One Day Lumbar Epidural Adhesiolysis and Hypertonic Saline
Neurolysis in Treatment of Chronic Low Back Pain:
A Randomized, Double-Blind Trial

Manchikanti, Laxmaiah; Jj, Rivera; Pampati,; Ks, Damron; Cd, McManus; De, Brandon; Wilson, F. F.

doi:10.36076/ppj.2004/7/177

Cited by 107 publications

(21 citation statements)

References 32 publications

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“…Hypertonic saline (hyperosmolar sodium chloride) is sometimes used as an adjuvant for epidural interventional procedures [31][32][33][34][35]. Adding 5-10% hypertonic sodium chloride during lumbar epidural interventions is effective and provides significant pain relief for at least 1 month.…”

Section: Discussionmentioning

confidence: 99%

Adjuvant administration of hypertonic saline in lumbar epidural intervention may be associated with successful response in patients with probable neuropathic radicular pain Screened by Douleur Neuropathique 4

et al. 2021

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Background: Chronic lumbar radicular pain often accompanies neuropathic pain. The treatment may follow a screening for probable neuropathic pain rather than the definitive diagnosis, which is often difficult in daily practice. However, interventional management may have limited effects on symptoms in patients with neuropathic radicular pain refractory to conservative treatments. The purpose of this study is to evaluate the factors associated with successful responses after lumbar epidural intervention in patients with chronic lumbar neuropathic radicular pain determined by Douleur Neuropathique 4 (DN4). Methods: We retrospectively reviewed 221 chronic lumbar radicular pain patients using a DN4 questionnaire prior to the epidural interventional procedure. The patients were divided into two groups according to the DN4 questionnaire: <4-point DN4 and ≥4 DN4. The numerical rating scale (NRS) for pain intensity, changes in physical functional status, and the use of pain medication were obtained before and 1 month after the procedure. Successful responder was defined based on robust combination of outcome parameters. The factors associated with successful response were analyzed using univariate and multivariate regression. Results: We found 170 (76.9%) patients with DN4 <4 and 51 (23.1%) with a score ≥4. Among the total 221 patients, 129 (58.4%) were successful responders and 92 (41.6%) were non-responders regardless of DN4 score. We observed a significantly lower proportion of successful responders among patients with a DN4 score ≥4 (22, 43.1%) than patients with a score <4 (107, 62.9%) (P=0.012). After adjusting in multivariate regression analysis, the DN4 score was independently associated with response after lumbar epidural intervention (odds ratio [OR]=0.838; 95% confidence interval [CI]=0.718-0.978; P=0.025). In subgroup logistic regression analysis according to the DN4 score, adjuvant administration of hypertonic saline during epidural interventions in patients with a DN4 score ≥4 (OR=3.71; CI=1.142-12.457; P=0.029) was associated with the success of the lumbar epidural procedure at 1 month. Conclusion: The adjuvant use of hypertonic saline in lumbar epidural interventions may be effective at least 1 month after the intervention in patients with probable neuropathic lumbar radicular pain ≥4 using the DN4.

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Section: Discussionmentioning

confidence: 99%

Adjuvant administration of hypertonic saline in lumbar epidural intervention may be associated with successful response in patients with probable neuropathic radicular pain Screened by Douleur Neuropathique 4

et al. 2021

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“…2,4, 35 The literature about epidural adhesiolysis in lumbo-sacral spinal pain indicates that this method is effective in the short-and long-term. 5-7,10,30-34, 36,37 There is also limited evidence on percutaneous neuroplasty in cervical spine stenosis. 38,39…”

Section: Indicationsmentioning

confidence: 99%

“…Improvement of patients' status was noted twice as often in groups treated with adhesiolysis when compared either to placebo or epidural steroid injections. 17,30,36,37 Manchikanti et al analyzed literature from 1996-2019 regarding epidural adhesiolysis in the treatment of chronic central lumbar spinal stenosis. Into their meta-analysis they included 2 RCTs, 4 observational studies and 5 studies for single arm meta-analysis and reported level II evidence for the effectiveness of both short-(≤6 months) and long-term (>6 months) treatment.…”

Section: Efficacymentioning

confidence: 99%

Percutaneous epidural adhesiolysis – treatment method for drug-resistant back pain

Zawadzka

Węclewicz

et al. 2021

Pol. Ann. Med.

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Introduction: Percutaneous epidural adhesiolysis (epidural decompressive neuroplasty, percutaneous epidural neuroplasty) is treatment method for drug-resistant back pain, including post-surgery syndrome, sciatica or spinal canal stenosis. Aim: To describe the method and outcomes of epidural adhesiolysis. Material and methods: The review of the literature on the topic of epidural adhesiolysis. Results and discussion: This procedure is usually performed in the lumbo-sacral part of the spine, although it can be also done in the cervical or thoracic parts as well. Its purpose is to administer anesthetic drugs, steroids, saline solution or hyaluronidase into the epidural space via one of the three approaches: caudal, interlaminar and transforaminal. The efficacy of epidural adhesiolysis was proven in numerous randomized controlled trials. Conclusions: The efficacy of epidural adhesiolysis was proven in numerous randomized controlled trials. When performed by an experienced physician, epidural adhesiolysis is a safe and effective method with infrequent adverse events.

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“…Manchikanti et al (34) evaluated the role of adhesiolysis, specifically with a control group receiving epidural steroid injection only where the catheter was inserted without adhesiolysis, followed by an injection of epidural steroid and local anesthetic injection with so-D espite advances in biomedical knowledge and the highest per capita health care expenditures in the world, the quality and outcome of health care vary dramatically across the United States (1-8). Accordingly, the trend to develop and implement research and support of evidence-based practice has been a focus of medical practice for the past decade.…”

Section: Targeted Delivery Of Steroids Adhesiolysis and Hypertonic Saline Neurolysismentioning

confidence: 99%

“…The results of epidural steroid injections have been variable based on the pathophysiology, the route of administration, injected drugs, and utilization of fluoroscopy (5,. In patients resistant to fluoroscopically directed epidural injections, percutaneous targeted delivery of injected drugs with or without adhesiolysis has been recommended (30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42)(43)(44). A number of studies have E93 Percutaneous Adhesiolysis in Low Back Pain without Post Surgery Syndrome or Spinal Stenosis dium chloride solution injection with a catheter in place in the sacral region (S2 or S3), and with Group II and Group III undergoing adhesiolysis.…”

Section: Introductionmentioning

confidence: 99%

Protocol for Evaluation of the Comparative Effectiveness of Percutaneous Adhesiolysis and Caudal Epidural Steroid Injections in Low Back and/or Lower Extremity Pain without Post Surgery Syndrome or Spinal Stenosis

Manchikanti

Pampati²,

Cash³

2010

Pain Phys

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Background: Treatment of chronic low back pain with or without lower extremity pain continues to be a challenge. Epidural steroids are commonly utilized in patients after the failure of conservative treatment. The results of epidural steroid injections have been variable based on the pathophysiology, the route of administration, injected drugs, and utilization of fluoroscopy. In patients resistant to fluoroscopically directed epidural injections, percutaneous epidural adhesiolysis and percutaneous targeted delivery of injections with or without adhesiolysis has been recommended. Percutaneous adhesiolysis has been studied in chronic pain syndromes related to post laminectomy syndrome and spinal stenosis with encouraging results. There is a paucity of literature regarding the effectiveness of the targeted delivery of medications with or without epidural adhesiolysis in patients recalcitrant to epidural steroid injections without a history of surgery and spinal stenosis. Study Design: A randomized, equivalence trial of percutaneous lumbar adhesiolysis and caudal epidural steroid injections in patients with low back and/or lower extremity pain without post surgery syndrome or spinal stenosis. Setting: An interventional pain management practice setting in the United States. Objective: The study is designed to evaluate the effectiveness of percutaneous epidural adhesiolysis in managing chronic low back and/or lower extremity pain in patients without post lumbar surgery syndrome or spinal stenosis and compare it with fluoroscopically directed caudal epidural steroid injections Methods: The study design includes 120 patients randomly assigned into 2 groups. Group I (60 patients), the control group, will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution; Group II (60 patients), the intervention group, will receive percutaneous adhesiolysis with target delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-participate betamethasone. Randomization will be performed by computer-generated random allocation sequence by simple randomization. Outcome Measures: Multiple outcome measures will be utilized including numeric rating scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3, 6, 12, 18 and 24 months post treatment. Significant pain relief is considered as 50% or more, whereas significant improvement in the disability score is defined as a reduction of 40% or more. Results: The results will be analyzed to show significant relief as well as improvement in functional status. Limitations: This study is limited by potentially inadequate double blinding and the lack of a placebo group.Conclusion: This protocol describes a comparative effectiveness evaluation of percutaneous adhesiolysis and epidural steroid injections in managing chronic low back and lower extremity pain in patients without post surgery syndrome or spinal stenosis utilizing a randomized, equivalence trial design. Clinical Trial Registration: NCT01053273 Key words: Chronic low back pain, disc herniation, post lumbar surgery syndrome, spinal stenosis, epidural steroid injections, percutaneous adhesiolysis, randomized trial, comparative effectiveness

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One Day Lumbar Epidural Adhesiolysis and Hypertonic Saline Neurolysis in Treatment of Chronic Low Back Pain: A Randomized, Double-Blind Trial

Cited by 107 publications

References 32 publications

Adjuvant administration of hypertonic saline in lumbar epidural intervention may be associated with successful response in patients with probable neuropathic radicular pain Screened by Douleur Neuropathique 4

Adjuvant administration of hypertonic saline in lumbar epidural intervention may be associated with successful response in patients with probable neuropathic radicular pain Screened by Douleur Neuropathique 4

Percutaneous epidural adhesiolysis – treatment method for drug-resistant back pain

Protocol for Evaluation of the Comparative Effectiveness of Percutaneous Adhesiolysis and Caudal Epidural Steroid Injections in Low Back and/or Lower Extremity Pain without Post Surgery Syndrome or Spinal Stenosis

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