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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.

ABSTRACT: 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.

SUBMITTER: Shanthanna H

PROVIDER: S-EPMC3894138 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

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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.

Shanthanna Harsha H Chan Philip P McChesney James J Thabane Lehana L Paul James J

Journal of pain research 20140110

<h4>Background</h4>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.<h4>Methods</h4>This was a single-center, placebo-controlled, triple-blinde ...[more]

PMID: 24453500

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Project description:IntroductionLumbar radicular pain (LRP) is a common symptom characterised by a sharp, shooting or lancinating sensation localised to one or more dermatomes of the lumbar spine. Despite its high prevalence and significant impact on quality of life, the most effective conservative treatment for patients with LRP remains uncertain. When conventional treatment methods do not provide satisfactory results, the option of using epidural steroids and/or pulsed radiofrequency (PRF) treatment may be considered as a secondary approach for managing the condition. Ongoing advances in the field have led to a wide range of PRF parameters being investigated and extensively documented. Therefore, this study will aim to evaluate the treatment efficacy, sustainability and adverse effects of PRF application for different durations in patients with LRP.Methods and analysisThis study will be a double-blind, randomised, controlled trial. Eligible patients with LRP who visit the International St. Mary's Hospital pain clinic in Korea will be assigned to three groups (1:1:1 ratio) based on the duration of PRF application: 240, 360 and 480 s. Outcome measures will include an assessment of radicular pain intensity, physical function, global improvement, treatment satisfaction and adverse events. The primary outcome will be a Numeric Rating Scale (NRS) score 3 months after the procedure. The secondary outcomes will be the number of subjects in each group reporting successful treatment defined as a significant decrease of NRS or improved physical function score or high satisfaction at the 3 and 6 months follow-up. X2 or Fisher's exact test and one-way analysis of variance will be used to compare the outcomes.Ethics and disseminationThis trial was approved by the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS23EISE0018). The findings will be disseminated in peer-reviewed journals and at scientific conferences.Trial registration numberKCT0008612.

Project description:BackgroundChronic lumbar radicular pain can be described as neuropathic pain along the distribution of a particular nerve root. The dorsal root ganglion has been implicated in its pathogenesis by giving rise to abnormal impulse generation as a result of irritation, direct compression and sensitization. Chronic lumbar radicular pain is commonly treated with medications, physiotherapy and epidural steroid injections. Epidural steroid injections are associated with several common and rarer side effects such as spinal cord infarction and death. It is essential and advantageous to look for alternate interventions which could be effective with fewer side effects. Pulse radio frequency is a relatively new technique and is less destructive then conventional radiofrequency. Safety and effectiveness of pulse radio frequency in neuropathic pain has been demonstrated in animal and humans studies. Although its effects on dorsal root ganglion have been studied in animals there is only one randomized control trial in literature demonstrating its effectiveness in cervical radicular pain and none in lumbar radicular pain. Our primary objective is to study the feasibility of a larger trial in terms of recruitment and methodology. Secondary objectives are to compare the treatment effects and side effects.Methods/designsThis is a single-center, parallel, placebo-controlled, triple-blinded (patients, care-givers, and outcome assessors), randomized control trial. Participants will have a history of chronic lumbar radicular pain for at least 4 months in duration. Once randomized, all patients will have an intervention involving fluoroscopy guided needle placement to appropriate dorsal root ganglion. After test stimulation in both groups; the study group will have a pulse radio frequency treatment at 42°C for 120 s to the dorsal root ganglion, with the control group having only low intensity test stimulation for the same duration. Primary outcome is to recruit at least four patients every month with 80% of eligible patients being recruited. Secondary outcomes would be to assess success of intervention through change in the visual analogue scale measured at 4 weeks post intervention and side effects. Allocation to each group will be a 1:1 ratio with allocation block sizes of 2, 4, and 6.Trial registrationClinicalTrials.gov NCT01117870.

Project description:Background: Clinical studies have shown that applying pulsed radiofrequency (PRF) to the neural stem could relieve neuropathic pain (NP), albeit through an unclear analgesic mechanism. And animal experiments have indicated that calcitonin gene-related peptide (CGRP) expressed in the dorsal root ganglion (DRG) is involved in generating and maintaining NP. In this case, it is uncertain whether PRF plays an analgesic role by affecting CGRP expression in DRG. Methods: Rats were randomly divided into four groups: Groups A, B, C, and D. In Groups C and D, the right sciatic nerve was ligated to establish the CCI model, while in Groups A and B, the sciatic nerve was isolated without ligation. After 14 days, the right sciatic nerve in Groups B and D re-exposed and was treated with PRF on the ligation site. Thermal withdrawal latency (TWL) and hindpaw withdrawal threshold (HWT) were measured before PRF treatment (Day 0) as well as after 2, 4, 8, and 14 days of treatment. At the same time points of the behavioral tests, the right L4-L6 DRG was sampled and analyzed for CGRP expression using RT-qPCR and an enzyme-linked immunosorbent assay (ELISA). Results: Fourteen days after sciatic nerve ligation, rats in Groups C and D had a shortened TWL (P<0.001) and a reduced HWT (P<0.001) compared to those in Groups A and B. After PRF treatment, the TWL of the rats in Group D gradually extended with HWT increasing progressively. Prior to PRF treatment (Day 0), CGRP mRNA expressions in the L4-L6 DRG of Groups C and D increased significantly (P<0.001) and were 2.7 and 2.6 times that of Group A respectively. ELISA results showed that the CGRP content of Groups C and D significantly increased in comparison with that of Groups A and B (P<0.01). After PRF treatment, the mRNA expression in the DRG of Group D gradually decreased and the mRNA expression was 1.7 times that of Group A on the 4th day(P> 0.05). On the 8th and 14th days, the mRNA levels in Group D were restored to those of Groups A and B. Meanwhile, the CGRP content of Group D gradually dropped over time, from 76.4 pg/mg (Day 0) to 57.5 pg/mg (Day 14). Conclusions: In this study, we found that, after sciatic nerve ligation, rats exhibited apparent hyperalgesia and allodynia, and CGRP mRNA and CGRP contents in the L4-L6 DRG increased significantly. Through lowering CGRP expression in the DRG, PRF treatment might relieve the pain behaviors of NP.

Project description:BackgroundThere is little evidence regarding the effectiveness of intervention methods in the treatment of zoster-related pain (ZAP) after the acute phase of zoster. Generally, if ZAP remains after more than 180 days from its onset, the likelihood of pain reduction is very low; this condition is considered as a "well established" post-herpetic neuralgia (PHN). Although the clinical efficacy of intrathecal steroid injection and spinal cord stimulation (SCS) for ZAP management has been reported, these interventions are not widely used due to inherent disadvantages. Continuous epidural block is widely used in clinical practice, and the effectiveness of pulsed radiofrequency (PRF) to the dorsal root ganglion (DRG) in the treatment of ZAP already has been reported.ObjectivesThe purpose of this study was to compare the clinical efficacy of continuous epidural block and DRG PRF beyond acute phase of zoster, bur before PHN was well established (from 30 days to180 days after zoster onset).Study designRetrospective comparative study.MethodsA total of 42 medical records were analyzed. Patients were divided into two groups according to the type of procedure utilized: continuous epidural block (continuous epidural group) and DRG PRF (PRF group). The clinical efficacy of the procedure was evaluated using a numeric rating scale (NRS) and the medication dose before and 1 to 6 months after the procedure.ResultsThere was a significant decrease in the NRS value with time in both groups. However, this decrease was more significant in the PRF group than in the continuous epidural group. The medication doses decreased significantly in the PRF group over time, but not in the continuous epidural group. The rate of clinically meaningful PHN (NRS≥3) was also lower in the PRF group than in the continuous epidural group.ConclusionsThis study revealed that DRG PRF was more effective than a continuous epidural block in treating ZAP after the acute phase of zoster. A neuromodulation method such as DRG PRF may be a useful option for reducing the progression of neuropathic changes caused by the persistent transmission of a pain signal after the acute phase of zoster.

Project description:BACKGROUND:We systematically reviewed the evidence on the efficacy and safety of dorsal root ganglion (DRG) targeted pulsed radiofrequency (PRF) versus any comparator for treatment of non-neuropathic pain. METHODS:We searched MEDLINE, CINAHL, Embase, PsycINFO, clinicaltrials.gov and WHO clinical trial register until January 8, 2019. All study designs were eligible. Two authors independently conducted literature screening. Primary outcomes were pain intensity and serious adverse events (SAEs). Secondary outcomes were any other pain-related outcome and any other safety outcome that was reported. We assessed the risk of bias using the Cochrane tool and Risk of Bias In Non-randomized Studies of Interventions (ROBINS-I). We conducted narrative evidence synthesis and assessed the conclusiveness of included studies regarding efficacy and safety. RESULTS:We included 17 studies with 599 participants, which analyzed various pain syndromes. Two studies were randomized controlled trials; both included participants with low back pain (LBP). Non-randomized studies included patients with the following indications: LBP, postsurgical pain, pain associated with herpes zoster, cervicogenic headache, complex regional pain syndrome type 1, intractable vertebral metastatic pain, chronic scrotal and inguinal pain, occipital radiating pain in rheumatoid arthritis and chronic migraine. In these studies, the PRF was usually initiated after other treatments have failed. Eleven studies had positive conclusive statements (11/17) about efficacy; the remaining had positive inconclusive statements. Only three studies provided conclusiveness of evidence statements regarding safety - two indicated that the evidence was positive conclusive, and one positive inconclusive. The risk of bias was predominantly unclear in randomized and serious in non-randomized studies. CONCLUSION:Poor quality and few participants characterize evidence about benefits and harms of DRG PRF in patients with non-neuropathic pain. Results from available studies should only be considered preliminary. Not all studies have reported data regarding the safety of the intervention, but those that did, indicate that the intervention is relatively safe. As the procedure is non-destructive and early results are promising, further comparative studies about PRF in non-neuropathic pain syndromes would be welcomed.

Dataset Information

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

Publications

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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