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.

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.

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 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.

Management of chronic pain of cervical disc herniation and radiculitis with fluoroscopic cervical interlaminar epidural injections.

STUDY DESIGN: A randomized, double-blind, active controlled trial. OBJECTIVE: To evaluate the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids in the management of chronic neck pain and upper extremity pain in patients with disc herniation and radiculitis. SUMMARY OF BACKGROUND DATA: Epidural injections in managing chronic neck and upper extremity pain are commonly employed interventions. However, their long-term effectiveness, indications, and medical necessity, of their use and their role in various pathologies responsible for persistent neck and upper extremity pain continue to be debated, even though, neck and upper extremity pain secondary to disc herniation and radiculitis, is described as the common indication. There is also paucity of high quality literature. METHODS: One-hundred twenty 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 0.5% lidocaine, 4 mL, mixed with 1 mL of nonparticulate betamethasone. Primary outcome measure was ≥ 50 improvement in pain and function. Outcome assessments included Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), opioid intake, employment, and changes in weight. RESULTS: Significant pain relief and functional status improvement (≥ 50%) was demonstrated in 72% of patients who received local anesthetic only and 68% who received local anesthetic and steroids. In the successful group of participants, significant improvement was illustrated in 77% in local anesthetic group and 82% in local anesthetic with steroid group. CONCLUSIONS: Cervical interlaminar epidural injections with or without steroids may provide significant improvement in pain and function for patients with cervical disc herniation and radiculitis.

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.

Evaluation of lumbar facet joint nerve blocks in managing chronic low back pain: a randomized, double-blind, controlled trial with a 2-year follow-up.

STUDY DESIGN: A randomized, double-blind, controlled trial. OBJECTIVE: To determine the clinical effectiveness of therapeutic lumbar facet joint nerve blocks with or without steroids in managing chronic low back pain of facet joint origin. SUMMARY OF BACKGROUND DATA: Lumbar facet joints have been shown as the source of chronic pain in 21% to 41% of low back patients with an average prevalence of 31% utilizing controlled comparative local anesthetic blocks. Intraarticular injections, medial branch blocks, and radiofrequency neurotomy of lumbar facet joint nerves have been described in the alleviation of chronic low back pain of facet joint origin. METHODS: The study included 120 patients with 60 patients in each group with local anesthetic alone or local anesthetic and steroids. The inclusion criteria was based upon a positive response to diagnostic controlled, comparative local anesthetic lumbar facet joint blocks.Outcome measures included the numeric rating scale (NRS), Oswestry Disability Index (ODI), opioid intake, and work status, at baseline, 3, 6, 12, 18, and 24 months. RESULTS: Significant improvement with significant pain relief of >or= 50% and functional improvement of >or= 40% were observed in 85% in Group 1, and 90% in Group II, at 2-year follow-up.The patients in the study experienced significant pain relief for 82 to 84 weeks of 104 weeks, requiring approximately 5 to 6 treatments with an average relief of 19 weeks per episode of treatment. CONCLUSIONS: Therapeutic lumbar facet joint nerve blocks, with or without steroids, may provide a management option for chronic function-limiting low back pain of facet joint origin.

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%.

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.

Prevalence of side effects of prolonged low or moderate dose opioid therapy with concomitant benzodiazepine and/or antidepressant therapy in chronic non-cancer pain.

BACKGROUND: Opioid use in the management of chronic pain is widespread in chronic pain settings. Opioid prescriptions for non-cancer pain and overall opioid sales have been soaring with the increasing nonmedical use of opioids in the United States. Prolonged use of high dose opioids has been associated with adverse consequences including tolerance, abuse, addiction, hyperalgesia, hormonal effects, and immunosuppression. Studies of high dose therapy have shown pain relief with a 30% decrease in the intensity of pain and that only 44% of the patients continue the treatment between 7 and 24 months. However, there is no data available on the prevalence of side effects associated with low or moderate dose opioid use in chronic non-cancer pain when administered in conjunction with interventional techniques. OBJECTIVE: To evaluate the prevalence of side effects, of low or moderate dose opioid therapy with or without benzodiazepines, antidepressants, and their combinations. METHODS: The evaluation was conducted by interviewing 1,000 patients on stable doses of opioids, with or without benzodiazepines, antidepressants, and their combinations. Patients were categorized into 4 groups with Group 1 receiving opioids only (n = 143), Group 2 receiving opioids and benzodiazepines (n = 159), Group 3 receiving opioids and antidepressants (n = 113), and Group 4 received opioids, benzodiazepines, and antidepressants (n = 118). RESULTS: Inclusion criteria was met in 533 patients receiving opioid therapy for longer than 6 months. The incidence of side effects in Group 1 was 18%, in Group 2 was 8%, in Group 3 was 17%, and in Group 4 was 14%. The most frequent complications were in patients receiving methadone (52%) followed by oxycodone (41%) and morphine (36%). Patients receiving hydrocodone had the least incidences of side effects with 7.5%. There were no significant differences noted based on the duration of therapy, age of the patient, and gender. Severe side effects accounted for only 14 of 137 instances. LIMITATIONS: Limitations of this study include the inability to incorporate multiple other drugs due to complicated nature with multiple groups and data collection and analysis. The other limitation is that the proportion of patients receiving methadone, oxycodone, morphine, and propoxyphene was low compared to hydrocodone with 77% of the patients. CONCLUSION: Moderate or low dose opioid therapy in conjunction with or without benzodiazepines, antidepressants, or in combinations are associated with minor side effects.

Influence of psychological variables on the diagnosis of facet joint involvement in chronic spinal pain.

BACKGROUND: Facet or zygapophysial joint pain is one of the common conditions responsible for chronic spinal pain. Controlled diagnostic blocks are considered the only means of reliable diagnosis of facet joint pain, due to the inability of physical examination, clinical symptoms, radiologic evaluation, and nerve conduction studies to provide a reliable diagnosis. The prevalence of facet joint pain has been established to be 15% to 45% of patients with low back pain, 39% to 67% of patients with neck pain, and 34% to 48% of patients with thoracic pain. However, using only a single block, false-positive rates of 27% to 63% in the cervical spine, 42% to 58% in the thoracic spine, and 17% to 50% in the lumbar spine have been reported. While there are multiple reasons for false-positive results, psychological variables may also contribute to false-positive results. A lack of influence of psychological factors on the validity of controlled diagnostic local anesthetic blocks of lumbar facet joints has been demonstrated. However, no such studies have been performed in the thoracic or cervical spine. OBJECTIVE: To study the influence of psychopathology (depression, generalized anxiety disorder, and somatization individually or in combinations of multiple psychopathologic conditions) on the ability of controlled, comparative local anesthetic blocks to accurately identify facet joint pain and false-positive rates with a single block. METHODS: Four hundred thirty-eight patients undergoing controlled, comparative local anesthetic blocks were included in the study. Patients were allocated based on their psychological profiles - each diagnostic group or combination was divided into distinct categories. Primary groups consisted of patients with major depression, generalized anxiety disorder, and somatization disorder. Combination groups consisted of 4 categories based on multiple combinations. All the patients were treated with controlled, comparative local anesthetic blocks either with 1% lidocaine or 1% lidocaine and 0.25% bupivacaine. A positive response was defined as at least an 80% reduction in pain and the ability to perform previously painful movements with appropriate relief with 2 separate local anesthetics. RESULTS: The prevalence of facet joint pain in chronic spinal pain ranged from 25% to 40% in patients without psychopathology, whereas it ranged from 28% to 43% in patients with a positive diagnosis of major depression, generalized anxiety disorder, and somatization disorder, respectively, compared to 23% to 39% in patients with a negative diagnosis. Regional facet joint pain prevalence and false-positive rates were higher in the cervical region in patients with major depression. In the lumbar and thoracic regions, no significant differences were noted. CONCLUSION: This study demonstrated that, based on patient psychopathology, there were no significant differences among the patients either in terms of prevalence or false-positive rates in the lumbar and thoracic regions. A higher prevalence and lower false-positive rates in the cervical region were established in patients with major depression.

Age-related prevalence of facet-joint involvement in chronic neck and low back pain.

BACKGROUND: Spinal pain is common in all age groups. While the research has focused primarily on incidence and prevalence in younger working adults, there is evidence that spinal pain is one of the most frequent complaints in older persons and is responsible for functional limitations. While facet arthrosis is a common radiographic finding, which has been suggested to be a potential cause of spinal pain, nearly 10% of all adults show signs of degeneration by the time they reach age 30. Radiographic changes of osteoarthritis have been shown to be equally common in patients with and without low back or neck pain. The studies of low back pain have shown the prevalence of facet joint involvement to be approximately 15% to 45%. However, age related prevalence of facet joint neck pain has not been studied. OBJECTIVE: To assess age-related prevalence and false-positive rates of facet-joint involvement in chronic spinal pain using controlled comparative local anesthetic blocks. DESIGN: Retrospective analysis of 424 patients, divided into 6 groups based upon age (Group I: aged 18 - 30 years, Group II: aged 31 - 40 years, Group III: aged 41 - 50 years, Group IV: aged 51 - 60, Group V: 61 - 70 years, and Group VI: greater than 70 years of age). RESULTS: The prevalence of cervical facet joint-related pain was the lowest (33%) in Group VI and highest (42%) in Group I. False-positive rates for cervical facet joint blocks ranged from 39% (Group III) to 58% (Group V) with an overall false-positive rate of 45%. The prevalence of facet joint involvement in lumbar spinal pain ranged from 18% (in Group II) to 44% (in Group IV), with significant differences noted when Group II and Group III were compared to other groups and with higher rates in Group V. CONCLUSION: This study demonstrated a variable age-related prevalence of facet joint pain in chronic low back pain, whereas in the cervical spine it was similar among all the age groups.

Preliminary results of a randomized, equivalence trial of fluoroscopic caudal epidural injections in managing chronic low back pain: Part 1--Discogenic pain without disc herniation or radiculitis.

BACKGROUND: Intervertebral discs, facet joints, ligaments, fascia, muscles, and nerve root dura have been described as tissues capable of transmitting pain in the low back. The pathophysiology of spinal radicular pain is the subject of ongoing research and controversy with discogenic pain assuming a major role as a cause of non-specific low back pain. Even though epidural injections are frequently administered in managing axial low back pain, the evidence is lacking. STUDY DESIGN: A randomized, double-blind, equivalence 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 or without steroids in managing chronic low back pain without disc herniation or radiculitis in providing effective and long-lasting pain relief 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 caudal epidural injections with 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. Randomization was performed by computer-generated random allocation sequence by simple randomization. OUTCOMES ASSESSMENT: Multiple outcome measures were utilized which included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3 months, 6 months, and 12 months post-treatment. Significant pain relief was defined as 50% or more, whereas significant improvement in disability score was defined as reduction of 40% or more. RESULTS: Significant pain relief (> or =50%) was demonstrated in 72% to 81% of patients and functional status improvement was demonstrated by a reduction of 40% in the ODI scores in 81% of the patients. The overall average procedures per year were 3.6 +/- 1.05 in Group I and 3.9 +/- 1.33 in Group II with an average total relief per year of 32.3 +/- 16.93 weeks in Group I and 30.7 +/- 17.94 weeks in Group II over a period of 52 weeks. LIMITATIONS: The results of this study are limited by lack of a placebo group and a preliminary report of 36 patients in each group. CONCLUSION: Caudal epidural injections with or without steroids may be effective in patients with chronic function-limiting low back pain without facet joint pain, disc herniation, and/or radiculitis in over 70% of the patients.

Preliminary results of a randomized, equivalence trial of fluoroscopic caudal epidural injections in managing chronic low back pain: Part 3--Post surgery syndrome.

BACKGROUND: Post surgery syndrome resulting in persistent pain following lumbar spine surgery is common. Speculated causes of post lumbar surgery syndrome include stenosis, degeneration of adjacent segments, internal disc disruption, recurrent disc herniation, retained disc fragment, epidural or intraneural fibrosis, radiculopathy, and various other causes. Epidural injections are most commonly used in post surgery syndrome. There is lack of evidence for the effectiveness of epidural injections in managing chronic low back pain with or without lower extremity pain secondary to post surgery syndrome. STUDY DESIGN: A randomized, double-blind, equivalence 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 in patients with chronic low back and lower extremity pain after surgical intervention with post lumbar surgery syndrome. METHODS: Patients were randomly assigned to one of 2 groups; Group I patients received caudal epidural injections with local anesthetic (lidocaine 0.5%), whereas Group II patients received caudal epidural injections with 0.5% lidocaine 9 mL mixed with 1 mL of 6 mg non-particulate Celestone. Randomization was performed by computer-generated random allocation sequence by simple randomization. OUTCOMES ASSESSMENT: Multiple outcome measures were utilized which included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3 months, 6 months, 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: Significant pain relief (> or =50%) was recorded in 60% to 70% of the patients with no significant differences noted with or without steroid over a period of one-year. In addition, functional assessment measured by the ODI also showed significant improvement with at least 40% reduction in Oswestry scores in 40% to 55% of the patients. The average procedures per year were 3.4 with an average total relief per year of 31.7 +/- 19.10 weeks in Group I and 26.2 +/- 18.34 weeks in Group II over a period of 52 weeks. LIMITATIONS: The results of this study are limited by the lack of a placebo group and the preliminary report size of only 20 patients in each group. CONCLUSION: Caudal epidural injections in chronic function-limiting low back pain in post surgery syndrome without facet joint pain demonstrated effectiveness with over 55% of the patients showing improvement in functional status with significant pain relief in 60% to 70%.

Preliminary results of a randomized, equivalence trial of fluoroscopic caudal epidural injections in managing chronic low back pain: Part 4--Spinal stenosis.

BACKGROUND: Spinal stenosis is one of the 3 most common diagnoses of low back and leg symptoms which also include disc herniation and degenerative spondylolisthesis. Spinal stenosis is a narrowing of the spinal canal with encroachment on the neural structures by surrounding the bone and soft tissue. In the United States, one of the most commonly performed interventions for managing chronic low back pain are epidural injections, including their use for spinal stenosis. However, there have not been any randomized trials and evidence is limited with regards to the effectiveness of epidural injections in managing chronic function-limiting low back and lower extremity pain secondary to lumbar spinal stenosis. STUDY DESIGN: A randomized, double-blind, equivalence 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 or without steroids in providing effective and long-lasting pain relief in the management of chronic low back pain in spinal stenosis and to evaluate the differences between local anesthetic with or without steroids. METHODS: 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. Randomization is being performed by computer-generated random allocation sequence by simple randomization. OUTCOMES ASSESSMENT: Multiple outcome measures were utilized which included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3 months, 6 months, and 12 months post-treatment. Significant pain relief was defined as 50% or more, whereas significant improvement in disability score was defined as reduction of 40% or more. RESULTS: Significant pain relief (> or =50%) was demonstrated in 55% to 65% of the patients and functional status improvement with 40% reduction in ODI scores in 55% to 80% of the patients. The overall average procedures per year were 3.4 +/- 1.27 in Group I and 2.6 +/- 1.35 in Group II with an average total relief per year of 30.3 +/- 19.49 weeks in Group I and 23.1 +/- 21.36 weeks in Group II over a period of 52 weeks. LIMITATIONS: The results of this study are limited by the lack of a placebo group and a preliminary report of 20 patients in each group, even though sample was justified. CONCLUSION: Caudal epidural injections with or without steroids may be effective in patients with chronic function-limiting low back and lower extremity pain with spinal stenosis in approximately 60% of the patients.

Lumbar facet joint nerve blocks in managing chronic facet joint pain: one-year follow-up of a randomized, double-blind controlled trial: Clinical Trial NCT00355914.

BACKGROUND: Lumbar facet joints have been implicated as the source of chronic pain in 15% to 45% of patients with chronic low back pain. Various therapeutic techniques including intraarticular injections, medial branch blocks, and radiofrequency neurotomy of lumbar facet joint nerves have been described in the alleviation of chronic low back pain of facet joint origin. OBJECTIVE: The study was conducted to determine the clinical effectiveness of therapeutic local anesthetic lumbar facet joint nerve blocks with or without steroid in managing chronic function-limiting low back pain of facet joint origin. DESIGN: A randomized, double-blind, controlled trial. SETTING: An interventional pain management setting in the United States. METHODS: This study included 60 patients in Group I with local anesthetic and 60 patients in Group II with local anesthetic and steroid. The inclusion criteria was based on the positive response to the diagnostic controlled comparative local anesthetic lumbar facet joint blocks. OUTCOME MEASURES: Numeric pain scores, Oswestry Disability Index, opioid intake, and work status. All outcome assessments were performed at baseline, 3 months, 6 months, and 12 months. RESULTS: Significant improvement with significant pain relief (> 50%) and functional improvement (> 40%) were observed in 82% and 85% in Group I, with significant pain relief in over 82% of the patients and improvement in functional status in 78% of the patients. Based on the results of the present study, it appears that patients may experience significant pain relief 44 to 45 weeks of 1 year, requiring approximately 3 to 4 treatments with an average relief of 15 weeks per episode of treatment. CONCLUSION: Therapeutic lumbar facet joint nerve blocks, with or without steroid, may provide a management option for chronic function-limiting low back pain of facet joint origin.

Effectiveness of thoracic medial branch blocks in managing chronic pain: a preliminary report of a randomized, double-blind controlled trial.

BACKGROUND: Thoracic facet joints have been implicated as the source of chronic pain in the mid back or upper back in 34% to 48% of the patients. Various therapeutic techniques utilized in managing chronic thoracic pain of facet joint origin include intraarticular injections, medial branch blocks, and radiofrequency neurotomy of thoracic facet joint nerves. OBJECTIVE: To determine the clinical effectiveness of therapeutic local anesthetic medial branch blocks with or without steroid in managing chronic function-limiting mid back or upper back pain of facet joint origin. DESIGN: A randomized, double-blind, controlled trial. SETTING: An interventional pain management private practice, a tertiary referral center, in the United States. METHODS: A total of 48 patients were included, with 24 patients in each of the local anesthetic and steroid groups. All of the patients met the diagnostic criteria of thoracic facet joint pain by means of comparative, controlled diagnostic blocks and the inclusion criteria. Group I patients received thoracic medial branch blocks with bupivacaine, whereas Group II patients received thoracic medial branch blocks with bupivacaine and non-particulate betamethasone. OUTCOME MEASURES: Numeric pain scores (NRS), Oswestry Disability Index (ODI), opioid intake, and return to work status. All outcomes were assessed at baseline, 3 months, 6 months, and 12 months. Significant pain relief was defined as > 50% pain relief. Significant functional improvement was defined as 40% reduction of ODI. RESULTS: In Group I, 79% of patients showed significant pain relief and functional improvement at 3 months, 6 months, and 12 months, a significant change from baseline. In Group II, 83%, 81%, and 79% of patients showed significant pain relief and functional improvement at 3 months, 6 months, and 12 months, a significant change from baseline. The majority of the patients experienced significant pain relief of 46 to 50 weeks, requiring approximately 3 to 4 treatments with an average relief of 16 weeks per episode of treatment. CONCLUSION: The majority of the patients in both groups experienced significant pain relief and improvement in functional status. Therapeutic thoracic medial branch blocks, with or without steroid, may provide a management option for chronic function-limiting mid back or upper back pain of facet joint origin.

Preliminary results of a randomized, equivalence trial of fluoroscopic caudal epidural injections in managing chronic low back pain: Part 2--Disc herniation and radiculitis.

BACKGROUND: The pathophysiology of lumbar radicular pain is a subject of ongoing research. The prevalence of sciatica or radiculitis ranges from 1.2% to 43%. Epidural injections are one of the most commonly performed interventions in the United States in managing chronic low back and lower extremity pain secondary to disc herniation and radiculitis. There is a paucity of evidence with contemporary methodology used in performing epidural injections under fluoroscopy and based on pain relief and functional status improvement. STUDY DESIGN: A randomized, double-blind, equivalence trial. SETTING: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. OBJECTIVE: To evaluate the effectiveness of caudal epidural injections with or without steroids in managing chronic low back and lower extremity pain secondary to disc herniation or radiculitis in providing effective and long-lasting pain relief and evaluate the differences between local anesthetic with or without steroids. METHODS: Patients were assigned to one of 2 groups; Group I patients received caudal epidural injections with an injection 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. Randomization was performed by computer-generated random allocations sequence by simple randomization. OUTCOMES ASSESSMENT: Multiple outcome measures were utilized which included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3 months, 6 months, and 12 months post-treatment. Significant pain relief was defined as 50% or more, whereas significant improvement in disability score was defined as a reduction of 40% or more. RESULTS: The percentage of patients with significant pain relief of 50% or greater at 12 months was 79% in Group I and 81% in Group II. Reduction of Oswestry scores of at least 40% was seen in 83% of the patients in Group I and 91% in Group II. The overall average procedures per year were 3.9 +/- 1.26 in Group I and 3.6 +/- 1.08 in Group II with an average total relief per year of 35.2 +/- 17.18 weeks in Group I and 35.9 +/- 15.34 weeks in Group II over a period of 52 weeks. LIMITATIONS: The results of this study are limited by lack of a placebo group and a preliminary report of 42 patients in each group. CONCLUSION: Caudal epidural injections with or without steroids may be effective in patients with disc herniation or radiculitis with between 79% to 91% of patients showing significant pain relief and improvement in functional status.

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.

Evaluation of lumbar facet joint nerve blocks in the management of chronic low back pain: preliminary report of a randomized, double-blind controlled trial: clinical trial NCT00355914.

BACKGROUND: The prevalence of persistent low back pain with the involvement of lumbar facet or zygapophysial joints has been described in controlled studies as varying from 15% to 45% based on the criteria of the International Association for the Study of Pain. Therapeutic interventions utilized in managing chronic low back pain of facet joint origin include intraarticular injections, medial branch nerve blocks, and neurolysis of medial branch nerves. OBJECTIVE: To determine the clinical effectiveness of therapeutic lumbar facet joint nerve blocks in managing chronic low back pain of facet joint origin. DESIGN: A prospective, randomized, double-blind trial. SETTING: An interventional pain management setting in the United States. METHODS: In this preliminary analysis, data from a total of 60 patients were included, with 15 patients in each of 4 groups. Thirty patients were in a non-steroid group consisting of Groups I (control, with lumbar facet joint nerve blocks using bupivacaine ) and II (with lumbar facet joint nerve blocks using bupivacaine and Sarapin); another 30 patients were in a steroid group consisting of Groups III (with lumbar facet joint nerve blocks using bupivacaine and steroids) and IV (with lumbar facet joint nerve blocks using bupivacaine, Sarapin, and steroids). All patients met the diagnostic criteria of lumbar facet joint pain by means of comparative, controlled diagnostic blocks. OUTCOME MEASURES: Numeric Rating Scale (NRS) pain scale, the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake. RESULTS: Significant improvement in pain and functional status were observed at 3 months, 6 months, and 12 months, compared to baseline measurements. The average number of treatments for 1 year was 3.7 with no significant differences among the groups. Duration of average pain relief with each procedure was 14.8 +/- 7.9 weeks in the non-steroid group, and 12.5 +/- 3.3 weeks in the steroid group, with no significant differences among the groups. CONCLUSION: Therapeutic lumbar facet joint nerve blocks with local anesthetic, with or without Sarapin or steroids, may be effective in the treatment of chronic low back pain of facet joint origin.