scholarly journals Intrathecal Infusion Systems for Long-Term Management of Chronic Non-Cancer Pain: An Update of Assessment of Evidence

2013 ◽  
Vol 2s;16 (2s;4) ◽  
pp. SE185-SE216
Author(s):  
Laxmaiah Manchikanti

Background: Intrathecal infusion systems are often used for patients with intractable pain when all else fails, including surgery. There is, however, some concern as to the effectiveness and safety of this treatment. Study Design: A systematic review of intrathecal infusion systems for long-term management of chronic non-cancer pain. Objective: To evaluate and update the effect of intrathecal infusion systems in managing chronic non-cancer pain. Methods: The available literature on intrathecal infusion systems in managing chronic pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the U.S. Preventative Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to December 2012, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: The primary outcome measure was pain relief with short-term relief < 12 months and long-term relief ≥ 12 months. Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake. Results: There were 28 studies identified for this systematic review. Of these, 21 were excluded from further review. A total of 7 non-randomized studies met inclusion criteria for methodological quality assessment. No randomized trials met the inclusion requirements. The evidence is limited based on observational studies. Limitations: The limitations of this systematic review include the paucity of literature. Conclusion: The evidence is limited for intrathecal infusion systems. Key words: Spinal pain, chronic low back pain, intrathecal infusion, intrathecal infusion systems, intrathecal drug delivery systems, intrathecal pumps, chronic non-cancer pain, chronic non-malignant pain, morphine, bupivacaine, ziconotide

2012 ◽  
Vol 3S;15 (3S;7) ◽  
pp. ES39-ES58 ◽  
Author(s):  
Lakshmi Koyyalagunta

Background: In all recommended guidelines put forth for the treatment of cancer pain, opioids continue to be an important part of a physician’s armamentarium. Though opioids are used regularly for cancer pain, there is a paucity of literature proving efficacy for long-term use. Cancer is no longer considered a “terminal disease”; 50% to 65% of patients survive for at least 2 years, and there are about 12 million cancer survivors in the United States. There is a concern about side effects, tolerance, abuse and addiction with long-term opioid use and a need to evaluate the effectiveness of opioids for cancer pain. Objective: The objective of this systematic review was to look at the effectiveness of opioids for cancer pain. Study Design: A systematic review of randomized trials of opioids for cancer pain. Methods: A comprehensive review of the current literature for randomized controlled trials (RCTs) of opioids for cancer pain was done. The literature search was done using PubMed, EMBASE, Cochrane library, clinical trials, national clearing house, Web of Science, previous narrative systematic reviews, and cross references. The studies were assessed using the modified Cochrane and Jadad criteria. Analysis of evidence was done utilizing the modified quality of evidence developed by United States Preventive Services Task Force (USPSTF). Outcome Measures: Pain relief was the primary outcome measure. Secondary outcome measures are quality of life (QoL) and side effects including tolerance and addiction. Results: The level of evidence for pain relief based on the USPSTF criteria was fair for transdermal fentanyl and poor for morphine, tramadol, oxycodone, methadone, and codeine. Limitations: Randomized trials in a cancer setting are difficult to perform and justify. There is a paucity of long-term trials and this review included a follow-up period of only 4 weeks. Conclusion: This systematic review of RCTs of opioids for cancer pain showed fair evidence for the efficacy of transdermal fentanyl and poor evidence for morphine, tramadol, oxycodone, methadone, and codeine. Key words: Opioids, pain relief, cancer pain, morphine, hydromorphone, methadone, fentanyl, oxymorphone, hydrocodone, oxycodone, buprenorphine.


2009 ◽  
Vol 2;12 (2;3) ◽  
pp. 349-360
Author(s):  
Vikram B. Patel

Background: Disability, societal, and health impact of chronic intractable pain secondary to various failed therapies is a major issue. As advanced therapy, implantable therapies, which include intrathecal devices and spinal cord stimulation systems, are frequently used in managing chronic intractable pain. Thus, continuous infusion of intrathecal medication is one of the methods used for the control of chronic, refractory, cancer, and non-cancer pain. However, despite the high costs of chronic non-cancer pain, it has been claimed that there is a lack of evidence for intrathecal infusion systems and the cost effectiveness of these systems has been questioned in improving pain and function. Study Design: A systematic review of intrathecal infusion devices for chronic non-cancer pain. Objective: To determine the efficacy, utilization, safety, and complications associated with the use of intrathecal infusion devices for long-term management of chronic non-cancer pain. Methods: Literature search was performed through EMBASE, Medline, Cochrane databases, and systematic reviews identified from 1966 to December 2008. Studies were then reviewed and assessed using the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies and the Cochrane Musculoskeletal Review Group criteria for randomized trials. The level of evidence was determined using 5 levels of evidence, ranging from Level I to III with 3 subcategories in Level II, based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Outcome Measures: The primary outcome measure was pain relief (short-term relief ≤ one-year and long-term > one-year). Secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake were also utilized. Results: The level of evidence for intrathecal infusion systems indicated either Level II-3 or Level III (limited) based on U.S. Preventive Services Task Force (USPSTF) criteria. Limitations: The limitations of this study include the paucity of literature, lack of quality evidence, and lack of randomized trials. Conclusion: This systematic review illustrates Level II-3 or Level III (limited) evidence for intrathecal infusion systems for long-term relief in chronic non-cancer pain. Key words: Intrathecal infusion, intraspinal infusion, programmable infusion systems, spinal infusion, intra-spinal infusion devices, baclofen infusion, intrathecal opiates


2011 ◽  
Vol 3;14 (2;3) ◽  
pp. E85-E102
Author(s):  
James Colson

Background: The prevalence of cancer-related pain and residual pain in cancer survivors is high. Opioids serve as the gold standard for treating moderate to severe cancer pain. The evaluation of the effectiveness of opioids in chronic non-cancer pain has shown a lack of effectiveness, or rather weak evidence for some of the drugs. In contrast, in cancer pain, opioids are expected to be very effective. Due to the nature of the disease, there is evidence of a paucity of randomized trials investigating opioid effectiveness in cancer pain on a long-term basis. Consequently, the effectiveness of opioids in managing cancer-related pain warrants further evidence-based review beyond randomized trials, including observational studies and case reports. Methods: The comprehensive literature search was conducted for the period 1996 through June 2010. Databases for the search included PubMed, EMBASE, Cochrane Reviews, and clinicaltrails.gov, along with reviews and cross references. Methodologic quality assessment of the observational studies managing chronic cancer pain with opioids was conducted utilizing the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. Analysis of evidence included 5 levels of evidence developed by the United States Preventive Services Task Force (USPSTF) ranging from Level I to III with 3 subcategories in Level II. Grading recommendations were based on Guyatt et al’s recommendations with 6 levels: 3 in the strong category and 3 in the weak category. Results: This evaluation is of 18 manuscripts considered for inclusion; 7 manuscripts met the inclusion criteria based on AHRQ quality assessment. Level of evidence for opioid therapy in cancer pain was Level II-3, and recommendations were 1C/strong recommendation based on observational studies, which could change based on future evidence. Conclusion: This systematic review of observational studies indicates Level II3 evidence for effectiveness of opioids in cancer pain therapy, with 1C/strong recommendation based on observational studies, which could change based on future evidence. Key words: Chronic pain, cancer pain, non-cancer pain, randomized trials, observational studies, case reports, opioids, effectiveness


2011 ◽  
Vol 3;14 (2;3) ◽  
pp. 91-121
Author(s):  
Laxmaiah Manchikanti

Background: Even though opioids have been used for pain for thousands of years, opioid therapy for chronic non-cancer pain is controversial due to concerns regarding the long-term effectiveness and safety, particularly the risk of tolerance, dependance, or abuse. While the debate continues, the use of chronic opioid therapy for chronic non-cancer pain has increased exponentially. Even though evidence is limited, multiple expert panels have concluded that chronic opioid therapy can be effective therapy for carefully selected and monitored patients with chronic non-cancer pain. Study Design: A systematic review of randomized trials of opioid management for chronic noncancer pain. Objective: The objective of this systematic review is to evaluate the clinical efficacy of opioids in the treatment of chronic non-cancer pain. Methods: A comprehensive evaluation of the literature relating to opioids in chronic non-cancer pain was performed. The literature was evaluated according to Cochrane review criteria for randomized controlled trials (RCTs) and Jadad criteria. A literature search was conducted by using PubMed, EMBASE, Cochrane library, ECRI Institute Library, U.S. Food and Drug Administration (FDA) website, U.S. National Guideline Clearinghouse (NGC), Database of Abstracts of Reviews of Effectiveness (DARE), clinical trials, systematic reviews and cross references from systematic reviews. The level of evidence was classified as good, fair, or poor based on the quality of evidence developed by the United States Preventive Services Task Force (USPSTF) and used by other systematic reviews and guidelines. Outcome Measures: Pain relief was the primary outcome measure. Other outcome measures were functional improvement, withdrawals, and adverse effects. Results: Based on the USPSTF criteria, the indicated level of evidence was fair for Tramadol in managing osteoarthritis. For all the drugs assessed, including Tramadol, for all other conditions, the evidence was poor based on either weak positive evidence, indeterminate evidence, or negative evidence. Limitations: A paucity of literature, specifically with follow-up beyond 12 weeks for all types of opioids with controlled trials for various chronic non-cancer pain conditions. Conclusions: This systematic review illustrated fair evidence for Tramadol in managing osteoarthritis with poor evidence for all other drugs and conditions. Thus, recommendations must be based on non-randomized studies. Key words: Chronic non-cancer pain, opioids, opioid efficacy, opioid effectiveness, significant pain relief, functional improvement, adverse effects, morphine, hydrocodone, hydromorphone, fentanyl, tramadol, buprenorphine, methadone, tapentadol, oxycodone, oxymorphone, systematic reviews, randomized trials


2009 ◽  
Vol 1;12 (1;1) ◽  
pp. 137-157
Author(s):  
Ramsin Benyamin

Background: Chronic neck pain is a common problem in the adult population with a typical 12-month prevalence of 30% to 50%, and 14% of the patients reporting grade II to IV neck pain with high pain intensity and disability that has a substantial impact on health care and society. Cervical epidural injections for managing chronic neck pain are one of the commonly performed interventions in the United States. However, the literature supporting cervical epidural steroids in managing chronic pain problems has been scant and no systematic review dedicated to the evaluation of cervical interlaminar epidurals has been performed in the past. Study Design: A systematic review of cervical interlaminar epidural injections. Objective: To evaluate the effect of cervical interlaminar epidural injections in managing various types of chronic neck and upper extremity pain emanating as a result of cervical spine pathology. Methods: The available literature of cervical interlaminar epidural injections in managing chronic neck and upper extremity pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the criteria developed by the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. The level of evidence was classified as Level I, II, or III based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF) for therapeutic interventions. Data sources included relevant literature of the English language identified through searches of PubMed and EMBASE from 1966 to November 2008, and manual searches of bibliographies of known primary and review articles. Outcome Measures: The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake. Results: The indicated evidence is Level II-1 in managing chronic neck and upper extremity pain. Limitations: The limitations of this systematic review include the paucity of literature and lack of randomized trials performed under fluoroscopy. Conclusion: The results of this systematic evaluation of cervical interlaminar epidural injection showed significant effect in relieving chronic intractable pain of cervical origin and also providing long-term relief with an indicated evidence level of Level II-1. Key words: Cervical disc herniation, cervical post surgery syndrome, cervical spinal stenosis, cervical radiculitis, cervical interlaminar epidural injections, local anesthetic steroids, chronic discogenic pain


BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e023223 ◽  
Author(s):  
Carlos Berlanga-Macías ◽  
Diana P. Pozuelo-Carrascosa ◽  
Celia Álvarez-Bueno ◽  
Jose Alberto Martínez-Hortelano ◽  
Miriam Garrido-Miguel ◽  
...  

IntroductionBreast feeding has been considered important due to its short-term and long-term benefits on infant and maternal health. Regarding the long-term benefits, the influence of exclusive breastfeeding on cardiorespiratory fitness (CRF) during childhood and adolescence has been studied, although with controversial conclusions. This study protocol aims to provide a clear and standardised procedure for systematically reviewing the relationship between breast feeding, in terms of duration and exclusivity, and CRF in children and adolescents.Methods and analysisThis systematic review and meta-analysis protocol is reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. A literature search will be conducted in MEDLINE, EMBASE, Web of Science and Cochrane Library. Observational studies regarding the association between breast feeding and CRF in children and adolescents written in English or Spanish will be included. A Critical Appraisal Checklist for Analytical Cross Sectional Studies and The Newcastle-Ottawa Quality Assessment Scale for longitudinal studies will be used for quality assessment of included studies. Standardised mean differences of CRF by exclusive breastfeeding categories will be calculated as the primary outcome. Subgroup analyses and meta-regression will be performed based on the sources of heterogeneity.Ethics and disseminationThis evidence-based systematic review will summarise the relevant information on the association of exclusive breast feeding and CRF in children and adolescents. The results will be disseminated by publication in a peer-reviewed journal. Given that the data used for this systematic review will be exclusively extracted from published studies, ethical approval will not be required.PROSPERO registration numberCRD42018082642.


2010 ◽  
Vol 37 (7) ◽  
pp. 675-684 ◽  
Author(s):  
Leandro Chambrone ◽  
Daniela Chambrone ◽  
Luiz A. Lima ◽  
Luiz A. Chambrone

2018 ◽  
Vol 10 (10) ◽  
pp. 195-199 ◽  
Author(s):  
Graeme Jones ◽  
Elena Panova

Rheumatoid arthritis is a leading musculoskeletal cause of disability in Western society. Therapeutic options have expanded rapidly with the advent of biological agents as treatment options. One of these, tocilizumab, targets the interleukin-6 receptor and has been approved since the late 2000s in many jurisdictions. This approval was based on 6–12 month trials. It is now appropriate to look at longer-term studies and what new insights they have provided into this agent. Data are based largely on observational studies with their well-known limitations as well as some further randomized trials and provide a number of important observations regarding both efficacy and safety. In conclusion, the longer-term data suggest tocilizumab efficacy increases over time for both signs and symptoms and radiographic change. It is also corticosteroid sparing. The safety data are consistent with the shorter-term trials and are largely reassuring but some questions still remain over cardiovascular safety and cancer risk.


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