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Relationship of Success Rate for Balloon Adhesiolysis with Clinical Outcomes in Chronic Intractable Lumbar Radicular Pain: A Multicenter Prospective Study.

ABSTRACT: Combined balloon decompression and epidural adhesiolysis has been reported to be effective in refractory lumbar spinal stenosis. Many cases of intractable stenosis have symptom-related multiple target sites for interventional treatment. In this situation it may not be possible to perform balloon adhesiolysis, or even only epidural adhesiolysis, for all target sites. Therefore, this multicenter prospective observational study aimed to evaluate the relationship of successful ballooning rate for multiple target sites with clinical outcome. Based on the ballooning success rate of multiple target sites, the patients were divided into three groups: below 50%, 50-85%, and above 85% ballooning. A greater ballooning success rate for multiple target sites provided a more decreased pain intensity and improved functional status in patients with chronic refractory lumbar spinal stenosis, and the improvement was maintained for 6 months. The estimated proportions of successful responders according to a multidimensional approach in the below 50%, 50-85%, and above 85% balloon success groups at 6 months after the procedure were 0.292, 0.468, and 0.507, respectively (p = 0.038). Our study suggests the more successful balloon adhesiolysis procedures for multiple target lesions are performed, the better clinical outcome can be expected at least 6 months after treatment.

SUBMITTER: Park JY

PROVIDER: S-EPMC6572522 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Relationship of Success Rate for Balloon Adhesiolysis with Clinical Outcomes in Chronic Intractable Lumbar Radicular Pain: A Multicenter Prospective Study.

Park Jun-Young JY Ji Gyu Yeul GY Lee Sang Won SW Park Jin Kyu JK Ha Dongwon D Park Youngmok Y Cho Seong-Sik SS Moon Sang Ho SH Shin Jin-Woo JW Kim Dong Joon DJ Shin Dong Ah DA Choi Seong-Soo SS

Journal of clinical medicine 20190503 5

Combined balloon decompression and epidural adhesiolysis has been reported to be effective in refractory lumbar spinal stenosis. Many cases of intractable stenosis have symptom-related multiple target sites for interventional treatment. In this situation it may not be possible to perform balloon adhesiolysis, or even only epidural adhesiolysis, for all target sites. Therefore, this multicenter prospective observational study aimed to evaluate the relationship of successful ballooning rate for mu ...[more]

PMID: 31058860

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Project description:BackgroundNo 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.MethodsThis 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.ResultsOver 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.ConclusionThe 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.

Project description:BackgroundChronic persistent low back and lower extremity pain secondary to central spinal stenosis is common and disabling. Lumbar surgical interventions with decompression or fusion are most commonly performed to manage severe spinal stenosis. However, epidural injections are also frequently performed in managing central spinal stenosis. After failure of epidural steroid injections, the next sequential step is percutaneous adhesiolysis and hypertonic saline neurolysis with a targeted delivery. The literature on the effectiveness of percutaneous adhesiolysis in managing central spinal stenosis after failure of epidural injections has not been widely studied.Study designA prospective evaluation.SettingAn interventional pain management practice, a specialty referral center, a private practice setting in the United States.ObjectiveTo evaluate the effectiveness of percutaneous epidural adhesiolysis in patients with chronic low back and lower extremity pain with lumbar central spinal stenosis.MethodsSeventy patients were recruited. The initial phase of the study was randomized, double-blind with a comparison of percutaneous adhesiolysis with caudal epidural injections. The 25 patients from the adhesiolysis group continued with follow-up, along with 45 additional patients, leading to a total of 70 patients. All patients received percutaneous adhesiolysis and appropriate placement of the Racz catheter, followed by an injection of 5 mL of 2% preservative-free lidocaine with subsequent monitoring in the recovery room. In the recovery room, each patient also received 6 mL of 10% hypertonic sodium chloride solution, and 6 mg of non-particulate betamethasone, followed by an injection of 1 mL of sodium chloride solution and removal of the catheter.Outcomes assessmentMultiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3, 6, and 12, 18 and 24 months post treatment. The primary outcome measure was 50% or more improvement in pain scores and ODI scores.ResultsOverall, a primary outcome or significant pain relief and functional status improvement of 50% or more was seen in 71% of patients at the end of 2 years. The overall number of procedures over a period of 2 years were 5.7 ± 2.73.LimitationsThe lack of a control group and a prospective design.ConclusionsSignificant relief and functional status improvement as seen in 71% of the 70 patients with percutaneous adhesiolysis utilizing local anesthetic steroids and hypertonic sodium chloride solution may be an effective management strategy in patients with chronic function limiting low back and lower extremity pain with central spinal stenosis after failure of conservatie management and fluoroscopically directed epidural injections.

Dataset Information

Relationship of Success Rate for Balloon Adhesiolysis with Clinical Outcomes in Chronic Intractable Lumbar Radicular Pain: A Multicenter Prospective Study.

Publications

Relationship of Success Rate for Balloon Adhesiolysis with Clinical Outcomes in Chronic Intractable Lumbar Radicular Pain: A Multicenter Prospective Study.

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