Primary studies included in this systematic review

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Primary study

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Pulsed radiofrequency treatment of the lumbar dorsal root ganglion in patients with chronic lumbar radicular pain: A randomized, placebo-controlled pilot study

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Journal Journal of pain research
Year 2014
Links Pubmed DOI PubMed Central

This article is included in 2 Systematic reviews Systematic reviews (2 references)

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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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A comparison of intraarticular lumbar facet joint steroid injections and lumbar facet joint radiofrequency denervation in the treatment of low back pain: a randomized, controlled, double-blind trial.

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Journal Anesthesia and analgesia
Year 2013
Links Pubmed DOI

This article is included in 3 Systematic reviews Systematic reviews (3 references)

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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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A randomized, placebo-controlled trial of transdiscal radiofrequency, biacuplasty for treatment of discogenic lower back pain.

Journal Pain medicine (Malden, Mass.)
Year 2013
Links Pubmed DOI

This article is included in 3 Systematic reviews Systematic reviews (3 references)

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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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An alternative distal approach for the lumbar medial branch radiofrequency denervation: a prospective randomized comparative study.

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Authors Moon JY , Lee PB , Kim YC , Choi SP , Sim WS
Journal Anesthesia and analgesia
Year 2013
Links Pubmed DOI

This article is included in 2 Systematic reviews Systematic reviews (2 references)

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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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Comparison of effectiveness of facet joint injection and radiofrequency denervation in chronic low back pain.

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Journal Turkish neurosurgery
Year 2012
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This article is included in 3 Systematic reviews Systematic reviews (3 references)

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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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A randomized, placebo-controlled study to assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint pain.

Authors Patel N , Gross A , Brown L , Gekht G
Journal Pain medicine (Malden, Mass.)
Year 2012
Links Pubmed DOI

This article is included in 3 Systematic reviews Systematic reviews (3 references)

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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

Unclassified

Effects of facet joint nerve block addition to radiofrequency in the treatment of low back pain

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Journal HealthMED
Year 2012

This article is included in 1 Systematic review Systematic reviews (1 reference)

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Primary study

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A comparison between pulsed radiofrequency and electro-acupuncture for relieving pain in patients with chronic low back pain.

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Authors Lin ML , Lin MH , Fen JJ , Lin WT , Lin CW , Chen PQ
Journal Acupuncture & electro-therapeutics research
Year 2010
Links Pubmed DOI

This article is included in 1 Systematic review Systematic reviews (1 reference)

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Many treatment options for chronic low back pain are available, including varied forms of electric stimulation. But little is known about the electricity effect between electro-acupuncture and pulsed radiofrequency. The objective of this study is to assess the difference in effectiveness of pain relief between pulsed radiofrequency and electro-acupuncture. Visual analog score (VAS) pain score, the Oswestry disability index (ODI) to measure a patient's permanent functional disability, and Short form 36 (SF-36) which is a survey used in health assessment to determine the cost-effectiveness of a health treatment, were used as rating systems to measure the pain relief and functional improvement effect of pulsed radiofrequency and electro-acupuncture, based on the methodological quality of the randomized controlled trials, the relevance between the study groups, and the consistency of the outcome evaluation. First, the baseline status before therapy shows no age and gender influence in the SF-36 and VAS score but it is significant in the ODI questionnaire. From ANOVA analyses, it is apparent that radiofrequency therapy is a significant improvement over electro-acupuncture therapy after one month. But electro-acupuncture also showed functional improvement in the lumbar spine from the ODI. This study provides sufficient evidence of the superiority of pulsed radiofrequency (PRF) therapy for low back pain relief compared with both electro-acupuncture (EA) therapy and the control group. But the functional improvement of the lumbar spine was proved under EA therapy only. Both therapies are related to electricity effects.

Primary study

Unclassified

A randomized double-blind controlled trial of intra-annular radiofrequency thermal disc therapy - A 12-month follow-up

Journal Pain
Year 2009
Links Pubmed DOI

This article is included in 4 Systematic reviews Systematic reviews (4 references)

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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. © 2009 International Association for the Study of Pain.

Primary study

Unclassified

Randomized placebo-controlled study evaluating lateral branch radiofrequency denervation for sacroiliac joint pain

Journal Anesthesiology
Year 2008
Links Pubmed DOI PubMed Central

This article is included in 3 Systematic reviews Systematic reviews (3 references)

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Background: Sacroiliac joint pain is a challenging condition accounting for approximately 20% of cases of chronic low back pain. Currently, there are no effective long-term treatment options for sacroiliac joint pain. Methods: A randomized placebo-controlled study was conducted in 28 patients with injection-diagnosed sacroiliac joint pain. Fourteen patients received L4-L5 primary dorsal rami and S1-S3 lateral branch radiofrequency denervation using cooling-probe technology after a local anesthetic block, and 14 patients received the local anesthetic block followed by placebo denervation. Patients who did not respond to placebo injections crossed over and were treated with radiofrequency denervation using conventional technology. Results: One, 3, and 6 months after the procedure, 11 (79%), 9 (64%), and 8 (57%) radiofrequency- treated patients experienced pain relief of 50% or greater and significant functional improvement. In contrast, only 2 patients (14%) in the placebo group experienced significant improvement at their 1-month follow-up, and none experienced benefit 3 months after the procedure. In the crossover group (n = 11), 7 (64%), 6 (55%), and 4 (36%) experienced improvement 1, 3, and 6 months after the procedure. One year after treatment, only 2 patients (14%) in the treatment group continued to demonstrate persistent pain relief. Conclusions: These results provide preliminary evidence that L4 and L5 primary dorsal rami and S1-S3 lateral branch radiofrequency denervation may provide intermediate-term pain relief and functional benefit in selected patients with suspected sacroiliac joint pain. Larger studies are needed to confirm these results and to determine the optimal candidates and treatment parameters for this poorly understood disorder. Copyright © 2008 The American Society of Anesthesiologists, Inc. Lippincott Williams & Wilkins, Inc.