A Randomized, Multicenter, Double-Blind, Parallel Pilot Study Assessing the Effect of Mechanical Adhesiolysis vs Adhesiolysis with Corticosteroid and Hyaluronidase Administration into the Epidural Space During Epiduroscopy

Rapčan, Róbert; Kočan, Ladislav; Mláka, Juraj; Burianek, Miroslav; Kočanová, Hana; Rapčanová, Simona; Hess, Michael G.; Hammond, Anthony; Griger, Martin; Venglarčík, Michal; Gajdoš, Miroslav; Vašková, Janka

doi:10.1093/pm/pnx328

Cited by 16 publications

(22 citation statements)

References 17 publications

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“…Two articles were RCTs, 36,37 three were prospective‐, 38–40 and four were retrospective 41–44 observational studies. Together, they included 392 patients.…”

Section: Resultsmentioning

confidence: 99%

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Effectiveness of Epiduroscopy for Patients with Failed Back Surgery Syndrome: A Systematic Review and Meta‐analysis

et al. 2020

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Introduction Low‐back or leg pain in patients suffering from failed back surgery syndrome (FBSS) is often severe, having a major impact on functionality and quality of life. Despite conservative and surgical treatments, pain can be persistent. An alternative treatment option is epiduroscopy, a minimally invasive procedure based on mechanical adhesiolysis of epidural fibrosis. As epidural fibrosis is speculated to be a major contributor in the pathophysiologic process of FBSS, this review evaluates the effectiveness of epiduroscopy in FBSS patients. Methods and materials A systematic literature search was performed in PubMed, Embase, and Cochrane databases. Critical appraisal was performed using validated tools. Meta‐analysis was performed using generic inverse variance analysis. Results From the 286 identified articles, nine studies were included. The visual analogue scale (VAS) average was 7.6 at baseline, 4.5 at 6, and 4.3 at 12 months. The Oswestry Disability Index (ODI) average was 61.7% at baseline, 42.8% at 6, and 46.9% at 12 months. An average of 49% of patients experienced significant pain relief at 6 and 37% at 12 months. Meta‐analysis showed a pooled VAS mean difference of 3.4 (2.6 to 4.1; 95% confidence interval [CI]) and 2.8 (1.6 to 4.0; 95% CI) and pooled ODI mean difference of 19.4% (12.5 to 26.4%; 95% CI) and 19.8% (13.8 to 25.9%; 95% CI) at 6 and 12 months, respectively. Conclusion Current literature demonstrates a clinically relevant reduction in pain and disability scores at 6 to 12 months after mechanical adhesiolysis in FBSS patients. The quality of evidence is moderate, and the level of recommendation is weak. Practitioners should consider the benefits of epiduroscopy after weighing the risks for individual patients with FBSS.

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“…Two articles were RCTs, 36,37 three were prospective‐, 38–40 and four were retrospective 41–44 observational studies. Together, they included 392 patients.…”

Section: Resultsmentioning

confidence: 99%

“…Together, they included 392 patients. Results from one of the RCTs are reported per study arm because both study arms included mechanical adhesiolysis with different targeted drug treatment regimens 37 . For further study characteristics, see Table 1.…”

Section: Resultsmentioning

confidence: 99%

Effectiveness of Epiduroscopy for Patients with Failed Back Surgery Syndrome: A Systematic Review and Meta‐analysis

et al. 2020

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“…A limitation of SCS is that some patients have reported complications, such as lead migration, local wound infection, pocket pain, loss of therapeutic effects, and cerebrospinal fluid leak with headache; these do not occur with ESP block [4]. Epiduroscopy is another option that may allow the physician to directly visualize the adhesions in the epidural space; this has also been reported to be effective [15]. However, this procedure is more invasive than ESP block and can only be performed at specialized institutions, particularly in Japan.…”

Section: Discussionmentioning

confidence: 99%

Erector spinae plane block for low back pain in failed back surgery syndrome: a case report

Takahashi

Suzuki

2018

JA Clin Rep

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Background: Patients with failed back surgery syndrome (FBSS) experience chronic back pain following spinal surgery, and effective treatment is difficult because of multiple contributing factors. Case presentation: Here we report a case involving a 72-year-old woman who experienced recurrent low back pain after undergoing two back surgeries. She was treated with erector spinae plane (ESP) block, which affected the dorsal rami of the spinal nerves from T12 to L5. Pain relief lasted for approximately 10 h after the initial block, and successful low back pain relief was achieved after a total of three trials. Conclusions: ESP block, which is an easy and safe procedure, can be used to treat FBSS-associated low back pain.

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“…Indeed, endoscopic adhesiolysis was shown to be more effective for lumbar PLS in the short term (<6 months) than in the long term (>6 months) [20]. Specifically, the ODI values were restored to baseline in most of the patients at the one-year follow-up in another study [21]. Similarly, the present results showed that the number of responders at the one-and six-month follow-up was 47 (32.0%) and 33 (22.4%), respectively ( Figure 2).…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of and Factors Associated with Balloon Adhesiolysis in Patients with Lumbar Post-Laminectomy Syndrome: A Retrospective Study

Shin

Kim

et al. 2020

JCM

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Post-laminectomy syndrome (PLS) is characterized by chronic pain and complex pathological entity after back surgery. An epidural adhesiolysis is considered an effective treatment option for lumbar PLS. In this study, we retrospectively analyzed the outcome and evaluated the predictive factors of combined epidural adhesiolysis and balloon decompression using inflatable balloon catheters in lumbar PLS cases. One hundred and forty-seven subjects were retrospectively assessed and analyzed. The percentages of patients who exhibited treatment response were 32.0%, 24.5%, and 22.4% of the study population at 1, 3, and 6 months, respectively. In multivariate logistic regression analysis, the pain duration was independently associated with the treatment response six months after combined epidural adhesiolysis and balloon decompression (odds ratio = 0.985, 95% confidence interval = 0.971–0.999; p = 0.038). In addition, the receiver operating characteristic curve analysis showed that the area under the curve of pain duration after lumbar surgery was 0.680 (95% confidence interval = 0.597–0.754, p = 0.002), with an optimal cut-off value of ≤14 months, sensitivity of 51.5%, and specificity of 81.4% Our results suggest that an early intervention using combined epidural adhesiolysis and balloon decompression in lumbar PLS patients may be associated with a favorable outcome, even though it has limited effectiveness.

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A Randomized, Multicenter, Double-Blind, Parallel Pilot Study Assessing the Effect of Mechanical Adhesiolysis vs Adhesiolysis with Corticosteroid and Hyaluronidase Administration into the Epidural Space During Epiduroscopy

Abstract: A significant improvement of leg and back pain was found in both groups after six months. ODI was significantly improved only in group B in both the six- and 12-month intervals. Back pain at one-year follow-up was only improved in group B.

Cited by 16 publications

References 17 publications

Effectiveness of Epiduroscopy for Patients with Failed Back Surgery Syndrome: A Systematic Review and Meta‐analysis

Effectiveness of Epiduroscopy for Patients with Failed Back Surgery Syndrome: A Systematic Review and Meta‐analysis

Erector spinae plane block for low back pain in failed back surgery syndrome: a case report

Effectiveness of and Factors Associated with Balloon Adhesiolysis in Patients with Lumbar Post-Laminectomy Syndrome: A Retrospective Study

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