Background and purpose Chronic hip dislocation in non-ambulatory individuals with cerebral palsy (CP) can lead to severe problems, of which pain is often the most severe. We studied the outcome of proximal femoral resection, especially regarding pain, sitting balance, perineal care, and patient satisfaction.Patients and methods During the period 1998–2005, we operated 20 non-ambulatory patients with spastic quadriplegic CP . 13 patients had unilateral dislocation and 7 had bilateral. The mean age at operation was 15 (3–27) years. The indications for operation were chronic hip dislocation plus severe problems with pain (17 patients), perineal care (16), and sitting (10). Patients were followed from 1 to 6 years.Results 14 patients were satisfied with the surgery, 3 were dissatisfied, 2 were uncertain, and 1 patient had died 5 days postoperatively. Of the 15 patients who had suffered from considerable pain before surgery, 8 had complete relief from pain and 7 patients experienced improvement. Of the 2 patients who had had mild pain, 1 was unchanged and 1 patient deteriorated. All patients who had not been able to sit were able to sit after the surgery. Only 1 patient had difficulties with perineal hygiene at follow-up. Postoperative complications included deep vein thrombosis (1 patient) and edema, loss of appetite, and the need for gastrostomy (1 patient). 7 patients had prolonged pain for up to 6 months after surgery. 1 of these was reoperated because of persistent pain due to a bony-spike heterotopic ossification.Interpretation Most patients with chronic hip dislocation and severe pain or other major problems appear to benefit from proximal femoral resection. Pain, sitting ability, and perineal care improved and most patients and caregivers were satisfied. Hip dislocation is not uncommon in patients with cerebral palsy, especially in the most severely retarded and non-ambulatory individuals. Hip dislocation can lead to several problems, of which pain is the most severe. The incidence of pain varies between 25% and 55% . SittingDuring the past decade, we have been performing proximal femoral resection interposition arthroplasty (PFRIA) as a salvage procedure in non-ambulatory CP patients with persistent pain, chronic hip dislocation, and markedly reduced function and mobility . We haveDuring 1998–2005, we operated 20 non-ambulatory patients  with spastic quadriplegic CP and chronic hip dislocation with severe problems. The mean age at operation was 15 (3–27) years. The medical charts were reviewed. Criteria for operation were dislocation of the hip that had lasted for more than 2 years and severe problems such as pain, sitting problems, and difficulties with perineal care . Most of13 patients were affected unilaterally and 7 were affected bilaterally. Preoperative anteroposterior radiographs were used to measure the migration percentage (MP), which is the lateral migration of the femoral head . If the The surgical technique was in accordance with Because most patients were severely impaired mentally and functionally, regular follow-up controls could not be performed. A telephone questionnaire was used to provide the necessary clinical information during follow-up. The informants were the patient in 2 cases and the primary caregivers in the remaining 18 (parents in 16 cases and a nurse who knew the patient well in 2). They were asked about the degree of pain: no, mild, or severe pain. Other questions included whether the patient could sit without problems in a wheel-chair and whether they had problems with perineal care. We asked if they were satisfied with the operation, using the alternatives “very satisfied”, “satisfied”, “dissatisfied”, or “uncertain”.An anteroposterior radiograph was taken on the day after surgery, and compared with those taken preoperatively and at the most recent follow-up examination at the hospital—to assess proximal femoral migration, which was related to the horizontal tangent of the most distal point of the os ischii on the same side . Pelvic obliquity was measured as the angle between the horizontal line and a line drawn through the most distal points of the left and right os ischii.Heterotopic bone formation was graded according to One patient died 4 days postoperatively, presumably from gastric ulcer with complications, and 1 patient died 3 months postoperatively from unknown causes. The follow-up time for clinical information in the remaining 18 patients was 47 (12–73) months. During the follow-up period 3 patients died, one 19 months postoperatively of unknown causes, one of pneumonia 6 years postoperatively, and one died of respiratory insufficiency 11 days after reoperation for pain from an ectopic bone spike.Preoperatively, 17 patients had experienced severe pain, 2 had had mild pain, and 1 patient had had no pain. Pain status improved in most of the patients with a follow-up of more than 1 year. Of the 15 patients who had suffered from severe pain, 8 experienced complete relief and 7 experienced improvement. Of the 2 patients who had had mild pain, 1 did not experience any change and 1 experienced deterioration , no. 1. Of the patients with survival of more than 1 year, 8 had had difficulties in sitting before surgery and all of them improved and were able to sit with support at follow-up. Preoperatively, 16 patients had had problems with perineal hygiene. At the time of follow-up, only 1 of these patients had such difficulties.Complications included prolonged pain lasting more than 3 months and up to 6 months postoperatively in 7 patients, one of which (a girl) was reoperated with resection of the bone spike causing complaints, but she died 11 days after surgery. Of the remaining patients, 4 were free of pain and 2 had mild pain at the latest follow-up. Other complications were deep vein thrombosis (1 patient) and edema, loss of appetite, and need of gastrostomy (1 patient). No patients had wound infections postoperatively.14 patients were satisfied (8 very satisfied) with the surgery, 3 were dissatisfied, 2 were uncertain, and 1 patient died 5 days postoperatively . 1 of thThe radiographic follow-up was not complete because the 1-day postoperative radiograph was lacking for 2 patients, and in 4 patients later radiographs had not been taken. In the remaining 14 patients, the last pelvic radiograph was taken during a follow-up period of 16 (1–49) months. The proximal femoral migration from preoperatively to the first postoperative day was mean 2.1 cm and the migration was significantly greater in patients with plaster postoperatively . The meaVarying amounts of heterotopic ossification developed in all the hips: type 1 in 3, type 2 in 6, and type 3 in 12 hips. The mean pelvic obliquity was 11 (0–33)° before surgery and 6.4 (0–15)° at follow-up (p = 0.1). There was no significant relationship between proximal femoral migration and grade of patient satisfaction (p = 0.2).In order to avoid hip dislocation, a screening program and early intervention appears to be effective . ProphylChronic dislocation of the hips in non-ambulatory individuals is not in itself an indication for surgery. However, dislocated hips tend to cause increasing problems because of stiffness and joint contractures. The most common complaints—as confirmed in our study—are pain, reduced sitting tolerance, and difficult perineal hygiene .There are very few good treatment options for the non-ambulatory patient with chronic hip dislocation and severe clinical problems. Arthrodesis would not be indicated because this requires being affected unilaterally, weight-bearing function, and no spine involvement . Total hThe remaining surgical option is femoral resection with soft tissue interposition. Our results confirm the experience from previous studies that this is a fairly reliable procedure in severely spastic non-ambulatory patients with symptomatic hip dislocation . AccordiPain was considerably reduced at the time of follow-up, which is in accordance with the results of All patients with sitting difficulties were able to sit at the time of the latest follow-up, confirming the results of previous studies that femoral resection provides a marked improvement in sitting ability . WidmannOne disadvantage of proximal femoral resection interposition arthroplasty is the relatively long hospital stay because of skeletal or skin traction, in order to avoid proximal migration of the femoral stump. From the first postoperative radiograph to the last follow-up, Postoperative skeletal traction was used by Heterotopic bone formation occurred in all the operated hips. The clinical consequence of ossification is unclear, because most our patients had no complaints from heterotopic bone, which confirms the experience of 14 of 19 patients or caregivers were satisfied with the surgery. This result is in accordance with the work of


Nonsteroidal anti-inflammatory drugs are recommended for the relief of pain associated with hand osteoarthritis (OA) but do not alter the underlying structural changes that contribute to impaired physical function. The current analysis examined the relationship of pain relief with measures of function and global rating of disease in patients with hand OA.This was a combined analysis of 2 prospective, randomized, double-blind, 8-week, multicenter, parallel-group studies comparing diclofenac sodium 1% gel with placebo gel (vehicle) in patients with radiographically confirmed mild to moderate hand OA. Patients (n = 783) aged ≥ 40 years applied diclofenac sodium 1% gel (2 g) or vehicle to each hand 4 times daily for 8 weeks. Outcome measures included pain intensity assessed on a 100-mm Visual Analog Scale (VAS); the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) subscales for pain, stiffness, and physical function (100-mm VAS); and a global rating of disease (100-mm VAS). Change in VAS pain intensity from baseline to week 8 was categorized  without regard to treatment and compared in each category with the mean change from baseline in each AUSCAN subindex and the global rating of disease. Pearson correlations between changes in outcome measures from baseline to week 8 were calculated.P < 0.001) between change in VAS pain intensity and changes in AUSCAN pain (correlation coefficient [r] = 0.81), AUSCAN function (r = 0.75), AUSCAN stiffness (r = 0.66), and global rating of disease (r = 0.76).Changes in VAS pain intensity were accompanied by similar changes in AUSCAN scores and global rating of disease. Pearson correlations confirmed significant associations (Pain relief correlated with improvements in physical function, stiffness, and global rating of disease in patients with hand OA, irrespective of treatment. This suggests that pain or anticipation of pain inhibits physical function and influences patient perception of disease severity in hand OA. These results also suggest that any intervention to relieve the pain of hand OA may improve function and patient perception of disease severity, despite the absence of a disease-modifying mechanism of action.Clinicaltrials.gov NCT00171652, NCT00171665. Hand osteoarthritis (OA) has an estimated prevalence of 20% to 30% ,2, makinFunction is irreversibly compromised in OA of the hand as articular surfaces are eroded and deformed. In OA of the knee and hip, a definitive improvement in function can be obtained with surgical replacement of the joint, but prosthetic joints have been less successful for hand OA . More ofNonsteroidal anti-inflammatory drugs (NSAIDs) are recommended for the management of pain in patients with hand OA who do not respond to physical measures and acetaminophen . Though Treatment guidelines recommend topical NSAIDs as effective monotherapy for relief of OA pain in superficial joints, such as those in the hands , with thNSAIDs relieve OA pain but are not believed to alter the underlying changes that produce biomechanical limitations of physical function in OA. However, other interventions that provide symptomatic relief without altering underlying structural changes, such as opioids, have been associated with improvement of physical function in OA of the knee and hip . This fiThis was an analysis of pooled data from two similar 8-week, randomized, double-blind, parallel-group, multicenter trials comparing diclofenac sodium 1% gel with vehicle gel in patients with mild to moderate hand OA. Efficacy and safety results for one of these studies have been presented elsewhere . EthicalPatients included men and women at least 40 years old who had a diagnosis of primary hand OA by American College of Rheumatology criteria , with syMain exclusion criteria were secondary post-traumatic OA, history or evidence (or both) of any other rheumatic disease involving the potential target hand or the arm, symptomatic OA at additional locations besides the hand(s) requiring any symptomatic or disease-modifying drug, adult juvenile chronic arthritis , history of rheumatoid arthritis or laboratory values indicative of rheumatoid arthritis, history of other inflammatory diseases (such as colitis) within the previous year, or a history of fibromyalgia within the previous year.® Gel; Endo Pharmaceuticals Inc., Chadds Ford, PA, USA) or vehicle. To that end, randomization numbers were allocated to centers in blocks to balance treatment allocation within each center.After screening, patients meeting inclusion criteria washed out previous analgesics for 1 week or at least five half-lives of the previous analgesic, whichever was longer. After washout, patients were randomly assigned (1:1 ratio) in a double-blind fashion to treatment with diclofenac sodium 1% gel (VoltarenPatients were assigned to receive 4 g diclofenac sodium 1% gel (2 g to each hand) or vehicle gel four times daily for 8 weeks. Diclofenac sodium 1% gel contains diclofenac sodium and its vehicle, which consists of isopropyl alcohol, propylene glycol, cocoyl caprylocaprate, mineral oil, ammonia solution, perfume cream 45/3, carbomer homopolymer type C, polyoxyl 20 cetostearyl ether, and purified water. Vehicle gel was identical to diclofenac sodium 1% gel in composition but did not include the active ingredient, diclofenac sodium. The two gels were identical in feel, appearance, and smell. Treatments were dispensed in kits containing six 50-g tubes of study medication (diclofenac sodium gel or vehicle) for a 2-week supply. Use of acetaminophen rescue medication was allowed up to a maximum daily dose of 4 g. However, rescue medication was not allowed within 36 hours of assessments. Disease-modifying drugs, muscle relaxants, additional analgesics, and alternative therapies  were not allowed.Measures of pain intensity were compared with measures of physical function and patient global rating of disease in all patients. Pain intensity in the dominant hand was assessed on a 100-mm VAS . Pain, stiffness, and function were also assessed using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN), a 15-item tool that focuses on the functional status of the dominant hand. Each AUSCAN item was assessed on a 100-mm VAS. Total AUSCAN scores were calculated for pain (questions 1 to 5), stiffness (question 6), and function (questions 7 to 15) as averages over the individual questions. A global rating of disease was assessed on a 100-mm VAS . For this assessment, patients responded to the following item: 'Considering all the ways osteoarthritis of your hands affects you, please indicate with an 'X' through the horizontal line how well are you doing'.The purpose of the present analysis was to determine whether changes in pain were accompanied by similar changes in function rather than to compare diclofenac sodium 1% gel with placebo. To that end, data on all patients who received at least one dose of study medication were pooled without regard to whether they were assigned diclofenac sodium 1% gel or placebo. Improvement in VAS pain intensity from baseline to week 8 was categorized according to percentage change  without regard to randomized treatment. Within each VAS pain intensity improvement category, AUSCAN pain, AUSCAN stiffness, and AUSCAN function subindices and global rating of disease were summarized by mean change from baseline to week 8. Mean percentage change from baseline to week 8 was computed by category as the mean change from baseline divided by the mean baseline value. The associations between change from baseline for VAS pain intensity and changes from baseline for the three AUSCAN subindices and the global rating of disease were also summarized as Pearson correlations. Postbaseline assessments were conducted at weeks 1, 2, 4, 6, and 8. For patients who terminated prematurely, the final available assessment was used instead of the week 8 assessment.Of 1,252 patients screened, 783 were randomly assigned to receive diclofenac sodium 1% gel (n = 400) or vehicle (n = 383)  with AUSCAN pain (correlation coefficient [r] = 0.81), AUSCAN function (r = 0.75), AUSCAN stiffness (r = 0.66), and global rating of disease (r = 0.76).Pearson correlations confirmed the association between change in VAS pain intensity and changes in AUSCAN scores and global rating of disease Table . Change In this analysis, we found that improvements in pain in patients treated with diclofenac sodium 1% gel or vehicle for symptomatic hand OA were accompanied by similar improvements in measures of functional status and patients' overall rating of OA disease status. Our study population included patients with mild to moderate hand OA (Kellgren-Lawrence grades 1 to 3), most of whom had structural changes that typically contribute to functional impairment in OA. Mean VAS pain intensity was moderate to severe.The similarity of mean changes in pain and functional impairment scores that we observed across Kellgren-Lawrence severity grades 1, 2, and 3 is consistent with research showing that radiographic findings in hand OA are only modestly associated with reports of pain and weakly associated with functional disability . The strImpairment of joint function in patients with hand OA is of great concern because of its impact on many activities of daily living and almost every type of employment. Unfortunately, effective disease-modifying interventions to slow or reverse the structural changes that impair function in hand OA have not yet been found. Modest results have been obtained in some studies of chondroitin sulfate -26 and dThe observed correlation in our analysis between reductions in pain and improvements in function suggests that some functional restriction associated with hand OA stems from patients voluntarily or involuntarily restricting activity because of perceived or anticipated pain and not solely from the biomechanical limitations of affected joints. Neither diclofenac sodium 1% gel nor its vehicle is believed to influence structural changes in hand OA or provide any disease-modifying benefit. This implies that the observed improvements in functional outcomes and health status occurred in the absence of structural improvement.The results of this analysis are consistent with a previous study that showed an association between pain and both functional and overall health status in patients with hand OA  and OA oOur results are also consistent with two trials assessing patients with OA of the knee or hip. In a 12-week placebo-controlled trial of the long-acting opioid tramadol extended release , reductiOur analysis differed from the study of tramadol in that we assessed pain and function in hand OA and evaluated health status using a global rating of disease instead of the SF-36. SF-36 is a broad rating of overall health status, whereas the global rating of disease specifically asks patients to rate the impact of OA on their daily lives. Thus, our results establish a link between pain, physical function, and patients' sense of how well they are coping with hand OA.Current guidelines for the management of hand OA do not recommend opioids but do suggest that studies be conducted to assess and compare the efficacy of acetaminophen, weak opioids (such as tramadol), and oral NSAIDs in this population . Accordipost hoc analysis, the results should be considered exploratory. The validity of the results would be strengthened if similar correlations could be found in other studies employing a variety of designs, especially those with alternative measures of pain and function, conducted for other purposes.A limitation of our study is that it was only 8 weeks. Hand OA is a chronic disease that may require treatment over several decades. Long-term trials would be necessary to determine whether the association between analgesia and functional improvement is maintained over time. Another limitation of our study is that we have not considered possible variations in response between subpopulations with different affected hand joints . Finally, because this was a Improvements in the pain of hand OA were associated with substantial improvements in physical function, stiffness, and overall rating of OA disease status, without regard to active versus placebo treatment. Diclofenac sodium 1% gel is indicated for relief of OA pain in joints amenable to topical treatment, such as the hands and knees. The placebo gel has no therapeutic indication. This suggests that pain or anticipation of pain inhibits physical function and influences patient perception of disease severity in hand OA. These results also suggest that any intervention to relieve the pain of hand OA may improve function and patient perception of disease severity, despite the absence of a disease-modifying mechanism of action.r: correlation coefficient; SD: standard deviation; SF-36: Short Form-36 Health Survey; VAS: Visual Analog Scale.AUSCAN: Australian/Canadian Osteoarthritis Hand Index; NSAID: nonsteroidal anti-inflammatory drug; OA: osteoarthritis; HRB and JHP declare that they have no competing interests. MBC is a full-time employee of Endo Pharmaceuticals Inc. MSG is a full-time employee of Novartis Consumer Health, Inc. . RDA has received research grants from Novartis Consumer Health, Inc. and Ferring Pharmaceuticals, Inc.  and consulting fees from Novartis Consumer Health, Inc., Ferring Pharmaceuticals, Inc., and Rottapharm  and has participated in speakers' bureaus for Ferring Pharmaceuticals, Inc. and Forest Laboratories, Inc. .post hoc analysis. MSG contributed to the conception and design of this post hoc analysis and provided statistical expertise. MBC contributed to the conception and design of this post hoc analysis and obtained funding. HRB and JHP helped to provide some of the study subjects for the original randomized clinical trials used in this post hoc analysis. All authors contributed to the analysis and interpretation of the data, drafting of the article, critical revision of the article for important intellectual content, and final approval of the article. All authors read and approved the final manuscript.RDA contributed to the conception and design of the original randomized clinical trials and helped to provide some of the study subjects for the original randomized clinical trials used in this


P<0.001). According to PMI, 616 out of 752 patients reporting pain (82%) received inadequate analgesic treatment. Bone metastases were associated with improved adequacy and worst pain with reduced adequacy at multivariate analysis. In conclusion, pain is common in patients with advanced NSCLC, significantly affects QoL, and is frequently undertreated. We recommend that: (i) pain self-assessment should be part of oncological clinical practice; (ii) pain control should be a primary goal in clinical practice and in clinical trials; (iii) physicians should receive more training in pain management; (iv) analgesic treatment deserves greater attention in protocols of anticancer treatment.Pain is a highly distressing symptom for patients with advanced cancer. WHO analgesic ladder is widely accepted as a guideline for its treatment. Our aim was to describe pain prevalence among patients diagnosed with advanced non-small-cell lung cancer (NSCLC), impact of pain on quality of life (QoL) and adequacy of pain management. Data of 1021 Italian patients enrolled in three randomised trials of chemotherapy for NSCLC were pooled. QoL was assessed by EORTC QLQ-C30 and LC-13. Analgesic consumption during the 3 weeks following QoL assessment was recorded. Adequacy of pain management was evaluated by the Pain Management Index (PMI). Some pain was reported by 74% of patients ; 50% stated pain was affecting daily activities . Bone metastases strongly affected presence of pain. Mean global QoL linearly decreased from 64.9 to 36.4 from patients without pain to those with severe pain ( Pain is a common symptom experienced by cancer patients . Pain prLung cancer is the first cause of cancer death  and it iDisease symptoms can have a great impact on functional status and quality of life (QoL). Pain is without any doubt among the most distressing symptoms experienced by cancer patients. A recent study of patients with chronic nonmalignant pain reported significant correlations between severity of pain and QoL , the impact of pain on health-related QoL and the adequacy of pharmacologic management of pain.All patients with advanced NSCLC enrolled in three multicentre randomised clinical trials of first-line chemotherapy performed by our cooperative group between 1996 and 2001  were eli−2 on days 1 and 8 every 3 weeks, for six cycles. The primary end point of the trial was health-related QoL. Recruitment started in April 1996 and overall 191 patients were randomised until November 1997.In the ELVIS study  vinorelbine was compared with supportive care alone in patients ⩾70 years . Vinorelvs the two single drugs (−2), gemcitabine alone (1200 mg m−2), or combination of vinorelbine (25 mg m−2) plus gemcitabine (1000 mg m−2). All treatments were delivered on days 1 and 8 every 3 weeks for six cycles. The primary end point was overall survival; 707 patients were randomised between December 1997 and November 2000.The MILES study  was conducted in the same age group of the ELVIS trial, and compared the combination of vinorelbine and gemcitabine −2, days 1 and 8) plus gemcitabine  or cisplatin-based chemotherapy: cisplatin  plus either gemcitabine  or vinorelbine  for six cycles of 21 days (The GEMVIN study was conducted with adult (<70 years) patients, randomly assigned either combination of vinorelbine (25 mg mThe European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (QLQ-C30) and the lung-cancer-specific module (QLQ-LC13), evaluating specific symptoms of lung cancer, were used to evaluate QoL (During the past week have you had pain?) and item 19 (During the past week did pain interfere with your daily activities?). Further three items addressing pain during the last week are present in the QLQ-LC13: item 10 (Have you had pain in your chest?), item 11 (Have you had pain in your arm or shoulder?) and item 12 (Have you had pain in other parts of your body). All these items are scored in four categories : in this paper, these categories have been renamed as no pain, mild, moderate and severe pain, respectively. In the present analysis, in order to describe the relationship between pain and QoL and to evaluate the adequacy of analgesic treatment, the worst pain reported by each patient at baseline assessment  has been considered.Pain is assessed by two items in the QLQ-C30: item 9  and item 30  of QLQ-C30. Both items are scored 1 (Very poor) to 7 (Excellent). Functional scales assessed by the QLQ-C30 are physical functioning (items 1–5), role functioning (items 6 and 7), emotional functioning (item 21–24), cognitive functioning (items 20 and 25) and social functioning (items 26 and 27). According to the Manual of the EORTC QoL Study Group ; (2) a weak opioid for mild to moderate pain (e.g. tramadol or codeine); and (3) a strong opioid for moderate-to-severe pain (e.g. morphine or fentanyl).In all the three trials, study protocols recommended that analgesic treatment should have been prescribed on an c ladder  was recoThe three trials had the same Case Report Form for data collection on supportive drugs. Data were collected from the starting date of chemotherapy until interruption, for up to seven drugs in each cycle of chemotherapy (corresponding to a theoretic 21-days period), with the daily dose and the number of days of assumption recorded. The CRF had to be filled in by the Investigator after each cycle, so the data refer to the actual assumption by the patient, and not to the intended prescription.Analgesic drugs assumed by patients have been coded according to the Anatomical Therapeutic Chemical (ATC) classification system  were considered. Analysis has been limited to 21 days in order to evaluate the adequacy of analgesic treatment in relation to pain assessed at baseline. According to the WHO guidelines, management of cancer pain is considered adequate when there is consistency between the level of pain reported by the patient and the potency of the analgesic drug prescribed.The Pain Management Index (PMI)  to +3 (a patient receiving a strong opioid and reporting no pain). Negative scores are considered to indicate inadequate analgesic treatment, and scores of 0 or higher are considered to be a conservative indicator of acceptable treatment.2 test.Patients studied had been enrolled in three different randomised clinical trials (RCT), two addressed to older people (⩾70 years) and one limited to adult patients (<70 years). To counteract differences in pain assessment and baseline covariates that could eventually occur among the three trials, all analyses were adjusted by stratifying by RCT. A preliminary comparison of baseline covariates was assessed by χ©, CYTEL software Corp. 2002); differences of worst reported pain among RCTs were assessed by Kruskal–Wallis nonparametric ANOVA.Stratified Wilcoxon rank-sum test was used to investigate relationship between the worst pain reported and baseline characteristics , stage (IV vs IIIB), bone metastases (yes vs no) and worst pain as a continuous variable. In this model, age could not be evaluated because it was completely confounded by stratification. To investigate the role of age a further logistic model not stratified by RCT was fitted, where age (⩾70 vs <70) was added to all the previous covariates.Association between adequacy of pain management and baseline covariates was assessed by Mantel–Haenszel test stratified by RCT. Factors affecting adequate pain management were finally evaluated by a stratified logistic regression model; the explanatory variables of the model, defined ‘Overall, 1312 patients had been enrolled in the three studies. Of these, 291 patients (22.2%) were excluded from this analysis: 164 patients (12.5%) for missing baseline QoL questionnaire, 70 (5.3%) for missing data about supportive drugs and 57 (4.3%) for missing both sets of information. Thus, a database of 1021 cases was used for all the analyses , in patients with worse performance status (45 vs 28%), in patients with metastatic disease (35 vs 22%) and in those with bone metastases (53 vs 25%). No significant association was evident between pain and gender.Overall, pain was reported by 752 patients ; it was mild in 42%, moderate in 24% and severe in 7% (Table 2P<0.001). Mean scores of the functioning scales  also linearly decreased with increasing pain severity.As shown in Table 4Analgesic medications assumed by the patients during the first 3 weeks following the baseline assessment are reported in Table 5Drugs falling in the first step of the WHO analgesic ladder were the most frequently used: 184 out of 256 patients receiving analgesics (72%) and 169 out of 752 patients reporting pain (22%). Patients with moderate or severe pain received an opioid in 18% of cases (a weak opioid in 8% and a strong opioid in 9%). Strong opioids, mostly orally administered slow-release morphine , were assumed by 4.4% of patients reporting pain (33 out of 752), in particular by 1, 8 and 12% of patients reporting mild, moderate and severe pain, respectively.vs 14%, P=0.02). Adequate pain treatment was more frequent in patients with bone metastases than in those without . No significant association with adequacy of pain treatment was evident for gender, performance status and stage of disease. At binary logistic regression, stratified by clinical trial, the presence of bone metastases  and worst reported pain  were independent predictors of the adequacy of the analgesic treatment (Table 8P=0.05).In all, 82% of patients (616 out of 752 with any pain) had negative scores of the Pain Management Index, indicating inadequate analgesia . The inaTable 7This study provides a description of the occurrence and the severity of pain in a large series of patients with advanced NSCLC. In addition, it provides two major findings, that is, a close relationship between pain and QoL indicators and a clear evidence of inadequate analgesic treatment in a large proportion of the patients.Knowledge of the prevalence of pain at diagnosis in patients affected with advanced cancers, for whom palliation is frequently the primary goal of treatment, may help planning organisation of therapeutic units and strategy of clinical research could be better planned if reasonable estimates of the major patients' needs were available. To the best of our knowledge this is the largest series of patients with advanced NSCLC in which prevalence of pain at diagnosis is described. This was possible by pooling the data of three prospective randomised clinical trials of chemotherapy, performed by the same cooperative group and coordinated by the same centre . All theAn important finding of the present study is that pain has a strong impact on the QoL of cancer patients. In most functioning scales, indeed, a clinically relevant change of 6–10 points , and gloBased on such considerations, one could argue that adequate pain relief could significantly improve overall QoL. Even, the improvement of QoL provided by adequate analgesic treatment could probably exceed that attributable to the most effective anticancer treatments, particularly for a disease, like advanced NSCLC, not highly sensitive to specific treatments. Unfortunately, in the present study, we found that more than 80% of patients suffering some degree of pain received inadequate analgesic medications, based on WHO ladder strategy for pain management and the definition of adequacy proposed by Several factors can produce undertreatment of pain. On the patient's side, reluctance to report pain (e.g. because of concerns about distracting physicians from treatment of underlying disease or fear that pain means worse disease) has been considered . FurtherA final note should be done as for age of patients, because older age has been indicated as a risk factor for pain undertreatment  tools for self-assessment of pain should be used in clinical practice management of patients with advanced cancer, to reduce underestimation of the symptom; (ii) pain should be clearly identified as preminent within more generic QoL definition and pain control should be directly addressed as a primary goal of treatment both in clinical practice and in clinical trials; (iii) training of physicians in the correct management of pain should be encouraged at all levels, to improve the appropriate use of analgesic drugs; (iv) great attention has to be paid to analgesic treatment in protocols of anticancer treatment, to avoid frustrating possible specific effects because of inadequate supportive care.


Joint, spinal and soft tissue injections are commonly performed by rheumatologists in their daily practice. Contrary to other procedures, e.g. performed in pediatric care, little is known about the frequency, the intensity and the management of procedural pain observed in osteo-articular injections in daily practice.This observational, prospective, national study was carried out among a French national representative database of primary rheumatologists to evaluate the prevalence and intensity of pain caused by intra-and peri-articular injections, synovial fluid aspirations, soft tissue injections, and spinal injections. For each physician, data were collected over 1 month, for up to 40 consecutive patients (>18-years-old) for whom a synovial fluid aspiration, an intra or peri-articular injection or a spinal injection were carried out during consultations. Statistical analysis was carried out in order to compare patients who had suffered from pain whilst undergoing the procedure to those who had not. Explanatory analyses were conducted by stepwise logistic regression with the characteristics of the patients to explain the existence of pain.Data were analysed for 8446 patients  recruited by 240 physicians. The predominant sites injected were the knee (45.5%) and spine (19.1%). Over 80% of patients experienced procedural pain which was most common in the small joints (42%) and spine (32%) Pain was severe in 5.3% of patients, moderate in 26.6%, mild in 49.8%, and absent in 18.3%. Pain was significantly more intense in patients with severe pain linked to their underlying pathology and for procedures performed in small joints.Preventative or post-procedure analgesia was rarely given, only to 5.7% and 36.3% of patients, respectively. Preventative analgesia was more frequently prescribed in patients with more severe procedural pain.Most patients undergoing intra-or peri-articular injections, synovial fluid aspirations and spine injections suffer from procedural pain. Most patients experience usually mild procedural pain and procedural pain management is uncommonly provided by physicians. Specific research and guidelines for the management of procedural pain related to rheumatologic care should be established to improve the quality of care provided by physicians. Patients undergoing physical examination, diagnostic and therapeutic interventions are often subject to pain as a result of their medical care. Despite this, nearly two-thirds of patients undergoing potentially painful medical procedures do not receive any form of analgesia . ManagemPain induced by medical procedures i.e. "procedural pain" has largely been studied in paediatric populations ,4 and, wSince invasive procedures such as corticosteroid injections, anaesthetic injections, and dry needling are carried out frequently in rheumatology ,16, it iThis national observational prospective study was set up to evaluate the frequency of puncture and/or infiltration-induced pain in rheumatological practice, and the different preventative and post-procedure therapeutic approaches currently used to manage procedural pain.approval of french national ethical committee (CCTIRS). Each participating rheumatologist was asked to record data for all consecutive adult patients who underwent a diagnostic or therapeutic procedure  at the time of consultation, irrespective of localisation. The observation period extended over 1 month of visits.This was an epidemiological observational, cross-sectional, national study carried out among French rheumatologists between 2006 and 2007, after obtaining Rheumatologists were selected from the French rheumatologist' representative TVF database (source CEGEDIM group). In order to guarantee a high level of respondents, details of the study and a request to participate were sent out to all rheumatologists across France in two mail-shots. This enabled some adjustment in the second mailing according to the level and regionality of the response to the first. The rheumatologists in the first mail-shot were chosen by drawing lots stratified according to administrative region.The experience of each rheumatologist was determined indirectly from their age, assuming that they had started practising professionally when they were 27-years-old. The study was proposed to 1800 French rheumatologists with private practice. After 2 contacts and propositions, 339 rheumatologists accepted to participate. Finally, of these 339 rheumatologists, only 252 rheumatologists have participated actively in the study and have recruited patients. The demographics of these rheumatologists were compared to the global demographics of French rheumatologists and did not demonstrate significant difference, according to age, sex-ratio, number of years of practicing, location.All consecutive adult patients (>18 years of age) suffering from a non-malignant musculoskeletal pathology for which a diagnostic and/or therapeutic procedure  was carried out at the time of consultation were recruited (maximum of 40 patients per rheumatologist). As this was an observational study, the only exclusion criteria were mesotherapy or acupuncture procedures. All patients provided informed consent before procedure.The following data were recorded for each patient: age; sex; underlying pathology for which the procedure was required; previous experience of the patient regarding a similar type of procedure; details of the procedure  performePain intensity was evaluated using verbal scale . The verbal rating scale is a commonly used scale, easier to understand than Visual Analog Scale. It has been validated in many studies and is one of the three most commonly used scale .Patient's pain intensity was assessed immediately before the procedure, considering mean pain intensity during the previous week before procedure. Then, after the procedure, patients had to report to the physician their level of pain induced by the procedure,.The primary objectives of the study were to evaluate: (i) the respective frequency of different articular and peri-articula	r procedures in rheumatological primary practice; (ii) the frequency and intensity of pain linked to these different procedures; (iii) the demographic factors for procedural pain. (iv) the type and frequency of analgesic treatment  administered for procedural pain;Statistical analysis was carried out in order to compare patients who had suffered from pain whilst undergoing the procedure to those who had not. Explanatory analyses were conducted with the characteristics of the patients to explain the existence of pain. When patients had more than one procedure during the visit, each procedure was assessed separately.2-Pearson or Fisher's exact test. The level of significance selected was 0.05.For descriptive data, quantitative variables are presented as number (n), means and standard deviation (SD), and qualitative variables as n and % of available data. For the descriptive and univariate analysis, quantitative variables were analysed using the Wilcoxon or Mann-Whitney test, and qualitative variables were compared using the ChiMultivariate analysis was carried out by stepwise logistic regression with the dependent variable being the presence or absence of pain. Significant factors to the threshold of 20% in univariate analysis were included in multivariate analysis. Entry threshold was set-up at 10% and conservation threshold to 15%.® .Statistical analysis was carried out using SASA total of 240 French rheumatologists took part in this study . 68.1% had exclusive private practice, 31.4% had a mixed hospital/surgery practice and the rest were practicing exclusively in hospital. The rheumatologists each had an average of 22 years experience.Data were analysed for 8446 patients who underwent a puncture, or infiltration, or both, during visit to 240 rheumatologists across France. The mean age of the patients was 62 ± 14 years and the majority were female (64.4%). The demographic characteristics of the patients are summarised in Table In 31.3% of the cases patients had joint osteoarthritis, tendonitis in 18.1%, radiculalgia in 9.1%, back pain in 7.2%, inflammatory rheumatological disorder in 3.8% (mostly rheumatoid arthritis), and a tunnel syndrome in 4.4%. In 66.8% of the cases, patients were prescribed analgesics for the pain related to the underlying pathology.In total, 91.8% of patients underwent only one procedure. The knee was the main site of intervention (45.4%), followed by spine (19.1%), shoulder (15.0%) and small joints (12.0%). The procedure was unilateral in 91.6% of patients, intra-articular in 57.0%.The procedure was carried out for therapeutic purposes in the majority of patients (91.8%), and was diagnostic and therapeutic in 6.8%. Over half of the patients (56.1%) were given a corticosteroid injection, while 26.0% received an injection of hyaluronic acid. In the remaining cases, procedure was a synovial fluid aspiration or combination of aspiration and injections (Table The majority of patients 81.7%) experienced some degree of pain induced by the procedure. Pain was considered to be severe by 5.3% of patients, moderate by 26.6%, and mild by 49.8%. A small proportion of patients (18.3%) experienced no pain  in 41% of cases involving the small joints, 32% involving the head and spine, 30% for the shoulders and 28% for the knees , aim of the procedure (therapeutic vs diagnostic procedure) were not significant factors for the occurrence of procedural pain.From this univariate analysis, fourteen demographic and pain ratings explanatory variables linked to the occurrence of pain during the procedure  were included in the multivariate analysis Table . It demoOn the whole, rheumatologists thought that the majority of their patients had tolerated the procedure very 53.1%) or quite (39.8%) well, and that only 0.7% of patients had suffered badly during the procedure  for their pain. Only 5.7% of patients were given preventative analgesic medication, usually local anaesthesia (34.8%), xylocaïne patches (20.5%), acetaminophen alone  and Step 2 analgesics (11.2%). In most patients this was initiated by the physician (82.6% of cases) rather than at the request of the patient. The mean duration between receiving preventative analgesia and the procedure was 38 ± 74 min. There was no significant difference in the use of preventative analgesia between patients undergoing a single procedure and those undergoing two (p = 0.683).Post-procedure analgesia was given to 36.3% of patients and was initiated by the physician in 94.6% of the cases. The most common analgesics prescribed were step 2 analgesics (weak opioids combined to acetaminophen) (35.8%), non-steroidal anti-inflammatory drugs (NSAIDs) (34.8%) and acetaminophen alone (34.2%).This research highlights a major problem in rheumatology care. Pain caused by injections and aspirations from the joints is a common occurrence for patients, in 81.7% of the cases and may represent a significant medical stressor. The large sample size of our study increases the relevance of the findings and the public health significance of the problem. These results imply that more should be done to manage the pain caused by procedures to relieve suffering and functional impairments in osteo-articular pathological conditions. Procedural pain has been investigated previously in a number of hospital populations ,6-13,22,Our observational study shows that the procedural pain can be moderate to severe in intensity in approximately one-third (31.9%) of patients, particularly if the procedure involves the small joints. Preventative and post-procedural pain management, both by pharmacological and non-pharmacological approaches should be performed specifically in these situations. There is also evidence that pain is more intense in patients with severe pain linked to their underlying pathology, and this also suggests that better pain control of the underlying pathology may decrease the discomfort related to the procedure.Local infiltration therapies including corticosteroid injections are commonly used in the management of musculoskeletal disorders and have been shown to bring about short-term pain relief in a number of conditions including osteoarthritis, inflammatory arthritis, synovitis, tendonitis and bursitis ,24. In tThe results of this study are subject to some limitations. Recruitment bias was overcome by selecting rheumatologists from a national list. Self-selection bias of patients is difficult to determine because the number and characteristics of non-volunteers were not assessed: rheumatologists were invited to include all consecutive patients, within a month, that needed joint procedure. Since this was an observational study, and because we did not want to burden the assessment procedure and the protocol for participating rheumatologists, we did not ask rheumatologists to assess patients who do not accept to participate in the study. Also for practical reasons and to raise the number of physicians and patients involved, we have used the more simple method to assess pain, a categorical verbal rating, that is a validated but a less accurate method than pain Visual Analog Scale (VAS) or pain Numerical Rating Scale (NRS). It is obvious that a pain VAS would have been an improvement. The study highlighted some demographic correlates of pain but it did not include any psychological or behavioral variables, as anxiety or fear of the procedure, that could be interesting data to analyse. Another limitation of our study is that we did not differentiate the devices used by the physicians. Several authors have emphasized the fact that size of the syringe and needle may influence pain and tissue trauma during procedure. Recent findings have also pointed out the usefulness of sonographic-guided injections to improve the quality of care in rheumatological procedures . The lasIt is important to make rheumatologists more aware that patients may find infiltrations and/or joint aspiration painful so that specific analgesic protocols can be implemented. In this study, analgesia was usually initiated by the rheumatologist rather than at the request of the patient. Thus, physicians have a pivotal role to play in the management of pain linked to musculoskeletal disorders and to any interventional procedures performed. Greater prescription of preventative and post-procedural analgesic procedures  should be encouraged in order to improve the quality of care offered by rheumatologists.This study was performed with the support of an independent grant provided by BMS-France pharmaceutical company.SP conceived of the study, participated in its design and drafted the manuscript, FL participated in the design of the protocol and in its writing, CP performed the statistical analysis, NS participated in the design of the protocol and in coordination, CPC participated in the design of the study and in its coordination. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/11/16/prepub


Choledochoduodenostomy (CDD) has been reported as a more effective treatment of CBD stones than T-tube drainage but it is regarded as a last resort or obsolete therapeutic method due to fears of higher mobidity, cholangitis, “sump” syndrome and liver dysfunction. We aimed to assess the aforementioned issues analyzing prospectively our experience from 1976 through Dec.92.Methods: CDD was performed in 89 females and 36 males, aged 60.2±8.7 years, 26 during repeat surgery. Duct stones were the indication in 94, Sphincter of oddi (SO) dysfunction in 23 and obstructive pancreatitis nodule in 8. Peroperative liver biopsies were obtained in 44 patients. The “follow-up” schedule (> 2.5 years in 110) included clinical interview and LFT's on an yearly basis. Ultra sound (USG) was obtained every one or two years. ERC was done in 10 symptomatic patients and in 25 others for protocul purposes. Liverbiopsies were taken four to nine years post surgery in 11 patients-five at relaparotomy for non-biliary causes and six percutaneously by fine needle. Ductal mucosa biopsy could safely be performed in one patient 10 years after surgery. The long-term results were classified as excellent, good, fair or poor. Poor meant the need for further invasive therapy (resurgery or EST).Results: There were two operative deaths (1.6%). The long-term results (123 survivors) were considered excellent in 89, good in 22, fair in 9 and poor in three. Three patients died from unrelated causes and eight others ceased the “follow-up” evaluation three to five years post surgery. All of them were considered as having excellent or good results. A widely patent anastomosis of approximately 20 mms without mucosal inflammatory changes was documented in every patient assessed via ERC. food “debris” was detected within the distal duct of four patients yet it was easily flushed through the stoma. Normal tissue patterns were observed in all long-term liver biopsies. Likewise the ductal mucosa biopsy failed to reveal any acute or chronic inflammatory changes.Conclusions: 1) CDD is ahighly effective short and long-term treatment of CBD lithiasis.2) It does not lead to bacterial or “chemical” cholangitis, to “sump” syndrome or to hepatic dysfunction, provided a wide anastomosis is accomplished.3) CDD should only be considered as obsolete after extensive, long-term, prospective, randomized assessments of laparoscopic or combined laparoendoscopic approaches have been shown to be as effective as or superior to CDD.


Autogenous Iliac Crest Bone Graft (ICBG) has been the "gold standard" for spinal fusion. However, bone graft harvest may lead to complications, such as chronic pain, numbness, and poor cosmesis. The long-term impact of these complications on patient function and well-being has not been established but is critical in determining the value of expensive bone graft substitutes such as recombinant bone morphogenic protein. We thus aimed to investigate the long-term complications of ICBG. Our second aim was to evaluate the psychometric properties of a new measure of ICBG morbidity that would be useful for appropriately gauging spinal surgery outcomes.Prospective study of patients undergoing spinal fusion surgery with autologous ICBG. The SF-36v2, Oswestry Disability Index, and a new 14-item follow-up questionnaire addressing persistent pain, functional limitation, and cosmesis were administered with an 83% response rate. Multiple regression analyses examined the independent effect of ICBG complications on physical and mental health and disability.The study population included 170 patients with a mean age of 51.1 years (SD = 12.2) and balanced gender . Lumbar fusion patients predominated . At 3.5 years mean follow-up, 5% of patients reported being bothered by harvest site scar appearance, 24% reported harvest site numbness, and 13% reported the numbness as bothersome. Harvest site pain resulted in difficulty with household chores (19%), recreational activity (18%), walking (16%), sexual activity (16%), work activity (10%), and irritation from clothing (9%). Multivariate regression analyses revealed that persistent ICBG complications 3.5 years post-surgery were associated with significantly worse disability and showed a trend association with worse physical health, after adjusting for age, workers' compensation status, surgical site pain, and arm or leg pain. There was no association between ICBG complications and mental health in the multivariate model.Chronic ICBG harvest site pain and discomfort is reported by a significant percentage of patients undergoing this procedure more than three years following surgery, and these complications are associated with worse patient-reported disability. Future studies should consider employing a control group that does not include autologous bone graft harvest, e.g., a group utilizing rhBMP, to determine whether eliminating harvest-site morbidity does indeed lead to observable improvement in clinical outcome sufficient to justify the increased cost of bone graft substitutes. Autologous iliac crest bone graft (ICBG) harvest is a common component of many spinal surgical procedures. Although historically considered the "gold standard" source of bone graft material, autograft bone is associated with numerous disadvantages, primarily related to additional morbidity incurred at the harvest site. Several studies have identified a surprisingly high rate of complications associated with autologous bone graft harvest, ranging from 9–49% -10. The Various strategies have been applied in an effort to reduce the patient's experience of postoperative donor site pain, including administration of local anesthesia with or without narcotics, as separate injections or as an infusion . PostopeComplete avoidance of autologous bone graft harvest is the only way to eliminate the significant risk of chronic donor site pain. Unfortunately, the high cost of effective alternatives such as rhBMPs prohibits widespread use; and other options such as allograft, synthetic substitutes, and non rhBMP so-called factor- or cell-based substitutes have been associated with less favorable clinical results. The purpose of this study is to investigate the long-term impact of the ICBG complications on patient function and well-being in a cohort of patients undergoing autologous ICBG harvest for various spinal procedures. We also aimed to evaluate the psychometric properties of a new measure of ICBG morbidity that would be useful for appropriately gauging spinal surgery outcomes.This prospective single institution study involved spinal fusion patients who had undergone autologous ICBG harvest as a component of their surgery between 2003 and 2005. During the fusion procedure, a separate incision was made over the posterior iliac crest through the subcutaneous tissue down to the fascia, where subperiosteal dissection was used to expose the outer table of the ilium. A retractor was placed into the wound under direct visualization, and cortical and cancellous bone graft strips were harvested. No patients had indwelling local anesthetic infusion catheters and no patients had bone graft harvest of both tables. There were no hernias related to the bone graft harvest site. There was no measurement of bone graft volume made for each surgery. All wounds were closed in layered fashion with absorbable suture material. Local anesthetic was infiltrated into the bone graft harvest site. The patients with increased post-operative graft harvest site pain were not treated with a pre-specified protocol. They were treated on an individual basis at the discretion of the surgeon. The most common treatments included oral narcotics, nonsteroidal anti-inflammatory medication, topical anesthetic patches , and hot/cold therapy. We were unable to discern a clear advantage in terms of one treatment modality over another, but this was not a predefined question of the study design.We implemented the study using the Dillman Tailored Design Method , a detaiOutcomes were measured using the Short-Form-36v2 (SF-36v2) , the OswOne-hundred-seventy questionnaires were obtained from a total of 205 patients contacted, resulting in a response rate of 83%. Of these 170 patients, longitudinal data for both one-year and final follow-up were available on a subgroup of 139 patients. Although most analyses were done with the full sample of 170 patients, one psychometric analysis utilized the smaller sample of 139 with longitudinal data to assess the stability of the measure.A comparison of the baseline and follow-up samples revealed they were comparable in age, gender distribution, diagnosis distribution, smoking status, worker's compensation status, time since surgery, and pre-operative reporting of chronic pain syndrome, severe pain, and pain tolerance Table .The study population included 170 patients with a mean age of 51.1 years (SD = 12.2) and balanced gender  . We should note that the Exploratory Factor Analysis results and they differ when using tetrachoric and polychoric correlations. With polychoric, two factors are identified (scar issues and ensuing difficulties with item 1 loading weakly on F1); the first factor explains 66% of the variance and the first two factors explain 80%, suggesting two factors. With tetrachoric, one factor is identified (item 1 loading weakly) and it explains 58% of the variance. We formed the scale score on the basis of the tetrachoric because this approach is generally considered more appropriate for dichotomous items. While using tetrachoric correlations might be more appropriate, the results using polychoric appear to be what one would expect looking at the item content.We used a criterion validity approach to evaluate the responsiveness of the ICBG, given the cross-sectional nature of the data. An analysis of variance revealed that the ICBG Complications score was significantly different by ODI score , with the largest group difference being between those with very low ODI scores as compared to the remainder of the sample. To evaluate the stability of the measure, we compared ICBG Complications scores on a subgroup of 139 patients for whom both one-year and final follow-up data were available. There was no difference in ICBG Complication score between the one-year and final follow-up data points . This suggests that the measure is stable during a period when little change is expected. There may, however, be a floor effect; approximately half of the sample reported zero ICBG Complications.An analysis of missing data patterns revealed that one item related to numbness was missing data because of a skip pattern in the questionnaire, and one item about job-related difficulty was missing data because of the number of retired patients. These were recoded to "0" or "1" as appropriate allowing retention of all patients in the analyses without changing overall relationships between ICBG morbidity and clinical outcomes. Validity of this approach was confirmed by scatter plots.At a mean of greater than 3 years following surgery, a relatively large percentage of patients continued to report being troubled by harvest site scar appearance (5%), numbness (24%), and bothersome numbness 13%). In particular, chronic harvest site pain resulted in difficulty with household chores (19%), recreational activity (18%), walking (16%), sexual activity (16%), their job (10%), and irritation from clothing (9%) , after adjusting for age, compensation status, pain at the primary surgical site, and residual extremity pain (Table 2 = 0.40), after adjusting for age, compensation status, pain at surgical site, and pain at extremities. There was no association between ICBG harvest-related complaints and mental health , after adjusting for age, compensation status, pain at surgical site, and pain at extremities. Whereas age was a significant covariate of physical health, it was not related to mental health or disability. Workers' compensation status was a significant covariate of disability, but not of physical or mental health. Persistent pain at the primary surgical site and affecting the extremities were significant predictors of worse scores on all outcomes.Regression analysis revealed that chronic ICBG harvest-related complaints were associated with significantly worse disability on the ODI 3.5 years post surgery , recreational activity 11.9%), work activity (9.7%), activities of daily living (8.2%), sexual activity (7.5%), and household chores (6.7%)[.9%, workThe largest previously reported prospective study of autologous bone graft harvest is by Robertson et al. and involved 106 patients undergoing posterior spinal fusion . AlthougThe strengths and limitations of this study should be noted. The strengths include the development of a psychometrically sound tool for evaluating ICBG morbidity. Further, this is the longest prospective study of ICBG morbidity to date with sufficient sample size to allow multivariate analyses of the independent impact of ICBG morbidity on physical and mental health. The limitations of the study are that 35 (17%) patients did not provide complete data on all of the questionnaires leading to a sample size of 170 in the multivariate regression models. This missing data problem may result in biased estimates of the effect of ICBG on clinical outcomes and may reduce our statistical power to detect clinically important effects on physical health. Second, our measures of key outcomes were limited. The pain measure was based on three individual VAS items, which have lower reliability than multi-item questionnaires. Future studies should consider employing a control group that does not include autologous bone graft harvest, e.g., a group utilizing rhBMP, to determine whether eliminating harvest-site morbidity does indeed lead to observable improvement in clinical outcome sufficient to justify the increased cost of bone graft substitutes. Finally, we had only cross-sectional data available for the full sample analysis and were thus unable to evaluate patterns of change over time. Future research should explore whether the new questionnaire used in this study can be improved by utilizing Likert rather than dichotomous response options. It would be worthwhile to investigate whether this modification in respondent options might reduce the floor effect detected in our data.In summary, the long-term impact of ICBG is substantial and clinically important. Our study suggests that about one-fifth of patients experience substantial pain and disability even three years after surgery, and these symptoms affect functioning. This information would support the use of bone graft substitutes that avoid ICBG harvesting. In addition to this clinical implication, our study provides a useful tool for the continued evaluation of ICBG complications for future research that seeks to evaluate the comparative efficacy of ICBG as compare to rhBMP.(ICBG): Iliac Crest Bone Graft; (rhBMPs): recombinant human bone morphogenetic proteins; (SF-36v2): Short-Form-36v2; (ODI): Oswestry Disability Index; (NDI): Neck Disability Index; (VAS): Visual Analogue Scale.The authors declare that they have no competing interests.CES conceptualized and designed the study, supervised the acquisition of data and data analysis, and drafted the manuscript; JFM, PK, DAW participating in the acquisition of data and participating in revising the manuscript critically for important intellectual content; RB and LL participated in data analysis; DHK conceptualized and designed the study, and drafted the manuscript. All authors read and approved the final manuscript.Appendix 1: ICBG Complications Questionnaire. Questionnaire used to assess the presence or absence of persistent pain, functional limitation, and cosmesis at the ICBG site.Click here for file


Cutpoints (CPs) for mild, moderate and severe pain are established and used primarily in cancer pain. In this study, we wanted to determine the optimal CPs for mild, moderate, and severe pain in joint replacement surgery candidates with osteoarthritis (OA) of the hip or knee, and to validate the different CPs.Patients (n = 353) completed the Brief Pain Inventory (BPI), the WOMAC Arthritis Index, and the SF-36 health status measure. Optimal CPs for categorizing average pain with three severity levels were derived using multivariate analysis of variance, using different CP sets for average pain as the independent variable and seven interference items from the BPI as the dependent variable. To validate the CPs, we assessed if patients in the three pain severity groups differed in pain as assessed with WOMAC and SF-36, and if BPI average pain with the optimal CPs resulted in higher correlation with pain dimensions of the WOMAC and SF-36 than other CPs.The optimal CPs on the 0–10 point BPI scale were CP  among hip patients and CP  among knee patients. The resulting pain severity groups differed in pain, as assessed with other scales than those used to derive the CPs. The optimal CPs had the highest association of average pain with WOMAC pain scores.CPs for pain severity differed somewhat for patients with OA of the hip and knee. The association of BPI average pain scores categorized according to the optimal CPs with WOMAC pain scores supports the validity of the derived optimal CPs. Patients with osteoarthritis (OA) of the hip or knee can experience pain for several years prior to joint replacement surgery -3, and iThe method for establishing cutpoints (CPs) to categorise pain severity is established for classification of cancer pain into mild, moderate, and severe pain . Using wIn patients with OA, because pain and decreased function are important clinical indicators of the need for surgery, it would be useful to know if specific pain severity categories were associated with poorer outcomes. No study has established CPs for pain severity in homogeneous samples of patients with pain from OA of the hip or knee who are scheduled for joint replacement surgery. Hence, it is unclear if CPs for pain severity are different in patients with OA of the hip or knee.The aims of the study were (1) to determine the optimal CPs for mild, moderate, and severe pain in patients with OA of the hip or knee, based on patients' ratings of average pain, and (2) conduct an initial validation of the BPI with different CPs, by investigating if the optimal CPs resulted in a higher association with the pain scales of a disease-specific measure of functional disability and a generic health-related quality of life measure, than other cutpoints.This study is part of a large, prospective, longitudinal, multi-center study that evaluated pain and HRQOL outcomes in patients with OA before and after joint replacement surgery. A total of 503 patients who entered the waiting list for hip or knee joint replacement surgery from six different hospitals in the eastern part of Norway were invited to participate in the study. Recruitment took place from June 2003 to June 2004. The participants were adults (> 18 years), who were enrolled on the waiting list for primary joint replacement surgery and able to read, write, and understand Norwegian. In total 353 patients accepted to participate in the study.In the six hospitals, a nurse or administrative staff member identified potential participants who were placed on the waiting list for a hip or knee replacement and determined whether they met the study's inclusion criteria. All patients who met the inclusion criteria were sent a letter that explained the study, a packet of questionnaires, and a stamped, self-addressed envelope. Participants returned the completed questionnaires, which constituted written informed consent, to the research office.Among the 353 participants, 318 provided complete data for this analysis. No differences in gender and type of surgery (hip or knee joint replacement) were found between those who did and did not participate in the study. However, participants were younger (69.5 years (SD = 9.3)) than non-participants (72.9 years (SD = 9.0); p < .001). Because this survey was mailed to potential participants, the reasons for not returning the questionnaires are not known. This study was approved by The National Committee for Research Ethics in Norway, the Norwegian Social Science Data Services, and each of the study sites.At baseline, patients completed a questionnaire that obtained data on gender, age, marital status, cohabitation, education level, employment status, type of surgery, duration of pain in the joint, number of years with ambulation problems, and a rating scale on urgency for surgery . In addiThe BPI is a short, self-administered questionnaire designed to evaluate the intensity of pain and the impairment caused by pain during the past 24 hours. Four items measure pain intensity  using 0 ("no pain") to 10 ("pain as bad as you can imagine") numeric rating scales. Seven items measure the level of interference with function caused by pain  using 0 (no interference) to 10 (complete interference) rating scales. In addition, patients rate the amount of pain relief they are experiencing using a 0% ("no pain relief") to 100% ("complete pain relief") rating scale. The Norwegian translation of the BPI, which has satisfactory validity and reliability , was useThe WOMAC is a three-dimensional, disease-specific, and self-administered instrument ,16 that The WOMAC is a valid, reliable, and sufficiently sensitive instrument that can detect clinically important changes following a variety of interventions for OA . For thiThe SF-36 consists of 36 items that evaluate eight conceptual domains of HRQOL: general health (GH), physical functioning (PF), mental health (MH), role limitations – physical (RP), role limitations- emotional (RE), vitality (VT), bodily pain (BP), and social functioning (SF) during the past 4 weeks . This reDescriptive statistics and frequency distributions were generated for the patients' demographic and disease-related characteristics. Data are presented as means and standard deviations (SD) or frequencies and percentages. Demographic characteristics were compared using the Kruskal-Wallis test or chi square test.CPs that divided the sample into mild, moderate, or severe pain groups were created for ratings of average pain using the analytic strategy described by Serlin and Mendoza et al. . In thisFor example, CPs , were coded so that a pain severity rating of 1 to 4 would correspond to "mild", > 4 to 7 to "moderate", and > 7 to 10 to "severe" pain. The criterion used to determine the optimal set of CPs for mild, moderate, and severe pain was that a MANOVA among pain severity categories yielded the largest F ratio for the between category effect on the seven interference items as indicated by Pillai's trace, Wilks' lambda, and Hotelling's trace F statistics. To determine the optimal CPs, we used the lowest median rank of the ranking of these three statistics.We used only the average pain CPs in our analysis, because a rating of average pain may be more representative of the chronic or persistent stable pain associated with a sample of patients with OA ,8.To determine if the BPI using different CPs for grading of pain severity, were associated with corresponding scales of the other questionnaires, namely the pain dimension of the WOMAC and the bodily pain scale of the SF-36, we used Spearman's rank correlation. We hypothesized that the optimal CPs would show higher association with these scales than non-optimal cutpoints. A confirmation of this would support the validity of the optimal CPs. Moreover, we would expect the association of the BPI scores with the WOMAC scale to be higher than with the Bodily Pain scale of the SF-36, because of the more similar time perspective in the framing of the questionnaire items.We assessed if the resulting pain severity groups differed in pain history and pain as assessed with other items of the BPI, which were not used for deriving the CPs. For this analysis, we used one-way analysis of variance (ANOVA) with Bonferroni correction for multiple comparisons.A p-value of < .05 was considered statistically significant, using two-sided tests. For the ANOVA analyses, the p-value presented for each pairwise contrast was adjusted so that a value of < .05 indicates statistical significance. Data were analyzed using SPSS for Windows version 12.0.The majority of the sample was female for both hip 71%) and knee (78%), with a mean age of 68.7 years  for hip and 69.1 years  for knee. In the hip sample, 67% were married/partnered, compared with 59 % in the knee sample. Among the patients with OA of the hip or knee, 67% and 80% had completed at least a secondary school education, respectively. Details about demographic characteristics are shown in Table % and kneNo difference in gender was found between patients who did (n = 318) and did not have (n = 35) complete data for the CPs calculations. However, patients with complete data were significantly younger (68.9 years (SD = 9.3)) than those who did not provide complete data for the CPs analysis (74.8 years (SD = 7.7); p < .001).The analysis resulted in different optimal CPs for patients with OA of the hip or knee. For average pain among patients with OA of the hip, the optimal CPs were ,  because they had the lowest median rank of the ranked between-category-F-ratios, using Pillai's trace, Wilks' lambda, and Hotelling's trace statistics Table . With thFor patients with OA of the knee the optimal CPs for average pain were ,  Table . With thWhen the three pain severity groups were compared, no differences were found in marital status, cohabitation, education level, employment status or activity level of job either among patients with OA of the hip or the knee (data not shown). However, patients with OA of the hip in the mild pain group were older than patients in the moderate pain group (p = 0.006). In addition, more women were in the severe pain group compared to the mild pain group (p = 0.003). There were no significant demographic differences according to pain severity groups among patients with OA of the knee.Patients with OA of the hip were in pain for almost 6.5 years, and had experienced mobility problems for almost 4 years before entering the waiting list. In contrast, patients with OA of the knee had experienced pain for 11 years and mobility problems for almost 7 years. No differences were found in the duration of pain or mobility problems, among the three pain severity groups  and knee  Table . For hipThis study is the first to determine CPs for mild, moderate, and severe pain in a sample of patients with OA of the hip or knee who are scheduled for joint replacement surgery. The optimal CPs for average pain, as assessed with the BPI and categorized as mild, moderate, and severe were CP for patients with OA of the hip and  for those with OA of the knee, respectively. Hence, the optimal CPs differed between the two patient categories.Another notable finding was that pain severity ratings were not associated with the duration of pain in either patient group. The optimal CPs for average pain resulted in the highest association with WOMAC pain for both patient categories and among the highest with the bodily pain scale of the SF-36, which supports the validity of the derived optimal CPs.Previous work in non-cancer pain has reported different CPs for phantom limb pain 4,7), back pain , and for pain in general  , back pa. Hence tIn the present study, we validated the BPI with the derived optimal CPs by assessing associations with the pain scales of the WOMAC and SF-36 questionnaires, using alternative CPs. The association of average pain with WOMAC pain was highest when using the derived optimal CPs, and among the highest with SF-36 bodily pain. In the framing of the items of the questionnaires, the time perspective for the BPI was the past 24 hours, for the WOMAC 48 hours, and for the SF-36 4 weeks. Therefore, a closer association of BPI average pain with WOMAC scores would be expected, and we would put more emphasis on this for the purpose of validation. This difference in time frame between the BPI and the WOMAC may possibly influence the results, however, we think the difference between 24 h and 48 h should be minor. Further, we asked the subjects to respond to questionnaires in relationship to the hip or knee joint that was to be replaced, however if subjects have multiple painful areas, they may have problems assessing the impact of one painful area on function.In a previous study of patients with unspecified OA, who were undergoing treatment with cyclooxygenase-2 specific inhibitors and non-steroidal anti-inflammatory drugs , averageIn non-cancer pain, only the studies by Zelman et al. attempted to validate the severity categories using other outcome measures ,8,9. TheWorsening pain is the main indication for joint replacement surgery , althougAs noted in some previous reports, pain has been suggested to be a better predictor of disability and the need for surgery than does radiographic evidence of disease ,35. HoweThe patients in the present study were representative of the population of patients with OA who were scheduled for hip or knee joint replacement surgery, and they had similar WOMAC scores as patients in previous studies ,26,27.Several limitations of this study must be noted. Since patients were recruited by mail, the reasons why patients chose not to participate are not known. However, the patients who chose to participate were approximately 3.5 years younger then those who did not participate which may have biased the sample towards the reporting of higher pain intensity scores . AnotherSome critique of the concept and use of CPs for pain should be raised. We have shown that the optimal CPs as derived with the standard methods differ between patient categories, which is also shown in previous studies. Therefore, there seems to be no universal optimal CPs, which makes such a classification difficult to use in practice. Because the CPs are based on the optimal group boundaries, this may not represent the best CPs for an individual patient , hence tIn summary, in the present study we have established optimal CPs for mild, moderate and severe pain among patients with OA of the hip or knee who were scheduled for joint replacement surgery. The optimal CPs differed between the patients categories. The associations between pain severity using these CPs support the validity of the optimal CPs, however, we think such a classification should be used cautiously. Whether the pain severity has a potential for clinical use or use in prioritization of patients for surgery could not be assessed in the present study, but may be a topic for future longitudinal studies.The author(s) declares that they have no competing interests.All authors participated in planning and design of the study. HK organised and supervised the data collection. HK and KS did the data analysis, drafted and revised the manuscript. BRH, NL and TR reviewed and commented on the manuscript. All authors read and approved the final manuscriptThe pre-publication history for this paper can be accessed here:


There is strong, internationally confirmed evidence for the short-term effectiveness of multimodal interdisciplinary specific treatment programs for chronic back pain. However, the verification of long-term sustainability of achieved effects is missing so far. For long-term improvement of pain and functional ability high intervention intensity or high volume seems to be necessary (> 100 therapy hours). Especially in chronic back pain rehabilitation, purposefully refined aftercare treatments offer the possibility to intensify positive effects or to increase their sustainability. However, quality assured goal-conscious specific aftercare programs for the rehabilitation of chronic back pain are absent.This study aims to examine the efficacy of a specially developed bio-psycho-social chronic back pain specific aftercare intervention (RÜCKGEWINN) in comparison to the current usual aftercare (IRENA) and a control group that is given an educational booklet addressing pain-conditioned functional ability and back pain episodes. Overall rehabilitation effects as well as predictors for compliance to the aftercare programs are analysed. Therefore, a multicenter prospective 3-armed randomised controlled trial is conducted. 456 participants will be consecutively enrolled in inpatient and outpatient rehabilitation and assigned to either one of the three study arms. Outcomes are measured before and after rehabilitation. Aftercare programs are assessed at ten month follow up after dismissal form rehabilitation.Special methodological and logistic challenges are to be mastered in this trial, which accrue from the interconnection of aftercare interventions to their residential district and the fact that the proportion of patients who take part in aftercare programs is low. The usability of the aftercare program is based on the transference into the routine care and is also reinforced by developed manuals with structured contents, media and material for organisation assistance as well as training manuals for therapists in the aftercare.Trial Registration number: NCT01070849 Chronic back pain (cbp) is one of the most frequent reasons for rehabilitation assignment in Germany and associated with high socio-economical burdens ,2. The mReferring to at least one of the outcomes, pain-conditioned functional ability, back pain episodes, health-related quality of life and days of sick leave, some evidence is reported for the short-term effectiveness of inpatient multimodal and interdisciplinary rehabilitation programs -15. Thes• the influence on subjective theories on back pain,• the reduction of fear-avoidance behaviour,• the modification of pain coping strategies and further psychological risk factors as well as• the compensation of physical deconditioning and the enhancement of physical activity and• the improvement of muscular stabilisation of the spine.Based upon the underlying evidence, these objectives are also considered to be important in current treatment recommendations -22. For However, the verification of long-term sustainability of achieved effects is missing so far . For a lPurposefully refined aftercare programs offer the possibility to intensify positive effects of inpatient and outpatient rehabilitation or to increase their sustainability -33. In oFor the purpose of implementing an aftercare program for chronic back pain, exercise therapy offers a broad approach, because of its inherent multidimensional structure. As a main therapy module in general rehabilitation as well as in rehabilitation of chronic back pain, it could provide improvement of pain-conditioned functional ability and back pain episodes by mediating adaptations in the relevant target areas. Furthermore, an exercise therapy based aftercare program, completed with parts of motivational and volitional aspects, has the potential to produce enduring health enhancing effects by persistently increasing health related physical activity ,29,34.Rückengesundheit - Wirksamkeit bewegungs- und verhaltensbezogener Interventionen in der Nachsorge, RÜCKGEWINN) obeys existing quality criterions and current recommendations for interventions with chronic back pain based on scientific evidence and should therefore improve the individual success of treatment . Th. Th38]. s random . In addiPrimary outcome is pain-conditioned functional ability as a direct expression of disability and core outcome component in treatments for chronic pain, measured with the Hannover Functional Ability Questionnaire (FFbH-R) -43. The Secondary outcome is the average pain intensity during the last six month measured with a NRS  ranging from 0 to 10 ,44,45. AFurther, secondary outcomes refer to factors relevant to active self management and address cognitive, emotional and behavioural coping strategies, physical activity and aftercare adherence behaviour. The latter includes motivational and volitional factors, depression, quality of life assessment, social demographic variables and days of sick leave. All outcomes and the way they are measured are shown in table Additionally, for each lesson, the participants' attendance and their perceived disability on a one item NRS is assessed in the two active study arms .The population we intend to examine are persons with a history of recurrent or enduring back pain episodes due to an unclear or unspecific cause which does not sufficiently explain the extent of experienced pain. Therefore 456 participants will be consecutively enrolled from inpatient and outpatient chronic back pain rehabilitation in six cooperating rehabilitation facilities, which cover the rehabilitative care of Berlin. For inclusion criteria the ICD-10 is used. We included the following diagnoses, in which back pain of unclear or unspecific cause is frequently encoded in medical practice: M51.2 - M51.4, M51.8 - M51.9 (other disk herniation), M53.8 - M53.9 (other specified/unspecified dorsopathies), M54.5, M54.8 - M54.9 , M54.4 (if radicular symptoms are not dominating). Patients with appropriate diagnosis are asked to take part in the study by the responsible physician. Before baseline assessment, an informed consent is taken to obtain the patients' approval and exclusion criteria are certified. For obvious reasons, we formulated the following exclusion criteria, although patients met the mentioned ICD-10 diagnoses:• specific reason for back pain, based on a clear cause or diagnosis, which could sufficiently explain its extent • already carried out surgery on the spine within the last year• additional serious psychic diagnosis• uncorrected serious visual and acoustic disability• seriously reduced health status (other diseases) with considerable reduction of dexterity• application for retirement• low German language skills (to fulfill the questionnaires)• age less than 18 or over 65• residential area outside of BerlinEligible patients are randomised and allocated to either one of the three aftercare treatments. To support the participant's recruitment process, a flow chart and a guiding paper was generated and provided to the clinic practitioners and staff.The sample size calculation was approximated with a 3x3-factorial ANOVA-approach based on the primary outcome and was done with the software "gpower 3.1" ,64. To pIn consideration of the logistic situation with several external and internal recruiting rehabilitation facilities and the provision of aftercare in diverse residential areas with miscellaneous aftercare patients in each aftercare facility, specific demands arise for the data management and the randomisation procedure. To accomplish a realisation with high scientific quality, we chose a largely electronic and internet-supported solution for data management including an online-randomisation feature. We implemented a data base for partly electronic data capturing where participants and patients not participating with the right inclusion diagnosis must be registered by the rehabilitation practitioners via a web-application. For an estimation of the participation ratio, all patients who meet one of the inclusion diagnoses are counted anonymously, independent of their participation in the study or any exclusion criterion. Registration of participants must be done before allocation is accomplished by the study software, so allocation concealment is assured automatically. For sequence generation we used an urn randomisation algorithm . This alFurther purpose of the electronic data management system is that, as a planning tool and tool for data transfer and communication with corresponding facilities, it allows to support the organisation of the aftercare groups.In the accomplishment of the medical rehabilitation, there will be no deviation from the usual routine treatment, except the described recruitment process. For long term sustainability and the enhancement of the intensity of the rehabilitation process, the investigational aftercare intervention "RÜCKGEWINN" shows formal and didactic divergences from the standard program "IRENA". Due to the fact that also "IRENA" has not been evaluated yet, we included another comparison treatment that has been shown efficacious already -70. All All participants in this study arm will receive an educational booklet from their rehabilitation practitioner in their dismissal examination as well as the advice to return to normal activities as soon as possible. As educational booklet, the German version of the "back book" of Burton et al. was chosen . This boAll participants in this study arm will be introduced into the normal IRENA program (in German: Intensivierte Rehabilitationsnachsorge), which is usual care in Germany . Every pRückengesundheit - Wirksamkeit bewegungs- und verhaltensbezogener Interventionen in der Nachsorge) is the investigational treatment. For its development, we referred to an existing concept and adapted it to aftercare requirements [The RÜCKGEWINN aftercare intervention  during aftercare interventions and quantified by an interaction effect of the corresponding categories of the factors study arm and time between second and third general assessment. Furthermore, the additional single change over time in rehabilitation phases compared to the change effect of aftercare treatment and overall treatment efficacy of rehabilitation plus aftercare intervention should be evaluated for each aftercare treatment. In consideration of adjusting respectively maintaining the multiple α-error for the mentioned aims, multiple hypotheses will be tested in a closed test procedure . Consist follows :I: general formII: reformuledi denotes the indicator variable for IRENA aftercare treatment and Ri the indicator variable for RÜCKGEWINN aftercare treatment of individual i in a dummy coding with "booklet control" as reference category [2 βand 3 βreflect directly the difference in "slope" of IRENA respectively RÜCKGEWINN to reference "booklet control" and for that reason the efficacy. AF an RF are dummy coded expressions for aftercare respectively rehabilitation facility of patient i, MPSS is also dummy coded variable for chronification stage according to Gerbershagen and G is a dichotomy gender variable. T denotes a suitable construction term for the b-spline for the additional effect (slope) of rehabilitation phases [Icategory . The corn phases .0 is used with the following global linear hypotheses:At first hierarchical, global level in a closed test procedure a likelihood ratio test of the shown specified model against a zero model mC is a suitable contrast matrix of fixed interaction effects:i β~2)t during aftercare treatments are performed with As shown in the specified model, we consider the stratified analysis to be the primary analysis carried out with the corresponding intention to treat collective. Other analyses are conducted as sensitivity analyses.To address secondary objectives of the study, the change of secondary outcomes in different aftercare treatments is also assessed. In order to identify effective components or partial goals that should be targeted in aftercare exercise programs, the time varying influence of secondary outcomes on the primary outcomes in the different treatments is modelled by multiple regression modelling.The study sponsor being the Deutsche Rentenversicherung Bund , which has an official assignment, this study inherently has to accomplish high ethical demands, especially in aspects of data privacy. Additionally, this investigation has been approved by the independent Research Ethics Committee of the Medical Faculty of Friedrich-Alexander-University of Erlangen-Nuremberg on 09.06.2009.Chronic back pain comes along with a hardly mastered individual disease burden and intrusively affects all areas of life negatively. It has critical consequences on social and occupational participation and causes serious disability. Empirical evidence encourages the relevance of theories for the chronification process of back pain that demand mutually increasing physiological and psychosocial factors that surpass simple additive effect structures (e.g. fear-avoidance model). Thereby, it was shown that particularly by exercise-related and behaviour-related interventions, the appearance as well as the duration of future back pain episodes can be decreased -76. MultDespite the possible high benefit for chronic back pain rehabilitants, special methodological and logistic challenges accrue in this study. A major logistic problem could possibly arise from low rate of patients that begin their prescribed aftercare. In usual aftercare this rate is about 18% concerning inpatient and about 43% concerning outpatient rehabilitation . In thisThe authors declare that they have no competing interests.CH drafted this manuscript and contributed substantially to the final development of the study protocol and study design as well as to the particularizing of the research question relying on the relevant literature. CH was responsible for planning and working out methodically aspects of the study, including e.g. patient enrollment, randomization, assessment and statistical analysis. CH was accountable for planning the implementation of the study, ethical aspects, and data management. CH also contributed to develop the experimental treatment.JH contributed to develop the research question from national and international literature. JH was responsible for the selection and compilation of the employed questionnaires according to the chosen primary and secondary outcomes. JH contributed to develop the experimental treatment.KP conceived the study and was responsible for identifying the research question beforehand. KP drafted the study design and was accountable for determining primary and secondary outcomes. KP contrived the basis for development of the experimental treatment.All authors red and approved the final version of the manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/11/266/prepub