The cervical zygapophyseal joints may be a primary source of pain in up to 60% of individuals with chronic whiplash associated disorders (WAD) and may be a contributing factor for peripheral and centrally mediated pain (sensory hypersensitivity). Sensory hypersensitivity has been associated with a poor prognosis. The purpose of the study was to determine if there is a change in measures indicative of sensory hypersensitivity in patients with chronic WAD grade II following a medial branch block (MBB) procedure in the cervical spine.Measures of sensory hypersensitivity were taken via quantitative sensory testing (QST) consisting of pressure pain thresholds (PPT's) and cold pain thresholds (CPT's). In patients with chronic WAD (n = 18), the measures were taken at three sites bilaterally, pre- and post- MBB. Reduced pain thresholds at remote sites have been considered an indicator of central hypersensitivity. A healthy age and gender matched comparison group (n = 18) was measured at baseline. An independent t-test was applied to determine if there were any significant differences between the WAD and normative comparison groups at baseline with respect to cold pain and pressure pain thresholds. A dependent t-test was used to determine whether there were any significant differences between the pre and post intervention cold pain and pressure pain thresholds in the patients with chronic WAD.At baseline, PPT's were decreased at all three sites in the WAD group (p < 0.001). Cold pain thresholds were increased in the cervical spine in the WAD group (p < 0.001). Post-MBB, the WAD group showed significant increases in PPT's at all sites (p < 0.05), and significant decreases in CPT's at the cervical spine (p < 0.001).The patients with chronic WAD showed evidence of widespread sensory hypersensitivity to mechanical and thermal stimuli. The WAD group revealed decreased sensory hypersensitivity following a decrease in their primary source of pain stemming from the cervical zygapophyseal joints. Cervical spine pain and dysfunction resulting from a motor vehicle collision (MVC) are common patient problems encountered by health care practitioners. Many patients will significantly recover with respect to neck pain and disability within the first six months to one year ,2. ReseaThe cervical zygapophyseal joint has been implicated as a source of pain in those with chronic WAD ,7. StudiResearch has indicated that the ongoing pain associated with chronic WAD may be due to altered pain processing as evidenced by sensory hypersensitivity at distant sites involving uninjured tissues -34. CentAlterations in neuronal excitability in the spinal cord, secondary to ongoing peripheral nociception, has been hypothesized as a mechanism of central hyperexcitability ,40. ContStructural injury secondary to trauma may lead to an inflammatory response characterized by the release of inflammatory mediators such as substance P, prostaglandins, and bradykinin ,43. As aThe aim of this study was to minimize cervical spine pain intensity in patients with chronic WAD and to evaluate its immediate effect on measures indicative of sensory hypersensitivity. We hypothesized that a decrease in cervical spine pain intensity following diagnostic blockade of the cervical zygapophyseal joints would result in a change in measures indicative of sensory hypersensitivity, specifically, an increase in pressure pain thresholds (PPT's) and a decrease in cold pain thresholds (CPT's).This exploratory study involved a pretest-posttest design. A healthy age- and gender-matched normative comparison group was measured at baseline.Eighteen volunteers  with whiplash associated disorders grade II as defined by the Quebec Task Force classification  including decreased range of motion and point tenderness) and 18 healthy age- and gender-matched volunteers  participated in this study . PatientEthics approval was granted by the Centre for Advancement of Health at the University of Calgary  and the Institutional Review Board at Andrews University .A single item Numeric Pain Rating Scale (0-10) was used to measure the patients' cervical spine pain intensity before and after the MBB procedure. Quantitative sensory testing (QST), consisting of PPT's and CPT's, was performed on the WAD and normative comparison subjects. The CPT's were measured using the TSA II Neurosensory Analyzer . The PPT's were measured by an electronic pressure algometer .Baseline measures also included a self-report measure of neck pain and disability via the Neck Disability Index (NDI: 0-100) . DemograCold pain thresholds were measured by placing the thermode on the skin over the articular pillars of the cervical zygapophyseal joints that were anaesthetized during the MBB procedure. The thermode size was 30 millimeters × 30 millimeters. The thermode temperature was set to 32°C. The temperature decrease was standardized at a rate of 1°C per second. The minimal temperature was set to zero degrees Celsius. To identify CPT's, the patients were asked to push a self-controlled switch as soon as the cold sensation changed to one of pain. Three tests were performed bilaterally at each site and the mean values were recorded for use in the statistical analyses.Psychometric properties for cold pain threshold testing are lacking in the literature. In a study in healthy adults, investigators reported good intrarater reliability, ICC's ranging from 0.79 to 0.94, for a clinical test of cold pain threshold .In our study, cold pain threshold testing was only performed at the cervical spine only in order to standardize our testing protocol with other investigations involving subjects with WAD ,49.2 and the rate of application was standardized to 40 kPa/sec. Three tests were performed at each site bilaterally and the mean values were recorded for use in the statistical analyses. Ten seconds was allowed between each test.Pressure pain thresholds were measured at the following sites: the articular pillars of the cervical zygapophyseal joints that were anaesthetized during the MBB procedure, the peripheral nerve trunk of the median nerve , and the tibialis anterior . The patients were asked to push a self-controlled switch as soon as the sensation of pressure changed to one of pain. The probe size was 1 cmPressure pain threshold testing has demonstrated good to excellent intrarater and interrater reliability in patients with chronic WAD, with ICC's ranging from 0.85 to 0.91 and 0.88 to 0.97 respectively .The QST protocols utilized in this study were replicated from previous studies in chronic whiplash patients ,36,49.® Amerslan Health, Oakville, ON, Canada) was utilized to confirm proper needle position. Subsequently, an injection of 0.5 cc of preservative free 1% Bupivicaine , a local anaesthetic, and 0.5 cc of Celestone , a corticosteroid, was made into the target zygapophyseal joint.The patients with chronic WAD were referred to our tertiary spinal care center for diagnostic cervical zygapophyseal joint blockade. This process involved two diagnostic zygapophyseal joint block procedures. Prior to the study, the patients with chronic WAD underwent a diagnostic intra-articular zygapophyseal joint block procedure. For this procedure, a 25-gauge spinal needle is advanced, under flouroscopic guidance, into the target zygapophyseal joint with the patient in the prone position. A small amount of nonionic contrast  was made to confirm the proper needle position. Subsequently, 0.5 cc of 2% Lidocaine , a local anaesthetic without preservatives, was injected onto the medial branch of the dorsal ramus. The medial branch of the dorsal ramus provides the sensory innervation to the zygapophyseal joint above and below the target joint as well as the deep paramedian muscles [The MBB involved the placement of a 25-gauge spinal needle, under fluoroscopic guidance, onto the medial branch of the dorsal ramus as it courses over the waist of the articular pillar at each spinal level. An injection of nonionic contrast material  within one hour post-MBB, they underwent a final round of QST . As the Descriptive and inferential statistics were applied to describe the baseline characteristics of the WAD and normative comparison groups. Sample means and standard deviations were applied to continuous data. Frequency counts were used to summarize categorical data. Reliability analyses, ICC , along with standard error of measurement calculations were performed on the left and right side mean PPT and CPT data at the three sites on the WAD group pre-and-post-MBB and the normative comparison group at baseline. If the absolute agreement was acceptable, then the mean left and right side data were averaged and a point estimate representative of each body region were used for further analyses.An independent t-test was applied to determine if there were any significant differences between the WAD and normative comparison groups at baseline, and following the MBB, with respect to cold pain and pressure pain thresholds. A dependent t-test was used to determine whether there were any significant differences between the pre and post-MBB cold pain and pressure pain thresholds in the patients with chronic WAD. The statistical software used to analyze the data was STATA 10.1 . Significance level was set at p < 0.05.An a priori sample size analysis indicated the need for at least 18 subjects in each group. For the sample size analysis, considering the requirements for a paired t-test, the investigators incorporated the following parameters: power of 0.80, effect size estimate of 0.60 (medium effect size), probabiTable The reliability analyses performed on all pairs of body parts for the CPT's and PPT's, pre-and post-MBB, in the WAD and normative comparison groups revealed ICC's  ranging from 0.977 to 0.994 (95% CI: 0.955 - 0.997) . The staThe mean CPT and PPT data, for the cervical spine, median nerve, and tibialis anterior test sites in the normative comparison and WAD groups, are summarized in Table An independent samples t-test revealed significant differences in CPT's at the cervical spine between the WAD and normative comparison groups p < 0.001) at baseline, with the WAD group having significantly reduced CPT's  at baseline, with the WAD group having significantly lower PPT's Fig. .A paired samples t-test revealed significant differences in cervical spine CPT's in the WAD group from baseline to post-MBB p < 0.001), with this group demonstrating a significant decrease in CPT's post-MBB , with this group demonstrating significant increases in PPT's post-MBB Fig. .An independent samples t-test revealed significant differences in CPT's at the cervical spine between the WAD post-MBB and normative comparison groups (p = 0.004), with the WAD post-MBB group having significantly reduced CPT's.An independent samples t-test revealed significant differences in PPT's at all sites between the WAD post-MBB and normative comparison groups (p < 0.001), with the WAD post-MBB group having significantly lower PPT's.The patients with chronic WAD in this study demonstrated evidence of sensory hypersensitivity reflected by reduced pain thresholds to cold temperature and pressure stimulation in the cervical spine as well as reduced pressure pain thresholds at distant sites over the peripheral trunk of the median nerve at the elbow and over the tibialis anterior. These findings are similar to those found in other studies investigating sensory hypersensitivity in patients with chronic WAD ,57,62. EFollowing anaesthetic blockade of the cervical zygapophyseal joint, and a subsequent significant decrease in self-reported cervical spine pain intensity, the patients with chronic WAD demonstrated significant changes in measures indicative of sensory hypersensitivity. Specifically, the WAD group revealed a decrease in CPT's and an increase in PPT's in the cervical spine and, importantly, an increase in PPT's at the distal sites examined. To our knowledge, this is the first study to reveal such findings in patients with chronic WAD. These findings suggest that sensory hypersensitivity may be modulated by minimizing a potential peripheral source of pain, the zygapophyseal joint, in patients with chronic WAD. The prompt increase in local PPT's and decrease in unilateral CPT's  noted in the WAD group post-MBB may have been the result of reduced peripheral sensitization via a reduction in receptive fields and/or deactivation of glial cells, thus mitigating primary hyperalgesia in the injured area ,64,65. SRecently, it has been shown that myofascial trigger points in the upper fibres trapezius of patients with chronic WAD may be a peripheral source modulating central hyperexcitability as evidenced by a decrease in widespread mechanical hyperalgesia (pressure pain thresholds) following local anaesthetic injections . Of inteThere are limitations of our study that warrant further discussion. Although the WAD group demonstrated significant changes in the measures of sensory hypersensitivity in the post-MBB follow-up period, conclusions cannot be made about long-term outcomes based on the study design. Without comparison to a placebo group, one cannot conclude that the outcomes of our study were specific to the facet joint block procedure or as a result of repeated testing. Although, our study hypothesis focused on outcomes related to measures of sensory hypersensitivity following a marked decrease in cervical spine pain intensity, a potential peripheral pain mechanism, not the efficacy of the facet joint block procedure itself.Based on the typical duration of the anaesthetic, 2% Lidocaine (2 hours), used for the MBB procedure in our study, we assume that the measures of sensory hypersensitivity eventually returned to baseline in the subjects with chronic WAD. We cannot discuss this with absolute certainty as the post-MBB measurement period was complete within one hour of the MBB procedure and no further follow-up was performed. Post-MBB, though the WAD group improved with respect to measures of sensory hypersensitivity, the WAD group remained statistically different from the normative comparison group. This suggests that the WAD group was still sensitized, to a certain extent, with respect to pressure pain and cold pain thresholds, in comparison to healthy individuals. Our results propose that minimizing pain intensity from a peripheral source of nociception may modulate sensory hypersensitivity, but may not amend central hyperexcitability to normative levels. This is most likely the result of the complex interaction between peripheral, spinal, and supraspinal mechanisms involved in central hyperexcitability ,39,69.In consideration of the diagnostic zygapophyseal joint blockade procedures used in our study one cannot rule out a false positive response with absolute certainty. Comparative local anaesthetic blocks have been advocated to guard against such responses . This inAlthough our study incorporated standardized measures of sensory hypersensitivity that have been detailed in published research ,36,49, tBased on the exploratory nature of our study, a cause and effect relationship cannot be ascertained, but our data illustrates that sensory hypersensitivity may be modulated in the short-term. As the study sample included a specific subset of the chronic WAD population, the results of the study may not necessarily be generalizable to all patients with chronic WAD. Future studies including the measurement of cold pain thresholds at distal sites may provide additional valuable information in the context of underlying pain mechanisms in patients with chronic WAD. Further research, incorporating longitudinal designs, examining the effects of interventions aimed at minimizing the primary source of cervical spine pain in patients with chronic WAD on measures of sensory hypersensitivity, as well as other clinical and functional outcome measures, is warranted.Our exploratory trial reveals a change in measures indicative of sensory hypersensitivity in patients with chronic WAD following a medial branch block procedure in the cervical spine. This suggests that sensory hypersensitivity may be modulated in the short-term when a primary source of pain is reduced. Large clinical trials involving long-term follow-up of interventions aimed at reducing or eliminating the primary source of cervical spine pain in patients with chronic WAD are necessary.The authors declare that they have no competing interests.GS: research design, data collection and statistical analysis, manuscript preparation and revision. AS: research design, manuscript preparation and revision. AH: research design, manuscript preparation and revision. PS: research design, statistical analysis, manuscript preparation and revision. KS: research design, data analysis, manuscript preparation and revision. MW: research design, manuscript preparation and revision. BF: research design, manuscript preparation and revision. LO: research design, data analysis, manuscript preparation and revision. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/11/29/prepub


After a lead-in phase of three infusions of 4 mg zoledronic acid in the hospital setting, 101 patients were randomized to receive three open-label infusions in the community or hospital setting, followed by three infusions in the opposite venue . The Brief Pain Inventory (BPI) and the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) were used to assess potential benefits of zoledronic acid therapy. At study end, analysis of the BPI showed significant reductions in worst pain (P=0.008) and average pain in the last 7 days (P=0.039), and interference with general activity (P=0.012). In each case, there were significantly greater improvements in pain scores after treatment in the community setting compared with the hospital crossover setting for worst pain (P=0.021), average pain (P=0.003), and interference with general activity (P=0.001). Overall global health status showed a significant median improvement of 8.3% (P=0.013) at study end. Physical, emotional, and social functioning also showed significant overall improvement . Furthermore, physical, role, and social functioning showed significantly greater improvements after treatment in the community setting compared with the hospital crossover setting . There was no difference between hospital and community administration in renal or other toxicity, with zoledronic acid being well tolerated in both treatment settings. These data confirm the safety and quality-of-life benefits of zoledronic acid in breast cancer patients with bone metastases, particularly when administered in the community setting.Patients with bone metastases from breast cancer often experience substantial skeletal complications – including debilitating bone pain – which negatively affect quality of life. Zoledronic acid (4 mg) has been demonstrated to reduce significantly the risk of skeletal complications in these patients and is administered via a short, 15-min infusion every 3 weeks, allowing the possibility for home administration. This study compared the efficacy and safety of zoledronic acid administered in the community setting  Each year, more than one million women will develop breast cancer worldwide with nearly half of these diagnoses occurring in the United States and Europe. Ultimately, more than 400 000 of these women will die of their disease . ResultiZoledronic acid is a new-generation nitrogen-containing bisphosphonate with evidence of significant efficacy in the treatment of bone lesions from multiple myeloma or a variety of solid tumours, including breast, prostate, lung, and renal cell cancer . In a loP<0.001) , and was at least as effective as pamidronate for the palliation of bone pain. Brief Pain Inventory (BPI) pain scores improved in 53–69% of patients with pain scores greater than zero at baseline, with no significant differences between treatment groups  significantly improved pain scores and reduced need for palliative radiation therapy compared with placebo  performance status ⩽2. Patients were not eligible if they were receiving chemotherapy or had abnormal renal function, defined as a serum creatinine level >1.5 times the upper limit of normal or a calculated creatinine clearance of <60 ml minvs the hospital setting. Patients received zoledronic acid (4 mg) via 15-min intravenous infusion every 3 weeks for up to 9 months. All patients received treatment in the hospital setting for up to three cycles  to ensure disease stabilisation on hormone therapy. Patients were then randomised to receive treatment for three cycles in either the community setting or the hospital setting. After the three cycles, patients were crossed over to receive three cycles of treatment in the opposite setting. Thus, patients received a total of nine infusions over the course of the study . Decreased renal function was defined as an increase in serum creatinine of ⩾44 or ⩾88 The efficacy analysis was carried out on an intention-to-treat (ITT) population defined as all patients who received ⩾1 dose of trial medication, provided baseline efficacy data, and from whom ⩾1 postbaseline measurement was obtained. The end point measurement for each randomised patient was the last postrandomisation measurement carried forward to the end of the 3-month phase . Patients in the ITT population had to provide efficacy data in all phases of the study.α=0.05. Novartis UK Medical Information Processing and Statistics carried out statistical analysis using SAS® software, version 8.2 (SAS Institute Inc.).Raw scores from the EORTC QLQ-C30 questionnaires were transformed according to standard methods (n=56) or administered in the hospital setting followed by the community setting (n=45). A total of 26 patients could not be randomised because of early progression of disease during the three initial hospital infusions. Of the 101 enrolled patients, 84 (83%) completed the study  and 79 (78%) patients were available for analysis, constituting the ITT population. Patient demographics and baseline disease characteristics were similar between treatment groups . The differences between community and hospital serum creatinine values were not significant and levels returned to near baseline when patients returned to the hospital setting (μmol l−1). Creatinine clearance was also normal for most patients; only 12 (9.4%) patients had one or more results >30% below baseline, and the majority of these patients only had one such decrease. Adverse events (regardless of relationship to study drug) were mild – most commonly flu-like symptoms, nausea, arthralgia, headache, pain, and vomiting (Zoledronic acid (4 mg) was well tolerated. Renal function was normal throughout the study for the majority of patients. Serum creatinine levels increased in only four of the 127 (3%) evaluable patients by >44  setting . All meavomiting . Severe P=0.077). However, treatment with zoledronic acid resulted in significant reductions in worst pain in the last 7 days (P=0.008), average pain in the last 7 days (P=0.039), interference with general activity (P=0.012), interference with walking ability (P<0.001), interference with normal work (P=0.005), interference with enjoyment of life (P=0.005), and interference with sleep (P=0.015) compared with baseline , worst pain in the last 7 days (P=0.021), average pain in the last 7 days (P=0.003), pain right now (P=0.013), interference with general activity (P<0.001), interference with mood (P=0.036), and interference with walking ability (P<0.001) in the community crossover phase compared with the hospital crossover phase. In each case, pain scores significantly improved in the community phase compared with baseline, whereas no significant changes were reported in the hospital crossover phase. Interference with normal work improved significantly greater in the community crossover phase compared with the hospital crossover phase (P<0.001), and this score improved significantly in both the community crossover phase (P=0.011) and the hospital crossover phase (P=0.015) compared with baseline.Infusion of zoledronic acid in the community setting achieved significantly greater improvement in BPI pain scores compared with the hospital crossover setting . SignifiP=0.013). Specifically, 36 of the 79 (46%) patients available for analysis reported increases in global health status, 24 (30%) patients reported no change, and 19 (24%) patients reported decreased health status. Assessment of the functional scales showed significant increases in mean scores for physical functioning , emotional functioning , and social functioning  compared with baseline , role functioning (P=0.001), and social functioning (P=0.026) compared with the hospital crossover setting (P=0.002) compared with a nonsignificant improvement in the hospital crossover phase. Similarly, role functioning scores increased significantly vs baseline in the community crossover phase , whereas a nonsignificant increase was reported during the hospital crossover phase. Social functioning scores were stable compared with baseline in both community crossover and hospital crossover phases.Infusion of zoledronic acid in the community crossover setting resulted in significantly greater improvement in physical functioning ( setting . PhysicaP=0.031) compared with the hospital crossover phase (P=0.01). Pain scores improved significantly by a mean of 4% from baseline in the community crossover phase (P=0.022) compared with a nonsignificant improvement in the hospital crossover phase. Similarly, diarrhoea scores improved significantly by 5% from baseline in the community phase (P=0.005) compared with a nonsignificant improvement during the hospital crossover phase. All other symptoms remained stable, with changes <5%.Assessment of patient perception of symptoms revealed significantly greater improvement in pain and diarrhoea scores in the community crossover phase (P=0.004). During the community crossover phase, patients reported a significant mean decrease of 4% in financial difficulties (P=0.029), whereas during the hospital crossover phase a significant mean increase of 5% (P=0.003) was reported compared with baseline. For all EORTC QLQ-C30 scales, an increase of >5% was considered to be clinically significant.Patients also experienced significantly fewer financial difficulties during the community crossover phase of the study compared with the hospital crossover phase (P<0.0001) in the entire patient population compared with baseline. However, sexual function significantly increased . Body image and systemic therapy side effects remained stable. Hair loss and sexual enjoyment had too few respondents to assess meaningfully. Arm symptoms showed significant differences between the community crossover and hospital crossover settings. In the hospital crossover setting, arm symptoms improved 3% (P=0.004), whereas the community setting arm symptoms worsened 4% (P=0.076) compared with baseline.Over the course of the study, patients reported significant declines in future perspective with a median change of 0 and a mean decrease of 17% .vs 83% for hospital crossover; P=0.048) and 100% satisfied .Overall, patients were satisfied with zoledronic acid treatment . Patientvs patients receiving chemotherapy. Therefore, this randomised crossover study investigated the efficacy and safety of zoledronic acid in the community setting vs the hospital setting in breast cancer patients with bone metastases receiving hormonal therapy. Results showed that zoledronic acid was safe in both the community and hospital settings, and analysis of BPI and EORTC QLQ-C30 quality-of-life scores demonstrated that zoledronic acid significantly improved composite pain scores and overall quality of life compared with baseline, particularly when administered in the community setting.Patients with breast cancer are at high risk for bone metastases, resulting in significant skeletal complications and bone pain that negatively affects their quality of life. Long-term treatment with zoledronic acid (4 mg) has been shown to reduce the risk of skeletal complications in these patients by an additional 20% compared with pamidronate, particularly in patients receiving hormonal therapy, in whom the risk was reduced by an additional 30%  , resulting in a significant 47% per capita savings in hospital costs (P=0.02) and an 18% reduction in total per capita healthcare costs (P=0.02) and caregiver (P=0.005) satisfaction with home care after 1 month of treatment. Therefore, home care may not only result in lowered healthcare costs and reduced expenses, but also a more satisfying and comfortable lifestyle for patients and caregivers.In addition to improved patient satisfaction and quality of life, home treatment may also reduce patient and healthcare costs. Many studies reported decreased healthcare costs (reductions ranging from 18 to 85%) for treatment provided in the home compared with the hospital (In summary, zoledronic acid is a safe and effective treatment for skeletal complications resulting from bone metastases in patients with breast cancer. Furthermore, infusion of zoledronic acid in the community setting significantly improved pain and quality of life compared with hospital administration, and patients were more satisfied with treatment in the home. A cost analysis that includes cost of treatment and patient out-of-pocket expenses needs to be conducted to assess fully potential economic benefits for patients and the healthcare system. However, the short infusion time of zoledronic acid and the patient benefits demonstrated by this study suggest that zoledronic acid is an excellent candidate for administration in the community setting.


Patients with chronic pain frequently display comorbid depression, but the impact of this concurrence is often underestimated and mistreated. The aim of this study was to determine the prevalence of unrecognized major depression and other mood disorders and comorbid unexplained chronic pain in primary care settings and to explore the associated factors.Also, to compare the use of health services by patients with unexplained chronic pain, both with and without mood disorder comorbidity.A cross-sectional study was carried out in a sample of primary care centers. 3189 patients consulting for "unexplained chronic pain" were assessed by the Visual Analogue Scales (VAS) and the Primary Care Evaluation of Mental Disorders (PRIME-MD) questionnaire.We report: a) a high prevalence of unrecognized mood disorders in patients suffering from unexplained chronic pain complaints ; b) a greater susceptibility of women to mood disorders ; c) a direct relationship between the prevalence of mood disorders and the duration of pain  d) a higher comorbidity with depression if the pain etiology was unknown  and, e) an increased use of health care services in patients with such a comorbidity (p < 0.0001).The prevalence of undiagnosed mood disorders in patients with unexplained chronic pain in primary care is very high, leading to dissatisfaction with treatment processes and poorer outcomes. Consequently, it seems necessary to explore this condition more regularly in general practice in order to reach accurate diagnoses and to select the appropriate treatment. Chronic pain and depression are amongst the most common health problems reported by patients attending primary care . Both coChronic pain and depression are frequently comorbid processes, with some studies showing a prevalence ranging from 15% to 100% . LikewisPatients with comorbid chronic pain and depression consult their doctor more often and become heavy consumers of medical services ,9. FurthIn primary care, depression is often undiagnosed, particularly in cases of patients suffering from chronic pain . The WHOFrom a neurobiological perspective, chronic pain and depression share similar neurobiological mechanisms and central nervous structures. For example, serotonin and noradrenaline are implicated in both processes, and it is well known that antidepressants that enhance serotonin and noradrenaline are effective analgesics -16. MoreDiagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV). Likewise, studies using specific structured interviews to assess these processes in primary care are not common.In spite of the overwhelming data demonstrating the relationship between chronic pain and depression, studies concerning the comorbidity of chronic pain, especially unexplained chronic pain, with other mood disorders are scarce. Most studies have focused on pain's relationship with Major Depressive Disorder (MDD), with few addressing other mood conditions such as minor depression, dysthymia or bipolar disorder included in the By means of a structured interview, this study investigated the prevalence of unrecognized mood disorders, not only MDD, in patients with medically unexplained chronic pain complaints in primary care settings, and also studied possible factors associated with the comorbid mood disorder. As a secondary outcome we aimed to compare the use of healthcare services in unexplained chronic pain patients with and without comorbid mood disorder.A cross-sectional study was carried out in a sample of primary care centers in Spain between April 2006 and December 2006. In order to obtain a representative sample, the number of primary care centers chosen in each Spanish region was proportionate to its number of inhabitants. Likewise, the selection process observed Spain's rural/urban ratio with at least 20% of the sample from primary care centers in cities of less than 50,000 inhabitants.In each primary care center, one general practitioner (GP) that voluntarily accepted to participate was selected, constituting a final sample of 600 GPs.The study was conducted in agreement with the Helsinki Declaration and with standard working procedures and protocols, and approved by the Clinical Research Ethics Committee at the Clinical and Provincial Hospital in Barcelona, ensuring adherence to the norms of good clinical practice.The study included men and women over 18 years of age who consulted their Primary Care Center for unexplained pain  lasting for at least 6 weeks. Thus, patients were considered with "unexplained chronic pain" and eligible for the study if the cause of their pain was either unknown or, in known, the cause was not fully explained by another medical or psychiatric disorder . The preTo obtain a prevalence of unexplained chronic pain and concomitant mood disorders of 20% with an accuracy of 3% and a confidence interval of 95%, based on the literature [To obtain the calculated number of patients each of the 600 selected GPs had to interview about 7 patients who consulted them and who fulfilled the inclusion criteria for the study. The patients were selected consecutively based on arrival at the primary care center, and patients who refused to participate were substituted for the next one who fulfilled the criteria.The interviews were performed at local primary care facilities by GPs who received a written guideline with instructions on the procedure to be used to collect that data. Information related to socio-demographic variables , clinical variables  and use of healthcare resources  was collected from a structured questionnaire and from the medical records of the patients.Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) and their sensibility and specificity are 83% and 88% respectively. A Spanish validated version of the PRIME-MD was used [The intensity of pain was measured with a Visual Analogical Scale (VAS) with a range of 0-100, where 0 was no pain and 100 was the worst pain possible . For thewas used .All possible PRIME-MD diagnoses according DSM-IV criteria were considered in our study: major depressive disorder, minor depressive disorder, partial remission from a major depressive disorder, dysthymic disorder, bipolar disorder or depression caused by a general medical condition, medication or drugs.Data collection forms were further monitored centrally to check and correct missing data or inconsistencies.In the descriptive analysis, absolute frequency and 95% CIs were calculated for categorical variables, and central trend and dispersion measurements were used for quantitative variables. The T- test, Wilcoxon test or chi-squared test (Student or Fisher) were used to study associations.The prevalence (CI 95%) of undiagnosed mood disorder was calculated as the number of patients with an undiagnosed illness detected with the PRIME-MD questionnaire divided by the total number of patients screened with the PRIME-MD questionnaire.To study the factors associated with mood disorders, a backward logistic regression model was used in which the outcome variable was the presence or absence of mood disorders, and the variables included in the model were: sex, age, location of pain , intensity of pain, duration of pain expressed as the percentage of the day in pain, number of pain locations, known cause of the pain (yes/no) and current treatment , analgesic opioids, anticonvulsants, anxiolitics). The variables were selected according to the statistical significance observed in the univariate analysis (p < 0.05) or according to the association with the dependent variables observed in the literature. The Hosmer-Lemeshow test was used to assess the goodness of fit of the model.3588 patients were initially included in the study, of whom 399 were excluded . Thus, the final number of patients studied was 3189 (response rate 88.9%) all of whom gave their written informed consent to participate in the study.The average age of the population was 53.9 (SD: 13.3), 72.8% were female, 78.9% had completed primary or secondary education and 64% lived with a partner.The average duration of pain was 30.8 months median 13.9), the average intensity on the VAS was 55.9 (SD: 19.8), the most common locations of pain were the neck and back  were undergoing some type of treatment for pain at the time of inclusion in the study. Of the 2729 patients under treatment with analgesics , 96.1% were taking a simple analgesic or NSAIDs, especially acetaminophen (54%) or ibuprofen (26%), and 10.6% were taking opioid analgesics  . Comorbidity was higher in the female population  but there were no differences related to patients' age (p = 0.42).The type of mood disorder most frequently diagnosed was major depression (56.2%), followed by minor depression (17.8%) and dysthymia (16.9%) Table .The analysis of the factors associated with the presence of mood disorders in patients suffering from unexplained chronic pain can be seen in Table As displayed in Table This study was undertaken to investigate the comorbidity of unrecognized mood disorders and unexplained chronic pain in primary care patients, as well as to determine the possible factors influencing such a relationship. In addition, the study also investigated the use of healthcare resources as a consequence of this comorbidity.The most important findings related to the aim of our study were: a) the existence of a high prevalence of undiagnosed mood disorders in patients suffering from unexplained chronic pain complaints evaluated in a primary care setting; b) the frequent presence in these patients of other mood disorders, different to MDD c) a greater susceptibility of women to mood disorders; d) a direct relationship between the prevalence of mood disorders and the duration of pain in the previous week; e) an absence of association between the intensity and number of pain-sites; f) a higher comorbidity if the reasons for suffering pain are unknown and, g) the observation of an increased use of healthcare services in patients with such comorbidity.Our results confirm previous studies reporting that the presence of painful physical symptoms increases the likelihood of a diagnosis of a mood or anxiety disorder by as much as 3-fold . Also, tDespite being very common in primary care settings, mood disorders are frequently undetected. A number of studies have found that about half of the patients who experience major depression are not diagnosed by their primary care physicians . In addiOne result found in this study, and which, to our knowledge has not been reported by other authors is the high frequency of minor depression or dysthymia observed in the patients. The presence of these mood disorders in almost 35% of the patients could be explained by the use of the PRIME-MD, which is better able to detect these processes in primary healthcare than instruments used in other studies.Our study also found that women suffer a greater risk of experiencing a comorbid pain-mood disorder. This result is congruent with findings by Ohayon and Schatzberg . CampbelIn this study, a direct association was found between the number of pain sites and the presence of mood disorder, as measured by the crude OR, but this relationship disappeared after adjustment by other variables. These data are contradictory when we refer to previous studies . Gureje We found a higher rate of comorbid pain-mood disorder if the reasons for suffering pain are unknown, and also when a precise diagnosis of the cause of pain is lacking. In some studies, a higher occurrence of depression is reported if the etiology of the pain condition is medically unexplained when compared to patients with a more defined pain disorder, such as neuropathy . MarazziFinally, we found an increased use of health care services when pain is comorbid with mood disorder. This result is replicated very often in other studies . The posIt is necessary to know the complex biological relationships between chronic pain and depression to better understand the frequency of this comorbidity. The convergence of depression and pain is reflected in the circuitry of the nervous system. Brain pathways that handle the reception of pain signals, including the limbic system, use some of the same neurotransmitters involved in the regulation of mood, especially serotonin and norepinephrine. When an alteration occurs in these pathways pain is intensified, along with depression and anxiety. This is one of the reasons why, in many cases, antidepressants - mainly those that inhibit the reuptake of norepinephrine or serotonin - are used, either alone or in combination with analgesics, to treat chronic pain .A limitation of our study is that the occurrence of other chronic medical or psychiatric conditions, has not been assessed and they are sometimes related to depression and often prevalent among people with chronic pain ,37. FurtWe have to point out the possible bias related to the subjective assessment of pain by the GP in order to consider the patients as being affected by unexplained chronic pain and thus to select the patients to be included in the study. However, this bias should be small because of the training given to the GP, and because of the use of objective assessment of pain by a VAS.Another limitation could be the lack of a confirmation of the diagnosis by means of a structured psychiatric interview. However the PRIME-MD is an instrument with tried and tested psychometric properties.A strength of this study is that our results are based on large datasets collected from a broad range of primary care centres by means of objective assessment of pain and using international criteria for mood disorder diagnosis from a validated tool.There is a very high under diagnosed prevalence of different mood disorders in patients with unexplained chronic pain visiting a primary care physician, leading to dissatisfaction with treatment processes and outcomes. Consequently, it seems necessary to explore this condition more regularly in general practice in order to achieve accurate diagnoses and to select the appropriate treatment.The authors declare that they have no competing interests.LA has made substantial contributions to the conception and design of the paper, and has given his final approval of the version to be published. Likewise, he had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. IF has made substantial contributions to the conception and design of the paper and the analysis and interpretation of data. She has also been involved in drafting the manuscript. JC has made substantial contributions to the coordination of the study and helped to write the manuscript. PD-F has made substantial contributions to the coordination of the study. JAM has been involved in drafting the manuscript and reviewing it critically for important intellectual content.All the authors have read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2296/11/17/prepub


Cancer-related pain is common and under-treated. This article describes a study designed to test the effectiveness of a theory-driven, patient-centered coaching intervention to improve cancer pain processes and outcomes.The Cancer Health Empowerment for Living without Pain (Ca-HELP) Study is an American Cancer Society sponsored randomized trial conducted in Sacramento, California. A total of 265 cancer patients with at least moderate pain severity  or pain-related impairment (Likert score >= 3 out of 5) were randomly assigned to receive tailored education and coaching (TEC) or educationally-enhanced usual care (EUC); 258 received at least one follow-up assessment. The TEC intervention is based on social-cognitive theory and consists of 6 components . Both interventions were delivered over approximately 30 minutes just prior to a scheduled oncology visit. The majority of visits (56%) were audio-recorded for later communication coding. Follow-up data including outcomes related to pain severity and impairment, self-efficacy for pain control and for patient-physician communication, functional status and well-being, and anxiety were collected at 2, 6, and 12 weeks.Building on social cognitive theory and pilot work, this study aims to test the hypothesis that a brief, tailored patient activation intervention will promote better cancer pain care and outcomes. Analyses will focus on the effects of the experimental intervention on pain severity and impairment (primary outcomes); self-efficacy and quality of life (secondary outcomes); and relationships among processes and outcomes of cancer pain care. If this model of coaching by lay health educators proves successful, it could potentially be implemented widely at modest cost.[Clinical Trials Identifier: NCT00283166] An estimated 90% of patients with cancer experience at least moderate pain at some point in their illness, and 42% of patients receive inadequate palliation  Aside frIn a series of articles published in the late 1980's, Greenfield, Kaplan, and colleagues showed that expanding patients' involvement in care can improve patient outcomes,6 In theIn a pilot evaluation of the intervention described in this article, Oliver et al randomized English-speaking adults with cancer and moderate pain to a 20-minute TEC session (n = 34) or to a control group (n = 33) At baselThe current study evaluates a brief, patient-centered, theory-driven intervention that, if shown to be effective, could be widely disseminated. The TEC intervention developed for this study is rooted in Social Cognitive Theory (SCT) as developed by Bandura. This thePain management self-efficacy is confidence in the ability to achieve control over one's pain. Communication self-efficacy is confidence in the ability to communicate effectively about pain with one's physician. These two forms of self-efficacy may mediate pain relief via separate pathways. As depicted in Figure Bandura's notion of self-efficacy is task specific. We hypothesized that two forms of self-efficacy may be germane to cancer pain management. Effective pain self-management requires the patient to apply a complex set of skills that involve monitoring, medicating (for chronic and breakthrough pain), anticipating (side effects), and communicating with the treating physician. SCT predicts that patients with greater self-efficacy for these behaviors will have a higher likelihood of actually performing them. The theory finds empirical support in a meta-analysis of psychosocial interventions among cancer patients In that This article describes the design and implementation of the Cancer Health Empowerment for Living without Pain (Ca-HELP) Study.The study was designed as a randomized controlled trial comparing TEC to educationally-enhanced usual care (EUC). The unit of randomization is the individual patient. The choice of design reflects several considerations. We used EUC rather than usual care as the comparator in order to control for the effects of time, information-giving and companionship. Thus, any improvement in observed pain outcomes would owe to the effects of activation-coaching over and above what might be accomplished by having an empathetic lay person provide educational materials and engage in supportive conversation. We chose to randomize individual patients rather than physicians or systems because: 1) the intervention is posited to exert its effects primarily by affecting patient knowledge, attitudes, self-efficacy, and behaviors; and 2) based on the known difficulties in consistently modifying physician behavior ,19, spilCancer care physicians were recruited from three health systems  and one private practice, all in Northern California. Medical, radiation, and (after March 2008) gynecological oncologists  were deemed eligible if they saw patients at one of the participating sites and were in clinical practice at least 20% time . Physicians gave blanket consent to contact all their eligible patients, or in several instances, selected patients only. Among the 49 participating physicians, 23 (47%) authorized audiorecording of the index study visit. Physicians were offered feedback on the outcomes of their own patients compared with the aggregate results but received no monetary compensation.Ethical approval was obtained by the Institutional Review Boards of University of California, Davis and the Kaiser Foundation Research Institute. Patients eligible for enrollment in the study included all cognitively intact, English-speaking adults obtaining care (active treatment or surveillance) from participating oncologists for selected solid tumors and who reported more than minimal cancer-related pain. "Cancer-related pain" was defined as "pain that you would bring to the attention of your cancer doctor" . More than minimal pain was defined as a score of 4 or greater  for "worst pain past two weeks" or pain that during the same period interfered at least moderately with function. Specific inclusion and exclusion criteria are presented in Table Potentially eligible patients were identified with the assistance of participating oncologists, who provided computer-generated lists of patients who had been seen within the past 3 months (UCDMC) or were scheduled to be seen within the next two months . Personalized letters were prepared notifying patients of the aims of the study and requesting assent to contact them by phone. A pre-paid post card was enclosed with the letter; patients wishing to avoid telephone contact returned the card and were not contacted further. After a minimum of three weeks, patients not returning the opt-out postcard were contacted by telephone, screened for eligibility, and invited to participate in the study. Verbally consenting patients were mailed a study enrollment packet containing a cover letter and a written consent form. Usually within three weeks , a study representative conducted an Enrollment Interview by phone. The purpose of the Enrollment Interview was to collect baseline information on pain, other cancer symptoms, psychological distress, health related quality of life, adherence, and self-efficacy. By collecting the majority of baseline data by telephone prior to the index visit, we limited respondent burden and were able to focus the index visit on delivery of the intervention rather than collection of data. Patients were promised a total of $80 compensation: $50 for completing the intervention and $10 for the 2-, 6-, and 12-week follow-up telephone surveys, respectively.At the conclusion of the Enrollment Interview, patients were randomized to the TEC or EUC groups using a blocked-randomization scheme to assure balanced assignment within physicians. For each physician in the study, a separate sequence of random 1's (TEC group) and 0's (EUC group) was generated for use in assigning patients. To preserve blinding, treatment assignment (0/1) was encoded as a set of 3-digit numbers maintained by the study statistician. The encoded sequences were printed on two adhesive labels, one affixed to the patient's Enrollment Interview form and another to the Tracking Sheet in each patient's Case Report File (CRF). The CRF served as the patient's study record and included a log of all contacts with research staff, all completed telephone surveys, the survey booklet completed by the patient on the date of the intervention, and documentation of payment for study participation.Patients were asked to arrive one hour prior to the next scheduled oncology appointment (referred to subsequently as the "index visit"). Upon arrival at the clinic waiting area, study participants were greeted by a trained Health Educator (HE), escorted to a quiet space, and given the opportunity to sign the Patient Bill of Rights, IRB-approved Consent Form, and the HIPAA Release Form. All patients then completed the Pre-visit/Pre-Intervention Questionnaire. This form was self-administered, but the HE was available to provide assistance if needed. At this juncture, patients received their assigned intervention (TEC or EUC). For quality control and training purposes, all interventions were audio-taped. Following the intervention (which lasted 20-40 minutes), patients completed another self-administered instrument, the Pre-visit/Post-Intervention Questionnaire. If the attending oncologist and patient had provided prior consent to be audiotaped , the HE placed a small audiorecording device in the exam room. Immediately after the visit, patients were intercepted by the HE and asked to complete the Post-visit Questionnaire. They were thanked for their participation and reminded that they would receive their first follow-up phone call in two weeks.The TEC intervention was based on the model previously described by Oliver et al This appAssessment of current knowledge, attitudes, and preferences . As an initial step in the TEC intervention, the HE reviews information supplied by the patient as part of the baseline interview, focusing on current symptoms, pain-related knowledge and attitudes, and self-efficacy expectations. Using a set of questions found in the TEC Training and Resource Manual, the HE also helps the patient to clarify his or her major pain-related concerns and treatment-preferences.(1) Correction of misconceptions about cancer pain control. Patients frequently harbor false or exaggerated beliefs that can interfere with effective management of cancer-related pain.Table ent ScaleAnxiety won Scale , while fon Scale Pain-relaalgesics.Self-effiy et al. , respectFor the subsample of visits that were audiorecorded (n = 148), two sets of communication measures were used, discourse coding of active patient participation and observer ratings of physician's informativeness and facilitative communication -30 UsingA prospective sample size calculation was performed during the protocol-writing stage. It aimed to determine a target sample size that would provide 80% power for two-tailed testing (at a type-1 error rate of 5%) of each of the key study hypotheses concerned with between arm differences in regression-adjusted follow-up outcome measures. The investigators concluded that an effect size of 0.33 units of standard deviation of the unadjusted outcome distribution was appropriately modest for a relatively inexpensive pain control intervention. Under plausible assumptions about the net variance reduction achievable through particular features of our study design [The first patient was enrolled on 10/30/2006. A DSMB was established shortly after project launch and met several times during the two-year data collection period. Members included a clinician-epidemiologist, an attorney affiliated with a non-profit medical research and policy foundation, and a senior academic statistician who served as the Board's chair. Based on the Board's recommendations issued in June 2007, project staff amended the study protocol to limit the number of enrolled patients per physician to a maximum of 40; increase the target sample size from 230 to 275; and develop procedures for dealing with  patients who were disturbed by the screening phone call because they were no longer in active treatment for their cancer. In the subsequent project year, the Board evaluated randomization procedures and requested additional analyses following the revelation that among the first 100 enrollees, intervention group patients were significantly older than control group patients. The Board found no irregularities and attributed the age imbalance to chance.Of 3720 patients sent a recruitment letter, 3413 were excluded due to returning an opt-out postcard (n = 1011); inability to contact by phone despite repeated calls (n = 1015); or ineligility at the time of screening (n = 1182), at enrollment (n = 202) or during follow-up   pain severity at two-weeks, measured as the mean of average and worst pain and 2) pain-related impairment at 2 weeks. To test for attenuation, the effect of the intervention on pain severity and impairment at latter follow-up occasions (i.e. at 6 and 12 weeks) will be reported as secondary outcomes. Additional secondary analyses will estimate effects of the intervention on average pain; self-efficacy for pain control; and self-efficacy for communication with the physician. Finally, exploratory analyses will assess the interaction between the intervention and minority race, as suggested by previous work The primThe Ca-HELP Study is a multi-site randomized trial of a patient-centered coaching intervention designed to improve cancer pain care and outcomes. Important features of the study include its focus on ambulatory patients with cancer-related pain recruited from several health care systems, broad inclusion criteria, strong theoretical foundations based on SCT, randomization at the patient level, and tracking of multiple outcomes at 2, 6, and 12 weeks. Use of multiple methods  and multiple measures  favors a comprehensive assessment of a complex behavioral intervention. We have demonstrated the ability to train lay HEs with high fidelity and recruit, enroll, and track large numbers of patients with cancer-related pain.Major challenges encountered during implementation of the study included recruiting and training HEs, complying with multiple Institutional Review Boards (IRBs), maintaining fidelity of the intervention, and dealing with patient fatigue and distress during advanced stages of illness. Seeking generalizability, we initially recruited a relatively large cohort of part-time lay HEs but found turnover was reduced by relying on a smaller number of more committed personnel. Recruitment of patients was slowed by IRB requirements that patients identified as appropriate candidates by their oncologists be allowed the opportunity to opt out by mail before being contacted by the study staff. However, these requirements were an artefact of the study and would not apply should the intervention be incorporated into routine clinical care. Fidelity to the ACT-PReP paradigm was ensured by universal monitoring and intermittent review and feedback. Finally, while the vast majority of patients expressed gratitude for being able to participate in the study, some had trouble with lengthy telephone follow-up instruments, which occasionally required interruption of the interviews with call-back at a more convenient time.In summary, the Ca-HELP Study has successfully trained lay HEs to deliver a theory-driven intervention designed to improve an important clinical target. Subsequent analyses will focus on the effects of the experimental intervention on pain, self-efficacy, and quality of life and examine relationships among processes and outcomes of cancer pain care.The authors declare that they have no competing interests.RLK generated the idea, obtained funding, and orchestrated implementation of the protocol. DJT contributed to the design and statistical analysis plan. RLS planned the clinical conversation analysis. DK contributed specialty expertise in pain management. TG coordinated implementation of the study at the HMO site. TW coordinated implementation at the academic site. CS and DED managed the project. LL served as lead health educator. PF contributed to all aspects of design and analytic planning. All authors read and approved the final version of the manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2407/9/319/prepub


P = NS) but the VAS score was significantly less in group II at 2, 4, 6, 8 h , and at 10 h the P value was not significant. Similarly, the systolic blood pressure was significantly less in group II at 2, 4, 6 h after surgery, that is P < 0.02, P < 0.01, P < 0.01, respectively, but at 8 and 10 h the pressures were comparable in both the groups. Adding TENS to epidural analgesia led to a significant reduction in pain with no sequelae. The haemodynamics were significantly stable in group II compared to group I. TENS is a valuable strategy to alleviate postoperative pain following thoracic surgery with no side effects and with a good haemodynamic stability; however, the effects are short lasting.The present randomized study was conducted in our institute of pulmonary medicine and tuberculosis over a period of 1 year. This study aimed to evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS) as an adjunctive to thoracic epidural analgesia for the treatment of postoperative pain in patients who underwent posterolateral thoracotomy for decortication of lung. Sixty patients in the age group 15–40 years scheduled to undergo elective posterolateral thoracotomy were divided into two groups of 30 each. Patients were alternatively assigned to one of the groups. In group I, only thoracic epidural analgesia with local anaesthetics was given at regular intervals; however, an identical apparatus which did not deliver an electric current was applied to the control (i.e. group I) patients. While in group II, TENS was started immediately in the recovery period in addition to the epidural analgesia. A 0–10 visual analog scale (VAS) was used to assess pain at regular intervals. The haemodynamics were also studied at regular intervals of 2 h for the first 10 h after the surgery. When the VAS score was more than three, intramuscular analgesia with diclofenac sodium was given. The VAS score and the systolic blood pressure were comparable in the immediate postoperative period ( The TENS treatment was not effective in the posterolateral thoracotomy group, but it was useful as an adjunct to other medications in the muscle-sparing thoracotomy, costotomy and sternotomy groups. TENS is not of major benefit compared with the usual opiod and nonopiod analgesics when pain intensity is high, but it can be used as an adjunct to other medications when the pain is moderate and can be the only pain therapy when the pain is mild.[Uncontrolled postoperative pain may produce a range of detrimental acute and chronic effects. Attenuation of perioperative pathophysiology that occurs during surgery through reduction of nociceptive input into the central nervous system (CNS) and optimization of perioperative analgesia may decrease complication and facilitate the patients' recovery during the immediate postoperative period and after discharge from the hospital. Epidural is mild. Narcotic is mild.After obtaining institutional ethical committee approval, 60 patients in the age group 15–40 years of either sex undergoing elective thoracotomies for decortication were included in this study. The patients were randomly divided into two groups of 30 each. One group received only epidural analgesia with local anaesthetics and the other received TENS with epidural analgesia in the postoperative period. Patients with coagulopathy, neurological diseases, spine deformities, diabetes mellitus, pacemaker implantation were excluded from the study.All the patients were subjected to epidural catheterization before anaesthesia. The catheter was placed in the T7–8 space through 18G Tuohy's needle taking all aseptic and antiseptic precautions. A test dose with 2 ml of 2% lignocaine was given to all the patients. A standard general anaesthetic technique was adopted. Epidural analgesia was given with 10 ml of 0.25% bupivacaine at hourly interval in all the patients intraoperatively. The last dose of analgesia was given 15 min before the closure in all the patients. The patients in both the groups were given epidural analgesia with 10 ml of 0.125% bupivacaine at 2-hourly interval. The time at which the patient was shifted to the recovery room was noted. In the postoperative period, TENS was started immediately in the group II patients by a portable stimulator. The electric current was delivered by two self-adhesive surface electrodes, placed on either side of the incision, approximately 3–4 cm from the suture line. During the 45-min treatment period, the frequency was kept constant at 80 Hz. The patients were shown the visual analog scale (VAS) in the preoperative period. They were asked to quantify their pain using a 10-cm VAS immediately after shifting to the recovery and then at 2, 4, 6, 8 and 10 h after the surgery. An identical apparatus which did not deliver an electric current was applied to the control  patients. The patients who had a VAS score more than 3 were supplemented with intramuscular diclofenac sodium. The haemodynamics, that is, systolic blood pressure was recorded regularly as planned, and plotted against time.P values were calculated. P < 0.05 was considered significant.Side effects, if any, were also observed and noted. The data were analyzed using chi-square test and the In this study 60 patients belonging to either sex were divided into two groups of 30 each: group I epidural analgesia and group II epidural analgesia + TENS.P = NS). The sex ratio in the two groups is shown in Analysis and comparison are discussed subsequently. As shown in Time intervals are as follows:A: Immediate postoperative; B: 2 h after surgery; C: 4 h after surgery; D: 6 h after surgery; E: 8 h after surgery; F: 10 h after surgery.P < 0.02), 4 h (P < 0.01), 6 h (P < 0.01) after the surgery compared to the group where TENS was not applied. However, the blood pressure was comparable at 8 and 10 h in both the groups (P = NS) [As shown in (P = NS) .As shown in In spite of the great interest in understanding the pain mechanism and pain management, a number of patients suffer from pain even today. So, it is clear that the solution to postoperative pain is not just developing a single technique or a drug to relieve it but to implement simple protocols that suit in different settings with strategies to exploit the available expertise. Anaesthesiologists with their expertise in understanding the pathophysiology of pain, technical expertise and commitment, can organize and manage pain services to the entire hospital.In the institute where the study was conducted, we get majority of tuberculous patients for thoracotomy. These patients are usually malnourished with restrictive lung patterns in the pulmonary function test and have deranged liver function tests. A thoracotomy is a painful incision as it involves multiple muscle layers, rib resections and continuous motion as the patient breathes. Pain relief is particularly important not only to keep the patient comfortable but also to minimize the pulmonary complications. It enables the patients to ambulate and to breathe normally (without splinting) and to cough deeply. AlthoughThough pharmacotherapy forms an integral part of management of acute pain, one has to look at various other methodologies to relieve postoperative pain. The nonpharmacological methods can be used as adjuvants to the main method of pain relief. A holistic approach can cut down costs and reduce the complications associated with the opiod and nonopiod drug usage and dosage. A lot of interest is being shown on complimentary and alternative medicine for chronic pain management, which could be applied for acute pain. Herbal medicine, hypnosis, homeopathy, therapeutic touch, meditation, TENS, acupuncture, heat application are a few to name. It is accepted that use of TENS either at acupoint or dermatome corresponding to surgical incision decreases the postoperative pain, opiod requirement and the related side effects. The effect of frequency of electrical stimulation was studied in 100 women undergoing gynecological surgeries. The application of TENS showed better pain relief and 55% decrease in morphine requirement, as well as reduced nausea and vomiting. The mechanism by which TENS produces analgesia is unclear and may be related to the modulation of nociceptive impulses in the spinal cord, release of endogenous enkephalins or a combination of these and other mechanisms. Although5TENS has been hypothesized to improve pain in multiple ways. Theories include effects on sensory nerves, interference with sensory discriminative pathways, stimulation of release of natural chemicals that affect the way pain is perceived and transmitted, for example, enkephalins and endorphins or through increased blood flow in treated areas such as the skin or heart. Recent det al.[et al. have proved in their study that TENS is beneficial for pain releif following thoracotomy and has no side effects and hence recommended the routine use of TENS following thoracic surgery.[In a controlled trial of TENS for postoperative pain relief following inguinal herniorraphy, pain was assessed over the first three postoperative days by VAS, expiratory peak flow rates and analgesics requirements. There was no difference between the two groups for pain scores and it was concluded that TENS does not reduce postoperative pain. However, it had considerable patient appeal and many patients believed that it was effective. Sodipo eet al. proved t surgery.P < 0.02), 4 h (P < 0.01) and 6 h (P < 0.01). However, the blood pressures were comparable in both the groups at 8 and 10 h (P = NS). The patients having VAS score of >3 were supplemented with an intramuscular dose of diclofenac sodium. The VAS score of 0 was considered as no pain, 1 as mild, 2 as moderate pain and 3 or more as severe. The VAS score was similar in both the groups in the immediate postoperative period (P = NS). At 2, 4, 6 and 8 h, the score was significantly lower in the group II patients . Again, at 10 h, the pain score was comparable in both the groups. The incidence of side effects was negligible in both the groups. The acceptance to chest physiotherapy in the patients who received TENS was more than the patients who did not receive it. The satisfaction level of the patients who received TENS was also more compared to those who did not receive it.Thoracic epidural analgesia is the gold standard for post-thoracotomy analgesia. Local anaesthetics given epidurally can supplement general anaesthesia during surgery, but postoperatively their addition may not significantly improve analgesia above the level achieved from epidural opiods only. Any concurrent hypotension and motor blockade from the local anaesthetics can limit the patients' ability to ambulate. Local anaesthetics can cause postoperative hypotension which is as high as approximately 7%, the average may be closer to 0.7–3%. Hence, tAddition of TENS to epidural analgesia by local anaesthetics intensifies the pain relief without causing any squeals in addition to stabilizing the haemodynamics. TENS can be used as an adjunctive to epidural analgesia for acute postoperative pain in patients of posterolateral thoracotomies.


The hypothesis is explored that CRPS I (the "new" RSD) persists due to undiagnosed injured joint afferents, and/or cutaneous neuromas, and/or nerve compressions, and is, therefore, a misdiagnosed form of CRPS II . An IRB-approved, retrospective chart review on a series of 100 consecutive patients with "RSD" identified 40 upper and 30 lower extremity patients for surgery based upon their history, physical examination, neurosensory testing, and nerve blocks. Based upon decreased pain medication usage and recovery of function, outcome in the upper extremity, at a mean of 27.9 months follow-up (range of 9 to 81 months), gave results that were excellent in 40% (16 of 40 patients), good in 40% (16 of 40 patients) and failure 20% (8 of 40 patients). In the lower extremity, at a mean of 23.0 months follow-up (range of 9 to 69 months) the results were excellent in 47% (14 of 30 patients), good in 33% (10 of 30 patients) and failure 20% (6 of 30 patients). It is concluded that most patients referred with a diagnosis of CRPS I have continuing pain input from injured joint or cutaneous afferents, and/or nerve compressions, and, therefore, similar to a patient with CRPS II, they can be treated successfully with an appropriate peripheral nerve surgical strategy. For the patient given the traditional diagnosis of "Reflex Sympathetic Dystrophy" (RSD) who fails to recover from sympathetic blocks, anti-inflammatory medication and physical therapy, current treatment options largely consign the patient to a Pain Management center for life.,2 ChangiPeripheral nerve surgery has been considered an option in the upper extremity for the diagnosis of co-existing carpal tunnel syndrome once the patient has passed the acute phase of pain and associated swelling.,14-16 ReWith the hypothesis that chronic pain input to the dorsal spinal columns can be the source of CRPS II, misdiagnosed as CRPS I, and with the hypothesis that injured joint and/or cutaneous afferents as well as chronic nerve compression can be the source of these painful dorsal column inputs, an approach was taken to re-evaluate patients with CRPS I of the upper or lower extremity. The results of this approach are now reported.Absolute: pain extending outside the area of trauma, impaired extremity function, and either cold or warm perceptions or temperature changes in the affected extremity; Relative: swelling, increased hair or nail growth, hyperalgesia, allodynia, abnormal skin coloring.An IRB-approved, retrospective chart review was carried out on a series of 100 consecutive patients with the diagnosis of "RSD" from a computer database from 01-01-2000 through 04-30-2006. Diagnosis was made based upon the International Association for Study of Pain criteria:[Inclusion into the surgery group required 1) failure to have the chronic pain resolve despite more than 6 months of therapy, edema control, anti-inflammatory medication, and opiates under the control of a pain management physician, 2) documentation of a pain input source by nerve blocks of joint and/or cutaneous afferents, with a ≥ 5 point reduction in pre-block pain on a Visual Analog Scale , and 3) documentation of chronic nerve compression by abnormal neurosensory testing and the presence of a positive Tinel sign at the known site of anatomic narrowing . Based upon these inclusion criteria, seventy patients from the 100 were selected for surgery, 40 patients had upper extremity and 30 patients had lower extremity CRPS.The nerve block was done using a 50:50 mixture of 1% xylocaine and 0.5% bupivicaine, each without epinephrine. Sterile technique was used. For each nerve block, 5 cc of this mixture was infiltrated into the region of the known joint afferent or suspected cutaneous neuroma. The joint itself was not infiltrated. The nerve itself was not knowingly injected. Sites of suspected nerve compressions were not injected to avoid increasing the pressure on the compressed nerve. Failure of the nerve block to relieve pain could imply that the block was not done properly, and therefore "failure" meant that while loss of sensation did occur in the distribution of the sensory nerve that was blocked, there was insufficient pain relief to deem that block successful. When this occurred, it was still possible that another nerve contributed to the pain mechanism and that the two sensory territories overlapped, e.g., the radial sensory nerve and lateral antebrachial cutaneous nerve, or the sural and superficial peroneal nerve territories. This anatomic possibility was investigated by a new block of the suspected adjacent nerve. If the pain remained after nerve block of all possible sensory nerve territories, then failure to obtain pain relief was interpreted to mean that there was a fixed central mechanism  for the pain and that peripheral nerve surgery would not be of benefit.Patient demographics are given in Table The distribution of the mechanisms of injury in each group is given in Table In patients with either 1) a history of repeated swelling or acute exacerbations of pain after extremity use, 2) evidence of persistent sympathetic over-activity, or 3) pre-emptive anesthesia was requested by the patient's Pain Management doctor, the surgery was done using indwelling brachial plexus or epiduThe distribution of surgical procedures done is given in Table Outcomes included measurement of pain, level of drug use, improved function as determined by activities of daily living and return to work. An excellent result required the pain level to be from 0 to 2, a cessation of opiate use, the ability to use the upper or lower extremity for normal activities of daily living, and the return to work (if previously employed) or school. A good result required the pain level to be from 3 to 4, an occasional use of a non-opiate, a slight restriction of activity of daily living, and the return to work (if previously employed) or school. All impairments greater than the above criteria were considered a failure. Descriptive statistics were used for the demographics.In order to evaluate whether there was a difference in outcomes between patients with a relatively short length of follow-up and those with a longer length of follow-up, the patient population was grouped into those whose follow up was ≥ 9 but ≤ 24 months, and those whose follow-up was > 24 months.In the upper extremity the results were excellent in 40% (16 of 40 patients), good in 40% (16 of 40 patients) and failure 20% (8 of 40 patients).In the lower extremity the results were excellent in 47% (14 of 30 patients), good in 33% (10 of 30 patients) and failure 20% (6 of 30 patients).In the upper extremity the results were excellent in 35% (9 of 26 patients), good in 38% (10 of 26 patients) and a failure in 27% (7 of 26 patients).In the lower extremity the results were excellent in 41% (7 of 17 patients), good in 35% (6 of 17 patients) and a failure in 24% (4 of 17 patients).In the upper extremity the results were excellent in 50% (7 of 14 patients), good in 43% (6 of 14 patients) and a failure in 7% (1 of 14 patients).In the lower extremity the results were excellent in 55% (7 of 13 patients), good in 30% (4 of 13 patients) and a failure in 15% (2 of 13 patients).There was no statistically significant difference between results in the upper versus the lower extremity or between any of the three time-frame groupings.This study demonstrated that more than 80% patients with a diagnosis of "CRPS I" of the upper or the lower extremity have one or more injured and/or compressed peripheral nerve(s) as the source of their continuing dorsal column painful neural input. This means that perhaps as many as 80% of patients with the current diagnosis of "CRPS I" should actually have a diagnosis of "CRPS II", and provides optimism that a peripheral nerve source for their pain can be identified and successfully treated using an appropriate peripheral nerve strategy.This study demonstrates that the accepted principles of upper extremity peripheral nerve surgery apply to the lower extremity. If nerve decompression of the median nerve in the carpal tunnel can be accomplished safely for the patient with CRPS I, then nerPainful dorsal column input can arise from injured joint afferents caused by wrist or ankle sprain/dislocation, arthroscopy, or total joint replacement. This source of pain can be determined by nerve block of the appropriate nerve(s). If the nerve block reduces the pain level by ≥ 5 on the Visual Analog Scale, partial joint denervation should be considered. For the wrist, partial denervation can be achieved by resecting the anterior and the posterior interosseous nerves.,26 For tPainful dorsal column input can arise from neuromas of cutaneous nerves, which can also be determined by nerve block of the appropriate nerve, taking care not to place the anesthetic where two nerves will be blocked simultaneously. If the nerve block reduces the pain level by ≥ 5 on the Visual Analog Scale, resection of the nerve(s) should be considered with implantation of the proximal end into a muscle with minimal excursion.Patients with "RSD" of the Knee -5 shouldThe group of patients with a poor result from this surgical approach, and those in the initial cohort identified by our computer search who were not selected for this peripheral nerve surgical approach, may be concluded to have CRPS I. It is possible that those in our failure group have a fixed central nervous system site for their pain generator, making them unresponsive to peripheral nerve surgery, even if they obtained some relief from a peripheral nerve block.While there is no doubt that patients with CRPS have impairment in their daily life, documenting this degree of disability is difficult. One approach is to use validated "instruments", or questionnaires to do this. A limitation of the present study is that it did not use a validated outcome instrument to measure the patients before and after their surgical treatment. The outcomes used to assess the results of the surgical interventions in this small group of upper and lower extremity patients with CRPS II do suggest that the appropriate surgical intervention can impact each patient's quality of life, and do this with a low risk of increasing their impairment. The results of the present study suggest that it would be appropriate for a prospective study to utilize both a generalized health-related quality of life instrument as well as one uniquely related to upper extremity function and lower extremity function. The first paper to study quality of life issues in patients with CRPS compared the Nottingham Health Profile, the European Quality of Life 5D, and the Sickness Impact Profile 68 to 100 patients with RSD, 33 in the upper and 21 in the lower extremity. RegardleIt is concluded that most patients referred with a diagnosis of CRPS I have continuing pain input from injured joint and/or cutaneous afferents, and/or chronic nerve compression(s), and therefore, similar to a patient with CRPS II, they can be treated successfully with an appropriate peripheral nerve surgical strategy. Using nerve blocks to identify patients whose pain is from a peripheral nerve source is critical to decision making with regard to which nerve(s) should be resected.ALD has a proprietary interest in the Pressure-Specified Sensory Device™ and owns Sensory Management Services, LLC.ALD originated the concept of the study, and the surgical procedures, wrote the first and final drafts of the manuscript. EA did the chart data review and analysis, and edited the Manuscript. GDR participated in the surgery, helped conceive the research design and IRB approval, reviewed the data and the manuscript.


Acupuncture is often used to treat fibromyalgia (FM), but it remains unclear whether acupuncture is effective. This study aims to evaluate the effects of acupuncture on pain and quality of life (QoL) in FM patients.n = 8) received five acupuncture treatments after the fifth week and group B received ten acupuncture treatments. Outcome measures used in this study were pain intensity  and the fibromyalgia impact questionnaire (FIQ).Sixteen patients (13 women and 3 men aged 25-63 years) suffering from FM were randomised into two groups: group A  in group B decreased and QoL  improved compared to group A.After the fifth week, pain intensity (The present study suggests that acupuncture treatment is effective to relieve pain for FM patients in terms of QoL and FIQ. Fibromyalgia (FM) is a condition of unknown cause; it is characterized by widespread musculoskeltal pain with symptoms including stiffness, fatigue, sleep disturbance and functional impairment ,2. AccorParticipants in the present study were 16 patients who were diagnosed with FM by specialists in respective hospitals and visited Acupuncture and Moxibustion Center, Meiji University of Integrative Medicine , seeking ways in relieving symptoms. Inclusion criteria were: (1) having met the American College of Rheumatology criteria for the diagnosis of FM for at least one year; (2) widespread pain for six months or more; (3) normal neurological examination findings of nerve function, including deep tendon reflexes, voluntary muscle action and sensory function; and (4) failure to respond to medications prescribed by FM specialists. Exclusion criteria were: (1) sufficient knowledge of acupuncture which may prevent blinding (e.g. having received acupuncture previously); (2) known bleeding diathesis; (3) having autoimmune or inflammatory diseases; (4) participation in other clinical trials; (5) pregnancy or lactation; or (6) receiving disability payments or involved in litigation related to FM. However, patients receiving FM medications were included if there had been no change in their medications for one month or longer prior to recruitment.Patients having signed a written informed consent were recruited and randomly assigned with a computerised randomisation program  to either group A where patients received acupuncture treatment followed by a control period or group B where they received continuous acupuncture. This study was approved by the Ethics Committee of Meiji University of Integrative Medicine.The two groups received a total of five (group A) or ten (group B) acupuncture treatments once a week. Each session lasted for 30 minutes. Group A (control) received a total of five acupuncture treatments after the control period of five weeks. Patients in group A received clinical examinations once or twice a week for over five weeks by a FM specialist prior to the intervention period whereas those in group B received a total of 10 acupuncture treatments . The current was rectangular with a biphasic top and a frequency of 4 Hz. Intensity of the current was set between the perception and pain thresholds inducing a visible muscular contraction. Disposable stainless steel needles  were inserted into the skin over the point to a depth of 5-20 mm. Depth of insertion was determined according to the patient's needling sensation of the specific site. Both sides of four common acupuncture points were used for patients receiving electroacupuncture.Up to ten additional sites were chosen according to the patient's symptoms and pain pattern as well as the empirical choice of trigger point in pain treatment. Disposable stainless steel needle  was inserted into the skin over the trigger point to a depth of 10-20 mm, appropriate to the muscle  and pain disability measured with the fibromyalgia impact questionnaire (FIQ)  on physiThe VAS and FIQ measures were completed by the patients immediately before each treatment and analysed immediately before the first treatment (pre), five and ten weeks after the first treatment.P value was less than 0.05. The success of blinding was analysed by Fisher's exact test. Statistical package SYSTAT 12  was used to perform all the statistical analyses in this study.Outcome measures are reported as medians and inter-quartile ranges. Mann-Whitney U test was used to analyse differences between groups at each time period. A difference was considered statistically significant when the Sixteen participants (13 women and 3 men aged 25-63 years) were randomised . Analyses were performed on the 13 patients who did complete the study.Two patients in group A and one patient in group B dropped out due to a lack of response to treatments. The dropout rates were not significantly different between the groups , whereas there was no significant difference between the groups at baseline  and at the tenth week  , whereas there was no difference between the groups at baseline  and at the tenth week   groups five weeks after the first treatment. Moreover, the additionally performed acupuncture treatment after the fifth week in the control group resulted in the further reduction of the FM symptoms. These results suggest that acupuncture treatment is capable of giving additional improvement to the standard medication in the treatment of FM.The importance of randomised controlled trials (RCT) to study the placebo effect of acupuncture was debated ,26. Acupet al. reported that addition of acupuncture to usual treatment for FM was beneficial for pain and QoL [Moreover, most studies on the efficacy of acupuncture to treat FM were uncontrolled case series with electroacupuncture treatment ,11. As e and QoL . Our stuThe present study suggests that acupuncture treatment is effective to relieve pain for FM patients in terms of QoL and FIQ. Further larger scale clinical trials are warranted to confirm the findings of this study.RCT: randomised clinical trial; FM: Fibromyalgia; QoL: Quality of Life; VAS: visual analogue scale; FIQ: Fibromyalgia Impact Questionnaire; CAM: Complementary and alternative medicine; ACR: American College of Rheumatology; TENS: transcutaneous electrical nerve stimulationThe authors declare that they have no competing interests.KI designed the clinical study, acupuncture and wrote the manuscript. HK designed and performed the statistical data analyses. Both authors read and approved the final version of the manuscript.