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Translational Pain Research: Achievements and Challenges.
Mao J.
J Pain. 2009;10(10):1001-11.
The achievements in both preclinical and clinical pain research over the past 4 decades have led to significant progress in clinical pain management. However, pain research still faces enormous challenges and there remain many obstacles in the treatment of clinical pain, particularly chronic pain. Translational pain research needs to involve a number of important areas including: 1) bridging the gap between pain research and clinical pain management; 2) developing objective pain-assessment tools; 3) analyzing current theories of pain mechanisms and their relevance to clinical pain; 4) exploring new tools for both preclinical and clinical pain research; and 5) coordinating research efforts among basic scientists, clinical investigators, and pain-medicine practitioners. These issues are discussed in this article in light of the achievements and challenges of translational pain research. PERSPECTIVE: The subjective nature of clinical pain calls for innovative research approaches. As translational pain research emerges as an important field in pain medicine, it will play a unique role in improving clinical pain management through coordinated bidirectional research approaches between bedside and bench.
Mao J.
J Pain. 2009;10(10):1001-11.
The achievements in both preclinical and clinical pain research over the past 4 decades have led to significant progress in clinical pain management. However, pain research still faces enormous challenges and there remain many obstacles in the treatment of clinical pain, particularly chronic pain. Translational pain research needs to involve a number of important areas including: 1) bridging the gap between pain research and clinical pain management; 2) developing objective pain-assessment tools; 3) analyzing current theories of pain mechanisms and their relevance to clinical pain; 4) exploring new tools for both preclinical and clinical pain research; and 5) coordinating research efforts among basic scientists, clinical investigators, and pain-medicine practitioners. -
Prescription monitoring programs for surveillance-analysis of Schedule II opioid prescription data in Massachusetts, 1996-2006.
Katz N, Panas L, Kim M, et al.
Pharmacoepidemiol Drug Saf. 2009;19(2):115-123.
PURPOSE: Electronic prescription monitoring programs (PMPs) have been developed in many states as a public health surveillance tool. We analyze herein 11 years of Massachusetts PMP data to evaluate trends in opioid prescribing, dispensing, and usage. METHODS: Prescription records from the Massachusetts PMP for Schedule II opioids from fiscal year 1996 to 2006 were analyzed. 'Questionable activity' (potential 'doctor shopping') estimates were based on individual use of multiple prescribers and pharmacies, and early refills. RESULTS: The number of prescriptions, doses prescribed, and individuals receiving Schedule II prescription opioids steadily increased from 1996 to 2006. Most individuals (87.5%) used 1-2 prescribers, 1-2 pharmacies, and had no early refills (2006). The greater the number of prescribers used, the greater the number of pharmacies used. When defined as the use of >/=4 prescribers and >/=4 pharmacies, questionable activity accounted for 2748 individuals, 47 953 prescriptions, and 2 966 056 doses (2006). The Schedule II opioid most highly associated with questionable activity was short-acting oxycodone. CONCLUSIONS: PMPs can become a useful public health surveillance tool to monitor the medical and non-medical use of prescription opioids and to inform public health and safety policy. Copyright (c) 2009 John Wiley & Sons, Ltd.
Katz N, Panas L, Kim M, et al.
Pharmacoepidemiol Drug Saf. 2009;19(2):115-123.
PURPOSE: Electronic prescription monitoring programs (PMPs) have been developed in many states as a public health surveillance tool. We analyze herein 11 years of Massachusetts PMP data to evaluate trends in opioid prescribing, dispensing, and usage. METHODS: Prescription records from the Massachusetts PMP for Schedule II opioids from fiscal year 1996 to 2006 were analyzed. 'Questionable activity' (potential 'doctor shopping') estimates were based on individual use of multiple prescribers and pharmacies, and early refills. RESULTS: The number of prescriptions, doses prescribed, and individuals receiving Schedule II prescription opioids steadily increased from 1996 to 2006. Most individuals (87.5%) used 1-2 prescribers, 1-2 pharmacies, and had no early refills (2006). -
Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial.
Lamb SE, Hansen Z, Lall R, et al.
Lancet. 2010 Feb 25. [Epub ahead of print]
BACKGROUND: Low-back pain is a common and costly problem. We estimated the effectiveness of a group cognitive behavioural intervention in addition to best practice advice in people with low-back pain in primary care. METHODS: In this pragmatic, multicentre, randomised controlled trial with parallel cost-effectiveness analysis undertaken in England, 701 adults with troublesome subacute or chronic low-back pain were recruited from 56 general practices and received an active management advisory consultation. Participants were randomly assigned by computer-generated block randomisation to receive an additional assessment and up to six sessions of a group cognitive behavioural intervention (n=468) or no further intervention (control; n=233). Primary outcomes were the change from baseline in Roland Morris disability questionnaire and modified Von Korff scores at 12 months. Assessment of outcomes was blinded and followed the intention-to-treat principle, including all randomised participants who provided follow-up data. This study is registered, number ISRCTN54717854. FINDINGS: 399 (85%) participants in the cognitive behavioural intervention group and 199 (85%) participants in the control group were included in the primary analysis at 12 months. The most frequent reason for participant withdrawal was unwillingness to complete questionnaires. At 12 months, mean change from baseline in the Roland Morris questionnaire score was 1.1 points (95% CI 0.39-1.72) in the control group and 2.4 points (1.89-2.84) in the cognitive behavioural intervention group (difference between groups 1.3 points, 0.56-2.06; p=0.0008). The modified Von Korff disability score changed by 5.4% (1.99-8.90) and 13.8% (11.39-16.28), respectively (difference between groups 8.4%, 4.47-12.32; p<0.0001). The modified Von Korff pain score changed by 6.4% (3.14-9.66) and 13.4% (10.77-15.96), respectively (difference between groups 7.0%, 3.12-10.81; p<0.0001). The additional quality-adjusted life-year (QALY) gained from cognitive behavioural intervention was 0.099; the incremental cost per QALY was pound1786, and the probability of cost-effectiveness was greater than 90% at a threshold of pound3000 per QALY. There were no serious adverse events attributable to either treatment. INTERPRETATION: Over 1 year, the cognitive behavioural intervention had a sustained effect on troublesome subacute and chronic low-back pain at a low cost to the health-care provider. FUNDING: National Institute for Health Research Health Technology Assessment Programme. Copyright © 2010 Elsevier Ltd. All rights reserved.
Lamb SE, Hansen Z, Lall R, et al.
Lancet. 2010 Feb 25. [Epub ahead of print]
BACKGROUND: Low-back pain is a common and costly problem. We estimated the effectiveness of a group cognitive behavioural intervention in addition to best practice advice in people with low-back pain in primary care. METHODS: In this pragmatic, multicentre, randomised controlled trial with parallel cost-effectiveness analysis undertaken in England, 701 adults with troublesome subacute or chronic low-back pain were recruited from 56 general practices and received an active management advisory consultation. Participants were randomly assigned by computer-generated block randomisation to receive an additional assessment and up to six sessions of a group cognitive behavioural intervention (n=468) or no further intervention (control; n=233). -
The Concept of Addiction in Law and Regulatory Policy Related to Pain Management: A Critical Review.
Gilson AM.
Clin J Pain. 2010;26(1):70-7.
OBJECTIVE: To present a critical appraisal of the present definitions of addiction-related terminology that appear in US laws and regulatory policies that apply to the prescription of controlled substances for pain management. METHODS: To establish an appropriate context for existing policy definitions, a historical review was conducted of reports from the World Health Organization expert committees on addiction-related concepts, beginning in 1950. In addition, current World Health Organization and American Psychiatric Association diagnostic classification nomenclature were examined. Results from recent criteria-based evaluations of federal and state laws and regulatory policies containing addiction-related terminology also were referenced. RESULTS: Numerous examples are provided to clarify how inaccurate understandings of the nature of addiction, which can be corroborated by archaic definitions in some states' laws, can impact treatment decisions and patient care. Finally, this article discusses terminological and treatment implications of such concepts as "risk mitigation" and "responsible prescribing", which are goals currently emphasized in the pain management field as principal means to reduce addiction to or abuse of prescription opioid medications. DISCUSSION: Although notable improvement has been achieved, policy content in some states has not kept pace with advancements in medical and scientific knowledge about the interface between pain management and addictive disease. Effective translation of addiction-related concepts into clinical practice remains an important objective for promoting public health related to treating pain and reducing non-medical use of opioids.
Gilson AM.
Clin J Pain. 2010;26(1):70-7.
OBJECTIVE: To present a critical appraisal of the present definitions of addiction-related terminology that appear in US laws and regulatory policies that apply to the prescription of controlled substances for pain management. METHODS: To establish an appropriate context for existing policy definitions, a historical review was conducted of reports from the World Health Organization expert committees on addiction-related concepts, beginning in 1950. In addition, current World Health Organization and American Psychiatric Association diagnostic classification nomenclature were examined. Results from recent criteria-based evaluations of federal and state laws and regulatory policies containing addiction-related terminology also were referenced. -
Impact of a pharmacist-developed protocol on the cardiac monitoring of methadone in chronic noncancer pain management.
Weidman-Evans E, Jacobs TF, Isherwood P, Evans JD, Jenkins T.
J Am Pharm Assoc (2003). 2009:e102-e109. [Epub ahead of print]
Objectives: To describe the roles of pharmacists in a chronic pain management clinic (PMC) and to discuss the impact of a pharmacist-developed protocol on monitoring for rate-corrected QT interval prolongation with methadone when used for chronic noncancer pain.Setting: An academic family medicine department with an affiliated PMC in which pharmacists practice, from 2005 to 2008.Practice description: Pharmacy services in the PMC included taking medication histories and reconciling the medication record at each visit, assessing the efficacy and safety of drug therapy, making therapeutic recommendations to the two PMC physicians, and counseling patients on their drug regimens. These services were provided by faculty pharmacists and by student pharmacists completing their advanced pharmacy practice experiences at the site.Practice innovation: Based on a need identified in a medication use evaluation performed by the pharmacists, a protocol was developed with the objective of increasing the rates of cardiac monitoring in high-risk patients prescribed methadone in all of the department's clinics.Main outcome measure: Rates of electrocardiogram (ECG) monitoring pre- and postprotocol were compared to determine the impact of the protocol.Results: A 19% absolute (136% relative) increase occurred in the proportion of high-risk patients who had an ECG performed (P = 0.02). The proportion of high-risk patients from the PMC who had an ECG increased by 20% (absolute; 27% relative; P = 0.005), with no significant change in the other clinics.Conclusion: The implementation of a pharmacist-developed protocol resulted in improvements in monitoring practices. The improvement was most pronounced in the PMC, which uses pharmacists in the patient care process. This suggests that the involvement of pharmacists in the application of the protocol may be more important than the existence of a protocol.
Weidman-Evans E, Jacobs TF, Isherwood P, Evans JD, Jenkins T.
J Am Pharm Assoc (2003). 2009:e102-e109. [Epub ahead of print]
Objectives: To describe the roles of pharmacists in a chronic pain management clinic (PMC) and to discuss the impact of a pharmacist-developed protocol on monitoring for rate-corrected QT interval prolongation with methadone when used for chronic noncancer pain.Setting: An academic family medicine department with an affiliated PMC in which pharmacists practice, from 2005 to 2008.Practice description: Pharmacy services in the PMC included taking medication histories and reconciling the medication record at each visit, assessing the efficacy and safety of drug therapy, making therapeutic recommendations to the two PMC physicians, and counseling patients on their drug regimens. -
Do past pain events systematically impact pain ratings of healthy subjects or fibromyalgia patients?
Staud R, Robinson ME, Price DD.
J Pain. 2010 Feb;11(2):142-8.
We previously reported that 3 different electronic visual analogue and numerical pain scales are useful in providing refined capacity to discriminate discrete levels of pain intensity. Using the same subjects and scales, we now investigated whether pain scaling is influenced by past pain events and by recalled memories of these events in the rating of pain. Normal control subjects (NC: 19 male, 30 female) and female fibromyalgia (FM) (n = 17) patients received 5-second suprathreshold heat stimuli (45-49 degrees C) to both forearms. The participants rated these experimental heat stimuli using the previously described electronic pain scales. Subsequently, they were asked to report whether they used any prior pain experiences during the process of rating their pain. Out of 49 NC, only 6 females (12.2%) and 7 males (14.3%), and out of 17 FM patients, only 3 females (17.6%) stated that they had used past pain experiences during scaling. Notably, pain ratings of experimental heat stimuli did not statistically differ between subjects who used past pain experiences during scaling as compared to those who did not. Furthermore, ratings of their most severe past pains were not significantly correlated with ratings of experimental pain stimuli. These results do not provide support for the strong assertion that pain rating scales are elastic, ie, being used differently depending on the severity of past pain events such as childbirth. PERSPECTIVE: Less than 25% of subjects used memories of past pain events during pain scaling. In addition, if they were used, these pain memories did not influence pain scaling with electronic eVAS and eNUM scales. Thus, use of these scales allows reliable comparisons of experimental and clinical pain ratings within and between subjects. Copyright 2010 American Pain Society. Published by Elsevier Inc. All rights reserved.
Staud R, Robinson ME, Price DD.
J Pain. 2010 Feb;11(2):142-8.
We previously reported that 3 different electronic visual analogue and numerical pain scales are useful in providing refined capacity to discriminate discrete levels of pain intensity. Using the same subjects and scales, we now investigated whether pain scaling is influenced by past pain events and by recalled memories of these events in the rating of pain. Normal control subjects (NC: 19 male, 30 female) and female fibromyalgia (FM) (n = 17) patients received 5-second suprathreshold heat stimuli (45-49 degrees C) to both forearms. The participants rated these experimental heat stimuli using the previously described electronic pain scales. Subsequently, they were asked to report whether they used any prior pain experiences during the process of rating their pain. Out of 49 NC, only 6 females (12.2%) and 7 males (14.3%), and out of 17 FM patients, only 3 females (17. -
Cognitive-behavioral therapy for sleep abnormalities of chronic pain patients.
Tang NK.
Curr Rheumatol Rep. 2009 Dec;11(6):451-60.
Chronic pain and insomnia often occur simultaneously, with the vast majority of chronic pain patients complaining of interrupted or poor quality sleep. The need to improve sleep in these patients is clear, given increasing evidence that sleep disturbance is associated with heightened pain sensitivity and elevated disability. This article evaluates the efficacy of pain management programs (PMPs) based on cognitive-behavioral therapy (CBT) principles and CBT for primary insomnia (CBT-I) in treating pain-related insomnia. Although PMPs effectively enhance pain management skills in patients, they do not adequately address insomnia. CBT-I has demonstrated strong efficacy in treating pain-related insomnia, but sleep improvement is not followed by pain reduction. As both CBT approaches involve strengths and limitations, a hybrid form of treatment is needed that simultaneously addresses pain and sleep.
Tang NK.
Curr Rheumatol Rep. 2009 Dec;11(6):451-60.
Chronic pain and insomnia often occur simultaneously, with the vast majority of chronic pain patients complaining of interrupted or poor quality sleep. The need to improve sleep in these patients is clear, given increasing evidence that sleep disturbance is associated with heightened pain sensitivity and elevated disability. This article evaluates the efficacy of pain management programs (PMPs) based on cognitive-behavioral therapy (CBT) principles and CBT for primary insomnia (CBT-I) in treating pain-related insomnia. Although PMPs effectively enhance pain management skills in patients, they do not adequately address insomnia. CBT-I has demonstrated strong efficacy in treating pain-related insomnia, but sleep improvement is not followed by pain reduction. -
Validation of Clinical Opiate Withdrawal Scale versus Clinical Institute Narcotic Assessment opioid withdrawal instrument
Tompkins DA, Bigelow GE, Harrison JA, et al.
Drug Alcohol Depend. 2009 Nov 1;105(1-2):154-9.The Clinical Opiate Withdrawal Scale (COWS) is an 11-item clinician-administered scale assessing opioid withdrawal. Though commonly used in clinical practice, it has not been systematically validated. The present study validated the COWS in comparison to the validated Clinical Institute Narcotic Assessment (CINA) scale. METHOD: Opioid-dependent volunteers were enrolled in a residential trial and stabilized on morphine 30 mg given subcutaneously four times daily. Subjects then underwent double-blind, randomized challenges of intramuscularly administered placebo and naloxone (0.4 mg) on separate days, during which the COWS, CINA, and visual analog scale (VAS) assessments were concurrently obtained. Subjects completing both challenges were included (N=46). Correlations between mean peak COWS and CINA scores as well as self-report VAS questions were calculated. RESULTS: Mean peak COWS and CINA scores of 7.6 and 24.4, respectively, occurred on average 30 min post-injection of naloxone. Mean COWS and CINA scores 30 min after placebo injection were 1.3 and 18.9, respectively. The Pearson's correlation coefficient for peak COWS and CINA scores during the naloxone challenge session was 0.85 (p<0.001). Peak COWS scores also correlated well with peak VAS self-report scores of bad drug effect (r=0.57, p<0.001) and feeling sick (r=0.57, p<0.001), providing additional evidence of concurrent validity. Placebo was not associated with any significant elevation of COWS, CINA, or VAS scores, indicating discriminant validity. Cronbach's alpha for the COWS was 0.78, indicating good internal consistency (reliability). DISCUSSION: COWS, CINA, and certain VAS items are all valid measurement tools for acute opiate withdrawal.
Tompkins DA, Bigelow GE, Harrison JA, et al.
Drug Alcohol Depend. 2009 Nov 1;105(1-2):154-9.The Clinical Opiate Withdrawal Scale (COWS) is an 11-item clinician-administered scale assessing opioid withdrawal. Though commonly used in clinical practice, it has not been systematically validated. The present study validated the COWS in comparison to the validated Clinical Institute Narcotic Assessment (CINA) scale. METHOD: Opioid-dependent volunteers were enrolled in a residential trial and stabilized on morphine 30 mg given subcutaneously four times daily. Subjects then underwent double-blind, randomized challenges of intramuscularly administered placebo and naloxone (0.4 mg) on separate days, during which the COWS, CINA, and visual analog scale (VAS) assessments were concurrently obtained. Subjects completing both challenges were included (N=46).
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Ethical issues in opioid prescribing for chronic pain.
Ballantyne JC, Fleisher LA.
Pain. 2010;148(3):365-7.
Medical ethics traditionally focused on ensuring that physicians used their powers benevolently. Since cure was unusual, palliation, symptom control and relief of suffering were central to the physician’s art. Not surprisingly, given their unique ability to control suffering, opioids were indispensable, and a constituent of many remedies. They were freely dispensed by pharmacists and physicians, their use being limited largely by the conscience of the individual, or by limited supplies. At the beginning of the 20th century, drug regulations were introduced into the United States and other industrialized nations. These regulations attempted to control the import, distribution and trade of narcotics, and placed the onus on physicians to control medical use of opioids. There was thus an immediate switch of the moral imperative from patient to physician, and in fact a chilling effect on the provision of opioids for pain. The stigmatization and criminalization of opioids produced by regulations continues to interfere with the rational use of opioids for pain to this day.
Ballantyne JC, Fleisher LA.
Pain. 2010;148(3):365-7.
Medical ethics traditionally focused on ensuring that physicians used their powers benevolently. Since cure was unusual, palliation, symptom control and relief of suffering were central to the physician’s art. Not surprisingly, given their unique ability to control suffering, opioids were indispensable, and a constituent of many remedies. They were freely dispensed by pharmacists and physicians, their use being limited largely by the conscience of the individual, or by limited supplies. At the beginning of the 20th century, drug regulations were introduced into the United States and other industrialized nations. These regulations attempted to control the import, distribution and trade of narcotics, and placed the onus on physicians to control medical use of opioids. -
Risks for opioid abuse and dependence among recipients of chronic opioid therapy: Results from the TROUP Study.
Edlund MJ, Martin BC, Fan MY, et al.
Drug Alcohol Depend. 2010 Jul 13.
OBJECTIVE: To estimate the prevalence of and risk factors for opioid abuse/dependence in long-term users of opioids for chronic pain, including risk factors for opioid abuse/dependence that can potentially be modified to decrease the likelihood of opioid abuse/dependence, and non-modifiable risk factors for opioid abuse/dependence that may be useful for risk stratification when considering prescribing opioids.METHODS: We used claims data from two disparate populations, one national, commercially insured population (HealthCore) and one state-based, publicly insured (Arkansas Medicaid). Among users of chronic opioid therapy, we regressed claims-based diagnoses of opioid abuse/dependence on patient characteristics, including physical health, mental health and substance abuse diagnoses, sociodemographic factors, and pharmacological risk factors.
RESULTS: Among users of chronic opioid therapy, 3% of both the HealthCore and Arkansas Medicaid samples had a claims-based opioid abuse/dependence diagnosis. There was a strong inverse relationship between age and a diagnosis of opioid abuse/dependence. Mental health and substance use disorders were associated with an increased risk of opioid abuse/dependence. Effects of substance use disorders were especially strong, although mental health disorders were more common. Concerning opioid exposure; lower days supply, lower average doses, and use of Schedule III-IV opioids only, were all associated with lower likelihood of a diagnosis of opioid abuse/dependence.
CONCLUSION: Opioid abuse and dependence are diagnosed in a small minority of patients receiving chronic opioid therapy, but this may under-estimate actual misuse. Characteristics of the patients and of the opioid therapy itself are associated with the risk of abuse and dependence.
Edlund MJ, Martin BC, Fan MY, et al.
Drug Alcohol Depend. 2010 Jul 13.
OBJECTIVE: To estimate the prevalence of and risk factors for opioid abuse/dependence in long-term users of opioids for chronic pain, including risk factors for opioid abuse/dependence that can potentially be modified to decrease the likelihood of opioid abuse/dependence, and non-modifiable risk factors for opioid abuse/dependence that may be useful for risk stratification when considering prescribing opioids.METHODS: We used claims data from two disparate populations, one national, commercially insured population (HealthCore) and one state-based, publicly insured (Arkansas Medicaid). Among users of chronic opioid therapy, we regressed claims-based diagnoses of opioid abuse/dependence on patient characteristics, including physical health, mental health and substance abuse diagnoses, sociodemographic factors, and pharmacological risk factors.
