Assessment of Prevalence of Cervical Facet Joint Pain with Diagnostic Cervical Medial Branch Blocks: Analysis Based on Chronic Pain Model.

BACKGROUND: Research into cervical spinal pain syndromes has indicated that the cervical facet joints can be a potent source of neck pain, headache, and referred pain into the upper extremities. There have been multiple diagnostic accuracy studies, most commonly utilizing diagnostic facet joint nerve blocks and an acute pain model, as Bogduk has proposed. Subsequently, Manchikanti has focused on the importance of the chronic pain model and longer lasting relief with diagnostic blocks. OBJECTIVE: To assess diagnostic accuracy of cervical facet joint nerve blocks with controlled comparative local anesthetic blocks, with updated assessment of prevalence, false-positive rate, and a description of philosophical paradigm shift from acute to chronic pain model, with concordant pain relief. STUDY DESIGN: This diagnostic accuracy study was performed with retrospective assessment of data to assess prevalence and false-positive rates. SETTING: The study was performed in a non-university-based, multidisciplinary, interventional pain management, private practice in the United States. METHODS: Cervical medial branch blocks were performed utilizing lidocaine 1% followed by bupivacaine 0.25% when appropriate response was obtained in an operating room under fluoroscopic guidance with 0.5 mL of lidocaine or bupivacaine from C3-C6 medial branches (levels blocked on joints involved). If a patient failed to respond to lidocaine with appropriate >= 80% pain relief, that patient was considered as negative for facet joint pain. If the response was positive with lidocaine block, a bupivacaine block was performed. RESULTS: The chronic cervical facet joint pain was diagnosed with cervical facet joint nerve blocks at a prevalence of 49.3% (95% CI, 43.6%, 55.0%) and with a false-positive rate of 25.6% (95% CI, 19.5%, 32.8%). This study also showed a single block prevalence rate of 66.3% (95% CI, 71.7%, 60.9%). Assessment of the duration of relief with each block showed greater than 80% for 6 days with lidocaine block and total relief of >= 50% of 31 days. In contrast, with bupivacaine, average duration of pain relief of >= 80% was 12 days with a total relief of >= 50% lasting for 55 days. CONCLUSION: Based on this investigation, utilizing a chronic pain model, there was significant difference in the relief patterns. This assessment showed prevalence and false-positive rates of 49.3% and 25.6% in chronic neck pain. Duration of relief >= 80% pain relief was 6 days with lidocaine and 12 days with bupivacaine, with total relief of >= 50% of 31 days with 55 days respectively.

Low Back Pain and Diagnostic Lumbar Facet Joint Nerve Blocks: Assessment of Prevalence, False-Positive Rates, and a Philosophical Paradigm Shift from an Acute to a Chronic Pain Model.

BACKGROUND: Lumbar facet joints are a clinically important source of chronic low back pain. There have been extensive diagnostic accuracy studies, along with studies of influence on the diagnostic process, but most of them have utilized the acute pain model. One group of investigators have emphasized the importance of the chronic pain model and longer lasting relief with diagnostic blocks. OBJECTIVE: To assess the diagnostic accuracy of lumbar facet joint nerve blocks with controlled comparative local anesthetic blocks and concordant pain relief with an updated assessment of the prevalence, false-positive rates, and a description of a philosophical paradigm shift from an acute to a chronic pain model. STUDY DESIGN: Retrospective study to determine diagnostic accuracy, prevalence and false-positive rates. SETTING: A multidisciplinary, non-university based interventional pain management practice in the United States. METHODS: Controlled comparative local anesthetic blocks were performed initially with 1% lidocaine, followed by 0.25% bupivacaine if appropriate response was obtained, in an operating room under fluoroscopic guidance utilizing 0.5 mL of lidocaine or bupivacaine at L3, L4 medial branches and L5 dorsal ramus. All patients non-responsive to lidocaine blocks were considered to be negative for facet joint pain. All patients were assessed after the diagnostic blocks were performed with >= 80% pain relief for their ability to perform previously painful movements. RESULTS: The prevalence of lumbar facet joint pain in chronic low back pain was 34.1% (95% CI, 28.8%, 39.8%), with a false-positive rate of 49.8% (95% CI, 42.7%, 56.8%). This study also showed a single block prevalence rate of 67.9% (95% CI, 62.9%, 73.2%). Average duration of pain relief >= 80% was 6 days with lidocaine block and total relief of >= 50% of 32 days. With bupivacaine, the average duration of pain relief >= 80% was 13 days with total relief of >= 50% lasting for 55 days. CONCLUSION: This study demonstrated that the chronic pain model is more accurate and reliable with concordant pain relief. This updated assessment also showed prevalence and false-positive rates of 34.1% and 49.8%.

Comparison of effectiveness for fluoroscopic cervical interlaminar epidural injections with or without steroid in cervical post-surgery syndrome.

BACKGROUND: Neck and back pain are leading sources of disability placing substantial burden on health care systems. Surgical interventions in managing chronic neck pain secondary to various disorders continue to increase. Even though surgical interventions are effective, a significant proportion of patients continue to have symptomatology and develop cervical post-surgery syndrome. This study was performed to know the effectiveness of cervical interlaminar epidural injections with or without steroids. METHODS: The effectiveness of fluoroscopic cervical interlaminar epidural injections in post-surgery syndrome was evaluated in a randomized, active controlled trial. The study population included 116 patients assigned to 2 groups. Group 1 received cervical interlaminar epidural injections with local anesthetic alone and Group 2 received injection with local anesthetic and steroids. The main outcomes were defined as significant improvement (greater than 50%) of pain relief using the numeric rating scale and/or functional status improvement using the Neck Disability Index (NDI). RESULTS: Both groups had similar results with significant improvement (≥ 50% pain relief and functional status improvement) in 69% of the patients in Group I, whereas, in Group II, 71% of the patients showed significant improvement at the end of 2 years. During a 2-year period, the average number of procedures was 5 to 6, with an average of approximately 12 weeks of significant improvement per procedure. CONCLUSIONS: Fluoroscopic cervical interlaminar epidural injections administered in cervical post-surgery syndrome using local anesthetic, regardless of the use of steroids, may be effective in approximately 70% of the patients at 2-year follow-up.

Do the gaps in the ligamentum flavum in the cervical spine translate into dural punctures? An analysis of 4,396 fluoroscopic interlaminar epidural injections.

BACKGROUND: Cervical interlaminar epidural injections are performed frequently in managing chronic neck and upper extremity pain, although less commonly than lumbar interlaminar epidural injections. Recently, the US Food and Drug Administration warnings and safeguards to prevent neurologic complications. These were developed by the Multi-Society Pain Workgroup have taken center stage for all types of epidural injections, including cervical interlaminar epidural injections. The recommendations of safeguards to prevent neurologic complications after epidural steroid injections include that cervical interlaminar epidural injections must be performed utilizing fluoroscopy with anteroposterior, lateral, or oblique views with injection of contrast medium and that entry be limited to the C7-T1 epidural space or occasionally the C6-C7 with requirements for magnetic resonance imaging assessment of the epidural space. OBJECTIVES: To assess the incidence of dural puncture associated with fluoroscopically directed cervical interlaminar epidural injections. STUDY DESIGN: A retrospective assessment of patients undergoing cervical interlaminar epidural injections from January 2013 through February 2015. SETTING: A private interventional pain management practice; a specialty referral center in the United States. METHODS: The data were collected for 4,396 consecutive cervical interlaminar epidural injections performed from January 2013 through February 2015. The procedures were all performed under fluoroscopic visualization under posteroanterior view with contrast medium injection with lateral view confirmation when indicated. The procedures were performed by one of 2 physicians; the dural puncture and subsequent postoperative complications with level of epidural entry were determined. OUTCOMES ASSESSMENT: The outcome was assessment of dural puncture. RESULTS: A review of multiple manuscripts showed that defects in the ligamentum flavum may extend to as much as 100% of the population. However, it also has been shown that among the levels with a gap, the location of a gap in the caudal third of the ligamentum flavum was more frequent than in the middle or cephalic portion of the ligamentum flavum. Among the 4,396 epidural injections performed at C7-T1, C6-C7, and C5-C6, 1,227 were performed at C7-T1; 1,835 were performed at C6-C7; and 1,334 were performed at C5-C6. Dural punctures were observed in 1.8% (24 procedures) at the C5-C6 level entry; 0.87% (16 procedures) at the C6-C7 level entry; and 1.71% (21 procedures) at the C7-T1 level. There was no significant difference among the entry levels. No complications or spinal cord damage or postdural puncture headache were observed. LIMITATIONS: The limitations of this report include that it is an assessment by only 2 well experienced physicians, even though it included a relatively large number of patients. CONCLUSION: This study illustrates that dural puncture is equally prevalent, though very rare, irrespective of the needle entry level into the epidural space, with an overall dural puncture rate of 1.4%, with 1.8% at the C5-C6 level, 0.87% at the C6-C7 level, and 1.71% at the C7-T1 level. Based on the present literature, it appears that performing the procedure by inserting the needle into the cephalic portion of the intervertebral space rather than the caudal portion may be safer.

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.

Transforaminal epidural injections in chronic lumbar disc herniation: a randomized, double-blind, active-control trial.

BACKGROUND: The estimated prevalence of lumbar radiculopathy has been described as 9.8 per 1,000 cases of low back pain. There are various surgical and nonsurgical modalities for treating lumbar disc herniation or radicular pain, including epidural injections. Epidural injection administration routes include transforaminal, interlaminar, and caudal approaches. The transforaminal approach requires the smallest volume to reach the primary site of pathology. Systematic reviews have yielded highly variable results, but a recent systematic review showed no significant difference among the 3 approaches. STUDY DESIGN: A randomized, controlled, double blind, active control trial. SETTING: An interventional pain management practice, a private specialty referral center in the United States. OBJECTIVES: To assess the effectiveness of transforaminal epidural injections of local anesthetic with or without steroids in managing chronic low back and lower extremity pain in patients with disc herniation and radiculitis. METHODS: One hundred twenty patients were randomly assigned to 2 groups: Group I received 1.5 mL of 1% preservative-free lidocaine, followed by 0.5 mL of sodium chloride solution. Group II received 1% lidocaine, followed by 3 mg, or 0.5 mL of betamethasone. The sodium chloride solution and betamethasone were either clear liquids or were provided in opaque-covered syringes. OUTCOMES ASSESSMENT: The primary outcome measure was significant improvement (at least 50%) measured by the average Numeric Rating Scale (NRS) and the Oswestry Disability Index 2.0 (ODI). Secondary outcome measures were employment status and opioid intake. RESULTS: At 2 years there was significant improvement in all participants in 65% who received local anesthetic alone and 57% who received local anesthetic and steroid. When separated into non-responsive and responsive categories based on initial relief of at least 3 weeks with 2 procedures, significant improvement (at least 50% improvement in pain and function) was seen in 80% in the local anesthetic group and 73% in the local anesthetic with steroid group. LIMITATIONS: Presumed limitations of this evaluation include the lack of a placebo group. CONCLUSION: Transforaminal epidural injections of local anesthetic with or without steroids might be an effective therapy for patients with disc herniation or radiculitis. The present evidence illustrates the lack of superiority of steroids compared with local anesthetic at 2-year follow-up.

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.

Two-year follow-up results of fluoroscopic cervical epidural injections in chronic axial or discogenic neck pain: a randomized, double-blind, controlled trial.

STUDY DESIGN: A randomized, double-blind, active-controlled trial. OBJECTIVE: To assess the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids for the management of axial or discogenic pain in patients without disc herniation, radiculitis, or facet joint pain. SUMMARY OF BACKGROUND DATA: Cervical discogenic pain without disc herniation is a common cause of suffering and disability in the adult population. Once conservative management has failed and facet joint pain has been excluded, cervical epidural injections may be considered as a management tool. Despite a paucity of evidence, cervical epidural injections are one of the most commonly performed nonsurgical interventions in the management of chronic axial or disc-related neck pain. METHODS: One hundred and twenty patients without disc herniation or radiculitis and negative for facet joint pain as determined by means of controlled diagnostic medial branch blocks were randomly assigned to one of the 2 treatment groups. Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL), whereas Group II patients received 0.5% lidocaine, 4 mL, mixed with 1 mL or 6 mg of nonparticulate betamethasone. The primary outcome measure was ≥ 50% improvement in pain and function. Outcome assessments included numeric rating scale (NRS), Neck Disability Index (NDI), opioid intake, employment, and changes in weight. RESULTS: Significant pain relief and functional improvement (≥ 50%) was present at the end of 2 years in 73% of patients receiving local anesthetic only and 70% receiving local anesthetic with steroids. In the successful group of patients, however, defined as consistent relief with 2 initial injections of at least 3 weeks, significant improvement was illustrated in 78% in the local anesthetic group and 75% in the local anesthetic with steroid group at the end of 2 years. The results reported at the one-year follow-up were sustained at the 2-year follow-up. CONCLUSIONS: Cervical interlaminar epidural injections with or without steroids may provide significant improvement in pain and functioning in patients with chronic discogenic or axial pain that is function-limiting and not related to facet joint pain.

A randomized, double-blind, active-control trial of the effectiveness of lumbar interlaminar epidural injections in disc herniation.

BACKGROUND: Among the multiple nonsurgical modalities, epidural injections are one of the most commonly utilized treatment modalities in managing chronic low back and lower extremity pain due to disc herniation and radiculitis. There is a paucity of randomized trials from contemporary interventional pain management settings utilizing fluoroscopy with long-term follow-up. STUDY DESIGN: Randomized, double-blind, active-controlled trial with 2-year follow-up. SETTING: An interventional pain management practice in the United States. OBJECTIVE: 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 disc herniation or radiculitis. METHODS: Two groups of patients were studied, with 60 patients in each group receiving either local anesthetic only or local anesthetic mixed with betamethasone. OUTCOME MEASURES: The primary outcome measure was defined as pain relief and functional status improvement of 50%. The outcomes were assessed by numeric rating scale (NRS) of pain and functional status with Oswestry Disability Index (ODI). Secondary outcome measures included employment status and opioid intake. RESULTS: Results showed significant improvement in 60% of patients in Group I and 70% of patients in Group II at the end of 2 years. In addition, in the successful groups, those with at least 3 weeks of relief (with the first 2 procedures), the improvement was 72% in Group I and 71% in Group II. Results were somewhat superior for pain relief at 6 months and functional status at 12 months in the steroid group. Thus, the results indicate that a patient's failure to respond to local anesthetic alone, may be treated with addition of steroids. 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 is an effective modality, in patients with chronic function limiting low back and lower extremity pain secondary to disc herniation after failure of conservative modalities.

A randomized, double-blind, active control trial of fluoroscopic cervical interlaminar epidural injections in chronic pain of cervical disc herniation: results of a 2-year follow-up.

BACKGROUND: A recent evaluation of the state of U.S. health from 1990 to 2010 placed neck pain as the fourth condition leading to disability, with low back pain being the number one. Multiple treatment modalities have been described in managing neck and upper extremity pain secondary to cervical disc herniation after the failure of conservative management. The treatment modalities for chronic persistent pain of cervical disc herniation include surgery and epidural injections. The growth of interventional techniques in managing chronic spinal pain in recent years has been enormous. Evidence for the efficacy of cervical interlaminar epidural injections, however, continues to be debated, despite positive evidence derived from controlled randomized trials and systematic reviews. STUDY DESIGN: A randomized, double-blind, active control trial. SETTING: A private, specialty referral, interventional pain management practice in the United States. OBJECTIVES: To evaluate the effectiveness of epidural injections in managing chronic pain related to cervical disc herniation. METHODS: Patients were randomly assigned to one of 2 groups of 60, with a total of 120 patients. Group I patients received cervical epidural injections with lidocaine 0.5% preservative-free, 5 mL, whereas Group II patients received 0.5% preservative-free lidocaine mixed with 1 mL or 6 mg of non-particulate betamethasone. OUTCOME ASSESSMENT: Multiple outcome measures included the numeric rating pain scale (NRS), the Neck Disability Index (NDI), employment status, opioid intake with assessment at 3, 6, 12, 18, and 24 months post treatment. Significant improvement was described as pain relief with a 50% improvement in functional status. RESULTS: This evaluation showed significant improvement as 50% pain relief and improvement in functional status in 72% of the patients at 2 year follow-up in the local anesthetic group and 68% in those patients receiving local anesthetic and steroid. In the successful group of participants however, significant improvement was seen in 77% in Group I and 80% in Group II. Overall, the average number of procedures was 5 to 6 in both groups. The average total relief for 2 years was 75.9 ± 29.9 weeks in Group I and 72.7 ± 31.1 in Group II, the successful group of participants. Taking into consideration all of the participants, the average total relief for 2 years was 69.6 ± 35 weeks in Group I and 62.1 ± 38.4 weeks in Group II. LIMITATIONS: The results of the study are limited by the lack of a placebo group. CONCLUSION: Cervical epidural injections with local anesthetic with or without steroids. [corrected].

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.

Cost utility analysis of caudal epidural injections in the treatment of lumbar disc herniation, axial or discogenic low back pain, central spinal stenosis, and post lumbar surgery syndrome.

BACKGROUND: In this era of escalating health care costs and the questionable effectiveness of multiple interventions, cost effectiveness or cost utility analysis has become the cornerstone of evidence-based medicine, and has an influence coverage decisions. Even though multiple cost effectiveness analysis studies have been performed over the years, extensive literature is lacking for interventional techniques. Cost utility analysis studies of epidural injections for managing chronic low back pain demonstrated highly variable results including a lack of cost utility in randomized trials and contrasting results in observational studies. There has not been any cost utility analysis studies of epidural injections in large randomized trials performed in interventional pain management settings. OBJECTIVES: To assess the cost utility of caudal epidural injections in managing chronic low back pain secondary to lumbar disc herniation, axial or discogenic low back pain, lumbar central spinal stenosis, and lumbar post surgery syndrome. STUDY DESIGN: This analysis is based on 4 previously published randomized trials. SETTING: A private, specialty referral interventional pain management center in the United States. METHODS: Four randomized trials were conducted assessing the clinical effectiveness of caudal epidural injections with or without steroids for lumbar disc herniation, lumbar discogenic or axial low back pain, lumbar central spinal stenosis, and post surgery syndrome. A cost utility analysis was performed with direct payment data for a total of 480 patients over a period of 2 years from these 4 trials. Outcome included various measures with significant improvement defined as at least a 50% improvement in pain reduction and disability status. RESULTS: The results of 4 randomized controlled trials of low back pain with 480 patients with a 2 year follow-up with the actual reimbursement data showed cost utility for one year of quality-adjusted life year (QALY) of $2,206 for disc herniation, $2,136 for axial or discogenic pain without disc herniation, $2,155 for central spinal stenosis, and $2,191 for post surgery syndrome. All patients showed significant improvement clinically and showed positive results in the cost utility analysis with an average cost per one year QALY of $2,172.50 for all patients and $1,966.03 for patients judged to be successful. The results of this assessment show a better cost utility or lower cost of managing chronic, intractable low back pain with caudal epidural injections at a QALY that is similar or lower in price than medical therapy only, physical therapy, manipulation, and surgery in most cases. LIMITATIONS: The limitations of this cost utility analysis include that it is a single center evaluation, even though 480 patients were included in the analysis. Further, only the costs of interventional procedures and physician visits were included. The benefits of returning to work were not assessed. CONCLUSION:   This cost utility analysis of caudal epidural injections in the treatment of disc herniation, axial or discogenic low back pain, central spinal stenosis, and post surgery syndrome in the lumbar spine shows the clinical effectiveness and cost utility of these injections at less than $2,200 per one year of QALY.

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.

A prospective evaluation of psychotherapeutic and illicit drug use in patients presenting with chronic pain at the time of initial evaluation.

BACKGROUND: Reports of chronic pain and associated opioid use, abuse, and fatalities continue to increase at an alarming rate, not only in the United States but also across the globe. In light of the many resultant fatalities, multiple authors and authorities have cautioned against the excessive use of opioids. Consequently, the Food and Drug Administration, Drug Enforcement Administration, and multiple state authorities have been proposing and implementing a plethora of regulations to curb opioid overuse and abuse. In the majority of cases, pain physicians have been portrayed as the perpetrators responsible for escalating use and abuse and resultant fatalities. OBJECTIVES: To assess the patterns of psychotherapeutic drug use and illicit drug use at the time of initial evaluation. STUDY DESIGN: A prospective evaluation. SETTING: A private, specialty referral interventional pain management clinic in the United States. METHODS: Participants were all new patients presenting to interventional pain management evaluated by one physician. Inclusion criteria was patients over 18 years of age with chronic spinal pain of at least one year duration. RESULTS: The results of this evaluation indicate that 94% of patients were on long-term opioids prior to presenting to interventional pain management. Illicit drug use is also common, although it has declined significantly. While a large proportion of individuals (45.7%) have used illicit drugs at some point in the past, current illicit drug use is present in only 7.9% of patients, both past and current use are similar to that of the general population. More importantly, a significant proportion of patients have been on opioids (high doses of more than 40 mg equivalents of morphine 48.8%) on a long-term basis, initiated and maintained by primary care physicians, prior to presenting to interventional pain management. Further, 35% were on benzodiazepines, and 9.2% on carisoprodol prior to presenting to interventional pain management. LIMITATIONS: The limitations of this evaluation include that it is a prospective, single center evaluation by one physician that is partially dependent on subjective recall of the patient. CONCLUSION: This study shows an overwhelming majority of patients were initiated and maintained with opioids in managing chronic noncancer pain. They were frequently on high doses over a long period of time with multiple drug combinations prescribed by primary care physicians.

The role of fluoroscopic interlaminar epidural injections in managing chronic pain of lumbar disc herniation or radiculitis: a randomized, double-blind trial.

BACKGROUND: There is continued debate on the effectiveness, indications, and medical necessity of epidural injections in managing pain and disability from lumbar disc herniation, despite extensive utilization. There is paucity of literature on interlaminar epidural injections in managing lumbar disc herniation or radiculitis in contemporary interventional pain management settings utilizing fluoroscopy. METHODS: A randomized, double-blind, active-control trial was undertaken to assess the effectiveness of lumbar interlaminar epidural injections with or without steroids for disc herniation and radiculitis. The primary outcome was defined as pain relief and functional status improvement of ≥ 50%. One hundred twenty patients were randomly assigned to 1 of the 2 groups. Group I patients received lumbar interlaminar injections containing a local anesthetic (lidocaine 0.5%, 6 mL), whereas Group II patients received lumbar interlaminar epidural injections of 0.5% lidocaine, 5 mL, mixed with 1 mL of non-particulate betamethasone. RESULTS: In the patients who responded with initial 2 procedures with at least 3 weeks of relief, significant improvement was seen in 80% of the patients in the local anesthetic group and 86% of the patients in the local anesthetic and steroid group. The overall average procedures per year were 3.6 in the local anesthetic group and 4.1 in the local anesthetic and steroid group, with an average relief of 33.7 ± 18.1 weeks in the local anesthetic group and 39.1 ± 12.2 weeks in the local anesthetic and steroid group over a period of 52 weeks in the overall population. CONCLUSIONS: Lumbar interlaminar epidural injections of local anesthetic with or without steroids might be effective in patients with disc herniation or radiculitis, with potential superiority of steroids compared with local anesthetic alone at 1 year follow-up.

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.

Fluoroscopic caudal epidural injections in managing post lumbar surgery syndrome: two-year results of a randomized, double-blind, active-control trial.

STUDY DESIGN: A randomized, active control, double-blind trial. OBJECTIVE: To evaluate the effectiveness of fluoroscopically directed caudal epidural injections with or without steroids in managing chronic low back and lower extremity pain secondary to post lumbar surgery syndrome. SUMMARY OF BACKGROUND DATA: There is a paucity of evidence concerning caudal epidural injections for managing chronic persistent low back pain with or without lower extremity pain caused by post lumbar surgery syndrome. METHODS: This active control randomized study included 140 patients with 70 patients in each group. Group I received 0.5% lidocaine, 10 mL; Group II received 9 mL of 0.5% lidocaine mixed with 1 mL of 6 mg of nonparticulate betamethasone. The multiple outcome measures included the numeric rating scale, the Oswestry Disability Index 2.0, employment status, and opioid intake with assessments at 3, 6, 12, 18, and 24 months posttreatment. Primary outcome was defined as at least 50% improvement in pain and Oswestry Disability Index scores. Patients with a positive response to the first 2 procedures with at least 3 weeks of relief were considered to be successful. All others were considered as failures. RESULTS: Overall in Group I, 53% and 47% of the patients and in Group II, 59% and 58% of the patients, showed significant improvement with reduction in pain scores and disability index at 12 months and 24 months. In contrast, in the successful groups, significant pain relief and improvement in function were observed in 70% and 62% of Group I at one and 2 years; in 75% and 69% of Group II at one and 2 years. The results in the successful group showed that at the end of the first year patients experienced approximately 38 weeks of relief and at the end of 2 years Group I had 62 weeks and Group II had 68 weeks of relief. Overall total relief for 2 years was 48 weeks in Group I and 54 weeks in Group II. The average procedures in the successful groups were at 4 in one year and 6 at the end of 2 years. CONCLUSION: Caudal epidural injections of local anesthetic with or without steroid might be effective in patients with chronic persistent low back and/or lower extremity pain in patients with post lumbar surgery syndrome.

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.

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.