To determine the frequency with which physicians address their older adult patients with chronic pain about the issue of sexuality.  It is a cross sectional, descriptive, analytical study in which physicians answered a questionnaire comprising questions related to addressing the issue of sexuality during appointments. A sample of 155 physicians was obtained, 63.9% stated they did not address sexuality in medical interviews and 23.2% did it most of the time. The main reasons for not addressing were lack of time, fear of embarrassing the patient and technical inability to address the issue. There is a need to develop strategies to increase and improve addressing of sexuality in elderly patients with chronic pain, in order to have better quality of life. The number of elderly in the total population is growing, especially in developing countries, like Brazil.-4 This happens as a result of three main incorrect concepts: First, sexuality in the elderly does not exist. It is known that older adults have sexual activity. According to Helgason et al., 46% of men aged 70-80 years, in the Swedish population, reported having at least one orgasm in the previous month. In the previous year, according to the study conducted by Lindau et al., 60% of elderly men and 30% of elderly women had had sexual intercourse. Second: sexuality in the elderly is wrong. Many elders are embarrassed to maintain or discuss their sex life because of stereotypical images of asexual elders, while, according to Drench et al., elderly people are afraid of being perceived as perverted or luxurious for having an active sex life. Third: sexuality in the elderly is funny. According to Bytheway et al., sexual difficulties in the elderly are subject to humor.Older adults usually neglect their sexuality. quality of life and mood, and longevity. There are, however, certain dysfunctions that appear at that age that impose barriers to continuing a good sexual life. In addition to the physiological changes, such as diminished lubrication and slower sexual response, there is the problem of multiple morbidity and social difficulties .Sexuality in the elderly is related to better cardiovascular health, pain is an unpleasant sensory and emotional experience, associated with actual or potential tissue damage. It becomes chronic when it surpasses the regular healing time and involves emotional aspects and central sensitization. Chronic pain is a prevalent condition in the elderly. Around the world, it varies from 48 to 83% of older adults,,17 while, in Brazil, it is 51.44%. Patients with chronic pain also suffer from sexual dysfunctions. According to Ambler et al., 73% of chronic pain patients reported sexual dysfunctions, while Bahouq et al. found that 81% of chronic back pain patients reported sexual problems.Additionally, regarding previously described barriers, chronic pain is an important factor to complicate a rather difficult sexual activity. According to the International Association for the Study of Pain, found that only 4-6% of patients sought medical assistance, and the main causes were the sociodemographic characteristics of the physician, the patient’s idea about sexuality in the elderly, shame due to the fact they think it is related to normal aging, and unawareness of the existence of specialized services. In a worldwide study, 9% of patients with sexual dysfunctions sought assistance in the previous year, and, in another study representative of the American population, 38% of men and 22% of women with sexual dysfunctions sought medical care.A major problem is that patients with sexual dysfunctions do not discuss the issue with their physicians. Gott et al. the main barriers to communication about sexuality between elderly women and physicians appeared related to the patient or physician. The patient-related barriers were intimidation, shame, fear of disrespecting the physician, sociodemographic differences, fear of exposing sexual orientation, and fear of inability or lack of interest by the physician in the problem.In a qualitative study,The physician-related barriers were the belief that senior people are not interested in sex, perceiving the patient as similar to the physician’s own parent, inability to address the issue, the belief that another type of doctor is responsible for that issue, worrying more about diseases than quality of life and poor quality of life prevention, lack of time, religious or his/her own sexual issues, and feeling embarrassed in dealing with the sexuality of older ladies.Thus, chronic pain interferes in a healthy sex life, and elderly patients dealing with these problems are unable to discuss the issue with their physicians. The main objective of this study is to determine the prevalence of addressing the issue of sexuality in medical interviews of elderly patients, as well as the factors related to not addressing the issue with the individual. A better understanding of this lack of addressing the issue can help develop teaching strategies to change the medical educational paradigm, promoting better health care for the elderly population.To determine the frequency with which physicians address their older adult patients with chronic pain about the issue of sexuality.This was a cross-sectional, observational, descriptive-analytical study performed at a teaching hospital, located in the city of São Paulo, in the Southeast of Brazil, with several physician specialties who provide care to elderly patients with chronic pain.The sample size calculation resulted in 119 participants; however, an actual sample of 155 physicians was obtained. was used:To calculate the sample size, the following equationn is the sample size and N is the universe size . Z is a constant of the critical value to obtain the desired confidence level. For 95%, Z is 1.96. The variable e is the maximum error margin accepted-in this case, 5%-and p is the literature-based prevalence - in this case, 9%.In this equation, There was no restriction on their specialties, years of experience practicing medicine, or position in the hospital (resident or attending physician), except those specialties that naturally address the issue of sexuality as part of their routine, such as urology and gynecology. The reason is that we wished to study the physicians who provide care to elderly with chronic pain, but who do not focus on sexuality frequently in their routines.Universidade Federal de São Paulo. To assure the participants’ anonymity, each questionnaire was detached From the Consent Terms and placed in an opaque envelope for separate analysis. The questions were created by the authors and were based on previous qualitative and quantitative studies related to the topic and were all multiple-choice questions.A 21-question self-administered closed-question survey relating to clinical practice was given to physicians who practiced specialties that usually involve examining elderly patients. The surveys were distributed individually at clinical meetings, clinics, and at the Hospital of the The participants were asked about their specialty, years of experience, mean age of their elderly patients, if the patients had chronic pain and what type of pain, if they had any training in addressing sexuality, and if they perceived sex and sexuality as different things. If they asked about the patients’ sexuality, they were asked how they did this and how often. It was specified in the questionnaire that this was related to outpatient interviews in order to guarantee that the interviews would occur in private office settings despite it being a teaching hospital. This condition was stated in a message at the beginning of the survey.If sexuality was addressed, the participants were asked if they were embarrassed by the same sex and/or opposite sex patients, if they found diverse sexual orientations in elderly patients, and if they found any relation with a specific type of pain. For those who did not ask about sexuality, they were asked the reasons, if they thought that seniors are sexual beings, and if chronic pain was related to sexual dysfunctions.χ2 test to check the statistical significance of the two variables. The confidence interval of the statistically significant relations was 95% with a p value ≤0.05.Statistical analysis used Statistical Package for the Social Sciences (SPSS), version 17.0, Minitab 16, and Microsoft Excel 2010 software. Analysis of variance (ANOVA) was used for the comparison of means, and the The characteristics of the 155 physicians are outlined in The physicians reported attending patients mostly between 70-79 years. The most frequent type of pain reported by the physicians was nociceptive. Most physicians reported not addressing the issue of sexuality. Fifty-six physicians did address the issue, accounting for 36.1% of sample.More experienced physicians addressed sexuality significantly more frequently compared to less experienced physicians. Among those who addressed the issue of sexuality, the mean years of experience was 6.09, as compared to 3.8 in the non-addressing group, with a p value of 0.009.Receiving training in sexual history taking had a statistically significant relation with addressing the issue of sexuality. Among those who addressed the issue, 29.63% had received training, while among the non-addressing group, 21.27% had received training. An absolute change of 8.36% represents the number needed to treat, which was 12.Among those who addressed the patients’ sexuality, 22% reported doing it in more than 60% of interviews. Most did it in less than 30% of interviews. Most (72.9%) of these physicians did not report any embarrassment in taking the sexual history; 74.2% of physicians understand sex and sexuality as different issues, while 17.4% of physicians think they are different topics, but that the difference is irrelevant for clinical practice .Most participants did not perceive any relation between sexual problems and a specific type of chronic pain. Roughly 87% of physicians who did not address sexuality found it normal for older individuals to have a sexual life. The vast majority of the sample did not receive any training in sexual history taking .Most physicians who addressed sexuality did not notice a clear relationship with a specific type of chronic pain. More than half of physicians (51.5%) who did not address the issue of sexuality reported chronic pain as potentially being related to sexual dysfunction; and 86.9% of those would be willing to change their practice patterns if it were proven that it had an impact on the patients’ quality of life. Among 99 physicians who did not take sexual history, 22.8% did not do it due to lack of time, 22.1% justified it by fear of embarrassing the patient, and 14.1% felt unable to do it. About 7% did not answer and 13.1% felt it was another physician’s responsibility .Geriatrics and Endocrinology were the specialties that addressed the issue of sexuality more often, with no statistically significant difference between them. Addressing sexuality was much less frequent among other specialties .Orthopedic surgeons did not take sexual history and geriatricians did it more often. Neurologists and rheumatologists communicated a lack of time as the main reason for not addressing the issue of sexuality. Physical Medicine and Rehabilitation Specialists feared embarrassing the patient. Geriatricians mentioned technical inability, and orthopedic surgeons believed another physician was responsible for the issue .Most participants reported questioning the patient directly, rather than waiting for the patient to ask, or asking subtle questions, regardless of the patient’s gender. There was a slight decrease in the rate of asking those questions directly to the patient of the opposite sex. Three physicians reported using indirect addressing of the issue, such as asking about marital status and relationship status.Sexuality still is, especially when related to elders, a taboo. Except for a few specialties that naturally address the issue of sexuality, such as Gynecology and Urology, most physicians still ignore/neglect the matter.In the present study, the sample included physicians from eleven diverse specialties. The mean physician experience was relatively low. However, this could be justified by the study setting, at a teaching hospital, which includes several newly graduated physicians in their residency programs . That is not necessarily a negative bias, since it could give a truer picture of medical schools in Brazil.It is very difficult to evaluate the content of medical appointments through interviews. The physician could be inhibited for being evaluated by a colleague, or not allow his/her patient to be assessed after the appointment. Patients, on the other hand, could be embarrassed to discuss such intimate matters with an unknown physician. In order to overcome these barriers, an anonymous self-administered questionnaire was chosen for use in this study. which already has barriers related to senescence itself. In this study, addressing the issue of sexuality for elderly patients with chronic pain was broader than it was in the existing literature. Here approximately one-third of participants referred to it. This could be explained again by the study being conducted in a teaching hospital setting where a thorough history-taking technique is regularly taught. The proximity between specialties can also be a reason since this promotes the exchange of knowledge.Coexistence of chronic pain can negatively impact sexual function,Geriatrics is a specialty with the highest proportion of addressing the issue of sexuality, probably because it studies the impact of aging in the human body and understanding complications of multimorbidity. The Comprehensive Geriatric Assessment is usually a longer interview that allows for more intimate matters to surface easier.Endocrinology, possibly due to the study of diseases with a high impact on sexual functions , had a rate of addressing comparable to geriatrics. Orthopedic surgeons addressed the issue the least. They justified this by reporting that the topic is not related to their specialty. Nevertheless, many elders have an orthopedic surgeon as their only physician, or their primary attending physician, when they complain of chronic pain. This setting makes it difficult for matters of “lesser” importance to physicians and patients  to show. It is necessary to rethink this style of medicine that gives priority to more interviews per hour rather than a comprehensive evaluation. There should be triage strategies for sexual dysfunction in shorter interviews.The main reason reported for not addressing the issue of sexuality in this study was a lack of time during interview. This could be a reflection of the Brazilian public health system, in which time is very reduced, worsening the quality of appointment.Another allegedly important reason for not addressing the issue of sexuality was the feeling of technical inability. Although sex Medicine is widely neglected in the syllabus of most medical schools, this absence of expertise is not a valid reason. A triage could be performed and a referral to a specialized colleague could be offered to the patient. Treating these individuals can bring benefits to quality of life and pain control because good sexual health is related to better pain control.Among the physicians who addressed sexuality in their appointments, only 13 discussed the issue in most events, which accounts for 8.38% of sample. This is very unsatisfying, since the prevalence of sexual dysfunction in chronic pain patients could be as high as 73%.There was a statistically significant difference in the number of years of medical experience between the addressing and non-addressing groups in this study. This result could be associated to two different reasons: First: more experience could mean greater maturity concerning sexual issues, and/or Second: changes made in the medical undergraduate course syllabus regarding approach of patient’s sexuality more difficult for younger physicians. two medical undergraduate student cohorts were assessed on their ability to take a sexual history; one had been trained in this matter and the training had a much better result for those cases in which the dysfunction was obvious. However, for subtle cases, it failed to show a difference from no training at all. Another study offered various strategies for teaching sexual history taking in medical schools.Being trained to take sexual history during the undergraduate course had a statistically significant and positive effect in the rate of positive responses to addressing the issue of sexuality. While in absolute numbers there was a slight change (an increase of 8.36%), this represents a number needed to treat of 12. This means that it takes 12 medical students to be trained in order to have one of them addressing sexuality of their patients routinely. This is a very good result considering the low cost involved. According to Lindau et al.,Regarding the difference between sex and sexuality, most of the sample knew there was a difference, irrespective of whether sexuality was addressed or not. It is worth mentioning that some physicians knew there was a difference, but thought it had no impact on clinical practice. Sex relates to actual intercourse. It is during sex that most dysfunctions appear. Sexuality is a broader concept, regarding the projection of sex in the patient’s “self,” including their expectations, frustrations, and series of actions related to sex itself, such as flirting, sexual fantasies, caressing, and masturbation. Perhaps it is a reflection of addressing the issue related to sex instead of sexuality. Additionally, it could be related to difficulties experienced by the elderly to come out/show their true sexuality. Since sexuality of the aged is a taboo, a greater problem can be expected regarding sexual minorities.Most participants did not report encountering sexual minorities in their practice. This does not correspond to reality according to the current Brazilian literature.Because of cultural nuances in Brazil, where elderly people are considered asexual beings, older adults with sexual dysfunctions might be inhibited to start a conversation about their sexuality. This demands a proactive role from the physician. A study conducted in the same environment as this one showed that 68.8% of very old women with chronic pain would like the physician to address the matter.Many patients seek medical care for treating chronic pain, ignoring the fact that possible concomitant sexual dysfunction can be treated as well. The patient is not expected to know that both problems could be related. The attending physician should be aware that there is a relation between them and treating the pain while ignoring sexual function can further worsen the sexuality issue.The present study showed that most physicians fail to address the issue of the sexuality of their elderly patients with chronic pain. It was also observed there were significant differences in the rate of addressing the issue among the medical specialties, with geriatrics and endocrinology performing it more often. The main reasons for not doing so were lack of time, fear of embarrassing the patient, and feelings of technical inaptitude. Longer experience in clinical practice was associated to a higher rate of addressing the issue of sexuality. It is necessary to develop strategies to improve instances of addressing the issue for elderly with chronic pain, by improving training of undergraduate medical students and performing continued medical education, in addition to promoting a positive impact on the quality of life of older adults.


Study Design: A controlled and retrospective study of 144 chronic low back pain patients to evaluate the effectiveness of an intensive functional restoration program in France. Objective: Evaluating the efficiency of an intensive, dynamic and multidisciplinary functional restoration program in patients with chronic low back pain (LBP), during 6 and 12 months follow up. Summary of background data: Chronic low back pain disease has a multifactor nature, involving physical, psychological professional and social factors. A functional restoration program (FRP) has been included in a multidisciplinary training program which provides an efficient therapeutic solution. However, the effectiveness of an FRP has not been yet established. Methods: 144 subjects  with chronic low back pain were included in a functional restoration program. The FRP includes physiotherapy and occupational therapy interventions together with psychological counselling. Patients participated as in- or outpatients 6 h per day, 5 days a week over 5 weeks. Pain intensity, trunk flexibility, trunk strength, lifting ability, quality of life and return to work were recorded before, immediately after, and at 6 months and 12 months after the treatment period. Results: All outcome measures were significantly higher just after the FRP (144 patients) and at 6 and 12 months (from available data in 31 subjects) compared to pre-treatment values. This FRP for chronic low back pain maintained its benefits whatever the patient’s activities. Conclusions: The effects reflected on all outcome measures, both on short and long term follow-up. The multidisciplinary FRP for chronic low back pain patients durably stopped the de-conditioning syndrome and involved new life-style habits for the patient, daily pain management and a return to work. In many countries, industrialisation has been instrumental in the development of musculoskeletal disorders, of which low back pain (LBP) is the most common and expensive ,2. Thus,et al. at the end of the 20th century [Chronic low back pain (CLBP) programs have been developed during the past two decades ,10,11,12 century ,23. The Hence, the aim of this present paper was to assess the short and long term effectiveness of a French-specific RFP. More precisely, the objective of this follow up was to evaluate the efficiency of a 6 and 12 month intensive, dynamic and multidisciplinary functional restoration program in patients with chronic low back pain (CLBP).The study was designed as a controlled, retrospective and non-randomized study in chronic low back pain patients to evaluate the effectiveness of an intensive functional restoration program.A total of 144 CLBP subjects  of the eligible patients referred by their general practitioner or medical specialist were included in the FRP of a re-education and rehabilitation centre. All 144 subjects participated in the 5 coverage weeks. A total of 31 subjects correspond to the patients who have participated in all the evaluations. Low back pain patients fit for following a reconditioning program have been included in this protocol. Employees, the intermediate professions and the working class are the socioprofessional classes dominant in low back pain populations. 61% of the 31 patients do not practice any physical activity. Of the others, half practice regular activity (twice or more/week), and half practice occasional activity. Among the 31 patients taking part in the study, 38% have an IMC > 25, among those, only two subject have an IMC > 30.The inclusion criteria were: aged between 18 and 65 years, presence of CLBP or lumbo radiculalgy existing for at least 3 months according to the criteria of the French health evaluation agency , sufferiThe intervention included participation in a FRP. The FRP, imported from the American rehabilitation institute of Dallas for Ergonomics (PRIDE), was standardised and proposed by a rehabilitation centre. This program included a multidisciplinary team of physicians, physiotherapists, occupational therapists, psychotherapists, sports therapists and social workers. The FRP involves the treatment of low back pain with a primary focus on return of function , rather The physical program consisted of muscle-strengthening , cardiovascular exercises, stretching and proprioceptive practice.A physiotherapist supervised the performed exercises and adjusted the exercise intensity to each CLBP patient. During the first week, patients learned muscular warm-up and stretching techniques, improved their flexibility and performed cardio-respiratory exercises. During the second week, patients began muscular-strengthening exercises. During the third week, muscular-strengthening increased with endurance exercises. Patients performed weightlifting as well as proprioception and coordination exercises. During the fourth and the fifth weeks, the intensity of strengthening exercises increased progressively.The endurance training (cycling) was adapted to each patient’s heart rate and to the exercise stress test performed before the program. The training program (cycling) was individualized according to heart rate and was intermittent in nature. It consisted of several series of low- or moderate-intensity exercises alternated with active recovery periods. In order to adapt the protocol to the exercise therapy program constraints, the subjects were trained for 21 min, by alternating 3 min at 70% and 3 min at 85% of peak heart rate (peak heart rate = 220-age).The CLBP patients also received ergonomic care and performed work simulations during occupational therapy sessions.Patients were referred to the psychologist at least once in the first week and for further treatment if necessary.In order to prepare the patients’ return to work, the social workers made contact with appropriate authorities. In this way, they could envisage the conditions for resumption of work .Each week, the patients attended a clinic with the specialist in physical medicine rehabilitation, who was the medical supervisor of the program.The FRP was based on five evaluations: before the program (T1), at the beginning (T0), immediately after the 5 weeks of the RFP (T5 weeks), and at 6 and 12 month  follow-up visits.Demographic Data and Clinical Characteristics: For each patient, the age, weight, height, gender, duration of complaints and disability, history of back surgery, sick leave duration, practice of physical and sports activities and tobacco consumption were recorded  with “no pain” on the left side and “unbearable pain”on the right side was used. Relevance, validity, and reliability have been sufficiently tested for patients with CLPB [ith CLPB ,27,28.Trunk Flexibility: Finger-to-floor distance (FTF) was used to evaluate flexibility [xibility .Trunk Strength: The strength of the trunk flexors and extensors was evaluated by using standardized iso-kinetic and iso-inertial lifting performance measurements on the Cybex Norm. Reciprocal concentric trunk flexion and extension peak torque values at different angular velocities using the Cybex NORM Trunk Modular Component™ isokinetic dynamometer were assessed at 30 degrees/s 60 degrees/s and 90 degrees/s angular velocities [locities . The isoMuscle strength assessment by isokinetic dynamometer was carried out with a Cybex Norm. The spinal flexors and extensors are concentrically explored at speeds of 60 degrees/s and 90 degrees/s. The parameters studied were peak torque (PT), work, power in the best repetition and total work (TW).Lifting Ability: The Progressive Iso-Inertial Lifting Evaluation (PILE) test evaluates the lifting ability of the CLBP patients [patients .Quality of life: The self-administrated Dallas Pain Questionnaire (DPQ) assesses the impact of the chronic low back pain in four aspects of the patients’ life: daily activities, work and leisure activities, perceived anxiety-depression, and sociability [iability .Working ability: Working ability was analysed by the social workers’ questionnaire to inform the duration to return to work, work status.t” test or a two way ANOVA. The results from post-treatment (T5 weeks) and follow-up sessions  were compared to the pre-treatment results (T0). Paired “t” test and repeated measure ANOVA were used to test differences over time for each variable.The statistical analysis was performed with sigma Stat version 2.03. The evolution of FTF, VAS, PILE, DPQ and trunk strength scores between men and women at T0 and T5 weeks were analysed by using a “One hundred and forty-four patients  were included in the trial. The mean age was 41.9 years. 31 patients (22%) performed all the tests. 144 patients performed only the pre- and post-tests.p < 0.001) and higher lifting results, their flexibility was less than women’s. Men were also heavier smokers in comparison with women.Regarding the demographic data and to the clinical characteristics , no statRegarding the percentages of the clinical characteristics before the FRP , nearly p < 0.001). This improvement was maintained at the 6 and 12 month follow-ups. The FRP considerably increased trunk strength, but principally the strength of the trunk extensors: maximal force, endurance force and speed force , and working ability after the treatment, compared to before . Two-thirds of the patients returned to work after an average of one month.etc.). Similar results were found in a systematic review by Guzman et al. [et al. [Our study was as a controlled, retrospective and non-randomized study in chronic low back pain patients. Our main objective was to assess the effectiveness of an intensive functional restoration program and show the medium- and long-term efficiency. We studied a homogeneous population of 144 CLBP patients living in the same area of France comprising a majority of employees. A total of 81% of the CLPB patients in our study returned to work, 57% without special facilities and 24% with such facilities , in accordance with other results [Physical parameter values were significantly higher at T5 weeks . Before  results . Althouget al. [et al. [At the end of the FRP, the CLBP patients in the present study recovered 75% of the isokinetic values at 30 °/s , 55% at 120 °/s  at T5 weeks and 73% and 47% respectively at T6mo of the standard values reported by Vanvelcenaher et al.  in a preet al. highlighted the role of pain intensity and reported that high pain intensities before the program are often associated with bad outcomes both in LBP and other musculoskeletal diseases [The FTF distance was significantly reduced after the FRP program. The improvement in flexibility could be the result of the frequency and the duration of stretching exercises performed every day in various forms: passive training with the physiotherapist, active training on an isokinetic machine, collective and active training during stretching sessions, and collective and active training in balneotherapy. Sessions of relaxation therapy and occupational therapy are also efficient in improving flexibility, alleviating distress and managing pain . Recentldiseases . In our diseases . MoreoveIn the present study, psychosocial measures were significantly improved . The redIn this study, it would have been interesting to learn about good and bad prognostic factors; however, this was not possible. In a future investigation, we plan to compare our results with those of a control group and to calculate correlation to the modalities included and the dose of therapy applied in order to increase our understanding of the physical therapy benefits for chronic low back pain patients.An intensive and multidisciplinary functional restoration program seems to stop the deconditioning syndrome (medium and long term effects) in CLBP and to improve functional, physical and psychosocial values. The stabilization of these values would depend on the active way of life of the subjects after the treatment. FRP would teach the CLBP patient new lifestyle habits, daily management of pain and a return to work.The reluctance of third–party payers to authorize the use of intensive interdisciplinary rehabilitation with functional restoration is due to its perceived high cost. This study confirms that such perceptions are misguided and incorrect in terms of the potential long-term cost savings of such programs.


For cancer patients with inadequate pain relief, a switch to an alternative opioid is the preferred option for symptomatic improvement. However, multiple opioids are often simultaneously administered for anecdotal reasons. This prospective study evaluated pain response to either opioid rotation or combination in patients with uncontrolled cancer pain.Patients suffering with uncontrolled cancer pain despite dose titration were randomly assigned to opioid rotation group or opioid combination group. Patients answered a questionnaire that included items on pain severity (0 to 10) and interferences at baseline and after one week.p = 0.08). The incidence of adverse events was similar in both groups, but fewer patients experienced constipation with opioid rotation than with combination . The frequency of rescue analgesics  and dose modification  were similar in the rotation and combination groups.Of the 50 patients registered, 39 patients answered the questionnaire after one week of treatment. After one week, the mean pain scores were significantly improved in both groups. Ten patients (42 %) in the rotation group and 16 patients (62 %) in the combination group reported that they achieved relief from pain .This study was registered in advance to ClinicalTrials.gov (no.  Chronic opioid therapy is the mainstay treatment for moderate to severe cancer pain. Experts agree that patients suffering with cancer-related pain should be treated with strong opioids as soon as the non-opioid analgesics become ineffective . HoweverAnecdotal reports have shown that multiple opioids are often simultaneously administered for different reasons , other tAlthough morphine is usually considered the preferred drug for the treatment of severe cancer pain, the use of transdermal fentanyl has been increasing in recent years. Transdermal fentanyl is a synthetic opioid originally that was used as a component of anesthetic regimens, and it provides patients with continuous systemic delivery of analgesic effect at a controlled rate for up to 72 h: this makes it suited for the treatment of chronic pain . More re2 retention, an active skin disease that precluded the use of transdermal patches, or on antitumor therapy of any kind. Other exclusion criteria included the inability to swallow oral medication, and impaired sensory or cognitive function. Patients who had an active infection, or uncontrolled central nervous system involvement were also excluded. All patients gave their written informed consent before participating in the study and the protocol was reviewed and approved by the Gil Medical Center  institutional review board.We performed a prospective study on a sample of consecutive patients who were admitted to a palliative cancer care unit for a period of 10 months. Patients were eligible to participate in the study if their clinician considered they had chronic uncontrolled pain associated with a histologically confirmed solid cancer that required stronger opioid therapy than they had been taking and they were over 18 years of age. Patients receiving oral opioids only were eligible. Chronic uncontrolled pain was defined if a patient had persistent pain despite adequate dose titration and being treated with oral morphine equivalent of 100 mg/d or more. Daily opioid requirement was calculated as the total amount of opioids administered including both long- and short-acting opioids. Patients were excluded if they were suspected to have narcotic abuse, clinically relevant COFollowing a screening procedure, the patients who completed the baseline questionnaire were randomly assigned to the rotation group  or the combination group . Patients who did not require a change in analgesic dosing during the screening period were considered ineligible. The dosing of transdermal fentanyl was mainly based on the National Comprehensive Cancer Network (NCCN) practice guidelines (adult cancer pain v2.2005), and on the department policy. These guidelines required a working knowledge of an equianalgesic dose table . An indiPatients answered a questionnaire that included items concerned with pain severity and interference with the activities of daily living from the modified short form of the Brief Pain Inventory . Pain wat-test. Although no direct between-group comparison of outcomes was planned, we investigated, for exploratory purposes, the effects of opioid rotation and combination by means of t-test and Fisher’s exact test. The results are presented as means ± SDs. All analyses were performed on the per-protocol population, which was defined as all patients who answered the baseline questionnaire and who took at least one dose of the study drug.This randomized study was treated, statistically, as two simultaneous phase II studies and the one-stage design was applied separately for each treatment group. At a two or more change of the pain NRS from baseline and with a standard deviation of 2 for the two groups, the required number of patients was calculated to be 21 per group (two-sided significance of 0.05 and a power of 90 %). For the primary outcome in each group, differences in the mean changes of the pain NRS between the groups were assessed by using a n = 24) or the combination group (n = 26). A summary of the demographic and baseline disease characteristics is presented in Table n = 20 vs. combination group, n = 19) answered the questionnaire after one week of treatment.A total of 50 patients were randomized to the rotation group n = 4 or the p = 0.03), compared with decrease from 6.5 (±1.8) to 4.8 (±2.1) in the combination group (p < 0.01). The current pain scores were significantly decreased in the rotation group  and also in the combination group . The mean NRS for minimal pain was decreased from 2.9 to 2.0 in the rotation group (p = 0.22) and from 3.0 to 1.8 in the combination group (p = 0.06). The average pain scores were also decreased in the rotation group  and in the combination group . Treatment success was achieved by 11 rotation group patients and 12 combination group patients (p = 0.98).As shown in Table p = 0.09), although this was statistically insignificant. Rescue analgesics were required in 50 and 69 % of patients in the rotation group and combination group, respectively (p = 0.17). During 7-days of the treatment period, modification in the analgesic dosing was done for 29 and 38 % of the patients in the rotation group and combination group, respectively (p = 0.49). The mean baseline NRS for each category of interference items  were similar for both groups . Of the original 50 patients, 5 (21 %) of the rotation group patients and 6 (23 %) of the combination group patients discontinued treatment before completing the study. Clinical deterioration of their general condition was the most common reason for discontinuation (n = 6). A similar number of patients withdrew treatment owing to adverse events (n = 2) or inadequate pain control (n = 3).The median fentanyl doses were 50 mcg/h  in the rotation group and 25 mcg/h  in the combination group. In the combination group, the median oxycodone dose was 30 mg/d . One patient in the rotation group died of massive upper gastrointestinal bleeding shortly after starting the study drug. This event was thought unlikely to be related to the study drug because his primary tumor was remained in the stomach. Treatment-related adverse events, which were defined as those events deemed to be related to the study drugs, were reported in 50 % of the rotation group and 54 % of the combination group patients. The incidence of adverse events was similar; however, more patients experienced constipation with opioid combination (42 %) than with rotation  are used. For the patients with chronic uncontrolled cancer pain, both opioid rotation and combination strategies appear to provide significant relief of pain and patient satisfaction. Although our trial was not intended to detect differences between the two groups, the efficacy of opioid rotation and opioid combination did not seem to differ in terms of pain control and the patient satisfaction. The clinical significance of these findings was supported by the secondary efficacy outcomes that measured relief of pain and the interference with the activities of daily living.The medical literature does not recommend the simultaneous use of two strong opioids for chronic cancer pain , 16. It The combination of transdermal fentanyl and oral oxycodone was well tolerated by cancer patients. After one week of treatment, the pain scores were significantly improved in both groups. More patients in the combination group (62 %), although statistically insignificant, reported that they achieved relief from pain than those in the rotation group (42 %). This observation should be interpreted with caution because it represents only a small group of patients with uncontrolled cancer pain and no formal comparisons of outcomes were planned between the two groups. The present study was not designed to compare the synergistic analgesic effect of two strong opioids to that of a single one. However, our results indicate that the combination of transdermal fentanyl and oral oxycodone could be a reasonable option for treating patients with chronic uncontrolled cancer pain. Fentanyl binds only the mu opioid receptor, while oxycodone is a putative kappa receptor agonist. It is possible that the synergistic analgesic effect may be the result of the simultaneous activation of both the mu and kappa opioid receptors. It was reported that the co-administration of sub-analgesic doses of oxycodone and morphine resulted in excellent pain relief with a reduction in opioid-related adverse events . In addiAlthough there is little controversy regarding the therapeutic efficacy of opioids for controlling chronic cancer pain, patient monitoring and continual reassessment are the keys to providing adequate relief of pain. The beneficial analgesic effect of opioids and the risk associated with their use can vary considerably among individuals. Some patients may not achieve adequate pain relief despite appropriate dose adjustments, whereas others may develop intolerable adverse events to a particular opioid. Therefore, opioid therapy must be individualized such that each dose would provide a balance between effective pain control and acceptable adverse events. To achieve this goal, both opioid rotation and combination therapy could be tried for all patients. The potential benefits and risks should be discussed with the patients.In summary, the present study demonstrated that both opioid rotation and combination strategies showed discrete therapeutic efficacy for cancer patients suffering with chronic uncontrolled pain. Taking into account all the uncertainties described above, more studies are needed to investigate whether there are real differences between opioid rotation and combination with respect to the efficacy and toxicity and their combination with other agents. Since no opioid combination regimen has yet reached the level of an evidence-based standard treatment, further research efforts, including studies on combination with other opioids and/or non-opioid analgesics, are encouraged as there continues to be an urgent need to improve our therapeutic strategies against cancer pain.


Diagnosing depression in chronic pain is challenging due to overlapping somatic symptoms. In questionnaires, such as the Beck Depression Inventory (BDI), responses may be influenced more by pain than by the severity of depression. In addition, previous studies have suggested that symptoms of negative self-image, a key element in depression, are uncommon in chronic pain-related depression. The object of this study is to assess the relationship of the somatic and cognitive-emotional items of BDI with the diagnosis of depression, pain intensity, and disability.One hundred consecutive chronic pain patients completed the Structured Clinical Interview for DSM Disorders (SCID) for the diagnosis of major depressive disorder (MDD) according to DSM-IV. Two subscales of BDI  were created according to the factor model presented by Morley.In the regression analysis, the somatic-physical function factor associated with MDD, while the negative view of self factor did not. Patients with MDD had higher scores in several of the BDI items when analysed separately. Insomnia and weight loss were not dependent on the depression diagnosis.The relatively small sample size and the selected patient sample limit the generalisability of the results.Somatic symptoms of depression are also common in chronic pain and should not be excluded when diagnosing depression in pain patients. Regardless of the assessment method, diagnosing depression in chronic pain remains a challenge and requires careful interpretation of symptoms. Depression is commonly observed to coexist with chronic pain. It is markedly associated with higher levels of reported pain, as well as with increased functional impairment –3. AssesThe widely used Beck Depression Inventory (BDI)  was origMorley and colleagues  analysedIn the present study, the aim was to analyse the association of chronic pain and depression. The specific goal was to assess how the somatic and cognitive-emotional aspects of depression measured by the Beck Depression Inventory (BDI) are associated with the diagnosis of depression, based on the Structured Clinical Interview for DSM-IV Diagnosis (SCID) . In ordeOne hundred chronic pain patients participated in the study. A total of 121 consecutive patients referred for assessment and treatment to the Helsinki University Central Hospital Pain Clinic were invited to participate during a scheduled visit to the clinic. Inclusion criteria were: aged from 30 to 60 years; chronic pain for at least one year; and fluency in the Finnish language. The exclusion criteria were: malignancy; medication with strong opioids; psychosis: and current drug or alcohol abuse. Eighteen patients chose not to participate. Three patients were excluded because of missing data. The study was approved by the Ethics Committee of the Helsinki University Hospital. All patients provided written informed consent.The Beck Depression Inventory ,20 is a The psychiatric assessment was performed using the Structured Clinical Interview for DSM-IV Axis 1 disorders (SCID-I) , with a www.suomenkivuntutkimusyhdistys.fi/), a routine self-administered questionnaire for all patients at the Helsinki University Central Hospital Pain Clinic, was used. Demographic information and the current pain intensity measurement using the Visual Analogue Scale (VAS) were extracted from this questionnaire. Pain intensity was assessed using the Visual Analogue Scale (VAS), a 10 cm horizontal line with 0 representing no pain and 10 maximum possible pain. The patients were asked to mark on the line an estimate of their current pain intensity. The questionnaire includes a pain disability section, comprising18 items. Each item has three options; 1 “not at all”, 2 “somewhat”, and 3 “much”. The question “does the pain interfere with the following activities?” is followed by a list of daily activities such as lying, sitting, standing, cleaning, reading, sleeping, driving, social activities, sexual activities etc. A sum score is calculated, a higher score indicating more severe disability. Pain specialist physicians made the pain diagnoses and classifications as part of the clinical treatment programme. The pain conditions were categorised into four etiological groups: neuropathic, nociceptive, visceral, and idiopathic pain. In the case of more than one chronic pain condition, the main presenting pain was chosen as the primary one.The Pain Questionnaire  in order to test whether our data fitted the model.Comparison was made between patients with or without the DSM-IV-based diagnosis of current major depressive disorder (MDD). Student`s t-test was used for continuous variables and the Mann-Whitney U test for non-parametric data. Due to multiple comparisons, the alpha level was corrected according to the Bonferroni correction or according to the recommendations concerning multiple correlated tests , 27. LogSixty-two (62%) of the patients were female. Mean age was 47.9 years . Sixty percent of the patients were married or cohabiting. Twenty-five percent had no professional education, 54% had a vocational education, and 21% had a university level education. Thirty-nine percent were employed and working, 39% on sick leave, 12% in receipt of a disability pension, and 4% unemployed. The median duration of pain was 4 years (range 1–44 years). Forty-nine percent of the patients were classified as having neuropathic pain, 21% nociceptive pain, 5% visceral pain, and 25% idiopathic pain. Descriptive statistics for the pain measures and psychological variables are presented in The zero-order correlations are shown in The Assessment of depression in chronic pain has been challenging because several somatic symptoms overlap between depression and pain. In the present study, we compared two different approaches of assessing depression in chronic pain, the DSM-IV MDD diagnosis and BDI, using the two-factor model recommended by Morley and colleagues . The datPatients with current MDD had higher scores in several of the BDI items than those without MDD. The items that were least associated with the depression diagnosis, such as insomnia, somatic preoccupation, and weight loss, may be considered to reflect the general distress attributable to a somatic disease. Concerning the two-factor model, the somatic/physical factor was more strongly related to MDD, four items of seven differing between the groups. The scores of the items that were not in the factor model showed a consistent pattern: patients with MDD had higher scores in most of these. The results give some support to the suggestion that there is less self-negativity in chronic pain-related depression. The regression analysis emphasises the role of somatic symptoms in pain-related depression. One conclusion is that the somatic symptoms have causal relevance in the diagnosis of MDD in pain patients. However, another explanation for the association can be the several somatic symptom criteria of MDD. The symptom overlap phenomenon thus concerns both the BDI and the diagnostic assessment.The pain disability measure correlated positively with the somatic/physical depression symptoms as well as with current pain intensity. However, it was not associated with the diagnosis of depression. This is contrary to the common finding of depression worsening the functional disability in pain patients . One expAccording to the DSM-IV diagnostic guidelines for depression, somatic symptoms should be excluded if they are “clearly and fully attributable to the somatic condition” . Even ifThe various criteria of depression may lead into problems of specificity. On the other hand, excluding somatic symptoms in the diagnosis of depression may drastically reduce the rate of diagnosis . Using sThis study has several limitations. The number of patients was low which reduced the statistical strength of the study in general. The number of patients who fulfilled the criteria of current MDD was too low to enable a separate factor analysis of BDI in this group. The discrepancies between the depression findings defined by the factor model and the MDD can partly be attributed to the low number of patients with MDD. We performed the entire SCID interview with all the patients; however, we used only the current major depressive disorder section in the analysis. The study was performed in a tertiary pain clinic, and the patients therefore represent a highly selected group of chronic pain patients. The pain disability measure of the study is widely used in clinical practice in the Pain Clinic of Helsinki University Central Hospital. The measurement is straightforward and covers broadly different areas of functional disability. However, it has not been largely used in previous studies and its validity and reliability need further assessment. Excluding chronic pain patients prescribed strong opioids may have excluded those with the most challenging pain problems.In conclusion, analysing separately the somatic and cognitive-emotional symptoms can shed more light on the depression concept in chronic pain. The important question for future research is whether the different symptoms of depression associate differently with other elements such as disability, pain intensity or treatment outcome. Longitudinal studies are needed to clarify further these mechanisms. These studies could address the temporal association of depression and pain both when these comorbidities develop and resolve. The assessment of depression in chronic pain remains a challenge even if one utilises the standardised diagnostic systems such as DSM. Considering the symptom overlap problem from the clinical point of view, one option is to at least partly accept the indistinct boundaries between chronic pain, distress, and depression. Combining different methodologies and assessment tools may help to understand the multifaceted nature of depression and its boundaries with chronic pain.S1 Table(DOC)Click here for additional data file.


There is minimal research on demographics, type of injury and diagnosis of injured workers with shoulder problems. The purposes of this study were: 1) to document the demographics of patients with shoulder complaints referred to an Early Shoulder Physician Assessment (ESPA) Program and to describe the recommended management, and 2) to examine the relationship between patient characteristics and their subjective complaints of pain and functional difficulty.This study involved a retrospective review of electronic files of injured workers mostly seen within the first 16 weeks of injury or recurrence. Measures of functional difficulty and pain were the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) and Numeric Pain Scale (NPS).Files of 550 consecutive patients, 260 females (47%), 290 men (53%) were examined. The average age was 49 , with 28 (5%) patients being 65 years of age or older. Patients who were not working were the most disabled group based on Quick DASH  and NPS . Patients who were working full time performing regular duties were the least disabled according to both measures, the QuickDASH  and NPS .Patients waiting more than 16 weeks were slightly older  than those who met the criteria for early assessment with similar levels of pain and functional difficulty. Biceps pathology had the highest prevalence (37%). Full thickness tear had a prevalence of 14%. Instability, labral lesions and osteoarthritis of glenohumeral joint were uncommon conditions . Fifty-five patients (10%) were surgical candidates and had higher scores on QuickDASH  and NPS  compared to those who did not require surgery.This study provides information on characteristics and prevalence of important variables in injured workers with shoulder problems and highlights the impact of these characteristics on pain and disability. Musculoskeletal injuries occurring at work are a significant contributor to disability and health care costs in the working population with recurrent disabling symptoms being common in some cases ,2. RecenThe limited literature suggests that patient’s demographics ,18 and sAs a part of improving care of injured workers in Canada, the Ontario Workplace Safety and Insurance Board (WSIB) initiated a new service specific to shoulder injuries beginning in November, 2012 . This sePersonal and life style characteristics, the type of injury and occupational characteristics are important predictors of recovery ,18,26-28The purposes of this study were: 1) to document the demographics of patients with shoulder complaints referred to an Early Shoulder Physician Assessment (ESPA) Program and to describe the recommended management, and 2) to examine the relationship between patient characteristics and their subjective complaints of pain and functional difficulty.This study involved a retrospective review of the electronic files of patients seen from the beginning of the program in November 2012 to July of 2014 at the Holland Orthopedic and Arthritic Centre, Toronto, Canada. Approval for using the existent data was obtained from the Research Ethics Board of the Sunnybrook Health Sciences Centre (project # 114–2014).All of the patients had an accepted shoulder claim by the WSIB with a diagnosis of bursitis, impingement syndrome, rotator cuff tendinitis, sprain/strain, a partial or full thickness rotator cuff tear, instability, or superior labral lesions within 16 weeks of the injury or recurrence.The assessment at the ESPA Program was conducted at the Holland Centre, which has a dedicated program for assessment and treatment of injured workers providing both conservative and surgical management. The ESPA Assessments are performed by an orthopedic surgeon and a physical therapist. The orthopedic surgeons have subspecialty in shoulder surgery and physical therapists have Masters’ degree or post graduate training and experience in this area. The assessments involve history taking and a clinical examination as well as arranging expedited investigations, conducting therapeutic cortisone injections and recommending treatment or surgery as needed. The information collected by examiners is entered into a fillable PDF form by the assessing physical therapist. The form includes details on the patient’s work status, the mechanism of injury, current symptoms, medication, investigations performed, relevant past medical history, life style factors, investigations performed, and physical examination. At the end of the assessment a clinical diagnosis is provided, and recommendations are made regarding further investigations, consultations and/or treatment along with appropriate worker accommodations and a return to work plan. Patients who may be candidates for surgery would then be referred to the Surgical Specialty Program, where they could undergo expedited surgery if required.Patient oriented outcome measures completed at the time of assessment include the QuickDASH  and the χ2) tests were used for categorical data and parametric and non-parametric analyses were used for continuous data as appropriate.Descriptive statistics  were performed for demographics. Age was categorized into two groups: 1) working age group (<65 years of age) and 2) 65 and older. Number and percentage of patients who underwent diagnostic investigations or were referred to the Shoulder Specialty Program (SSP) and were booked for surgery were calculated. Subgroup analyses were conducted to examine potential differences in demographics and pain (as measured by NPS) and functional difficulty (as measured by QuickDASH) between patients a) who waited longer than 16 weeks versus those who did not, and b) patients who were surgical candidates vs. those who did not require surgery. In addition, the relationship between pain and functional difficulty and work status was examined. The Chi square  waiting more than 16 weeks (group1) and 521 patients waiting ≤16 weeks (group 2). Patients who waited longer than 16 weeks (group 1) were slightly older  than group 2. There was no gender discrepancy between groups. Groups had comparable level of pain and disability as measured by the numeric pain scale  and Quick DASH . Management of these patients did not differ in terms of having more investigations, referral for surgical consultation or requiring surgery.Twenty-six percent 143) of the patients had a previous related work injury with 14% (78) reporting a non-work related shoulder injury .No significant difference was found between men and women in the distribution of more minor rotator cuff pathology  or biceps pathology (p > 0.05). However men had a statistically significant higher rate of full-thickness tears than women  in the sample studied. Similarly, osteoarthritis of the glenohumeral joint was an uncommon condition (1%) and was typically observed in association with other injury related conditions . Cervical spine radiculopathy was common, involving 30% of the patients with 9% of the patients having neurological findings.Table Seventy-seven patients (14%) were deemed to require further assessment and potentially surgery and were referred to the Surgical Specialty Program (SSP). Fifty-five patients (71% of the referred group and 10% of the entire sample) were deemed surgical candidates and 40 (7%) patients were booked for surgery within the time frame of the manuscript preparation. Patients who were referred to the SSP were more disabled  than those who were not referred . Similarly, surgical candidates had higher QuickDASH  and pain  than those who did not require surgery.This study presents the demographics of a large consecutive sample of injured workers who underwent an early assessment through a newly established program. In addition, we explored the relationship between perceived pain and ability to function and important patient-related factors.In our sample, QuickDASH was affected by reporting psychological issues . The QuickDASH was also correlated with work status with the score being lowest in workers doing regular duties. However, non-working individuals were not necessary experiencing more psychological problems. Pichora and Grant who investigated the difference between working and non-working individuals with upper extremity injuries found that non-workers suffered from poorer mental functioning . OverallThere are clinical practice guidelines for ordering costly investigations such as MRI for workers with acute occupational low back injuries  but we aThe injured workers in our sample had a variety of diagnoses, mostly related to bursitis, tendonitis and partial-thickness tears of the rotator cuff and biceps which is consistent with common pathologies of the shoulder joint. Full-thickness tears comprised a small percentage of the diagnostic categories (14%) with the biceps pathologies making up the highest proportion of clinical diagnosis 37%). Prevalence of biceps pathology in injured workers is not clearly defined in the literature. The overall prevalence of full-thickness tears in non-work related injuries in patients seen in secondary clinics is reported at about 8% . However%. PrevalAdhesive capsulitis had a rate of 9% in injured workers seen in this early assessment program. Rate of adhesive capsulitis has been reported to be at approximately 2% in the general population, increasing drastically in diabetic patients ,40. We aInstability related pathologies and labral tears had the lowest prevalence in our sample varying from 2 to 3%. In a large epidemiology of surgical interventions of upper extremity, Jain et al. found a prevalence of 13% for instability and SLAP repairs . The preAs seen in our sample, cervical spine radiculopathy appears to be a common associated comorbidity which may be missed in the busy clinics of primary family physicians. Having expert examiners is expected to help identifying associated pathologies more accurately that contribute to patients symptoms.The gender distribution was of interest with men and women being fairly similar when all pathologies were considered together. However, consistent with the literature ,43-46, mManagement recommendations for injured workers included active treatment physiotherapy programs (91%), medication (18%) including analgesic and non-steroidal antiinflammatories, referral for surgery (14%), and corticosteroid injections (10%) including subacromial and intraarticular glenohumeral. Less than 1% of the patients were referred to a pain clinic for a multidisciplinary approach. Abnormal pain response which is clinically associated with poorer outcome had a low prevalence of 8%. Our results may indicate that an early referral to shoulder specialty clinics is associated with less exaggerated pain behaviors and more importantly helps with promoting a more active treatment and less reliance on chronic pain management.In the sample studied, 10% of the injured workers did not require any medical management and 10% were surgical candidates. Efficiency improvements are possible in early assessment models of care if patients who are likely to require surgical treatment (i.e. full-thickness rotator cuff tears) were referred directly to the clinics with access to surgical resources. Access to a management algorithm may facilitate the referrals made by case managers or family physicians.Establishing a timely recommendation for appropriate surgical intervention may help to avoid problems associated with delayed treatment  and could lead to improved outcomes and faster recovery. In our sample, 14% of patients assessed in the ESPA clinic required a referral to SSP. This result shows the importance of early assessment for an early diagnosis followed by a direct path through to treatment and recovery. Early assessment of patients with rotator cuff pathology has shown to significantly decrease medical costs and time spent waiting for surgery and being off work .Access to programs for early assessment, diagnosis and management of shoulder conditions are still not that common and more improvement could be made in this area. Improving the timely access to appropriate management is expected to reduce the costs it places on the health care system and workforce. Future studies may provide evidence for a reduction in costs and improvement in expenditure in this area.This descriptive study involved a retrospective analysis of data of consecutive injured workers. Although the data were extracted from standardized forms, the analysis was limited to available variables. For example, mental health, alcohol consumption and smoking were limited to categorical data of yes and no. In addition, we had access only to the total score of the QuickDASH. This measure is reported to show factorial structure inconsistency in patients with shoulder conditions mostly related to one of the questions that explores neurological symptom of tingling ,49. FutuThis study provides descriptive information on a large sample of injured workers seen within a short period of time following injury. Early diagnosis made by expert clinicians with appropriate investigations is expected to facilitate more timely conservative or surgical management, leading to better overall management.


Objective. Opioid therapy in patients with chronic noncancer pain must be preceded by evaluation of the risk of opioid misuse. The aim of this study was to evaluate the predictive validity of the Italian translation of the Pain Medication Questionnaire (PMQ) and of the Diagnosis Intractability Risk and Efficacy Score (DIRE) in chronic pain patients. Design. 75 chronic noncancer pain patients treated with opioids were enrolled and followed longitudinally. Risk of opioid misuse was evaluated through PMQ, DIRE, and the physician's clinical evaluation. Pain experience and psychological characteristics were assessed through specific self-report instruments. At follow-ups, pain intensity, aberrant drug behaviors, and presence of the prescribed opioid and of illegal substances in urine were also checked. Results. PMQ demonstrated good internal consistency (Cronbach's α = 0.77) and test-retest reliability (r = 0.86). Significant correlations were found between higher PMQ scores and the number of aberrant drug behaviors detected at 2-, 4-, and 6-month follow-ups (P < 0.01). Also the DIRE demonstrated good predictive validity. Conclusions. The results obtained with specific tools are more reliable than the clinician's evaluation alone in predicting the risk of opioid misuse; regular monitoring and psychological intervention will contribute to improving compliance and outcome of long-term opioid use. The problem of poorly controlled pain is still considerable: in Europe 19% of adults suffer from continuous pain that seriously compromises the quality of their emotional, social, and working life . Indeed, misuse and abuse according to the following definitions [ Substance misuse is the use of any drug in a manner other than how it is indicated or prescribed, while substance abuse is defined as the use of any substance when such use is unlawful or when it is detrimental to the user or to others.In this paper we use the termsinitions . SubstanMoreover, the prevalence may depend also on the different populations tested. In Italy there are no data about opioid misuse and abuse since, until recently, opioids were not prescribed but in a small percentage of terminal patients , 7, due Risk factors for opioid abuse and addiction can be divided into three categories: genetic, substance-related, and psychosocial factors. Patients with a personal or family history of substance abuse and with one or more psychosocial issues  are at greater risk of developing addiction, especially if the treatment is not carefully structured .The aim of pain treatment is effective pain relief and the consequent functional improvement. Therefore, specialists are concerned about the possibility of abuse as well as about the lack of compliance with the analgesic treatment, including the patient's decision to decrease the prescribed dosage or to stop the treatment. For this reason, the detection of aberrant drug-related behaviors seems to be mandatory. An aberrant drug-related behavior is defined  as any mGuidelines recommend that the use of opioids in patients with chronic noncancer pain must be preceded by an assessment of potential benefits and risks of aberrant drug-related behaviors and should include a psychological and psychiatric assessment , 9.In recent years, many tools have been developed for this purpose , 11: amoThe present study examines the psychometric properties and clinical utility of the Italian translation of the PMQ and the DIRE. The predicting validity of the two tools was assessed by (a) the numbers of aberrant drug behaviors at 2-, 4-, and 6-month follow-ups and (b) the positivity of urine toxicology screening performed at 2- and 6-month follow-ups.The scores obtained with the two instruments were also compared with the clinical evaluation made by the physicians in the pretreatment phase based on their subjective impression.Furthermore, as psychosocial distress has been previously found to be a relevant risk factor in the development of opioid misuse , 12, the88 consecutive patients meeting the inclusion criteria were referred to the Pain Management Units of San Bortolo Hospital in Vicenza and Sant'Antonio Hospital in Padua, between December 2009 and January 2012. Inclusion criteria were age between 18 and 70, presence of noncancer pain for at least 6 months, a score of 4 or over in the last month average pain intensity as assessed on an 11-point Numerical Rating Scale, good knowledge/understanding of Italian, absence of cognitive deficit, pain not controlled by weak opioids or other pharmacological and nonpharmacological treatments used for at least 3 months, and informed consent to participate in the study. Of these, 75 agreed to participate in the study ; the sociodemographic and clinical characteristics of the group of subjects are represented in  Pain Medication Questionnaire (PMQ) [There (PMQ)  is a selre (PMQ) . Diagnosis Intractability Risk and Efficacy (DIRE) Score [TheE) Score  is a too medical risk evaluation requires the physician to provide a clinical estimate based on subjective impression, of the risk of opioid misuse answering 4 questions on an 11-point numerical scale: (a) compliance with medical treatment , (b) risk of abuse, (c) risk of underuse of the drug , and (d) expected efficacy of treatment .The aberrant drug behaviors (ADB): based on the current literature [Theterature , a list Urine toxicology screening was performed with fast immunodosages that could be read visually, allowing the qualitative determination of the pharmacological substances and their metabolites present in the urine. For opiates, marijuana, and buprenorphine, QuikStrip OneStep immunodosages by Syntron Bioresearch were used; QuikPac IITM OneStep was used to detect the presence of amphetamines, methamphetamines, cocaine, and oxycodone. In case of uncertainty the urine sample was sent to the laboratory for gas chromatography confirmation.The psychological assessment included a structured interview and the following tools. Visual Analogue Scale (VAS) consists of a 10 cm long horizontal line, the start and end points of which are labeled “no pain” and “worst possible pain,” respectively. The patient is asked to mark the points corresponding to his/her worst, least, and average pain intensity in the last month.The Minnesota Multiphasic Personality Inventory II (MMPI-2) [The(MMPI-2) , 17 is a Beck Depression Inventory II (BDI-II) [The(BDI-II) , 19 is a State Trait Anxiety Inventory-Y (STAI-Y) [The(STAI-Y) , 21 is a Pain Related Self-Statement Scale (PRSS) [Finally, thee (PRSS) , 23 is aThis is an observational, prospective, and longitudinal study, and it consisted of the following assessment phases: patient selection, collection of pretreatment data, and 2-, 4-, and 6-month follow-ups. The specialist physician selected patients according to the clinical criteria indicated above. Pretreatment data were collected in the two-week period following selection. It included the filling-out of the PMQ by the patient and of the DIRE by the multidisciplinary team. Questionnaires to assess the pain intensity (VAS), coping strategies (PRSS), affective/emotional condition , and personality characteristics (MMPI-2) were also administered in pretreatment assessment. Medical and psychological follow-ups were scheduled 2, 4, and 6 months after the start of treatment and included the filling-out of ADB and the readministration of VAS, STAI, and BDI-II. At each follow-up session patients were also required to collect a urine specimen which was immediately examined by the same person in both centers; in case of uncertainty the urine sample was sent to the laboratory for gas chromatography confirmation.Both PMQ and DIRE were translated by the authors, according to the guidelines for the process of cross-cultural adaptation of self-report measures, and approved by the first author of each instrument.The study protocol was approved by the Institutional Ethic Committee of both hospitals.r (PMQ) and internal consistency was determined by Cronbach's α (PMQ and DIRE). Spearman's nonparametric coefficient was used to examine the relationship between the PMQ and DIRE scores and the number of aberrant drug behaviours detected at the medical follow-up.Continuous variables are expressed with mean, standard deviation, minimum and maximum, and centiles, when appropriate. As the studied variables were not normally distributed (assessed by Kolmogorov-Smirnov test), to examine the differences between continuous variables, Kruskal-Wallis and Kolmogorov-Smirnov nonparametric analyses of variance tests were used; Chi-square test was used for the comparison of frequency distributions. Repeated measures ANOVA was used to analyze the presence of significant differences in pain intensity among patients at high/low risk of opioid misuse. Bonferroni correction was used in post hoc analysis to control for type II errors. The reliability was assessed through test-retest Pearson's All patients reported continuous pain; P < 0.001) reduction at 2-, 4-, and 6-month follow-ups; no statistically significant changes in VAS scores from baseline to 6-month follow-up were related to age, sex, and type of pain. The adherence to the treatment protocol was very high; only four out of 75 patients dropped the treatment due to side effects.In the repeated measures ANOVA, both worst and average pain as measured with VAS underwent a statistically significant (Approximately one-third of the patients (35%) reported the presence of at least one side effect at follow-up; the most frequently reported side effects were sleepiness (12%), nausea (11.3%%), and constipation (8.8%).At 6-month follow-up, 46.2% of patients did not display any aberrant drug-related behaviors, 15.4% manifested only one, and the remaining 38.4% manifested two or more. In particular, 28.2% showed little interest in managing themselves and in rehabilitation, 24% frequently cancelled appointments, and 12.6% reported minimal or inadequate pain relief.The urine toxicology screens with immunoassay did not identify the prescribed opioid in only one patient at the two-month follow-up, whereas it was identified in all patients at the 4- and 6-month follow-ups. In only one patient the result was questionable for illegal substances (suspect positivity for cocaine): so gas chromatography determination was made, which resulted negative.T scores ≥ 65) in at least one of the clinical scales with psychopathological content . As for the affective-emotional variables, the depression score at BDI-2 was clinically significant (scores higher than 95th percentile) in 52.2% of patients; at STAI-trait anxiety 22.5% of patients showed a clinically significant score of anxiety.As regards the psychological variables investigated in the pretreatment assessment (mean scores in N = 75) yielded a mean PMQ score of 25.4 (±10.35), a median score of 24, and a mode of 20 . There were no significant age and gender differences in the PMQ scores.The sample . As for the predictive validity of the tool, highly significant correlations were found between the total PMQ score and the number of aberrant drug-related behaviors at 2-month , 4-month , and 6-month follow-ups . The mean time required by the patient to complete the questionnaire was 12′16′′ .Analysis of internal consistency produced an alpha coefficient of 0.77, indicating an adequate internal coherence; the test-retest reliability at 2 months was very high , 4-month , and 6-month follow-ups   .F1,70 = 6.75;  P < 0.01) (One-way repeated measures ANOVA showed a minor reduction in the worst pain intensity in the high-PMQ and moderate-PMQ groups when compared to the low-PMQ group ( < 0.01) .The group was subsequently divided, according to the scores obtained at PMQ, in order to analyze the presence of any significant differences in the psychological variables considered in the study.P < 0.01) between high- and low-PMQ scores in the following clinical scales: STAI-trait anxiety, BDI-total score, PRSS catastrophizing, MMPI hypochondriasis, MMPI depression, MMPI psychopathic deviate, MMPI Paranoia, MMPI psychasthenia, and MMPI Schizophrenia. As it can be seen in T scores ≥ 65) in at least one of the MMPI-2 clinical scales with psychopathological content .In general, Kruskal-Wallis analyses revealed significant differences (α if item deleted = 0.48).In the DIRE, the scores varied from 12 to 19, with a mean of 15.7 (SD = 1.8) and both median and mode of 16; there were no significant differences between the mean scores of men  and women . 85.3% of patients were found to be good candidates to start chronic opioid treatment according to the cut-offs established by Belgrade et al. . No signP < 0.01) in all the assessment times. With regard to the predictive validity of the tool, significant correlations were found between a lower total DIRE score (higher risk of opioid misuse) and a higher number of aberrant drug-related behaviors detected at 2-month , 4-month , and 6-month follow-ups .In F1,70 = 5;  P < 0.05) at 6-month follow-up  than “not suitable” patients   in the “not suitable” group on two MMPI-2 scales: frequency (Z = 1.81) and Schizophrenia (Z = 1.66); a tendency toward significant differences (P < 0.05) was even found on STAI-trait anxiety (Z = 1.37) and BDI-total score (Z = 1.39) scales, with lower scores in the “suitable” for opioid therapy group .r = −0.40;  P < 0.01) between high total PMQ scores (high risk of opioid misuse) and low DIRE total scores (not suitable) was found. As regards the 4 subscales of the medical risk evaluation, positive correlations (P < 0.01) were only found between the physician's estimate of the “opioid abuse” subscale and aberrant drug-related behaviors at 2-month (r = 0.32) and 6-month follow-ups (r = 0.39). No significant correlations emerged between the four scales of the medical risk evaluation and the PMQ total score. Instead, significant positive correlations (P < 0.01) were found between DIRE total score and the physician's evaluation of “compliance to treatment” (r = 0.33) and “treatment efficacy” (r = 0.34) while the DIRE total score correlates negatively with the physician's estimate of “opioid abuse” (r = −0.35) and risk of “underuse” (r = −0.34).As for the concurrent validity of the PMQ and DIRE, a significant negative correlation  and the Diagnosis Intractability Risk and Efficacy Score (DIRE) in predicting the risk of opioid misuse in patients with chronic noncancer pain.The total group of 75 patients had a mean age of 51.5 years, with a prevalence of females (76%), and a long history (roughly 10.5 years) of severe chronic pain condition, most often classified as nociceptive.As for the psychological variables considered in the study, half of the samples reported clinically significant levels of depression and 22.5% of the patients displayed high levels of anxiety. In addition, there was a high incidence of elevation in patients' personality profiles: 24.5% of women and 27.7% of men reported clinically significantly high scores in at least one of the clinical content scales of the MMPI-2. These data are in line with the findings of many authors  and suggAccording to the PMQ scores, about half of the group (53.3%) showed no particular risks of opioid misuse, while 24% of the subjects were found to be at high risk. A strong correlation was found between high-PMQ scores and the number of aberrant drug behaviors after 2, 4, and 6 months of treatment. No significant differences in demographic variables emerged between high- and low-PMQ scoring groups.A further interesting result is represented by the lower pain reduction that occurred in patients at high risk of misuse, possibly due to inadequate use of the prescribed opioids. Patients classified as high risk of misuse, based on the cut-offs suggested by Dowling et al. , were foHigh-risk patients also reported higher mean scores and a higher percentage of clinically significant scores on the “Paranoia,” “Schizophrenia,” and “Hypomania” scales of the MMPI-2. Thus, the elevation of these scales, characterized by psychopathological traits, as well as a passive attitude in managing pain condition, and a greater tendency to produce pessimistic and catastrophic thoughts about pain are associated with a higher risk of opioid misuse. The association of high-PMQ scores, symptoms of depression, and psychological distress appears to be in line with previous findings , 28. FurAll these data suggest that the tool provides a reliable estimate of the risk of medication misuse and appears to be a reliable indicator that the clinician can use to plan regular treatment monitoring. The strong association of high-PMQ scores and the presence of symptoms of depression, anxiety, hypochondria, and catastrophizing suggest that opioid therapy needs to be combined with psychological treatments to reduce the affective and emotional distress and modify the patient's dysfunctional beliefs and behaviors related to the use of these drugs.Also for the Italian translation of the DIRE, the results show that the total score is a good predictor of the risk of drug misuse: patients that obtained low scores in this instrument showed a significant greater frequency of aberrant drug-related behaviors in all the assessment times than those classified as good candidates for opioid therapy. Besides, suitable patients obtained a greater improvement in pain control than poor candidates at 6-month follow-up.However, the DIRE has low internal consistency: this means that the items are very heterogeneous and that the tool probably has a multifactorial structure. Thus, our finding does not agree with the results reported by Belgrade et al.  in the oPoor candidates for opioid treatment according to the DIRE score reported higher mean scores in anxiety, depression, and Schizophrenia-MMPI scales when compared to the good candidates. These results are consistent with previous findings, which identified the presence of psychiatric disorders as one of the most predictive factors of opioid abuse , 30. ComThe two tools selected appear to be correlated; then both assess the same construct.The physician's risk evaluation was found to be valid in estimating only the risk of opioid abuse at 2- and 6-month follow-ups; there were no significant relations between aberrant drug behaviors and medical risk evaluation of compliance with treatment, underuse of the drugs, or efficacy of treatment. Moreover, the correlations found between the physician's subjective evaluation for the risk of opioid abuse and the number of aberrant drug behaviors were weaker when compared to those obtained by using the PMQ and the DIRE. This result highlights the need to integrate clinical evaluation with the use of tools specifically created to assess the risk of opioid misuse in the chronic pain patient.The urine toxicology screens were not able to identify the prescribed opioids only in one specimen out of 71. On the other hand, no illegal drugs were identified in any specimen. These data seem rather surprising compared with those reported by other authors in USA studies, who found up to 46.5% of the sample to have abnormal urine toxicology screen results –34.The preliminary results seem to suggest that in our context the most frequent problem may be the underuse of opioid analgesics rather than their compulsive use and abuse as reported in the American literature: this interpretation is supported by the difficulty, frequently expressed by our patients and their families, in accepting these drugs for fear of addiction, loss of mental lucidity, or social stigmatization. This attitude seems to reflect the history of limited opioid use in Italy, which is one of the countries with the lowest morphine consumption in Europe , 7.A further important objective of the multidisciplinary team is thus to assess patients' beliefs about these drugs so as to be able to modify any dysfunctional and unrealistic expectations. At the same time, the use of tools that allow identifying patients at risk of opioid misuse can reassure physicians that often tend to overestimate the risk of addiction. The short time required by the patient and the multidisciplinary team to complete their respective questionnaires supports the routinely use of these instruments in the clinical setting.One may object that if universal precautions are used, stratification seems irrelevant. In fact this study reflects the Italian situation, where the Government has recently issued regulations aiming at promoting the use of analgesic opioids for therapeutic purposes. Consequently, we can expect the number of patients treated with opioids to grow significantly in the next years. The majority of these patients will be cared for by the General Practitioners who may not have the experience in the field or the time necessary to follow all of them with the maximal diligence according to the universal precautions. Hence it is important to carry out stratification of the risk of drug misuse before starting chronic opioid treatment, so that high-risk patients can be referred to interdisciplinary pain relief centers where they can be carefully monitored and trained on self-reliance.In contrast with what is reported in the literature , 34, theOur results support the adequate psychometric properties and clinical utility of the two screening measures employed. Besides, both PMQ and DIRE are more reliable than the clinician's evaluation alone in predicting the risk of opioid misuse, and the brevity in the administration allows their routinely use in a clinical setting. Both tests appear to be predictive of patient compliance and efficacy of analgesia in long-term opioid analgesic treatment. Nevertheless, the PMQ brevity of administration made it more useful for screening purposes in primary care setting, where the assessment is made in a short time and by General Practitioners. On the other hand, the DIRE required a multidisciplinary assessment, including an in-depth examination of psychosocial characteristics and attitude towards drugs and therapy. For this reason it could be more easily conducted in an interdisciplinary pain relief center to identify the specific support needs of the patient.The limitations of this study are primarily the small number of subjects enrolled and the differing distribution of men and women. Despite these limitations, the study has allowed us to conduct preliminary analyses on the predictive validity and psychometric properties of the Italian translation of the PMQ and the DIRE, as well as to analyze affective-emotional variables and personality characteristics in patients treated with opioids.Overall, our results highlight the need for a multidisciplinary assessment of patient candidates for chronic opioid treatment and for the use of tools specifically designed to predict the risk of misuse. Regular monitoring, psychological interventions, and urine drug screening will contribute to improve the compliance and outcome of long-term opioid use.


Pain in the immediate post-operative period after anterior cruciate ligament (ACL) surgery, apart from an unpleasant experience for the patient, can act as a barrier for static quadriceps contractions and optimum execution of the initial rehabilitation protocol resulting in slow recovery and a later return to full function for a sportsperson. There is no report in the literature comparing pain in the immediate post-operative period after using the two most widely used autografts, bone patellar tendon bone (BPTB) graft and hamstring graft.t test was applied to compare pain scores between the BPTB and hamstring cohorts.The present study compared the visual analogue scale (VAS) pain score in the immediate post-operative period after arthroscopic ACL reconstruction with the BPTB and hamstring autografts. Both groups consisted of 50 patients each. The mean age of the BPTB and hamstring cohorts was 26.9 ± 7.3 years (age range 18–59 years) and 26.7 ± 9.0 years (age range 17–52 years), respectively. Unpaired p value of 1, 0.665, 0.798, 0.377, 0.651 and 0.215 at 6, 12, 18, 24, 36 and 48 h, respectively).In the present study, patients in the BPTB cohort showed higher mean pain scores across all the post-operative time intervals except at 6 h. However, the difference in the mean VAS pain score at post-operative 6, 12,18, 24, 36 and 48 h in the two groups was statistically not significant (Our study concludes that the arthroscopic ACL reconstruction with BPTB autograft and hamstring autograft is associated with similar pain in the immediate post-operative period. As a result, aggressive physiotherapy regime is not affected by the type of graft being used for ACL reconstruction, as the pain scores in the immediate post-operative period are similar for both techniques.CTRI/2016/01/006502Clinical Trials Registry-India,  Pain in the immediate post-operative period, due to surgical trauma, can be an important barrier for starting an early rehabilitation programme after anterior cruciate ligament (ACL) reconstruction surgery, which can in turn delay the restoration of quadriceps contractions and range of motion at the knee joint. Additionally, the post-operative pain can result in an unpleasant experience of surgery for the patient. Whether there is any difference between the two most commonly used grafts for ACL reconstruction, the BPTB and hamstring grafts, in terms of pain in the immediate post-operative period, has not been reported in the international literature so far.The relative merits of these two autograft types have been extensively investigated in the long term. The BPTB autograft has the reported advantage over the semitendinosus-gracilis (STG) autograft of having bone plugs on each end of the graft that provide excellent fixation points for the graft-screw interface and rapid healing within bone tunnels –7. HowevThus, there is enough data in the literature comparing the results of ACL reconstruction using the BPTB and STG autografts. However, there is still no consensus regarding the superiority of one graft over the other , 14.The present study was designed to compare pain in the immediate post-operative period after arthroscopic ACL reconstruction by the same surgeon using hamstring tendon autograft and patellar tendon autograft while following a similar aggressive post-operative rehabilitation protocol in both groups. In this study, we hypothesized that the use of the STG autograft in ACL reconstruction is associated with less pain in the immediate post-operative period as compared to the BPTB autograft.After approval by the Government Medical College and Hospital ethics committee (Chandigarh) and obtaining written informed consent from all the patients, 100 male patients presenting with ACL tear were enrolled in the study. The diagnosis of ACL tear and associated injuries was based on clinical examination  and magnetic resonance imaging (MRI) of knee joint. Out of 100 patients, 50 patients underwent arthroscopic ACL reconstruction surgery using BPTB graft  and 50 pn = 50) or group B (n = 50). Allocation concealment was done using sequentially numbered coded sealed envelopes. In group A, ACL reconstruction was done by using BPTB graft, in which the size of the bone plug was 10 mm in all the patients. In group B, ACL reconstruction was done by using quadrupled STG graft.The study design was prospective, randomized and controlled. Using a computer-generated random number table, patients were randomly allocated to either group A (w/v bupivacaine in 8 % dextrose (hyperbaric solution) by an anaesthesiologist having more than 5-year experience in anaesthesia practice. No intravenous analgesics were given in the intraoperative period. The surgical and anaesthetic technique, post-operative rehabilitation and pain management were standardized in all the patients. The CONSORT flow diagram for the study is given in Fig. All the patients were administered subarachnoid block using 2 ml of 0.5 % After surgery, both groups underwent the same rehabilitation protocol. A long knee brace was applied to all patients. Isometric quadriceps exercises, knee bending and active straight leg raising were started on day 0 as per tolerance of pain by the patient immediately after surgery when the motor block of spinal anaesthesia had regressed and patients were encouraged to bear the full weight depending upon pain tolerance. Patients were advised to walk with a brace locked in full extension. In case any patient experienced severe pain, injection of tramadol hydrochloride (100 mg) by intravenous route was administered as rescue analgesia.In each patient, a generic unidimensional pain questionnaire with visual analogue scale (VAS) scores was recorded, starting at 6 h post-surgery , every 6 h for the first 24 h post-surgery and then every 12 h till 48 h post-surgery. The VAS used was a continuous scale comprising of a horizontal line, 10 cm (100 mm) in length, anchored by two verbal descriptors, one for each symptom extreme. For pain intensity, the scale was anchored by “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” (score of 10) on a 10-cm scale .t tests to compare pain scores between the BPTB and STG cohorts. All tests of significance were two-sided, and the results were considered to be significant at p < 0.05. For pain scores, we calculated 95 % confidence intervals (CIs) of the difference of the means.We performed unpaired p value = 0.146). All participants of the study were male patients.The mean age of the BPTB cohort was 26.9 ± 7.3 years (age range 18–59 years). The mean age of the STG cohort was 26.7 ± 9.0 years (age range 17–52 years). Both groups were statistically comparable with respect to age .The mean duration of surgery for the BPTB cohort was 55.46 ± 0.93 min (range 40–60 min). The mean duration of surgery for the STG cohort was 40.66 ± 0.64 min (range 30–50 min). The difference in the mean duration of surgery for the two groups was found to be statistically significant . The details of the mean VAS scores for the two groups over the 48-h post-operative period are as shown in Fig. Patients in the BPTB cohort showed higher mean pain scores across all the post-operative time intervals except at 6 h. However, the difference in the mean VAS pain score at post-operative 6, 12,18, 24, 36 and 48 h in the two groups was statistically not significant . However, additional data in terms of the total dose of consumption and the time to first dose of rescue analgesia should be recorded to make the data more credible.For the study, the major limitation is the use of tramadol hydrochloride to relieve pain. It was administered in a total of 12 patients amongst the two groups in the first 6 h only , and the use was comparable  being used for ACL reconstruction, as the pain scores in the immediate post-operative period are similar for both the techniques.ACL, anterior cruciate ligament; BPTB, bone patellar tendon bone; CI, confidence interval; MRI, magnetic resonance imaging; STG, semitendinosus-gracilis; VAS, visual analogue scale.