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

BACKGROUND: Chronic persistent low back and lower extremity pain secondary to central spinal stenosis is common and disabling. Lumbar surgical interventions with decompression or fusion are most commonly performed to manage severe spinal stenosis. However, epidural injections are also frequently performed in managing central spinal stenosis. After failure of epidural steroid injections, the next sequential step is percutaneous adhesiolysis and hypertonic saline neurolysis with a targeted delivery. The literature on the effectiveness of percutaneous adhesiolysis in managing central spinal stenosis after failure of epidural injections has not been widely studied. STUDY DESIGN: A prospective evaluation. SETTING: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. OBJECTIVE: To evaluate the effectiveness of percutaneous epidural adhesiolysis in patients with chronic low back and lower extremity pain with lumbar central spinal stenosis. METHODS: Seventy patients were recruited. The initial phase of the study was randomized, double-blind with a comparison of percutaneous adhesiolysis with caudal epidural injections. The 25 patients from the adhesiolysis group continued with follow-up, along with 45 additional patients, leading to a total of 70 patients. All patients received percutaneous adhesiolysis and appropriate placement of the Racz catheter, followed by an injection of 5 mL of 2% preservative-free lidocaine with subsequent monitoring in the recovery room. In the recovery room, each patient also received 6 mL of 10% hypertonic sodium chloride solution, and 6 mg of non-particulate betamethasone, followed by an injection of 1 mL of sodium chloride solution and removal of the catheter. OUTCOMES ASSESSMENT: Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3, 6, and 12, 18 and 24 months post treatment. The primary outcome measure was 50% or more improvement in pain scores and ODI scores. RESULTS: Overall, a primary outcome or significant pain relief and functional status improvement of 50% or more was seen in 71% of patients at the end of 2 years. The overall number of procedures over a period of 2 years were 5.7 ± 2.73. LIMITATIONS: The lack of a control group and a prospective design. CONCLUSIONS: Significant relief and functional status improvement as seen in 71% of the 70 patients with percutaneous adhesiolysis utilizing local anesthetic steroids and hypertonic sodium chloride solution may be an effective management strategy in patients with chronic function limiting low back and lower extremity pain with central spinal stenosis after failure of conservatie management and fluoroscopically directed epidural injections.

Fluoroscopic caudal epidural injections 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.

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 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.

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.

Controlled substance abuse and illicit drug use in chronic pain patients: An evaluation of multiple variables.

BACKGROUND: Opioids are used extensively for chronic pain management in the United States. The frequency of opioid use prior to presenting to interventional pain management settings and in interventional pain management settings has been shown to be above 90%. Opioid abuse has been demonstrated in 9% to 41% of patients receiving chronic pain management. Illicit drug use has been reported in 14% to 34% of patients in chronic pain management settings. OBJECTIVES: To evaluate and correlate multiple variables with opioid abuse and illicit drug use. DESIGN: A prospective, consecutive study. SETTING: Interventional pain management practice setting in the United States. METHODS: A total of 500 consecutive patients prescribed opioids, considered to be receiving stable doses of opioids supplemental to their interventional techniques were evaluated for opioid abuse and for illicit drug use. Abuse was defined as a patient receiving controlled substances from any source other than the prescribing physician at our center with the exception of controlled substances for acute injuries unrelated to the problem being treated, or for emergencies. Urine drug testing for illicit drugs was performed by urine rapid drug screen (Instant Technologies, iCup Norfolk, VA). Results were considered positive if one or more of the monitored illicit drugs including cocaine, marijuana (THC), phencycledane methamphetamine or amphetamines were detected. RESULTS: Opioid abuse was seen in 9% of patients, with illicit drug use in 16% of patients. Significant differences were noted in the prevalence of opioid abuse in patients who developed chronic pain following motor vehicle accident(s) and in patients presenting with pain in three regions of the body. Illicit drug use (marijuana) was more common in females. Illicit drug use was also more common in patients younger than 45, after motor vehicle injury, and in patients with involvement of three regions of the body. CONCLUSION: Opioid abuse and illicit drug use were common in chronic pain patients with a prevalence of 9% and 16%, respectively. Age, pain after motor vehicle accident, involvement of multiple regions and past history of illicit drug use were identified as risk factors.

Does adherence monitoring reduce controlled substance abuse in chronic pain patients?

BACKGROUND: Opioids are used extensively for chronic pain management in the United States. The frequency of opioid use prior to presenting to interventional pain management settings and in interventional pain management settings has been shown to be above 90%. Given that controlled substance abuse and illicit drug use are prevalent phenomena, adherence monitoring of patients that are prescribed opioids is becoming common. Adherence monitoring is carried out by an appropriate history, periodic evaluation of appropriate intake of drugs, random drug testing, and pill counts. Crucial to adherence monitoring is an initial controlled substance agreement and repeated review of the terms of this agreement with on-going education. However, the effect of adherence monitoring on drug abuse is unclear. OBJECTIVE: To identify controlled substance abuse through implementation of the terms of a controlled substance agreement, including periodic review and monitoring outside the organization. STUDY DESIGN: Prospective evaluation with historical controls. METHODS: Five hundred consecutive patients receiving prescription controlled substances were followed in a prospective manner. The evaluation consisted of a chart review to monitor controlled substance intake, with special attention to drugs obtained from outside the organization. Data collection for this purpose included information from records, pharmacies, referring physicians, and all the physicians involved in the treatment of the patient. RESULTS: Results from 500 consecutive patients were evaluated. Controlled substance abuse was seen in 9% of patients; overall, 5% of patients were obtaining controlled substances from other physicians, and 4% from illegal sources. CONCLUSION: Adherence monitoring, including controlled substance agreements and various periodic measures of compliance was associated with a 50% reduction in opioid abuse.

Does random urine drug testing reduce illicit drug use in chronic pain patients receiving opioids?

BACKGROUND: Prescription drug abuse and illicit drug use are common in chronic pain patients. Adherence monitoring with screening tests, and urine drug testing, periodic monitoring with prescription monitoring programs, has become a common practice in recent years. Random drug testing for appropriate use of opioids and use of illicit drugs is often used in pain management practices. Thus, it is expected that random urine drug testing will deter use of illicit drugs, and also improve compliance. OBJECTIVES: To study the prevalence of illicit drug use in patients receiving opioids for chronic pain management and to compare the results of illicit drug use with the results from a previous study. DESIGN: A prospective, consecutive study. SETTING: Interventional pain management practice setting in the United States. METHODS: A total of 500 consecutive patients on opioids, considered to be receiving stable doses of opioids supplemental to their interventional techniques, were studied by random drug testing. Testing was performed by rapid drug screen. Results were considered positive if one or more of the monitored illicit drugs including cocaine, marijuana (THC), methamphetamine or amphetamines were present. RESULTS: Illicit drug use was evident in 80 patients, or 16%, with marijuana in 11%, cocaine in 5%, and methamphetamine and/or amphetamines in 2%. When compared with previous data, the overall illicit drug use was significantly less. Illicit drug use in elderly patients was absent. CONCLUSION: The prevalence of illicit drug abuse in patients with chronic pain receiving opioids continues to be a common occurence. This study showed significant reductions in overall illicit drug use with adherence monitoring combined with random urine drug testing.

The effect of sedation on diagnostic validity of facet joint nerve blocks: an evaluation to assess similarities in population with involvement in cervical and lumbar regions (ISRCTNo: 76376497).

BACKGROUND: Zygapophysial or facet joint pain in patients suffering with chronic spinal pain without disc herniation or radiculopathy may be diagnosed with certainty by the use of controlled diagnostic blocks. But, in patients suffering with either lumbar or cervical facet joint pain, even this diagnostic approach may be confounded by false-positives when using a single diagnostic block. It may also be confounded by the administration of anxiolytics and narcotics prior to, or during, the controlled diagnostic facet joint blocks. The effect of sedation on the validity and potential differential results in patients suffering with combined cervical and lumbar facet joint pain has not been evaluated. OBJECTIVE: To assess the effects of midazolam and fentanyl on the diagnostic validity of facet joint blocks in patients suffering with both cervical and lumbar facet joint pain. STUDY DESIGN: Randomized, double-blind, placebo-controlled study. METHODS: The design consisted of a placebo group receiving a sodium chloride solution and two experimental groups receiving either midazolam or fentanyl. Patients included in the study had been diagnosed with facet joint pain using controlled comparative local anesthetic blocks of the medial branches and L5 dorsal rami. They had been treated with lumbar and cervical facet joint nerve blocks and experienced good pain relief; and were presenting for repeat treatment after a period of symptom relief. The study was performed in an interventional pain management practice in the United States; a total of 60 patients participated with 20 patients randomly allocated into each group. Outcome measures included numeric pain scores, proportion of pain relief, and ability to perform prior painful movements. OUTCOME MEASURES: Outcomes were assessed at baseline and after the administration of 1 of the 3 solutions (Group I, sodium chloride solution; Group II, midazolam; or Group III, fentanyl). RESULTS: Overall, 50% of the patients were relaxed or sedated in the placebo group, while 100% of the patients in the midazolam and fentanyl groups were relaxed or sedated. As many as 10% of the patients reported significant relief (>= 80%) with the ability to perform prior painful movements. CONCLUSIONS: Perioperative administration of sodium chloride, midazolam, or fentanyl can confound results in the diagnosis of combined cervical and lumbar facet joint pain. False-positive results with placebo or sedation may be seen in a small proportion of patients.

[ISRCTN 16558617] A randomized, controlled trial of spinal endoscopic adhesiolysis in chronic refractory low back and lower extremity pain.

BACKGROUND: Postoperative epidural fibrosis may contribute to between 5% to 60% of the poor surgical outcomes following decompressive surgery. Correlations have been reported between epidural scarring and radicular pain, poor surgical outcomes, and a lack of any form of surgical treatment. The use of spinal endoscopic adhesiolysis in recent years in the management of chronic refractory low back and lower extremity pain has been described. METHODS: A prospective, randomized, double-blind trial was conducted to determine the outcome of spinal endoscopic adhesiolysis to reduce pain and improve function and psychological status in patients with chronic refractory low back and lower extremity pain. A total of 83 patients were evaluated, with 33 patients in Group I and 50 patients in Group II. Group I served as the control, with endoscopy into the sacral level without adhesiolysis, followed by injection of local anesthetic and steroid. Group II received spinal endoscopic adhesiolysis, followed by injection of local anesthetic and steroid. RESULTS: Among the 50 patients in the treatment group receiving spinal endoscopic adhesiolysis, significant improvement without adverse effects was shown in 80% at 3 months, 56% at 6 months, and 48% at 12 months. The control group showed improvement in 33% of the patients at one month and none thereafter. Based on the definition that less than 6 months of relief is considered short-term and longer than 6 months of relief is considered long-term, a significant number of patients obtained long-term relief with improvement in pain, functional status, and psychological status. CONCLUSION: Spinal endoscopic adhesiolysis with targeted delivery of local anesthetic and steroid is an effective treatment in a significant number of patients with chronic low back and lower extremity pain without major adverse effects.

Prevalence of illicit drug use among individuals with chronic pain in the Commonwealth of Kentucky: an evaluation of patterns and trends.

The abuse of prescription-controlled substances is a common phenomenon, associated with illicit drug use, in patients suffering with chronic pain and receiving controlled substances for the management of pain. Prescription drug abuse in Kentucky has led to an increase in Medicare and Medicaid fraud, as well as physician indictments for unscrupulous practices and increased vigilance and prosecution by the authorities. This study was undertaken to evaluate 400 consecutive patients receiving controlled substances in an interventional pain management practice in Western Kentucky to evaluate the prevalence of illicit drug use and opioid abuse and noncompliance with opioid therapy. Results indicated that patients covered by third-party insurance showed 17% (95% CI, 10%-24%) prevalence of illicit drug use, with patients on Medicare, with or without third-party insurance, showing 10% (95% CI, 4%-6%) prevalence, compared to patients on Medicare and Medicaid with 24% (95% CI, 16%-32%) prevalence, and patients with only Medicaid with 39% (95% CI, 29%-49%) prevalence of illicit drug use. In addition, combined use of illicit drugs and misuse of prescription drugs was also seen in a substantially greater proportion of patients in Groups III and IV, with the highest (60%) in Group IV with Medicaid only, followed by Group III with Medicaid supplementation of Medicare insurance in 40% of the patients. Overall illicit drug use, opioid abuse, and noncompliance of opioids is significant in patients in Western Kentucky receiving Medicaid as a primary insurance or as a supplemental insurance to Medicare, despite extensive monitoring, written agreement, and education.

Reliability of psychological evaluation in chronic pain in an interventional pain management setting.

BACKGROUND: Psychological disorders may be associated with poor pain related treatment outcomes. However, there may be limitations with studies evaluating the relationship between pain and psychopathology. OBJECTIVE: To assess the reliability of psychological evaluations in interventional pain management by MCMI-III(R) and P-3(R). STUDY DESIGN: Prospective evaluation of consecutive patients in an interventional pain management center. METHODS: Patients were evaluated using a DSM-IV-TR(R) questionnaire with a physician interview as an integral part of their comprehensive evaluation. In addition, all the patients participating in this study also underwent psychological evaluation with MCMI-III and P-3. A positive diagnosis of major depression or generalized anxiety disorder based on DSM-IV-TR criteria was considered as the criterion standard. All of the patients presented for treatment of chronic pain. The data based on the criterion standard were compared with results of the diagnostic impression from the MCMI-III and the P-3 evaluation utilizing criteria for average, and above average, patient pain scores. RESULTS: Major depression was diagnosed in a total of 59 of 100 patients using DSM-IV-TR criteria, in 32 patients based on MCMI-III criteria, and in 55 patients based on P-3 evaluations utilizing average pain patient criteria. Generalized anxiety disorder was diagnosed in 55 patients by means of DSM-IV-TR, 45 patients by MCMI-III, and 55 patients by P-3 Profile utilizing average pain patient scores. The specificity of MCMI-III was 100% with a sensitivity of 54% for diagnosis of depression; whereas it was 78% specificity and sensitivity for P-3, with average pain patient scores. For generalized anxiety disorder, specificity of MCMI-III was 89% with a sensitivity of 73% compared to specificity of 80% and sensitivity of 84% for average pain patient scores for P-3. CONCLUSION: MCMI-III and P-3 are highly specific in diagnosing depression and generalized anxiety disorder, with variable sensitivity. A DSM-IV-TR questionnaire evaluation incorporated into the pain management questionnaire, along with a short clinical interview, is a reliable means of assessing depression and anxiety in patients suffering with chronic pain.

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.

Prospective evaluation of patients with increasing opiate needs: prescription opiate abuse and illicit drug use.

BACKGROUND: Multiple aberrant behaviors have been described to identify patients abusing opioids and using illicit drugs. However, patient behavior encompassing aggressive seeking or complaining about the need for higher doses of opioids has not yet been evaluated with regards to misuse or abuse patterns of prescription drugs and illicit drug usage. OBJECTIVE: The objective of this study was to evaluate and identify the prevalence of illicit drug use and prescription drug abuse or misuse in patients seeking higher doses of opioids and compare to a group of patients not seeking higher doses of opioids. DESIGN: A prospective, non-randomized, consecutive, observational study. METHODS: A total of 200 patients from an interventional pain management setting with 100 consecutive patients in each group either not seeking additional opioids (Group I) or seeking higher doses of opioids (Group II) were evaluated with urine testing for illicit drug use, and/or misuse or abuse of opioids. Drug testing was carried out by Rapid Drug Screen. RESULTS: Results of this study showed a significantly greater proportion of patients in Group II using illicit drugs (15% vs 32% P = 0.005). Combined use of illicit drugs and abuse of non-prescribed opioids was also present in a significantly greater proportion of patients in Group II (15% vs 39% P = 0.000). A significant number of patients in Group I (32%) and Group II (30%) failed to show the prescribed drug in their urine. CONCLUSION: A significant proportion of patients, whether they were seeking additional opioids or not, used illicit drugs. Further, a greater proportion of patients in Group II used illicit drugs and non-prescribed opioids.

Patterns of illicit drug use and opioid abuse in patients with chronic pain at initial evaluation: a prospective, observational study.

BACKGROUND: Over the years, there has been a shift toward the increased reliance on opioids for the treatment of chronic pain. It is well known that some patients do not provide an appropriate history or underestimate their drug intake, and may exaggerate reported pain levels. Numerous studies have documented the incidence of illicit drug use and abuse of opioids in chronic pain patients. It is not known what proportion of patients have already been exposed to controlled substances prior to presenting for interventional pain management. OBJECTIVE: To evaluate and identify the prevalence of controlled substance use, demographic characteristics, and psychological characteristics of patients presenting for interventional pain management along with illicit drug use. STUDY DESIGN: A prospective, observational study. METHODS: A total of 100 patients presenting at an interventional pain management setting for initial evaluation were evaluated by detailed history and urine drug testing for controlled substance use and illicit drug use. RESULTS: Duration of pain on average was 9.3 years, 57% of the patients had involvement of more than one body region, 90% were taking opioids, 47% had been seen by 5 or more providers, and more than 70% presented with psychological problems. Twenty-three patients tested positive for illicit drugs and 12 patients were positive for opioids even though they had no prescription and denied taking opioids. Twenty-seven patients either under-reported (16) or over-reported (11) opioid use. CONCLUSION: Ninety percent of these patients were taking opioids. Twenty-seven patients incorrectly reported opioid use, either underuse or overuse, with 23 patients using illicit drugs, 12 using non-prescription opioids, and with 35 of 100 patients at initial evaluation exhibiting one of the abuse behaviors.

A double-blind, controlled evaluation of the value of sarapin in neural blockade.

OBJECTIVE: To demonstrate the effectiveness of Sarapin in prolonging the action of neural blockade with improved pain relief. DESIGN: Prospective, continuous, double-blind trial including 500 consecutive patients undergoing either caudal epidural injections; cervical, thoracic, lumbosacral facet joint nerve blocks; and/or intercostal nerve blocks or a combination thereof. BACKGROUND: Sarapin has been reported as an agent to provide pain relief without motor weakness with an excellent risk/ benefit ratio in neural blockade. Sarapin is a suspension of powdered Sarracenia purpurin (pitcher plant) in alkaline solution. Researchers theorize that the distillate contained an unidentified biological substance that potentiates the action of the ammonium ion. Modest but significant benefits were demonstrated with diagnostic blocks, with diagnostic lumbar medial branch blocks, therapeutic lumbar medial branch blocks, and caudal epidural injections. In an experimental study in the horse, no benefits were seen by injection of Sarapin. The authors proposed that there may not be any benefits in other species as well. Multiple therapeutic agents utilized in neural blockade, including local anesthetics, steroids, and neurolytic agents, have been evaluated extensively. Sarapin has not been evaluated in controlled trials. METHODS: Five hundred consecutive patients undergoing either caudal epidural injections; cervical, thoracic, or lumbosacral facet joint nerve blocks; or intercostal nerve blocks or a combination thereof were included in the study. Each patient was treated with two blocks. The treatments were dou-ble-blind and prospective. Each patient acted as their own control. RESULTS: The results showed that 500 patients received a total of 828 treatments, once with Sarapin and once without. There were no significant differences between these groups, either with pain relief measured by numeric pain scale or duration of significant relief defined as 50% or greater relief. CONCLUSION: This prospective, double-blind trial of 500 patients undergoing 828 treatments, one time with Sarapin and a subsequent time without, with each patient acting as their own control, showed no significant differences in the pain relief or duration of significant relief with the addition of Sarapin.

Evaluation of variables in illicit drug use: does a controlled substance abuse screening tool identify illicit drug use?

STUDY DESIGN: A retrospective, case-controlled study. OBJECTIVE: To identify variables in patients with or without illicit drug use. BACKGROUND INFORMATION: Studies documenting a high incidence of controlled substance abuse in chronic pain continue to increase. Over the years, multiple evaluation tools have been proposed. The need to identify predictors of aberrant drug related behavior and addiction in patients being treated with controlled substances for pain has been emphasized. METHODS: A total of 150 patients were included in the study. One hundred consecutive urine tests without the presence of illicit drugs and 50 consecutive urine tests with the presence of illicit drugs of patients receiving controlled substances, were selected for evaluation of multiple variables of illicit drug use. They were divided into four groups with Group I with no controlled substance abuse and no illicit drug abuse with 70 patients; Group II with no controlled substance abuse, however, with positive illicit drug use with 33 patients; Group III with positive controlled abuse, however, with no illicit drug use with 30 patients; and Group IV with controlled substance abuse and illicit drug use with 17 patients. RESULTS: Results of this study showed that of the eight variables described in a previous study in identifying controlled substance abuse, four variables were crucial. The four significant items identified in this evaluation were excessive opiate needs, deception or lying to obtain controlled substances, current or prior intentional doctor shopping, and current or prior use of illicit drugs and denial. These four variables were accurate in identifying controlled substance abuse. However, they failed to identify illicit drug use. CONCLUSION: The presently available and validated screening tool for controlled substance abuse failed to identify illicit drug use in patients receiving controlled substances.

Evaluation of lumbar transforaminal epidural injections with needle placement and contrast flow patterns: a prospective, descriptive report.

BACKGROUND: Transforaminal epidural steroid injection is one of the commonly employed modalities of treatment in managing nerve root pain. However, there have been no controlled prospective evaluations of epidural and nerve root contrast distribution patterns and other aspects of fluoroscopically directed lumbosacral transforaminal epidural steroid injections. OBJECTIVES: To evaluate contrast flow patterns and intravascular needle placement of fluoroscopically guided lumbosacral transforaminal epidural injections. DESIGN: A prospective, observational study. METHODS: A total of 100 consecutive patients undergoing fluoroscopically guided transforaminal epidural steroid injections were evaluated. The contrast flow patterns, ventral or dorsal epidural filling, nerve root filling, C-arm time, and intravascular needle placement were evaluated. RESULTS: Ventral epidural filling was seen in 88% of the procedures, in contrast to dorsal filling noted in 9% of the procedures. Nerve root filling was seen in 97% of the procedures. Total intravenous placement of the needle was noted in 22% of the procedures, whereas negative flashback and aspiration was noted in 5% of the procedures. CONCLUSION: Lumbosacral transforaminal epidural injections, performed under fluoroscopic visualization, provide excellent nerve root filling and ventral epidural filling patterns. However, unrecognized intravascular needle placement with negative flashback or aspiration was noted in 5% of the procedures.

Evaluation of fluoroscopically guided caudal epidural injections.

OBJECTIVE: To evaluate accuracy of needle placement and flow patterns of fluoroscopically guided caudal epidural injections. DESIGN: A prospective observational study of patients with low back pain undergoing caudal epidural injections under fluoroscopy. BACKGROUND: Epidural administration of corticosteroids is one of the commonly used interventions in managing chronic low back pain. Sacral or caudal epidural placement of the needle is one of the commonly used means to access the lumbar epidural space for administration of various drugs. METHODS: A total of 100 consecutive patients underwent fluoroscopically guided caudal epidural injections. Needle insertion was performed blindly (without the use of fluoroscopic guidance) based on palpable landmarks, palpation of subcutaneous airflow, subjective impression that the needle was in a satisfactory position, and ease of injection of contrast. These clinical criteria were compared with the position of the needle as seen under fluoroscopy and the spread of radiopaque contrast in the epidural space. The contrast flow patterns, ventral or dorsal epidural filling, nerve root filling, and correlation of filling to the side of pain were evaluated. RESULTS: Successful injection placement without fluoroscopic visualization was confirmed on subsequent fluoroscopic visualization in 77% of the patients. Various filling and flow patterns showed that with injection of 10 mL of contrast, filling was noted up to S1 in 70% of the patients, followed by L5 nerve root filling in 12% of the patients. Ventral epidural filling was seen in 69% of the patients, in contrast to dorsal filling in 92% of the patients. Nerve root filling correlated with leg pain in only 43% of the patients. Intravenous placement of the needle was noted in 14% of the patients with positive flashback and aspiration in 50% of the patients. CONCLUSION: Caudal epidural injections are ideally performed with fluoroscopic guidance as the gold standard for accurate needle placement. However, this does not assure either targeted delivery or accurate placement of the drug.

A randomized, prospective, double-blind, placebo-controlled evaluation of the effect of sedation on diagnostic validity of cervical facet joint pain.

BACKGROUND: Based on responses to controlled diagnostic blocks of cervical facet joints, the prevalence of cervical facet joint pain in chronic neck pain has been shown to range from 54% to 67%, with false-positive results of 27% to 63% with a single diagnostic block. Other confounding factors claimed to influence the diagnostic validity of cervical facet joint blocks include administration of anxiolytics and narcotics prior to or during the procedure. OBJECTIVE: To evaluate the effect of midazolam and fentanyl on the validity of diagnosis of cervical facet joint pain. STUDY DESIGN: Randomized, prospective, double-blind, placebo-controlled evaluation. METHODS: The study was undertaken in an interventional pain management practice. The design consisted of a placebo group receiving sodium chloride solution and two experimental groups receiving either midazolam or fentanyl. The patients included in the study were treated in the past and were presenting for repeat treatment after a significant period of symptom relief. OUTCOME MEASURES: Outcomes were assessed at baseline and after the administration of 1 of the 3 solutions (Group I, sodium chloride solution; Group II, midazolam; or Group III, fentanyl). Outcome measures included numeric pain scale, proportion of pain relief, and ability to perform prior painful movements. RESULTS: Pain relief of > or = 80% was noted in 5% of the patients in Group I, 8% in Group II, and 8% in Group III. However, > or = 50% relief was noted in 8% of the patients in Group I, 13% in Group II, and 27% in Group III. Overall, 8% of the patients in Group I, 13% in Group II, and 27% in Group III were able to perform movements which were painful prior to injection. CONCLUSION: The administration of sedation with midazolam or fentanyl is a confounding factor in the diagnosis of cervical facet joint pain in patients with chronic neck pain. However, if > or = 80% pain relief with ability to perform prior painful movements is used as the standard for evaluating the effect of controlled local anesthetic blocks, the diagnostic validity of cervical facet joint nerve blocks may be preserved.