive of the MEDLINE data base. Sixty-five articles were found through SCOPUS, including forty-four that were initially identified through the MEDLINE search. Of the sixty-five articles identified in SCOPUS data base, twenty were exclusive. The ISI Web of Knowledge search yielded thirty-two articles, of which twenty-three were previously identified. The ISI Web of Knowledge had eight exclusive articles. Three articles were found through CENTRAL and they had already been identified, so there were no exclusive articles in CENTRAL data base. In 2000 was published two of the selected articles (2,6%). In 2002 were published three of the selected articles (3,8%). In 2003 were published eight of the selected articles (10,2%). In 2004 were published six of the selected articles (7,7%). In 2005 were published eight of the selected articles (10,2%). In 2006 were published eleven of the selected articles (14,2%). In 2007 were published fourteen of the selected articles (17,9%). In 2008 were published thirteen of the selected articles (16,6%). In 2009 were published eleven of the selected articles (14,2%). In 2010 were published two of the selected articles (2,6%) as Figure 1 shows. 16 14 12 10 8 6 4 2 0 2000 2002 2004 2006 2008 Figure 1 - Publication year of the identified studies 2010 The top three journals who contributed with more articles in our search were “Pain Practice: The Official Journal of World Institute of Pain” with thirteen articles (16,6%), the “Pain Physician” with nine articles (11,5%) and the “Pain Medicine (Malden, Mass.)” with seven articles (8,9%). Studies Selection In the selection process, were excluded sixty-five studies. Two articles (3,1%) were excluded because their theme did not match the expected. One (1,6%) article was excluded because the treatment was not used to treat chronic pain. Fifty-nine articles (90,7%) were excluded because the type of article was not the desired. Three articles (4,6%) were excluded because the study was not conducted in humans. All titles and abstracts were studied by two reviewers and in the inclusion/exclusion argument there were no disagreements (0%) and 78 agreements (100%). In 74 cases (94,8%) there were agreements concerning the reason of exclusion. In 4 cases (5,2%) there were disagreements concerning the reason of exclusion and was needed a third reviewer. The MEDLINE search identified forty-eight articles, of which nine met the inclusion criteria. Sixty-five articles were found through SCOPUS, including forty-four that were initially identified through the MEDLINE search. Three of the remaining articles met the inclusion criteria. The ISI Web of Knowledge search yielded thirtytwo articles, of which twenty-three were previously identified. Two of the remaining articles were included. Three articles were found through CENTRAL and they had already been identified. At the end, seventyeight articles were found and thirteen were included in this systematic review. Characteristics of included studies the author’s last name, journal in which were published and their publication year. provisionally These studies were published between 2003 and 2010. The Table 1 shows their title, first Table 1 - Characteristics of the provisionally included studies Title Percutaneous pulsed radiofrequency applied to the L2 dorsal root ganglion for treatment of chronic lowback pain: 3-year experience Last name of first author Tsou Journal Publication year Database Journal of Neurosurgery: Spine 2010 PubMed, SCOPUS, ISI Web Pulsed radiofrequency on L2 dorsal root ganglion as a therapeutic method for lumbar discogenic pain Assis Coluna/Columna 2009 SCOPUS Response to pulsed and continuous radiofrequency lesioning of the dorsal root ganglion and segmental nerves in patients with chronic lumbar radicular pain Simopoulos Pain Physycian 2008 PubMed, SCOPUS, ISI Web, CENTRAL A comparison of conventional and pulsed radiofrequency denervation in the treatment of chronic facet joint pain Tekin Clinical Journal of Pain 2007 PubMed, SCOPUS, ISI Web, CENTRAL Pulsed radiofrequency adjacent to the cervical dorsal root ganglion in chronic cervical radicular pain: a double blind sham controlled randomized clinical trial Van Zundert Pain 2007 PubMed, SCOPUS, ISI Web, CENTRAL Contemporary role of radiofrequency treatment for intractable pain syndromes Park European Congress of Neurosurgery 2007 ISI Web Pulsed radiofrequency treatment of the lumbar medial branch for facet pain: a retrospective analysis Lindner Pain Medicine 2006 PubMed, SCOPUS, ISI Web Pulsed radiofrequency of the dorsal root ganglia is superior to pharmacotherapy or pulsed radiofrequency of the intercostal nerves in the treatment of chronic postsurgical thoracic pain Cohen Pain Physician 2006 PubMed, SCOPUS Radiofrequency in the treatment of chronic cervical spine pathology. 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