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

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

The prevalence of facet-joint-related chronic neck pain in postsurgical and nonpostsurgical patients: a comparative evaluation.

BACKGROUND: Facet (zygapophysial) joints may be clinically important sources of chronic cervical spinal pain. Previous studies have demonstrated the value and validity of controlled, comparative local anesthetic blocks in the diagnosis of facet joint pain, and reported an overall prevalence of 36% to 67% facet joint involvement in cervical spinal pain. The reports of lumbar facet joint-involvement in postsurgery syndrome have been shown to be highly variable with prevalence ranging from 8% to 32%. To date, however, the prevalence of postsurgical facet joint-related pain in the cervical spine has not been evaluated. In light of this, the present retrospective study was conducted to assess and compare the prevalence of chronic postsurgical facet joint cervical spinal pain to nonsurgical, chronic cervical facet joint pain. METHODS: Patients presenting with chronic neck pain were studied. The procedures were performed by a single physician in an interventional pain management ambulatory surgery center. The prevalence of cervical facet joint pain in postsurgical patients was assessed and compared to nonsurgical patients. RESULTS: A total of 251 patients (45 postsurgery vs. 206 nonsurgical patients) with chronic persistent neck pain were evaluated using controlled, comparative local anesthetic blocks in accordance with IASP criteria. The prevalence of the cervical facet joint pain and false-positive rate of single blocks in postsurgical patients were 36% and 50% compared with 39% and 43% in nonsurgical patients. CONCLUSIONS: Cervical facet joints are clinically important pain generators in a significant proportion of patients with chronic persistent neck pain after surgical intervention(s). The prevalence of cervical facet joint pain was similar in both postsurgical and nonsurgical patients.

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.

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.

[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.

One day lumbar epidural adhesiolysis and hypertonic saline neurolysis in treatment of chronic low back pain: a randomized, double-blind trial.

BACKGROUND: Chronic, refractory low back pain is a common problem. Percutaneous adhesiolysis with hypertonic saline neurolysis was described in the management of chronic refractory low back pain, non-responsive to conservative modalities of management. OBJECTIVE: To determine the ability of percutaneous adhesiolysis and hypertonic saline administration to reduce pain and improve functional and psychological status in patients with chronic low back pain. DESIGN: Randomized, double-blind, controlled trial. METHODS: A total of 75 patients were studied, with 25 patients in each group. Three types of interventions were included, with Group I serving as control with catheterization without adhesiolysis, followed by injection of local anesthetic, normal saline, and steroid. Group II consisted of catheterization and adhesiolysis, followed by injection of local anesthetic, normal saline, and steroid. Group III consisted of adhesiolysis followed by injection of local anesthetic, hypertonic saline, and steroid. Statistical analysis incorporated intent-to-treat analysis. OUTCOME MEASURES: Visual Analogue Scale pain scores, Oswestry Disability Index, work status, opioid intake, range of motion measurement, and P-3 (R). Significant pain relief was defined as average relief of 50% or greater. RESULTS: Significant improvement was seen in patients in Group II and III, at 3 months, 6 months, and 12 months, compared to baseline measurements, as well as compared to Group I without adhesiolysis. Seventy-two percent of patients in Group III (adhesiolysis and hypertonic neurolysis), 60% of patients in Group II (adhesiolysis only), compared to 0% in Group I (control) showed significant improvement at 12-month follow up. The average number of treatments for one year were 2.76 in Group II and 2.16 in Group III. Duration of significant relief with the first procedure was 2.8 +/- 1.49 months in Group II and 3.8 +/- 3.37 months in Group III. CONCLUSION: Percutaneous adhesiolysis, with or without hypertonic saline neurolysis, is an effective treatment for chronic low back pain.

Spinal endoscopic adhesiolysis in the management of chronic low back pain: a preliminary report of a randomized, double-blind trial.

Epidural adhesiolysis with spinal endoscopy is an emerging interventional pain management technique in managing chronic refractory low back and lower extremity pain. However, there is a lack of significant data demonstrating the effectiveness of spinal endoscopic adhesiolysis. This randomized, double-blind controlled trial was undertaken to determine the ability of spinal endoscopic adhesiolysis to reduce pain and improve functional and psychological status. The study was performed in an interventional pain management practice, a specialty referral center, in a private practice setting. This trial extended from January 2002 to December 2002. However, only the patients with 6-month follow-up were included. Any relief of less than 6 months was considered as short-term and 6-months or longer was considered as long-term. All the patients with chronic low back pain of at least 6 months and having failed conservative modalities of management, including fluoroscopically directed epidural steroid injections and percutaneous adhesiolysis, were included. Patient assignment was by randomized selection from all eligible subjects. Two types of interventions were included with Group I serving as the control with endoscopy to the sacral level without adhesiolysis, followed by injection of local anesthetic and steroid. Group II consisted of spinal endoscopy and appropriate adhesiolysis, followed by injection of local anesthetic and steroid. Outcome measures were focused to evaluate and demonstrate a clinically significant difference between the treated patients and those patients randomized to the control group in multiple parameters of pain, functional status, psychological, and behavioral status. Overall, 13 of 23 patients (57%) showed significant improvement without adverse events. Based on the definition that less than 6 months of relief is considered as short-term and longer than 6 months is considered as long-term, a significant number of patients obtained long-term relief. The results showed significant improvement in patients undergoing spinal endoscopic adhesiolysis at 1-month, 3-months, and 6-months, compared to baseline measurements, as well as compared to the control group without adhesiolysis. Spinal endoscopic adhesiolysis with targeted injection of local anesthetic and steroid, is an effective treatment in a significant number of patients without major adverse effects at 6-month follow-up.