A randomized, double-blind controlled trial of lumbar interlaminar epidural injections in central spinal stenosis: 2-year follow-up.

BACKGROUND: While low back pain is the number one cause of disability in the United States, lumbar spinal stenosis along with intervertebral disc herniation and degenerative spondylolisthesis is one of the 3 most common diagnosis of low back and leg pain for which surgery is performed. Numerous modalities of treatments including drug therapy and complex surgical fusions have been recommended for treatment of central spinal stenosis. Epidural injections are one of the commonly performed nonsurgical interventions in managing central spinal stenosis; however, there has been paucity of literature in reference to efficacy of epidural injections in managing central spinal stenosis with lumbar interlaminar epidural injections. STUDY DESIGN: A randomized, double-blind, active controlled trial. SETTING: Private interventional pain management practice and specialty referral center in the United States. OBJECTIVE: To assess the effectiveness of lumbar interlaminar epidural injections with or without steroids in providing effective and long-lasting pain relief with improvement in functional status for the management of chronic low back and lower extremity pain related to lumbar central spinal stenosis. METHODS: A randomized, double-blind, active-control trial was designed with the inclusion of 120 patients assigned to 2 groups. Group I patients received lumbar interlaminar epidural injections of local anesthetic (lidocaine 0.5%) 6 mL, whereas Group II received lumbar interlaminar epidural injections with local anesthetic (lidocaine 0.5%) 5 mL mixed with 1 mL of steroids and 6 mg of betamethasone. OUTCOMES ASSESSMENT: Outcomes were assessed utilizing the numeric pain rating scale (NRS) and Oswestry Disability Index (ODI) at 3, 6, 12, 18, and 24 months post treatment. The primary outcome measure was significant improvement, defined as 50% improvement in pain and disability scores. RESULTS: Significant relief and functional status improvement was seen in 72% and 73% of patients in Groups I and II at the end of 2 years considering all participants; however, this was 84% and 85% in the successful group. Overall significant improvement was achieved for 65.7 ± 37.3 weeks in Group 1 and 68.9 ± 37.7 weeks in Group II at the end of 2 years when all participants were considered; whereas, this was 77 ± 27.8 weeks and 77.9 ± 30.2 weeks when they were separated into successful categories. The average number of procedures per patient was 5 to 6 in both groups. LIMITATIONS: Limitations of this trial include lack of placebo control group and treatment of patients with multiple procedures over a period of 2 years. CONCLUSION: Lumbar interlaminar epidural injections of local anesthetic with or without steroids provide relief in a significant proportion of patients with lumbar central spinal stenosis. CLINICAL TRIAL: NCT00681447.

Thoracic interlaminar epidural injections in managing chronic thoracic pain: a randomized, double-blind, controlled trial with a 2-year follow-up.

BACKGROUND: Reports of prevalence of spinal pain indicate the prevalence of thoracic pain in approximately 13% of the general population compared to 32% of the population with neck pain and 43% of the population with low back pain during the past year. Even though, thoracic pain is less common than neck or low back pain, the degree of disability resulting from thoracic pain disorders seems to be similar to other painful conditions. Interventions in managing chronic thoracic pain are also less frequent, leading to the paucity of literature about various interventions in managing chronic thoracic pain. Thoracic intervertebral discs and thoracic facet joints have been shown to be pain generators, even though thoracic radicular pain is very infrequent. Thoracic epidural injections are one of the commonly performed procedures in managing thoracic pain. The efficacy of thoracic epidural injections has not been well studied. STUDY DESIGN: A randomized, double-blind, active controlled trial. SETTING:   Private interventional pain management practice and specialty referral center in the United States. OBJECTIVE: The primary objective was to assess the effectiveness of thoracic interlaminar epidural injections in providing effective pain relief and improving function in patients with chronic mid and/or upper back pain. METHODS: One hundred and ten patients were randomly assigned into 2 groups with 55 patients in each group receiving either local anesthetic alone (Group I) or local anesthetic with steroids (Group II). Randomization was performed by computer-generated random allocation sequence by simple randomization. OUTCOMES ASSESSMENT: Outcomes were assessed utilizing Numeric Rating Scale (NRS), the Oswestry Disability Index (ODI) 2.0, employment status, and opioid intake. The patients experiencing greater than 3 weeks of significant improvement with the first 2 procedures were considered as successful. Others were considered as failed participants. Significant improvement was defined as a decrease of greater than 50% NRS scores and ODI scores with measurements performed at baseline, 3, 6, 12, 18, and 24 months post treatment. RESULTS: Significant improvement was seen in 71% in Group I and 80% in Group II at the end of 2 years with all participants; however, improvement was seen in 80% and 86% when only successful patients were considered. Therapeutic procedural characteristics showed 5 to 6 procedures per 2 years with total average relief of 80 weeks in Group I and 78 weeks in Group II in the successful patient category; whereas, it was 71 and 72 weeks when all patients were considered. LIMITATIONS: Limitations of this assessment include lack of a placebo group. CONCLUSIONS: Based on the results of this trial, it is concluded that chronic thoracic pain of non-facet joint origin may be managed conservatively with thoracic interlaminar epidural injections with or without steroids.

A randomized, double-blind, active-controlled trial of fluoroscopic lumbar interlaminar epidural injections in chronic axial or discogenic low back pain: results of 2-year follow-up.

BACKGROUND: Chronic low back with or without lower extremity pain is extremely common, expensive, and disabling. However, all modalities of treatments are directed towards disc herniation which is responsible for a very small proportion of the patients. Thus, chronic low back pain without disc herniation is common. Multiple modalities of treatments are utilized in managing axial or discogenic pain including surgery and epidural injections including surgery, intradiscal therapies, and epidural injections. However, there is continued debate on the effectiveness, indications, and medical necessity of all modalities treatments in managing axial or discogenic pain in the lumbar spine. STUDY DESIGN: A randomized, double-blind, active control trial. SETTING: A private practice, specialty referral, interventional pain management practice in the United States. OBJECTIVES: To evaluate the ability to assess the effectiveness of lumbar interlaminar epidural injections in managing chronic axial or discogenic low back pain with epidural injections of local anesthetic with or without steroids. METHODS: In this study, a total of 120 patients were randomly allocated to one of the 2 groups receiving either local anesthetic alone or local anesthetic with steroids with 60 patients in each group. The primary outcome measure was at least 50% improvement in the numeric rating scale (NRS) and Oswestry Disability Index (ODI). Outcomes were assessed at 3, 6, 12, 18, and 24 months post treatment. RESULTS: Significant pain relief and functional status improvement defined as at least 50% or more reduction in scores from baseline were observed in 72% of patients receiving local anesthetic alone and 67% of the patients receiving local anesthetic with steroids. Opioid intake was reduced from baseline in each group for 2 years. LIMITATIONS: The results of the study are limited by the lack of a placebo group. CONCLUSION: Lumbar interlaminar epidural injections of local anesthetic with or without steroids are effective in patients with chronic axial low back pain of discogenic origin without facet joint pain, disc herniation, and/or radiculitis. TRIAL REGISTRATION: NCT00681447.

An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations.

OBJECTIVE: To develop evidence-based clinical practice guidelines for interventional techniques in the diagnosis and treatment of chronic spinal pain. METHODOLOGY: Systematic assessment of the literature. EVIDENCE: I. Lumbar Spine • The evidence for accuracy of diagnostic selective nerve root blocks is limited; whereas for lumbar provocation discography, it is fair. • The evidence for diagnostic lumbar facet joint nerve blocks and diagnostic sacroiliac intraarticular injections is good with 75% to 100% pain relief as criterion standard with controlled local anesthetic or placebo blocks. • The evidence is good in managing disc herniation or radiculitis for caudal, interlaminar, and transforaminal epidural injections; fair for axial or discogenic pain without disc herniation, radiculitis or facet joint pain with caudal, and interlaminar epidural injections, and limited for transforaminal epidural injections; fair for spinal stenosis with caudal, interlaminar, and transforaminal epidural injections; and fair for post surgery syndrome with caudal epidural injections and limited with transforaminal epidural injections. • The evidence for therapeutic facet joint interventions is good for conventional radiofrequency, limited for pulsed radiofrequency, fair to good for lumbar facet joint nerve blocks, and limited for intraarticular injections. • For sacroiliac joint interventions, the evidence for cooled radiofrequency neurotomy is fair; limited for intraarticular injections and periarticular injections; and limited for both pulsed radiofrequency and conventional radiofrequency neurotomy. • For lumbar percutaneous adhesiolysis, the evidence is fair in managing chronic low back and lower extremity pain secondary to post surgery syndrome and spinal stenosis. • For intradiscal procedures, the evidence for intradiscal electrothermal therapy (IDET) and biaculoplasty is limited to fair and is limited for discTRODE. • For percutaneous disc decompression, the evidence is limited for automated percutaneous lumbar discectomy (APLD), percutaneous lumbar laser disc decompression, and Dekompressor; and limited to fair for nucleoplasty for which the Centers for Medicare and Medicaid Services (CMS) has issued a noncoverage decision. II. Cervical Spine • The evidence for cervical provocation discography is limited; whereas the evidence for diagnostic cervical facet joint nerve blocks is good with a criterion standard of 75% or greater relief with controlled diagnostic blocks. • The evidence is good for cervical interlaminar epidural injections for cervical disc herniation or radiculitis; fair for axial or discogenic pain, spinal stenosis, and post cervical surgery syndrome. • The evidence for therapeutic cervical facet joint interventions is fair for conventional cervical radiofrequency neurotomy and cervical medial branch blocks, and limited for cervical intraarticular injections. III. Thoracic Spine • The evidence is limited for thoracic provocation discography and is good for diagnostic accuracy of thoracic facet joint nerve blocks with a criterion standard of at least 75% pain relief with controlled diagnostic blocks. • The evidence is fair for thoracic epidural injections in managing thoracic pain. • The evidence for therapeutic thoracic facet joint nerve blocks is fair, limited for radiofrequency neurotomy, and not available for thoracic intraarticular injections. IV. Implantables • The evidence is fair for spinal cord stimulation (SCS) in managing patients with failed back surgery syndrome (FBSS) and limited for implantable intrathecal drug administration systems. V. ANTICOAGULATION • There is good evidence for risk of thromboembolic phenomenon in patients with antithrombotic therapy if discontinued, spontaneous epidural hematomas with or without traumatic injury in patients with or without anticoagulant therapy to discontinue or normalize INR with warfarin therapy, and the lack of necessity of discontinuation of nonsteroidal anti-inflammatory drugs (NSAIDs), including low dose aspirin prior to performing interventional techniques. • There is fair evidence with excessive bleeding, including epidural hematoma formation with interventional techniques when antithrombotic therapy is continued, the risk of higher thromboembolic phenomenon than epidural hematomas with discontinuation of antiplatelet therapy prior to interventional techniques and to continue phosphodiesterase inhibitors (dipyridamole, cilostazol, and Aggrenox). • There is limited evidence to discontinue antiplatelet therapy with platelet aggregation inhibitors to avoid bleeding and epidural hematomas and/or to continue antiplatelet therapy (clopidogrel, ticlopidine, prasugrel) during interventional techniques to avoid cerebrovascular and cardiovascular thromboembolic fatalities. • There is limited evidence in reference to newer antithrombotic agents dabigatran (Pradaxa) and rivaroxan (Xarelto) to discontinue to avoid bleeding and epidural hematomas and are continued during interventional techniques to avoid cerebrovascular and cardiovascular thromboembolic events. CONCLUSIONS: Evidence is fair to good for 62% of diagnostic and 52% of therapeutic interventions assessed. DISCLAIMER: The authors are solely responsible for the content of this article. No statement on this article should be construed as an official position of ASIPP. The guidelines do not represent "standard of care."

Assessment of effectiveness of percutaneous adhesiolysis in managing chronic low back pain secondary to lumbar central spinal canal stenosis.

BACKGROUND: Chronic 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 DESIGN: A prospective evaluation. SETTING: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. OBJECTIVE: To evaluate the effectiveness of percutaneous epidural adhesiolysis in patients with chronic low back and lower extremity pain with lumbar central spinal stenosis. METHODS: Seventy 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 ASSESSMENT: Multiple 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. RESULTS: Overall, 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. LIMITATIONS: The lack of a control group and a prospective design. CONCLUSIONS: Significant 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.

Fluoroscopic caudal epidural injections in managing chronic axial low back pain without disc herniation, radiculitis, or facet joint pain.

BACKGROUND: Chronic low back pain without disc herniation is common. Various modalities of treatments are utilized in managing this condition, including epidural injections. However, there is continued debate on the effectiveness, indications, and medical necessity of any treatment modality utilized for managing axial or discogenic pain, including epidural injections. METHODS: A randomized, double-blind, actively controlled trial was conducted. The objective was to evaluate the ability to assess the effectiveness of caudal epidural injections of local anesthetic with or without steroids for managing chronic low back pain not caused by disc herniation, radiculitis, facet joints, or sacroiliac joints. A total of 120 patients were randomized to two groups; one group did not receive steroids (group 1) and the other group did (group 2). There were 60 patients in each group. The primary outcome measure was at least 50% improvement in Numeric Rating Scale and Oswestry Disability Index. Secondary outcome measures were employment status and opioid intake. These measures were assessed at 3, 6, 12, 18, and 24 months after treatment. RESULTS: Significant pain relief and functional status improvement (primary outcome) defined as a 50% or more reduction in scores from baseline, were observed in 54% of patients in group 1 and 60% of patients in group 2 at 24 months. In contrast, 84% of patients in group 1 and 73% in group 2 saw significant pain relief and functional status improvement in the successful groups at 24 months. CONCLUSION: Caudal epidural injections of local anesthetic with or without steroids are effective in patients with chronic axial low back pain of discogenic origin without facet joint pain, disc herniation, and/or radiculitis.

Fluoroscopic lumbar interlaminar epidural injections in managing chronic lumbar axial or discogenic pain.

Among the multiple causes of chronic low back pain, axial and discogenic pain are common. Various modalities of treatments are utilized in managing discogenic and axial low back pain including epidural injections. However, there is a paucity of evidence regarding the effectiveness, indications, and medical necessity of any treatment modality utilized for managing axial or discogenic pain, including epidural injections. In an interventional pain management practice in the US, a randomized, double-blind, active control trial was conducted. The objective was to assess the effectiveness of lumbar interlaminar epidural injections of local anesthetic with or without steroids for managing chronic low back pain of discogenic origin. However, disc herniation, radiculitis, facet joint pain, or sacroiliac joint pain were excluded. Two groups of patients were studied, with 60 patients in each group receiving either local anesthetic only or local anesthetic mixed with non-particulate betamethasone. Primary outcome measures included the pain relief-assessed by numeric rating scale of pain and functional status assessed by the, Oswestry Disability Index, Secondary outcome measurements included employment status, and opioid intake. Significant improvement or success was defined as at least a 50% decrease in pain and disability. Significant improvement was seen in 77% of the patients in Group I and 67% of the patients in Group II. In the successful groups (those with at least 3 weeks of relief with the first two procedures), the improvement was 84% in Group I and 71% in Group II. For those with chronic function-limiting low back pain refractory to conservative management, it is concluded that lumbar interlaminar epidural injections of local anesthetic with or without steroids may be an effective modality for managing chronic axial or discogenic pain. This treatment appears to be effective for those who have had facet joints as well as sacroiliac joints eliminated as the pain source.

Results of 2-year follow-up of a randomized, double-blind, controlled trial of fluoroscopic caudal epidural injections in central spinal stenosis.

BACKGROUND: Lumbar spinal stenosis is one of the most common causes of low back pain among older adults and can cause significant disability. Despite its prevalence, there is a paucity of literature concerning the treatment of spinal stenosis symptoms. Multiple interventions, including surgery and interventional techniques such as epidural injections and adhesiolysis, are commonly utilized in managing pain related to central spinal stenosis. However, there is a paucity of literature from randomized, controlled trials about the effectiveness of epidural injections for lumbar central spinal stenosis. OBJECTIVE: This study sought to assess the effectiveness of caudal epidural injections with or without steroids in providing effective and long-lasting pain relief for the management of chronic low back pain related to lumbar central stenosis. STUDY DESIGN: A randomized, double-blind, active-controlled trial. METHODS: One hundred patients were randomly assigned to one of 2 groups, with Group I patients receiving caudal epidural injections of local anesthetic (lidocaine 0.5%), whereas Group II patients received caudal epidural injections with 0.5% lidocaine 9 mL mixed with 1 mL of steroid, 6 mg (non-particulate betamethasone). OUTCOMES ASSESSMENT: Multiple outcome measures, including the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake were utilized. Assessments were carried out at 3, 6, 12, 18, and 24 months posttreatment. The primary outcome was defined as pain relief and improvement in disability scores of 50% or more. Successful treatment was considered as at least 3 weeks of relief following the first 2 injections, categorizing these patients into a successful group, and others into a failed group. RESULTS: Significant pain relief and functional status improvement were seen in 51% in Group I and 57% in Group II at the end of 2 years in the successful group when the participants were separated into successful and failed groups. However, overall, significant pain relief and functional status improvement (≥ 50%) was demonstrated in 38% in Group I and 44% in Group II at the end of 2 years. The overall number of procedures for 2 years were 4 in both groups, with 5 procedures on average in the successful groups, and approximately 60 weeks of relief in Group I and 54 weeks of relief in Group II at 2 years in the successful group. CONCLUSION: Caudal epidural injections of local anesthetic with or without steroids provide relief in a modest proportion of patients undergoing the treatment and may be considered as an effective treatment for a select group of patients who have chronic function-limiting low back and lower extremity pain secondary to central spinal stenosis.

American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part I--evidence assessment.

BACKGROUND: Opioid abuse has continued to increase at an alarming rate since the 1990 s. As documented by different medical specialties, medical boards, advocacy groups, and the Drug Enforcement Administration, available evidence suggests a wide variance in chronic opioid therapy of 90 days or longer in chronic non-cancer pain. Part 1 describes evidence assessment. OBJECTIVES: The objectives of opioid guidelines as issued by the American Society of Interventional Pain Physicians (ASIPP) are to provide guidance for the use of opioids for the treatment of chronic non-cancer pain, to produce consistency in the application of an opioid philosophy among the many diverse groups involved, to improve the treatment of chronic non-cancer pain, and to reduce the incidence of abuse and drug diversion. The focus of these guidelines is to curtail the abuse of opioids without jeopardizing non-cancer pain management with opioids. RESULTS: 1) There is good evidence that non-medical use of opioids is extensive; one-third of chronic pain patients may not use prescribed opioids as prescribed or may abuse them, and illicit drug use is significantly higher in these patients. 2) There is good evidence that opioid prescriptions are increasing rapidly, as the majority of prescriptions are from non-pain physicians, many patients are on long-acting opioids, and many patients are provided with combinations of long-acting and short-acting opioids. 3) There is good evidence that the increased supply of opioids, use of high dose opioids, doctor shoppers, and patients with multiple comorbid factors contribute to the majority of the fatalities. 4) There is fair evidence that long-acting opioids and a combination of long-acting and short-acting opioids contribute to increasing fatalities and that even low-doses of 40 mg or 50 mg of daily morphine equivalent doses may be responsible for emergency room admissions with overdoses and deaths. 5) There is good evidence that approximately 60% of fatalities originate from opioids prescribed within the guidelines, with approximately 40% of fatalities occurring in 10% of drug abusers. 6) The short-term effectiveness of opioids is fair, whereas the long-term effectiveness of opioids is limited due to a lack of long-term (> 3 months) high quality studies, with fair evidence with no significant difference between long-acting and short-acting opioids. 7) Among the individual drugs, most opioids have fair evidence for short-term and limited evidence for long-term due to a lack of quality studies. 8) The evidence for the effectiveness and safety of chronic opioid therapy in the elderly for chronic non-cancer pain is fair for short-term and limited for long-term due to lack of high quality studies; limited in children and adolescents and patients with comorbid psychological disorders due to lack of quality studies; and the evidence is poor in pregnant women. 9) There is limited evidence for reliability and accuracy of screening tests for opioid abuse due to lack of high quality studies. 10) There is fair evidence to support the identification of patients who are non-compliant or abusing prescription drugs or illicit drugs through urine drug testing and prescription drug monitoring programs, both of which can reduce prescription drug abuse or doctor shopping. DISCLAIMER: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care."

American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2--guidance.

RESULTS: Part 2 of the guidelines on responsible opioid prescribing provides the following recommendations for initiating and maintaining chronic opioid therapy of 90 days or longer. 1. A) Comprehensive assessment and documentation is recommended before initiating opioid therapy, including documentation of comprehensive history, general medical condition, psychosocial history, psychiatric status, and substance use history. ( EVIDENCE: good) B) Despite limited evidence for reliability and accuracy, screening for opioid use is recommended, as it will identify opioid abusers and reduce opioid abuse. ( EVIDENCE: limited) C) Prescription monitoring programs must be implemented, as they provide data on patterns of prescription usage, reduce prescription drug abuse or doctor shopping. ( EVIDENCE: good to fair) D) Urine drug testing (UDT) must be implemented from initiation along with subsequent adherence monitoring to decrease prescription drug abuse or illicit drug use when patients are in chronic pain management therapy. ( EVIDENCE: good) 2. A) Establish appropriate physical diagnosis and psychological diagnosis if available prior to initiating opioid therapy. ( EVIDENCE: good) B) Caution must be exercised in ordering various imaging and other evaluations, interpretation and communication with the patient, to avoid increased fear, activity restriction, requests for increased opioids, and maladaptive behaviors. ( EVIDENCE: good) C) Stratify patients into one of the 3 risk categories - low, medium, or high risk. D) A pain management consultation, may assist non-pain physicians, if high-dose opioid therapy is utilized. ( EVIDENCE: fair) 3. Essential to establish medical necessity prior to initiation or maintenance of opioid therapy. ( EVIDENCE: good) 4. Establish treatment goals of opioid therapy with regard to pain relief and improvement in function. ( EVIDENCE: good) 5. A) Long-acting opioids in high doses are recommended only in specific circumstances with severe intractable pain that is not amenable to short-acting or moderate doses of long-acting opioids, as there is no significant difference between long-acting and short-acting opioids for their effectiveness or adverse effects. ( EVIDENCE: fair) B) The relative and absolute contraindications to opioid use in chronic non-cancer pain must be evaluated including respiratory instability, acute psychiatric instability, uncontrolled suicide risk, active or history of alcohol or substance abuse, confirmed allergy to opioid agents, coadministration of drugs capable of inducing life-limiting drug interaction, concomitant use of benzodiazepines, active diversion of controlled substances, and concomitant use of heavy doses of central nervous system depressants. ( EVIDENCE: fair to limited) 6. A robust agreement which is followed by all parties is essential in initiating and maintaining opioid therapy as such agreements reduce overuse, misuse, abuse, and diversion. ( EVIDENCE: fair) 7. A) Once medical necessity is established, opioid therapy may be initiated with low doses and short-acting drugs with appropriate monitoring to provide effective relief and avoid side effects. ( EVIDENCE: fair for short-term effectiveness, limited for long-term effectiveness) B) Up to 40 mg of morphine equivalent is considered as low dose, 41 to 90 mg of morphine equivalent as a moderate dose, and greater than 91 mg of morphine equivalence as high dose. ( EVIDENCE: fair) C) In reference to long-acting opioids, titration must be carried out with caution and overdose and misuse must be avoided. ( EVIDENCE: good) 8. A) Methadone is recommended for use in late stages after failure of other opioid therapy and only by clinicians with specific training in the risks and uses. ( EVIDENCE: limited) B) Monitoring recommendation for methadone prescription is that an electrocardiogram should be obtained prior to initiation, at 30 days and yearly thereafter. ( EVIDENCE: fair) 9. In order to reduce prescription drug abuse and doctor shopping, adherence monitoring by UDT and PMDPs provide evidence that is essential to the identification of those patients who are non-compliant or abusing prescription drugs or illicit drugs. ( EVIDENCE: fair) 10. Constipation must be closely monitored and a bowel regimen be initiated as soon as deemed necessary. ( EVIDENCE: good) 11. Chronic opioid therapy may be continued, with continuous adherence monitoring, in well-selected populations, in conjunction with or after failure of other modalities of treatments with improvement in physical and functional status and minimal adverse effects. ( EVIDENCE: fair). DISCLAIMER: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care."

Fluoroscopic caudal epidural injections with or without steroids in managing pain of lumbar spinal stenosis: one-year results of randomized, double-blind, active-controlled trial.

STUDY DESIGN: A randomized, double-blind, active-controlled trial. OBJECTIVE: To evaluate the effectiveness of caudal epidural injections with or without steroids in providing effective and long-lasting pain relief in the management of chronic low back pain related to lumbar spinal stenosis. SUMMARY OF BACKGROUND DATA: Multiple interventions including surgery and interventional techniques such as epidural injections and adhesiolysis are commonly performed in managing pain related to spinal stenosis. There is continuing debate on the effectiveness of all interventions, and a paucity of literature regarding effectiveness. METHODS: One-hundred participants were randomly assigned to 1 of the 2 groups, with Group I participants receiving caudal epidural injections of local anesthetic (lidocaine 0.5%), whereas Group II participants received caudal epidural injections with 0.5% lidocaine 9 mL mixed with 1 mL of steroid (nonparticulate Celestone). OUTCOMES ASSESSMENT: Multiple outcome measures were used, 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 months posttreatment. Significant pain relief and improvement in disability were defined as 50% or more. RESULTS: Overall, significant pain relief and functional status improvement (≥50%) were demonstrated in 48% in Group I and 46% in Group II. However, significant pain relief and functional status improvement were seen in 60% of the participants in both groups in the successful category when the participants were separated into successful and failed categories. The overall number of procedures was 3.1±1.3 or 3.6±1.1 in the successful category in Group I, with overall 2.9±1.4 or 3.5±1.2 in the successful category in Group II. CONCLUSION: Caudal epidural injections of local anesthetic with or without steroids may be an effective treatment for a select group of patients with chronic function-limiting low back and lower extremity pain secondary to spinal stenosis.

Fluoroscopic cervical interlaminar epidural injections in managing chronic pain of cervical postsurgery syndrome: preliminary results of a randomized, double-blind, active control trial.

BACKGROUND: Cervical postsurgery syndrome is common with increasing cervical surgical interventions. Cervical spine surgery may fail in a certain proportion of patients with continued pain secondary to pseudoarthrosis, adjacent segment degeneration, inadequate decompression, iatrogenic instability, facet joint arthritis, deformity, and spinal stenosis. Among the various treatments available for managing cervical postsurgery syndrome, epidural steroid injections are one of the most common nonsurgical interventions. However there have not been any systematic evaluations regarding the effectiveness of cervical epidural injections in cervical postsurgery syndrome. STUDY DESIGN: A randomized, double-blind, active control trial. SETTING: A specialty referral, private interventional pain management practice in the United States. OBJECTIVES: To evaluate the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids in providing effective and long-lasting relief in the management of chronic neck pain and upper extremity pain in patients with cervical postsurgery syndrome, and to evaluate the differences between local anesthetic with or without steroids. METHODS: Patients were randomly assigned to one of 2 groups: Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL); Group II patients received cervical interlaminar epidural injections with 0.5% lidocaine, 4 mL, mixed with 1 mL of nonparticulate betamethasone. The study was designed to include 120 patients with 60 patients in each group. This analysis includes 56 patients. Randomization was performed by computer-generated, random allocation sequence by simple randomization. OUTCOMES ASSESSMENT: Outcome measures included the Numeric Rating Scale (NRS), the Neck Disability Index (NDI), employment status, and opioid intake. Assessments at baseline and 3, 6, and 12 months posttreatment. Significant pain relief was defined as 50% or more; significant improvement in NDI was defined as a reduction of 50% or more. RESULTS: Significant pain relief (>/= 50%) was demonstrated in 71% of patients in Group I and 68% of patients in Group II. Functional status improvement was demonstrated by a reduction (> 50%) in the NDI scores in 71% of Group I and 64% of Group II at 12 months. The overall average procedures per year were 4.0 ± 0.7 in Group I and 4.1 ± 1.0 in Group II; the average total relief per year was 39.6 ± 11.8 weeks in Group I and 41.2 ± 15.8 weeks in Group II over the 52 week study period in the patients defined as successful. In the successful group, the combined pain relief and neck disability improvement was seen in 87% in Group I and 72% of the patients in Group II. LIMITATIONS: The study results are limited by the lack of a placebo group and a preliminary report of 56 patients, 28 in each group. CONCLUSION: Cervical interlaminar epidural injections with local anesthetic with or without steroids were effective in 67% of patients overall and 87% in Group I and 72% in Group II, in successful group patients with chronic function-limiting neck pain and upper extremity pain secondary to cervical postsurgery syndrome. CLINICAL TRIAL: NCT01071369.

Lumbar interlaminar epidural injections in central spinal stenosis: preliminary results of a randomized, double-blind, active control trial.

BACKGROUND: Chronic, persistent low back and lower extremity pain is often caused by spinal stenosis. Surgery and other interventions, including epidural injections, have been used to relieve this pain. However, there is little in the medical literature to support interlaminar, or transforaminal epidural injections under fluoroscopy for managing lumbar pain of central spinal stenosis, while the caudal epidural approach has been studied. STUDY DESIGN: A randomized, double-blind, active, control trial. SETTING: A private, interventional pain management practice, specialty referral center in the United States. OBJECTIVE: This study sought to determine if low back and lower extremity pain secondary to lumbar central stenosis can be managed and long-lasting pain relief can be achieved with interlaminar epidural injections of local anesthetic, with or without steroids. METHODS: The study comprised 2 groups: one that received local anesthetic only and another received local anesthetic combined with nonparticulate betamethasone. A total of 120 patients were randomized by a computer-generated random allocations sequence to one of the 2 groups. The results of 30 patients in each group were assessed. OUTCOMES ASSESSMENT: Sixty patients were included in this analysis. Outcomes measurements were taken at baseline and at 3, 6, and 12 months post-treatment. Measurements taken were Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status and opioid intake. A decrease in both the NRS and ODI of  >/= 50% was considered significant. RESULTS: Significant pain relief and improvement in ODI scores were seen in both groups at 12 months. Group I's significant pain relief was 70%; Group II's was 63%. The significant ODI improvement in Group I was 70%; in Group II it was 60%. Group I patients on average received 3.8 procedures a year; Group II patients received 4.0 procedures a year in successful group. Over 52 weeks in the successful group, total relief for Group I was 40.8 ± 11.7 weeks; for Group II it was 37.1 ± 12.6 weeks. Combined pain relief and functional status improvement were seen in 80% of patients in Group I and 72% in Group II in successful group. LIMITATIONS: The lack of a placebo group and preliminary results are limitations. CONCLUSION: Patients might benefit from receiving lumbar interlaminar injections with or without steroids for lumbar central spinal stenosis. CLINICAL TRIAL: NCT00681447.

Fluoroscopic epidural injections in cervical spinal stenosis: preliminary results of a randomized, double-blind, active control trial.

BACKGROUND: Cervical spinal stenosis is a common disease that results in considerable morbidity and disability. There are multiple modalities of treatments, including surgical interventions and multiple interventional techniques including epidural injections. The literature on the effectiveness of cervical epidural steroids is sporadic. Emerging evidence for cervical interlaminar epidurals for various conditions in the cervical spine is positive; however, the effect of fluoroscopic epidural injections in cervical spinal stenosis has not been studied. STUDY DESIGN: A randomized, double-blind, active control trial. SETTING: A private interventional pain management practice, a specialty referral center in the United States. OBJECTIVES: To evaluate the effectiveness of cervical interlaminar epidural injections with local anesthetic with or without steroids in the management of chronic neck pain with upper extremity pain in patients with cervical central spinal stenosis. METHODS: Patients with cervical central spinal stenosis were randomly assigned to one of 2 groups: injection of local anesthetic only or local anesthetic mixed with non-particulate betamethasone. Sixty patients were included in this analysis. Randomization was performed by computer-generated random allocation sequence by simple randomization. OUTCOMES ASSESSMENT: Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Neck Disability Index (NDI), employment status, and opioid intake with assessment at 3, 6, and 12 months post-treatment. Significant pain relief or functional status was defined as a 50% or more reduction of NRS or NDI scores. RESULTS: Significant pain relief was seen in 73% in Group I and 70% in Group II, in Group II showing both significat pain releif and functional status improvements. Group I's average relief per procedures was 11.3 ± 5.8 weeks; for Group II it was 8.6 ± 3.6 weeks, whereas after initial 2 procedures, average relief was 13.7 ± 8.7 weeks in Group I, and 13.6 ± 4.7 weeks in Group II. In the successful group, the average total relief in a one-year period was 42.2 ± 14.7 weeks in Group I and 34.3 ± 13.4 weeks in Group II, with 76% in Group I and 77% in Group II. LIMITATIONS: Study limitations include the lack of a placebo group and that this is a preliminary report of only 60 patients, 30 in each group. CONCLUSION: Patients who have chronic function-limiting pain that is secondary to cervical central stenosis might receive relief with cervical interlaminar epidurals of local anesthetic, whether with or without steroids. CLINICAL TRIAL: NCT01071369.

A prospective evaluation of bleeding risk of interventional techniques in chronic pain.

BACKGROUND: The role of antithrombotic therapy is well known for primary and secondary prevention of cardiovascular disease to decrease the incidence of acute cerebral and cardiovascular events. Data shows that the risk of coronary thrombosis after antiplatelet drug withdrawal is much higher than that of surgical bleeding if the antiplatelet drug therapy were continued. However, it has been a common practice to discontinue antiplatelet therapy prior to performing interventional techniques, which may potentially increase the risk of acute cerebral and cardiovascular events. STUDY DESIGN: A prospective study of 3,179 patients undergoing interventional techniques with 12,000 encounters and 18,472 procedures from May 2008 to December 2009. STUDY SETTING: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. OBJECTIVE: To assess the rates of adverse events in patients undergoing interventional techniques on antithrombotic therapy with cessation or without cessation and compare them to a group of patients without antithrombotic therapy. METHODS: Measurable outcomes employed were intravascular entry of the needle, bruising, local bleeding, profuse bleeding, local hematoma, oozing, and postoperative soreness.The prospective evaluation was performed utilizing the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement which was developed with recommendations to improve the quality of reporting observational studies. RESULTS: The results of this study illustrated that in one-quarter (3,087) of patient encounters utilizing interventional pain management techniques, antithrombotic therapy was included. Among these, for approximately 55%, or 1,711 encounters, antithrombotic therapy was continued during the interventional techniques, whereas, for 45%, or 1376 encounters, antithrombotic therapy was discontinued. Overall, these results illustrate that while intravascular penetration and oozing were higher in patients with continued antithrombotic therapy, bruising and local bleeding were higher in patients with discontinued antithrombotic therapy without any difference either statistical or clinical in any of the other aspects, either intraoperative, post procedure in the recovery room, or postoperative period. LIMITATIONS: Limitations include the nonrandomized observational nature of the study and that antiplatelet therapy was limited to aspirin and clopidogrel (Plavix). CONCLUSION: No significant prevalence of adverse events was observed in those who continued with or ceased antithrombotic therapy.

One-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections with or without steroids in managing chronic discogenic low back pain without disc herniation or radiculitis.

BACKGROUND: Lumbar radicular pain pathophysiology continues to be the subject of research and debate as discogenic pain is increasingly seen as a cause of non-specific low back pain. Among non-surgical methods used to manage chronic low back pain with or without disc herniation, epidural injections are one of the most common modalities. However, there is little evidence utilizing contemporary methodology for using epidural injections in patients with discogenic pain. STUDY DESIGN: A randomized, double-blind, active-controlled trial. SETTING: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. OBJECTIVES: To evaluate the effectiveness of caudal epidural injections with local anesthetic, with or without steroids, in managing chronic low back pain without disc herniation or radiculitis. METHODS: A total of 120 patients were assigned to one of 2 groups. Group I patients received caudal epidural injections with local anesthetic (lidocaine 0.5% 10 mL); Group II patients received caudal epidural injections with 9 mL of 0.5% lidocaine mixed with 1 mL of steroid (either brand name or non-particulate betamethasone [6 mg] or methylprednisolone [40 mg]). Computer-generated randomization and random allocation sequence by simple randomization were the randomization techniques utilized. OUTCOMES ASSESSMENT: Multiple outcome measures were utilized which included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, functional status, and opioid intake at 3, 6, and 12 months post treatment. Significant pain relief and functional status improvement were described as a 50% or more reduction in scores from baseline. RESULTS: Significant pain relief and functional status improvement were observed in 55% of the patients in Group I and 68% of the patients in Group II. In contrast, 84% of patients in Group I and 85% in Group II saw significant pain relief and functional status improvement in the successful group (62% in Group I and 68% in Group II). The average procedures per year were 3.8 ± 0.9 for Group I and 4.3 ± 0.9 for Group II. Average pain scores decreased from 8.0 ± 0.9 to 4.3 ± 1.79 for Group I and from 7.9 ± 1.0 to 3.8 ± 1.59 for Group II. There were no differences among the patients receiving one of the 3 steroids. LIMITATIONS: The results of this study are limited by lack of a placebo group. CONCLUSION: Caudal epidural injections with local anesthetic with or without steroids are effective in patients with chronic low back pain of discogenic origin without facet joint pain, disc herniation, and/or radiculitis.

A preliminary report of a randomized double-blind, active controlled trial of fluoroscopic thoracic interlaminar epidural injections in managing chronic thoracic pain.

BACKGROUND: The proportion of patients suffering from thoracic pain secondary to thoracic disorders is relatively small compared to low back and neck pain. Furthermore, thoracic interventions are not performed as often as in cervical and lumbar regions. In addition, there is a paucity of literature regarding thoracic intervertebral discs and thoracic disc herniation as causative structures of thoracic pain. STUDY DESIGN: A randomized, double-blind, active controlled trial. SETTING: A private practice, interventional pain management and specialty referral center in the United States. OBJECTIVES: To evaluate the effectiveness of thoracic interlaminar epidural injections in providing effective pain relief in managing chronic mid and upper back pain secondary to disc herniation or radiculitis and discogenic pain with local anesthetic alone or with steroids. METHODS: Inclusion criteria consisted of patients who either had disc herniation or radiculitis, or patients with discogenic pain proven by controlled comparative local anesthetic blocks not to be caused by facet joint pain. Patients were assigned to one of 2 groups. One group received injections containing local anesthetic only; the other group, local anesthetic mixed with non-particulate betamethasone. Randomization was performed by computer-generated random allocations sequence by simple randomization. OUTCOMES ASSESSMENT: Participant outcomes were measured at baseline, 3, 6, and 12 months post-treatment with the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake. Decrease of >/= 50% of NRS scores and Oswestry scores were considered significant. RESULTS: A total of 40 participants are included in this preliminary report with 20 participants in each group. Significant pain relief (>/= 50%) and reduction (by at least 50%) in ODI from baseline was seen at 12 months in 80% of patients in Group I and 85% in Group II. LIMITATIONS: This is a preliminary report and there was no placebo group. Overall, 80% of participants in Group I (who received injections without steroids) and 85% in Group II (who received injections with steroids) with thoracic pain secondary to disc herniation or radiculitis and discogenic pain might benefit from thoracic interlaminar epidural injections. CLINICAL TRIAL: NCT01071369.

Preliminary results of a randomized, double-blind, controlled trial of fluoroscopic lumbar interlaminar epidural injections in managing chronic lumbar discogenic pain without disc herniation or radiculitis.

BACKGROUND: Low back pain without disc herniation is the most common problem among chronic pain disorders. Epidural injections are commonly used interventions in managing chronic low back pain without disc herniation. However, little evidence exists regarding the effectiveness, indications, and medical necessity of lumbar epidural injections in managing axial low back pain without disc herniation or radiculitis. STUDY DESIGN: A randomized, double-blind, controlled trial. SETTING: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. OBJECTIVES: To evaluate the ability to provide effective and long-lasting pain relief with lumbar interlaminar epidural injections with local anesthetic with or without steroids in managing chronic low back pain not caused by disc herniation or radiculitis. METHODS: Patients were randomly assigned to one of 2 groups with Group I patients receiving local anesthetic only, whereas Group II patients received local anesthetic mixed with non-particulate betamethasone. Seventy patients were included in this analysis. Randomization was performed by computer-generated random allocation sequence by simple randomization. OUTCOMES ASSESSMENT: Outcome measures included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake. The assessments were done at baseline, 3 months, 6 months, and 12 months post-treatment. Significant pain relief and/or improvement in disability were defined as at least 50% improvement. RESULTS: Significant pain relief (> or = 50%) was demonstrated in 74% of patients in Group I and 63% in Group II. Functional status improvement (reduction of > or = 50%) in the ODI scores was seen in 71% of patients in Group I and 60% of patients in Group II. The overall average procedures per year were approximately 4. LIMITATIONS: The results of this study are limited by the lack of a placebo group and a preliminary report of 35 patients in each group with a total of 70 patients. CONCLUSION: Lumbar interlaminar epidural injections of local anesthetic with or without steroids was effective in 63% and 74% of patients with chronic function-limiting low back pain without facet joint pain, disc herniation, and/or radiculitis.

Protocol for accuracy of point of care (POC) or in-office urine drug testing (immunoassay) in chronic pain patients: a prospective analysis of immunoassay and liquid chromatography tandem mass spectometry (LC/MS/MS).

BACKGROUND: Therapeutic use, overuse, abuse, and diversion of controlled substances in managing chronic non-cancer pain continues to be an issue for physicians and patients. It has been stated that physicians, along with the public and federal, state, and local government; professional associations; and pharmaceutical companies all share responsibility for preventing abuse of controlled prescription drugs. The challenge is to eliminate or significantly curtail abuse of controlled prescription drugs while still assuring the proper treatment of those patients. A number of techniques, instruments, and tools have been described to monitor controlled substance use and abuse. Thus, multiple techniques and tools available for adherence monitoring include urine drug testing in conjunction with prescription monitoring programs and other screening tests. However, urine drug testing is associated with multiple methodological flaws. Multiple authors have provided conflicting results in relation to diagnostic accuracy with differing opinions about how to monitor adherence in a non-systematic fashion. Thus far, there have not been any studies systematically assessing the diagnostic accuracy of immunoassay with laboratory testing. STUDY DESIGN: A diagnostic accuracy study of urine drug testing. STUDY SETTING: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. OBJECTIVE: To compare the information obtained by point of care (POC) or in-office urine drug testing (index test) to the information found when all drugs and analytes are tested by liquid chromatography tandem mass spectroscopy (LC/MS/MS) reference test in the same urine sample. METHODS: The study is designed to include 1,000 patients with chronic pain receiving controlled substances. The primary outcome measure is the diagnostic accuracy. Patients will be tested for various controlled substances, including opioids, benzodiazepines, and illicit drugs. The diagnostic accuracy study is performed utilizing the Standards for Reporting of Diagnostic Accuracy Studies (STARD) initiative which established reporting guidelines for diagnostic accuracy studies to improve the quality of reporting. The prototypical flow diagram of diagnostic accuracy study as described by STARD will be utilized. RESULTS: Results of diagnostic accuracy and correlation of clinical factors in relation to threshold levels, prevalence of abuse, false-positives, false-negatives, influence of other drugs, and demographic characteristics will be calculated. LIMITATIONS: The limitations include lack of availability of POC testing with lower cutoff levels. CONCLUSION: This article presents a protocol for a diagnostic accuracy study of urine drug testing. The protocol also will permit correlation of various clinical factors in relation to threshold levels, prevalence of abuse, false-positives, false-negatives, influence of other drugs, and demographic characteristics. CLINICAL TRIAL REGISTRATION: NCT 01052155.

The preliminary results of a comparative effectiveness evaluation of adhesiolysis and caudal epidural injections in managing chronic low back pain secondary to spinal stenosis: a randomized, equivalence controlled trial.

BACKGROUND: Lumbar surgery and epidural injections for spinal stenosis are the most commonly performed interventions in the United States. However, there is only moderate evidence to the effectiveness of surgery and caudal epidural injections. The next sequential step is adhesiolysis and hypertonic neurolysis with targeted delivery. There have not been any randomized trials evaluating the effectiveness of percutaneous adhesiolysis and targeted delivery of local anesthetic, steroid and hypertonic sodium chloride solution in lumbar spinal stenosis. STUDY DESIGN: A randomized, equivalence, controlled trial. SETTING: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. OBJECTIVES: To evaluate the effectiveness of percutaneous epidural adhesiolysis in patients with chronic low back and lower extremity pain with lumbar central spinal stenosis and compare with fluoroscopically directed caudal epidural injections. METHODS: Patients were randomly assigned to one of 2 groups with 25 patients in each group. Group I patients received caudal epidural injections with catheterization up to S3 with local anesthetic, 0.9% sodium chloride solution, non-particulate betamethasone and served as the control group. Group II patients received percutaneous adhesiolysis with targeted delivery and injection of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate Betamethasone and formed the intervention group. Randomization was performed by computer-generated random allocation sequence by simple randomization. OUTCOMES ASSESSMENT: Multiple 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 months post treatment. Significant pain relief was described as 50% or more, whereas significant improvement in the disability score was defined as a reduction of 40% or more. RESULTS: This evaluation showed significant pain relief (>or= 50%) in 76% of the patients at one year follow-up in the adhesiolysis group compared to 4% of the patients in the control group. LIMITATIONS: The results of this study are limited by the lack of a placebo group, the fact that it is a preliminary report, and there are only 25 patients in each group. CONCLUSIONS: With significant pain relief in 76% of patients, percutaneous adhesiolysis utilizing local anesthetic, steroids and hypertonic sodium chloride solution may be effective in patients with chronic function-limiting low back and lower extremity pain with spinal stenosis.