Pain is considered as an importantissue after cesarean section. Multimodal approach to post cesarean pain management may not only enhance analgesia but also reduce side effects after the surgery.This study was aimed to evaluate the clinical efficacy of subcutaneous injection of low dose ketamine at the incision site to reduce cesarean section pain.Sixty patients, aged between 18 and 25 years old, scheduled for elective cesarean section, were enrolled to this double-blind randomized controlled trial study. Patients were divided into three groups of 20 patients each group one (k-pre) received 0.5 mg/kg ketamine before skin incision and normal saline after skin closure, group two (k-post) received normal saline before skin incision and 0.5 mg/kg ketamine after skin closure and group three (C) received normal saline before skin incision and after skin closure; subcutaneously at the incision site. The first analgesic request, the amount of analgesic and the pain intensity were evaluated for 24 hours.The first time analgesic requested was longer and the amount of analgesic used during the first 24 hours was significantly lower in groups K-pre and K-post compared with group C (P < 0.05). Pain intensity was significantly lower at 2, 4, 6 and 12 hours in groups K-pre and K-post compared with group C (P < 0.05). Nevertheless, pain intensity was not significantly different at 18 and 24 hours in group C (P > 0.05). The first requested time, total used amount of analgesicand pain intensity were not meaningfully different in K-pre and K-post groups (P > 0.05).Patients who were given ketamine before or after cesarean section subcutaneously at incision site had lower pain intensity and less analgesic consumption than patients who were given placebo. Pain - a sensational and emotional experience due to tissue injury - is one of the most important reasons for the patients’ maladies after surgery. Many studies have shown that the use of analgesic drugs reduces the postoperative complications, however in most cases the pain is not controlled adequately -3. PostoThe studies have shown that preemptive pain control results in weakening afferent pain signals towards spinal cord, which appears to be far more effective than controlling the pain after its occurrence . There eThis study aimed to evaluate the analgesic effect of subcutaneous low dosage of ketamine at incision site before and after cesarean section under spinal anesthesia.This study was a double blind and prospective clinical trial that was conducted during the year 2013. The case and the control groups were all selected from patients being referred to Ahvaz Imam Khomeini Hospital in Iran. The approval was granted by Ethics Committee of Ahvaz Jundishapur University of Medical Sciences  and a written consent was taken from patients after providing them the detailed information of the steps, methods and drugs. The researcher was available there to answer the questions and the patients were allowed to leave the study whenever they decided. Sixty pregnant women aged between 18 to 25 years old with the inclusion criteria of first or second pregnancy and American Society of Anesthesiology class I (ASA I) who were candidates for elective cesarean section with Pfannenstiel incision were selected. The patients were divided into three groups of 20 persons on a random basis through a computer-generated list of random numbers. Patients had a known history of hypertension, hyperthyroidism, psychiatric disorders, chronic pain syndrome, allergy to ketamine, renal or hepatic insufficiency, seizure or intracranial hypertension and drug or alcohol abuse in the preceding six months. Notably, spinal anesthesia refusal was excluded. Electrocardiogram monitoring, pulse oximetry and blood pressure measurement were performed for the patients. All patients were hydrated with 10 mL/kg of Ringer’s solution. Then, spinal anesthesia was completed perform by 60 mg lidocaine 5%  in the sitting position with mid line technique and needle number 25 gauge  at L3-L4 level, after aspiration of 0.2 cc of the cerebro spinal fluid. After ensuring the neuraxial blockade at T4 dermatome based on needle’s tip sensation, in the first group (K-pre), 0.5 mg/kg ketamine , reached volume of 10 cc by normal saline, was injected subcutaneously in the same volume and within equal intervals at the incision site before skin cut. Again, another 10 cc of normal saline was injected subcutaneously with equal intervals and volumes at the end of the surgery and after skin closure.2 saturation and heart rate of the patients were monitored after spinal anesthesia with five minutes intervals. The patients received 5 mg ephedrine on the condition of O2 % fall of systolic blood pressure. Moreover, they would also receive 0.5 mg atropine if the heart rate reached less than 60 bpm. The related dosages would be repeated if needed.Given the second group (K-post), 10 cc of normal saline was injected subcutaneously before skin incision and 0.5 mg/kg ketamine with volumes of 10 cc administered at the incision site subcutaneously after skin closure. For the third group (C), 10 cc of normal saline was injected subcutaneously with the same intervals and volumes before skin incision and after skin closure. All the surgical incisions were started five minutes after the first prescription. It is worth mentioning that the gynecologists and the patients did not know about the group classifications. Same syringes 10 cc were used for all the cases and the drug was prepared by the anesthesiologist. Systolic and diastolic blood pressures, OAll the patients received six liters of oxygen per minute with a surgical mask. The systolic and diastolic blood pressure as well as heart rate of the patients were evaluated after sending them to recovery room. Patients were discharged from recovery room after the return of pain sensation level to T10 dermatome when they reacted to recognition of needle tip. After educating the patients, the intensity of the postoperative pain was surveyed at 2, 4, 6, 12, 18 and 24 hours after the beginning of anesthesia measured by V visual analogue scale (VAS) in which the minimum pain score is zero and the maximum is 10. Duration of the surgery was recorded as the first incision occurred until the last suture of the skin. The questionnaire was completed by the residents of anesthesiology who were uninformed of the drugs’ type. The patients received diclofenac if they had the VAS score of three or above . The first analgesic requested from the beginning of the anesthesia and the total needed amount of analgesic were recorded. The side effects such as dizziness, allergic reactions, nausea, vomiting and hallucination were evaluated in the recovery room at 2, 4, 6, 8, 12, 18 and 24 hours after the commencement of anesthesia.1 = 0.7, S2 = 0.5, X1 = 2.3, X2 = 1.5. But then again, for greater certainty, 60 samples were selected, 20 samples each group. Normal distributed statistical data mean ± standard deviation (SD) and non-normal statistical data were reported based on median ± IQR. Comparing the studied groups was accomplished by one-way ANOVA statistical test, and Tukey’s post-hoc test were used after analyzing normal distributed data. Kruskal Wallis, Mann Witney U-test and Alfa correction were also employed after analyzing non normal data. Bonferroni test was used for repeated data measurement. P value < 0.05 was considered significant. Statistical analysis was performed using SPSS version 16.Calculating the power of 95% and the confidence coefficient of 95%, the sample size was 16 in each group which were 48 samples in total by this formula: SIn this study, 60 patients were divided into three groups and there was no patient excluded: group received normal saline only (C), group with ketamine subcutaneously at incision site before surgery and skin incision (K-pre), and the group received ketamine subcutaneously at incision site after the surgery and skin closure (K-post). As shown in As depicted in The results of this study showed that the subcutaneous prescription of low dose ketamine (0.5 mg/kg) as antagonist of NMDA receptor before and after surgery can reduce the postoperative pain during the first 12 hours in comparison with receiving placebo. In addition, the subcutaneous consumption of ketamine before or after the surgery can not only delay the first analgesic request time but also reduce the total dosage of the analgesic compared with the control group. In this study, the drug types as well as the dosage of spinal anesthesia and local anesthetic were the same during all the stages; moreover, no opioid was used. Significant difference was seen in the patients’ pain intensity, revealing that the used amount of NSAIDs may be due to the subcutaneous prescription of ketamine in this study.In a similar study, Honarmand et al. maintains that the subcutaneus or intravenous prescription of 0.5 mg/kg ketamine before the incision effectively reduces the postoperative pain as well as the amount of opioid used in appendectomy . Dal et In the conduced study, there was no substantial difference in the rate of the postoperative pain and the total used analgesic between the two groups receiving ketamine before and after surgery which was the same as the results of Menigaux et al.’s study  regardinIn Kwok et al.’s study, no patient experienced problems caused by ketamine such as delusion, illusionand nightmare disorders due to the low dosage of intravenous ketamine (0.15 mg/kg)  similar


Motor function, rather than sensory function, is the primary concern for most brachial plexus surgeons. After root avulsions from the spinal cord, numbness in the affected limb may be associated with extreme, almost unbearable, intractable pain. Deafferent pain is the result of avulsion of the root from the spinal cord. Pain from the brachial plexus avulsion probably arises from the disinhibition of neurons within the substantia gelatinosa that fire spontaneously. The convulsive pain of the brachial plexus injury may correlate with the burst pattern of firing in lamina V also observed in higher levels of the central nervous system including the thalamus. It has been postulated that the lack of sensory input into the spinal cord leads to spontaneous discharges of the neurons in the dorsal horn, therebycausing pain.In our experience, one-third of patients with C5 and C6 root avulsion presented with pain on the dorsal radial aspect of the hand correlated with the superficial radial nerve distribution. Nerve transfer may inhibit abnormal electrical activity in the dorsal horn or higher levels of the central nervous system such as the thalamus by restoring the input to the damaged limb.In 2011 we described the technique “End-to-Side Radial Sensory to Median Nerve Transfer to Restore Sensation and Relieve Pain in C5 and C6Nerve Root Avulsion” in 8 patients. Six patients had S2 and 2 patients had S3. All patients perceived at least one number lower of the Semmes-Weinstein filament in the dorsal radial aspect of the affected hand compared with the preoperative status. The best result was perception of the 3.61 filament in 2 patients. No downgrading of the donor nerve was observed after surgery. All patients had relief of pain 2 weeks after surgery, and the pain decreased dramatically at the last follow-up.An interesting finding in our patients is that we observed no cross-misperception between the injured nerve and donor nerve territories. One hypothesis is that the induced collateral axons are specifically aimed to their new target reconnecting with the spinal cord neurons; another explanation is that there is an unknown mechanism of brain plasticity.Recently, we performed end-to-side median nerve into contralateral C7 transfer to relieve pain at the median nerve distribution area of the hand in late total arm type brachial plexus injury in 7 patients. All patients perceived at least 2 number lower of the Visual Analog Scale (VAS) for pain at the median nerve distribution area of the affected hand and at least 20% decrease in the PSRS compared with the preoperative status. The mean VAS was decreased from 7.8 to 4.1 and the mean PSRS was decrease from 28.4 to 17.5 at last F/U. No downgrading of the donor nerve was observed after surgery. None of the patients experienced any major complication. This nerve transfer could be an alternative method to treat refractory deafferent pain in total arm type brachial plexus injury without major complications.


Orchalgia is a common problem with varicoceles however the association between varicocele embolisation for the treatment of varicocele related pain has not been widely investigated. We aim to investigate the effectiveness of varicocele embolisation for the treatment of orchalgia secondary to varicoceles; and to see if pre-embolisation pain scores can be used to predict treatment outcomes.A prospectively collected database of patients undergoing varicocele embolisation for pain was analysed over a 10-year period. Pain scores were assessed with a 10-point visual analogue score. Analgesia requirements and satisfaction scores were assessed with questionnaires.Total of 96 cases. Median age was 34 years old. Median pain scores reduced significantly following embolisation (p < 0.001). 74% had reduced pain (30% of these had resolution of pain), 24% had no change in symptoms and 1% had worsening pain. Those with moderate or severe pain had a reduction of pain in 81 and 79% of cases respectively, however 64% of cases with mild pain did not experience any benefit. We also noted a reduction in analgesia requirements and a median satisfaction score of 8/10.Primary varicocele embolisation can successfully reduce varicocele related orchalgia. It works best in those with moderate or severe pain. The majority of patients with mild pain may not experience any benefit so should be counseled appropriately. The classification of patients into those with mild, moderate or severe symptoms prior to embolisation should be done, so robust consenting can be performed. Varicoceles are abnormal dilated and incompetent veins within the pampiniform plexus of the spermatic cord , 0 = no pain and 10 = worse possible pain. Patients were asked to describe their pain when it was at its least, its most typical and when it was at its worst. Based on the most typical response patients were stratified into four main groups, no pain (VAS = 0), mild symptoms (VAS = 1–3), moderate symptoms (VAS = 4–7) and severe symptoms (VAS = 8–10). Pre and post procedure data were compared. Analgesia requirements were assessed, with patients divided into four main groups . Post embolisation questionnaires were collected within 12 months of treatment.A total of 96 cases were identified. The mean age was 34 (17–75). 89% were located on the left side, 6% on the right side and 5% were bilateral. The mean number of coils used was 4 (2–8). The median time from embolisation to post operative questionnaire response was 12 months (95% CI).Post-embolisation median pain scores reduced significantly in all three pain cohorts  when compared to the pre-embolisation pain scores p < 0.001) The average post-procedure decrease in pain score in those with mild, moderate and severe pain was 1.2, 4 and 4.4 respectively.Post-embolisation analgesia requirements were reduced when compared to pre-embolisation analgesia requirements. Those patients who often/always took analgesia for pain pre-embolisation experienced either moderate or severe pain Fig. . VaricocMultiple studies have examined the role of varicoceles treatment for subfertility. However the primary treatment of painful varicoceles through embolisation has not been widely investigated. From our literature review this is the first study to report the relationship between varicocele embolisation and orchalgia. With varicoceles being relatively common and a significant number of these patients experiencing pain, we need to be able to advise our patients on the best chance of success with treatment.Standard management of patients with painful varicoceles would be a conservative approach, encompassing scrotal support and analgesia. If this fails then invasive treatments such as radiological embolisation or surgical ligation  are considered. To date the role of embolisation for varicocele related orchalgia has been unclear, particularly whether technically successful embolisation of the varicocele actually improves pain.We have demonstrated that varicocele embolisation can decrease scrotal pain in the presence of varicoceles with an overall reduction of pain in 74% of cases of which 30% were cured. This is relatively comparable with laparoscopic ligation  can accurately and reliably diagnose varicoceles and this is now regarded as the most robust investigation for diagnosing and grading varicoceles , compared to patients who had short-term pain of <3 months , which is comparable to the documented literature of 5 (Iaccarino and Venetucci In our review we have demonstrated that primary varicocele embolisation can decrease discomfort in those with symptomatic varicoceles, with an overall reduction of pain in the majority of cases. Patients with mild pain may not experience as much benefit as those with more severe pain. As such the severity of scrotal pain in the presence of varicoceles has been found to be an important independent prognostic indicator. Therefore the classification of patients into those with mild, moderate or severe symptoms prior to embolisation should be performed so robust consenting can be achieved.


Hallux valgus deformity is not a single disorder as the name might imply, but a complex multifactorial deformity of the first ray that is often accompanied by deformity and symptoms of pain even in the lesser toes. Research into foot pain has been limited by the lack of a clear understanding as a whole as to what constitutes foot problems. The aim of this study was to measure the effects of the combined Scarf and Akin’s osteotomy with or without 2/3 toe correction for Hallux valgus deformity at 6 months period. Outcome measures used were the pain scale (VAS) and the Manchester-Oxford Foot Questionnaire (MOXFQ).The study was a prospective design and included 30 patients aged 18 to 65+ years with painful bunions plus or minus lesser toe involvement with foot deformity in the study who went on to be treated by the above mentioned surgical procedure with normal heel postoperative weightbearing in a stiff soled surgical shoe during a 6 months period. Mean age of patients at the time of surgery was 59 years, 25 patients were female and 4 were male. History and physical pre-operative assessments  including outcome measures (VAS & MOXFQ) results were performed both at baseline and at 6 months. Post-operative management of the patients was as per normal guidelines set by the department of Podiatric Surgery following a reconstructive bunion surgery.The patient related outcome measures, VAS and the MOXFQ questionnaire for the cohort clearly showed statistical significances following foot surgery. The VAS pain scale domain, the median based on the post-surgical scores, was reduced to 0 (IQR 0) with a score change of -6 (IQR 3) (P<0.001). The MOXFQ pain domain, the median based on the post-surgical scores, was reduced to 5 (IQR 0) with a score change of -55 (IQR 27) (P<0.001). The MOXFQ walking and standing domain, the median based on the post-surgical scores was reduced to 0 (IQR 15) with a score change of -50 (IQR 28) (P<0.001). The MOXFQ social interaction domain, the median based on the post-surgical scores, was reduced to 0 (IQR 7) with a score change of -50 (IQR 25) (P<0.001). No post-operative complications were observed, only one patient was lost to post op follow up and her data was discarded.A combined Scarf Akin osteotomy with or without 2/3 toe is an effective procedure for the correction of symptomatic Hallux valgus foot deformity at 6 months. It permits early weight bearing of the treated extremity and it requires exact pre-operative planning and strict adherence to the operative technique if pain is to be effectively eliminated and the HRQOL restored with above satisfactory results.


Chronic pain places an enormous burden on health care systems. Multidisciplinary pain management services are well documented as an effective means to improve patient outcomes. However, waiting lists to access these services are long and outcomes deteriorate. Innovative solutions such as social media are gaining attention as a way to decrease this burden and improve outcomes. It is a challenge to design research that demonstrates whether social media are acceptable to patients and clinically effective.The aim was to conduct a longitudinal pilot study to understand what aspects of research design are key to the success of running a larger-scale study of social media use in the clinical management of chronic pain.A 12-week study examined social media use by patients on the waiting list for the Royal Melbourne Hospital Pain Management Service. Selected social media resources were suggested for use by patients waiting for an appointment at the clinic. Patients filled out measures for pain interference and pain self-efficacy before and after the study. Follow-up was conducted at monthly intervals via telephone semistructured interviews to discuss engagement and garner individual perceptions towards social media use. A social media-use instrument was also administered as part of the after-study questionnaire.Targeted recruitment refined 235 patient referrals to 138 (58.7%) suitable potential participants. Contact was made with 84 out of 138 (60.9%) patients. After a further exclusion of 54 out of 84 (64%) patients for various reasons, this left 30 out of 84 (36%) patients fitting the inclusion criteria and interested in study participation. A final study cohort of 17 out of 30 (57%) was obtained. Demographics of the 17 patients were mixed. Low back pain was the primary condition reported as leading to chronic pain. Semistructured interviews collected data from 16 out of 17 (94%) patients who started the trial, and at final follow-up 9 out of 17 (53%) patients completed questionnaires. Low specificity of the resources to one’s condition and time poorness may have been barriers to engagement.Results suggest that with refinements, this study design can be implemented successfully when conducting a larger social media study. At present, comment cannot be made on what effect using social media can have on patients on hospital waiting lists, nor whether those who use social media while waiting in pain achieve better outcomes from eventual participation in a chronic pain program. Long-term follow-up should be included in future studies to answer this. Future research should focus on multicenter randomized controlled trials, involving patients in the intervention design for improved participation and outcomes and for evidence to be sound. Chronic pain is one facet of chronic disease placing a significant burden on health care systems and individuals alike, through stigma, personal suffering, loss of income, and isolation. It is estimated to affect approximately 1 in 5 Australians and to cost the economy AUD $34 billion a year ,5.Specialized multidisciplinary team approaches and pain management programs are well-established forms of management  for the Barlow and colleagues describe self-management as the individual’s ability to manage the symptoms and treatment, as well as the physical and social consequences of lifestyle changes linked to living with a chronic condition . VariousInnovative and cost-effective strategies are recommended to alleviate the pressing need for self-management support ,10. Web-The success of Web-based resources may lie in their ability to provide individuals with a means to tailor management to their own needs, as well as a channel for support outside of traditional clinic hours ,11. ThisSocial media—sometimes referred to as Health 2.0 tools—provide an innovative approach to Web-based resources. Unlike general Web-based interventions, social media are characterized by more highly evolved platforms that allow enhanced user engagement and autonomy, as well as greater social functionality and interaction ,15. ThisStudies have examined social media use in chronic pain -21. HoweTherefore, the aim of this pilot study was to understand what aspects of research design are key to the success of running a larger-scale study of social media use in the clinical management of chronic pain.The methodology of this pilot study aligns with previous research into the therapeutic affordances of social media in PWCP -27. ThisThe setting chosen for the study was the Royal Melbourne Hospital—Pain Management Services (RMH-PMS). The Royal Melbourne Hospital (RMH) is a large publicly funded hospital in Melbourne, Australia. It offers one of the most comprehensive outpatient pain management services in the country. RMH-PMS has between 900 and 1100 outpatient referrals per year. At any one time, there are from 200 to 300 PWCP on the waiting list, and they have a wait time of 6 to 8 months for a first appointment. RMH-PMS provides an ideal context in which to test a social media intervention.The Human Research Ethics Committees of Melbourne Health and the University of Melbourne approved this study (ID No. 2014.043). During the review of the project, the ethics committee specifically considered the following areas of study design:1. The sample: comments were made about representativeness and selection of the sample, as well as the impact using social media may have on expectations of patients for management of their condition.2. Social media resources: feedback centered on anticipated outcomes and what impact social media would have on participants’ conditions. Queries related to the appropriateness of the resources, who would be responsible for the content, and monitoring the resources.3. Logistics and staff allocation: this covered staff and time required to recruit, to manage participant numbers during the study, to collect data, and to conduct follow-up.The sample pool consisted of patients with chronic pain—pain of greater than 3-months duration ,30—on thA clinically relevant sample was sought. Desired cohort size for this study was estimated based on the following factors: participant numbers used in pilot studies within a similar domain -38, the priority 2 were sourced from the RMH-PMS Direct Access Unit referrals database. Priority 2 includes patients receiving support via a primary care practitioner while waiting for a consult at RMH-PMS. Referrals are received from general practitioners in the local area, community health centers, other medical specialists, and internal referrals from RMH. Each referral was reviewed for preliminary suitability by two of the study’s investigators who met nine times between April and September 2014. Potentially suitable participants were flagged based on matching information recorded in their referral with study inclusion/exclusion criteria . Recruitment was conducted via phone calls from July to September 2014. The people reached were advised of typical waiting list times and introduced to this study as a self-management strategy available in the meantime. The phone transcript can be found in Potential patients classified as Interested patients were emailed with a link to the study website and a unique identifier. The link led to SurveyMonkey—an online survey site—where the study information, consent form, and pretest questionnaire were hosted. After 1 week, follow-up phone calls were made to discuss the study, determine suitability, confirm Internet competence, and to ensure the prestudy questionnaire was submitted to confirm registration in the study. Once registered, contact was made to discuss final details and educational material was emailed that contained links to the suggested social media resources and instructional videos—filmed by the study’s primary investigator—to act as an introduction to the resources and provide instructional information for using the resources. The educational material can be found in Patients who were ineligible to participate in the study were provided with information about online resources  if theyEach enrolled patient completed the intervention over 12 weeks and because recruitment was staggered, some commenced at different points in time. The entire intervention period ran from July 24 to December 5, 2014. Waiting list time is typically between 6 and 8 months with specialist preclinic pain education provided close to the medical admission appointment. Therefore, treatment was not delayed by completing this study. No incentives were offered to participate. It was also explained that the study was a pilot study and that participant feedback may help to shape future consideration of social media resources for the RMH-PMS.Patients were informed that the intervention consisted of using the suggested social media-based pain management resources in an unrestrained fashion over the allotted time period. Patients were asked to interact with these at their own pace. They were given the autonomy to be selective as to which they interacted with and how. Of interest was the impact that use might have on their condition and on their understanding about pain management, and finally, to know how they interacted with the resources—this would be examined during monthly semistructured interviews that will be described further.The social media resources incorporated into this study included a large chronic pain support community on Facebook, a selection of chronic pain blogs, and pain management YouTube videos filmed by painHEALTH. Further detail about these resources and their selection for this study can be found in Pre- and postintervention data were collected, as well as data collected at monthly intervals during the study. To start, participants completed a questionnaire on SurveyMonkey that amalgamated demographic information, chronic pain status, and patient-reported outcome measures (PROMs)—pain interference and pain self-efficacy—into one survey see . PatientPain interference (PI) is an example of a regularly examined standardized outcome that measures the burden on an individual across a wide range of health-related quality-of-life (HRQOL) measures ,40. PI wefficacy determines the effort and persistence an individual will apply when faced with hurdles and adverse experiences. Like PROMIS-PI, the PSEQ provides a means to overcome inconsistency and generalizability among previous existing legacy measures covering a range of general behaviors and activities, and directly contextualizes self-efficacy in regard to living with pain [Pain self-efficacy (PSE), or confidence in one’s ability to perform certain tasks in the face of pain, was measured using the 10-item Pain Self-Efficacy Questionnaire (PSEQ) . Social ith pain ,42. SimiAt the end of the study, patients were guided to a second SurveyMonkey questionnaire that amalgamated all PROMs (PROMIS-PI and PSEQ) and a social media-use instrument into one survey see . The socAt monthly intervals during the intervention period, patients were also contacted on the phone by the primary investigator to complete a brief 10- to 15-minute, semistructured interview see . Semistrinductive phenomenological approach on the semistructured interview data to uncover any emergent themes.Major study design procedures and the study process are the focus of the results described. Brief descriptive statistics of pre- and posttest survey data are also presented. Pertinent to the study was the examination of barriers to engagement with the resources and intervention. To explore these, thematic analysis was employed using a grounded theory Deductive coding of semistructured interviews was also conducted to categorize patient comments against our list of five therapeutic affordances: self-presentation, connection, exploration, narration, and adaptation. These results will be the subject of a separate manuscript.t tests and Fisher's exact test. In order to compute the PROMIS-PI data, raw scores were first translated into a T score for each patient. The T score rescales the raw scores into a calibrated and standardized score with a mean of 50 and standard deviation of 10. The value of hypothesis testing is limited due to the small sample size and given that potential covariates such as gender, age, and educational level were not able to be stratified [Furthermore, the posttest PROMs were analyzed using paired ratified .During nine rounds of referral screening at RMH-PMS Direct Access Unit, 235 referrals were examined for suitability. A total of 138 out of 235 (58.7%) were deemed appropriate for possible study inclusion. A total of 55 out of 235 (23.4%) were inappropriate for inclusion based on priority status for medical intervention and/or medical status, planned discharge, psychological status, drug-seeking behavior, and/or cognitive impairment. A further 42 out of 235 (17.9%) were from non-English-speaking backgrounds (NESBs) and, thus, inappropriate for this particular study see .self  or external . self-exclusion were as follows: no interest in participating and no connected devices. External reasons for exclusion included the following: patient moved to priority treatment, medically inappropriate, and non-English speaking.This process left a total of 30 out of 84 (36%) patients fitting the inclusion criteria and interested in study participation. All 30 patients were emailed the study information for registration purposes; this process yielded a final study cohort of 17 out of 30—indicated in blue in Demographics are presented in Enrolled patients were asked to provide information about their chronic pain. A total of 9 out of 17 (53%) patients reported a duration of chronic pain between 1 and 5 years; 7 out of 17 (41%) reported pain duration of greater than 5 years. Low back pain was the primary ailment reported —defined as upper/middle/lower back pain—whereas 3 out of 17 (18%) patients reported hip/leg/foot pain as their primary pains. Various offline treatment modalities—in the last 12 months—for pain management were noted. Doctor’s visits  and medication  were most reported. Physical therapies  were next , followed equally by exercise classes and relaxation/meditation , and finally, psychology/counseling . Other free-text responses also highlighted acupuncture and walking.flared or stable at the time of the study. The majority  reporting flared, with 12 out of 17 (71%) patients reporting average day-to-day pain at a level of 6 to 7 out of 10 . Patients were also asked to indicate whether they had been formally diagnosed with a condition causing their pain and 10 out of 17 (59%) indicated this was the case. Fibromyalgia  and osteoarthritis  were most noted. Other recorded conditions included, but were not limited to, posttraumatic stress, temporomandibular joint syndrome, sciatica, and low back pain.Each patient was asked whether their pain was Out of 17 patients, 16 were contactable, supplying data for this study (94% success rate).A total of 12 patients out of 17 (71%) reported using the resources during the study. Based on the number of times each patient could be reached on the phone to collect data (n=38) and call durations of 15 minutes, on average, it is approximated that a rich dataset of 570 minutes or 9.5 hours of qualitative interview data was collected.Study completion rate was calculated based on the number of completed posttest questionnaires received. Despite the success of the semistructured interviews, 9 out of 17 completed posttest questionnaires were received, giving a study completion rate of 53%. Out of 17 patients, 1 (6%) dropped out between study enrolment and first feedback phone call, 1 (6%) withdrew before final follow-up as she reported no longer needing pain management services, 2 (12%) submitted the final questionnaire but reported not having used the resources , and finally, 4 (24%) failed to submit the posttest questionnaire despite several attempts to contact them. No contact by patients was attempted during any phase of data collection requesting assistance completing the surveys. This satisfied the research team that the data collection tools were acceptable.time poor and low specificity of resources to one’s condition were most noted. Effects of medication was also highlighted; patients noted that this was due to their sedative effect and/or impact on concentration. Only 2 out of 17 patients (12%) suggested access to the Internet was an issue.Coding of the semistructured interview data yielded eight separate engagement themes see . Based olow specificity of resources. According to Patient SM021, “I have a more localized pain condition and most of the resources were for generalized conditions so I had trouble relating to many of them.” This was echoed by Patient SM112, who stated, “I think that because they weren’t about my pain and there were none about the pain I was going through I found it not very useful.”Some of these barriers were also identified in the free-text responses of the posttest survey, for example, The aim of this study was to examine the pilot-testing of social media use with patients in the clinical setting, focusing on major aspects of the study design. The study also produced evidence to support social media use and PROs from earlier studies ,27. HoweThe use of mixed methods in eHealth research is often advocated -48. ThisBy combining empirical PROs data from PROMIS-PI, PSEQ, and from the social media-use instrument with the qualitative semistructured interview data and free-text responses about social media use from the posttest survey, a rich dataset was obtained. This becomes particularly useful with a small sample size, such as the one in this study. It helps to cross-validate findings and strengthen converging inferences .Collecting empirical data about social media use was able to corroborate semistructured interview data. Similarly, data collected regarding patient perceptions toward each of the five therapeutic affordances of social media helped validate findings from a global online survey of PWCP ,27. ThisThe recruitment procedure used in this study was extensive and demonstrates a targeted method aimed at recruiting the most suitable clinical cohort that might benefit from the intervention. It is the belief of the research team that the method for recruiting such a targeted cohort in this study is appropriate and would be scalable in a larger-scale randomized controlled trial (RCT) study. This is because the aim was to refine the most suitable cohort required to test the effectiveness of social media to positively impact PROs. This was not a study of readiness to adopt social media. A similar targeted approach has been seen in other pilot studies within a similar study domain ,36,50.However, targeted recruitment does highlight pertinent ethical considerations, such as “representativeness and selection.” Internet access and English language problems were two considerations noted from the RMH-PMS population. Similarly to this study, most social media interventions target Internet-competent, social media-using participants and/or people thinking about engaging in health behavior change ,51,52. WDemographic characteristics predicting participation in social media or other Web-based interventions for chronic disease management are also interesting and relevant. This has traditionally been skewed towards well-educated females of a relatively high socioeconomic status. Marital status and age are more varied but studies are typically slanted toward those in relationships/married and aged 30 to 60 years -55. Litebarriers to engagement, may have been low specificity of resources to one’s condition and lack of time to use the resources.According to Sheaves et al , the stuThe semistructured interviews conducted monthly by telephone were an important tool in understanding reasons for engagement or nonengagement above. In contrast to overall completion rate, results showed that 94% (16/17) of patients were able to be engaged by phone. This enhanced collaboration between patients and the research team and placed greater emphasis on patient preferences and perceptions about using social media for their self-management. In other studies, such as that of Sheaves et al , email wAs noted from patient feedback, low specificity of resources to one’s condition negatively influenced engagement. It has been reported that often those living with chronic conditions have multiple comorbid manifestations and, hence, Web-based resources can fail to cover enough of their individualized needs for them to be deemed of significant value . As coulSuggesting certain social media resources as a starting point was done to provide some element of quality control and uphold ethical standards of care. However, freedom was encouraged for patients to use the resources as they wished and explore different avenues using the social media resources. Unlike many earlier studies conducted in this space, the aim of the present study was to more closely replicate social media use in day-to-day life  rather than to create a specific online intervention that dictates exactly what patients engage with and how they engage with it.Finally, facilitated engagement of social media interventions, or involvement of clinicians, has been reported as another positive way to improve participation and intervention adherence. In turn, this has a positive flow onto PROs ,20,53-55The foremost strength of this pilot study lay in the intervention design. The choice was to encourage participating patients to be more autonomous and decide on which social media to use and how to use them as part of self-management. This breaks away from conventional Web-based intervention design based on constrained, predefined online interventions. As discussed, this idea fits within a participatory model, suggesting, not prescribing, a Web-based intervention. It places greater weight on patients’ perceptions and preferences for health self-management online.Web-based interventions in chronic pain traditionally collect data using several disparate PROMs. As seen and described in Buhrman et al , the decRCT designs are synonymous with robust health research. This method is strongly advocated in trials of effectiveness and has been employed in other Web-based chronic pain studies ,50. HoweThe decision to merely suggest social media resources, but allow patients to make their own decisions about which to use, meant that the resources patients actually used were not able to be verified. PROs collected may be in reference to a variety of social media resources, both reputable and not. Thus, study findings are open to interpretation bias. This is one of the reasons that emphasis is not placed on posttest PROMIS-PI and PSEQ findings in this study.There is a trade-off between targeted recruitment of competent and enthusiastic social media-using chronic pain population members and ensuring all chronic pain patients who may benefit from social media can participate. Until social media interventions can better address the needs of chronic pain patients who suffer from a lack of Internet access, poor literacy skills, poor Internet literacy, and language barriers, they will always be biased toward self-selecting populations. Hence, any conclusions drawn from this pilot study regarding recruitment, intervention design, and engagement are in reference to the current sample only.Other pilot studies ,33 have This pilot study has outlined key considerations for conducting social media interventional research in the clinical setting, in particular, study design, recruitment, and engagement.Targeted recruitment of social media users indicates that enthusiastic, competent social media users may be still largely underrepresented on pain management services’ waiting lists. Therefore, these interventions may not yet be appropriate for all PWCP. Further work is required to ensure that those in need of online support will also be catered to by social media’s integration into clinical service models. In line with recommendations by Sheaves et al , future As patients become increasingly connected and active shared decision makers in their self-management, researchers would be advised to pay close attention to study designs that give patients greater flexibility and empower them to make decisions about the online resources they use. This is where the potential for social media sits above traditional Web-based interventions. Social media resources must actively engage patients as seen in this study. Finally, acknowledging patient preferences for resources that adequately address disease-specific needs is also a consideration.Future research into the effectiveness and potential for social media use in the clinical management of chronic pain is warranted. While this study cannot ascertain what effect the use of social media resources can ultimately have on hospital waiting lists, a considered approach to conducting this type of research has been offered. Future studies need to focus on larger-scale, multicenter RCTs and involve patients in the intervention design in order to achieve desired effect sizes and for evidence to be sound.


P < 0.001). The impairment of exercise tolerance could be reduced from 7 to 2 points (P < 0.001). The duration of treatment was 6.3 (SD: 4.3) days on average. The FDM therapy is a potential effective method for acute treatment of MTSS.Medial tibial stress syndrome (MTSS) is a common problem among athletes and soldiers. There is no proven theory that could explain the pathophysiology of shin splints. The therapies described so far are time-consuming and involve a high risk of relapse. The method according to the fascial distortion model (FDM) addresses local changes in the area of the lower leg fascia. It is suited to reduce pain and functional impairments associated with this symptom complex by applying targeted manual techniques. 32 patients  participated in this study. Visual analogue scale (VAS) was used for the quantification of pain. Scores were also given to rate the maximum painless exercise tolerance of the patients. Subsequently treatment of the crural fascia was performed. Patients retested ability of running and jumping. Therapy was continued until full exercise tolerance or painlessness was reached. A significant reduction of the VAS pain score from 5.2 to 1.1 could be achieved ( In 1966 the term “shin splints” was defined by the American Medical Association in the “Standard Definition of Athletic Injuries.” At that time, the definition was as follows: “pain and discomfort in the leg from repetitive running on hard surfaces or forcible extensive use of flexors…” . Various“Gold standards” exist for stress fracture and exertional compartment syndrome. There is a lack of a “gold standard”—particularly for soft tissue injury . TreatmeThe treatment method derived from the fascial distortion model is based on an anatomical model and was introduced by Typaldos . During The treatment of fascial distortions is based on targeted manual techniques which are to be described as nonspecific. Therapeutic success was described for shoulder pain, in particular for the management of frozen shoulder , 23. In 2. The study included patients who were diagnosed with MTSS, because they showed the typical symptoms of pain following exercise as well as tenderness of the anterior or posterior medial and lateral anterior surfaces of the tibia [A total of 32 patients  participated in the study. The patients were soldiers who participated in sports courses at the Bundeswehr Sports School in Warendorf. The study was approved by the Ethics Committee of the University of Muenster (Ref. no. 2012-200-f-S). On average, the patients were 26.3 ± 4.1 years old, weighed 80.9 ± 10.4 kg, and were 1.79 ± 0.07 m tall. Their average BMI was 25.3 ± 2.6 kg/mhe tibia . In someThe quantification of pain was based on the visual analogue scale (VAS). The patients rated the intensity of their pain on a scale with numerical values between 0 (no pain) and 10 (the strongest pain imaginable). Painless running for defined periods of time or courses was used to quantify exercise tolerance . We had The patients were asked to indicate the location of pain. The diagnosis was derived from the body language and the description of the patient, using the fascial distortion model according to Typaldos . The MTSSubsequent to diagnosis, the patients were informed about the therapy according to the fascial distortion model. The patients who had decided to undergo this therapy were treated after signing the declaration of consent. Prior to that, they were asked to indicate their current exercise tolerance according to the scoring matrix. Here they were asked what distance they were able to run and if running or even walking was impossible. Further they were asked at what speed they were able to run. The third dimension was the ability to jump. They had to decide if jumping was possible or not and if there was slight or severe pain. High levels were addicted to high limitation. The value of each dimension is shown in P values were two-tailed and a P value < 0.05 was considered significant. Data were stored and analysed using SPSS 15.0 software .The statistical description included the determination of maximum, minimum, mean value, and standard deviation. The statistical evaluation and significance test were performed by using the Wilcoxon test. All The average duration of treatment was 6.3 (±4.3) days. On average, four treatment sessions (±2.0) were performed until the therapy was terminated. One patient quit the study at his own request.P < 0.001; P < 0.001; During the course of the therapy, the average level of exercise-induced pain on the visual analogue scale (VAS) could be reduced from 5.2 ± 1.5 points to 1.1 ± 1.7 points (end of treatment)  to 2.1 (SD ± 2.8) (The results of this clinical study show that the treatment method according to the fascial distortion model is a quick and effective option to relieve patients of pain and restore their exercise tolerance. In comparison Andrish et al. randomised 97 military recruits with MTSS into 5 groups to determine the effects of rest and ice, aspirin, phenylbutazone, calf-stretching, and plaster casting . RecoverHowever, the therapy according to the fascial distortion model proved to be superior to other physiotherapy methods in the management of shoulder pain syndromes , 23. The


Although results of case series support the use of spinal cord stimulation in failed back surgery syndrome patients with predominant low back pain, no confirmatory randomized controlled trial has been undertaken in this patient group to date. PROMISE is a multicenter, prospective, randomized, open-label, parallel-group study designed to compare the clinical effectiveness of spinal cord stimulation plus optimal medical management with optimal medical management alone in patients with failed back surgery syndrome and predominant low back pain.Patients will be recruited in approximately 30 centers across Canada, Europe, and the United States. Eligible patients with low back pain exceeding leg pain and an average Numeric Pain Rating Scale score ≥5 for low back pain will be randomized 1:1 to spinal cord stimulation plus optimal medical management or to optimal medical management alone. The investigators will tailor individual optimal medical management treatment plans to their patients. Excluded from study treatments are intrathecal drug delivery, peripheral nerve stimulation, back surgery related to the original back pain complaint, and experimental therapies. Patients randomized to the spinal cord stimulation group will undergo trial stimulation, and if they achieve adequate low back pain relief a neurostimulation system using the Specify® 5-6-5 multi-column lead  will be implanted to capture low back pain preferentially in these patients. Outcome assessment will occur at baseline (pre-randomization) and at 1, 3, 6, 9, 12, 18, and 24 months post randomization. After the 6-month visit, patients can change treatment to that received by the other randomized group. The primary outcome is the proportion of patients with ≥50% reduction in low back pain at the 6-month visit. Additional outcomes include changes in low back and leg pain, functional disability, health-related quality of life, return to work, healthcare utilization including medication usage, and patient satisfaction. Data on adverse events will be collected. The primary analysis will follow the intention-to-treat principle. Healthcare use data will be used to assess costs and long-term cost-effectiveness.Recruitment began in January 2013 and will continue until 2016.NCT01697358 Clinicaltrials.gov:  Following lumbosacral spine surgery, between 5 and 50% of patients suffer from chronic back and/or leg pain, commonly known as failed back surgery syndrome (FBSS) ,2 and chTreatment of FBSS pain by further operations or medical management is often unsuccessful and places a heavy economic financial burden on healthcare systems ,3. In coThe effective targeting of the back pain component of FBSS remains a challenge -13. OngoThe PROMISE study is a RCT comparing the clinical effectiveness of SCS using the Specify® 5-6-5 surgical lead  plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to FBSS. After the 6-month visit, patients can change treatment to that received by the other randomized group. All patients will be followed for 24 months post randomization.The primary objective is to determine the difference in the proportion of patients receiving SCS plus OMM versus the proportion receiving OMM alone who have ≥50% reduction in back pain intensity, as measured by the Numeric Pain Rating Scale (NPRS), from baseline to 6 months. Secondary objectives are to compare changes in the following outcomes from baseline to 6 months between the two groups: low back pain intensity, as measured by the NPRS ; leg paiThis protocol is reported in accord with the SPIRIT 2013 guidance for protocols of clinical trials .This multicenter study has an open-label, randomized, parallel-group design. Patients will be randomized 1:1 to SCS using the Specify® 5-6-5 surgical lead  plus OMM (SCS group) or to OMM alone (OMM group) and followed for 6 months . After completion of the 6-month (Period I) outcome assessment, patients will be systematically reminded (through electronic tablets used for questionnaire completion) that they have completed the randomized period of the study and can change treatment to that received by the other randomized group. Reasons for treatment switching will be recorded. Patients will be followed to 24 months post randomization .The trial will be conducted at approximately 30 investigative sites globally, with approximately 15 to 20 sites in the USA and 10 to 15 sites in Europe and Canada. Additional locations may be added during the course of the study. No single center can exceed 10% of all randomized patients. The study design is summarized in Figure The study population comprises patients suffering from chronic low back (predominant) and leg pain due to FBSS. A patient must meet all of the inclusion criteria and none of the exclusion criteria to be eligible for the study.The subject is a candidate for SCS with the multicolumn Specify® 5-6-5 surgical lead  as assessed by the baseline NPRS; is suspected by the investigator of substance abuse that might confound the study results; has unresolved major issues of secondary gain, as determined by the investigator; exhibits major psychiatric morbidity, untreated or refractory to treatment as determined by the investigator; has consistent severe pain  without fluctuation, which might confound the results of this study; has radiographic evidence of instability requiring fusion; has pain relieved completely by recumbency ; has a serious neurologic deficit; has a history of coagulation disorder, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis, or ankylosing spondylitis; has calcific arachnoiditis; has severe thoracic stenosis; has life expectancy < 24 months beyond study enrolment; is <18 years of age; is pregnant or planning to become pregnant during the course of the study; is enrolled in or plans to enroll in any study that might confound the results of this study; would be unable to operate the SCS equipment, based on the opinion of the principal or sub-investigator; is unwilling to be treated with SCS, attend visits as scheduled, and/or comply with study requirements; is unable to undergo study assessments or complete questionnaires independently ; and is a member of a vulnerable population.A screening log will be kept at each site to identify potential subjects. All FBSS patients identified through standard clinical practice at the site  will be listed on the screening log. Potentially eligible subjects will be provided with detailed information about the study including a description of SCS and of OMM.A patient is considered enrolled in the study upon completion of the informed consent process. Enrolled subjects will be taught how to complete a pain diary between the enrolment visit and the randomization visit. The subject will record his/her low back and leg pain scores during a 7-day pain diary period prior to randomization. Subjects will not be told what confirmatory pain scores are required for study inclusion. The inclusion criteria of average NPRS score to assess low back and leg pain will be evaluated after the subject completes the pain diary. Candidacy for SCS with the Specify® 5-6-5 implant will also be confirmed based on appropriate imaging according to usual practice. In addition, where a psychological evaluation  is standard of care and/or required, the evaluation must take place prior to randomization. The principal investigator will document whether the patient has received the required evaluation and the results of that evaluation. FBSS diagnosis will also be confirmed based on appropriate imaging according to usual practice.The principal investigator or his/her designee will review the diary to confirm that the pain intensity scores and pain location meet the inclusion/exclusion criteria (see above). In addition, the principal investigator will document that the patient is a candidate for implantation of a Specify® 5-6-5 SCS system. Upon confirmation of eligibility, OMM treatment planning and completion of the questionnaires, subjects will be randomized to one of the two treatment groups. Subjects who do not complete or meet preliminary eligibility requirements will not be randomized and will be exited from the study.Pain treatment will be evaluated, and medical management of patient’s pain will be optimized in both arms. As part of the confirmation of eligibility (prior to randomization), the investigator and subject will determine an individual OMM treatment plan, which should include non-investigational pharmacologic agents  and/or interventional therapies  as appropriate. The following treatments are excluded from OMM: intrathecal drug delivery, peripheral nerve stimulation (not an approved indication in the United States), back surgery at the location related to the patient’s original back pain complaint, and experimental therapies. Data regarding pain treatments implemented during the study will be collected to reveal how medical management was optimized. After randomization, as well as at all scheduled follow-up visits, the subject and physician will further discuss OMM to determine the best course of continued action.In addition to OMM, patients randomized to the SCS arm will undergo an SCS screening test (3-day minimum). The screening test may be conducted with the Specify® 5-6-5 surgical lead or with a percutaneous lead(s). If successful, a SCS system will be implanted. A screening test will be determined to be successful if the subject finds the feeling of paresthesia acceptable and has adequate low back pain relief with usual activity and appropriate analgesia as assessed by the physician. Physicians can consider a conducting second screening test with the Specify® 5-6-5 lead if a screening test with a percutaneous lead led to inadequate paresthesia coverage of low back pain and/or painful extraneous stimulation . The final system implanted will consist of a Medtronic pulse generator (rechargeable or primary cell) and a Specify® 5-6-5 surgical lead. Subjects should receive their permanent implant within 60 calendar days from randomization. They will be programmed to their optimal programming parameters and will be able to adjust their stimulation with the patient programmer, within the settings programmed in the clinic. Subjects will be provided with a patient programmer manual and will be instructed on the proper use and handling of the patient programmer. Subjects who fail the screening test (and do not proceed to implant) will be followed in the study according to the principles of intention-to-treat analysis.Outcome measures selected for this trial are based on a review of the previous RCTs of SCS and a consideration of IMMPACT recommendations .The day of randomization is day 0 for the study periods. Subjects will be assessed prior to randomization (baseline) and at 1-month, 3-month, 6-month, 9-month, 12-month, 18-month and 24-month follow-up visits. Visit windows for Period I and Period II will remain constant based on the original date from the randomization visit, regardless of whether any change in therapy occurs. Assessments will be performed by appropriately trained and delegated study staff according to the usual practices of the site. Electronic case report forms will be used for this study with patients completing the study questionnaires confidentially on electronic tablets, and these data will be uploaded to a web-based server. Table The primary outcome is the proportion of subjects with ≥50% reduction in low back pain intensity measured using the NPRS at 6 months . Pain reSecondary outcomes are: Back and leg NPRS score ; OswestrOther outcomes include: Mental Component Summary score on Short-Form 36 ; EuroQoLAt the screening and baseline visits, the following additional information will be collected: subject demographics  and a neuropathic pain assessment by clinician-administered diagnostic questionnaire (Douleur Neuropathique en 4 questions) to discriminate neuropathic pain components of low back pain . SubjectBased on the results of the PROCESS study , with thA single interim analysis is planned after 140 randomized subjects reach the end of Period I. This analysis will provide data to support a decision to re-estimate the sample size if necessary in order to achieve conditional statistical power of at least 90%. For planning and simulation purposes, a ceiling of 400 randomized patients is imposed for the final analysis.n = 212); or increase the sample size to a specified size in order to achieve ≥90% conditional power to achieve superiority based on the observed interim results.Enrolment, randomization, and follow-up will continue during the interim analysis. The interim analysis will be conducted by an independent statistician, and one of the following possible outcomes will be communicated to the trial sponsor: continue the study with a total of 212 subjects ; however, to minimize potential assessment bias, questionnaires will be completed by patients without study staff consultation or visibility, using a secured electronic tablet.To minimize attrition bias, if a subject misses a study visit the site’s study staff will make at least three documented attempts to bring that subject in for a study visit. The numbers and reasons for dropouts and losses to follow-up will be reported for each arm of the study.To quantify potential performance bias, the level of OMM treatment and the addition/removal of SCS therapy for all participants at each follow-up to 24 months will be recorded. Additionally, we will compare changes in pain medication use and other healthcare utilization from baseline to the end of Period I for subjects in the SCS group with those in the OMM group. Any imbalance in OMM therapy between study arms will be considered in interpreting between-group outcome differences.For primary and secondary objectives, the primary analysis method will follow the intention-to-treat principle supported by completers’ and as-treated analyses. The following definitions will be applied: intention-to-treat analysis, between-group comparison based on random allocation of all subjects at the 6-month visit; completers’ analysis, between-group comparison based on random allocation of subjects with complete data at the 6-month visit; and as-treated analysis, between-group analysis based on the treatment subjects with complete data at the 6-month visit received at the 6-month visit.Z-test using unpooled standard deviation with continuity correction, and a logistic regression model will be used for exploratory analysis. Secondary objectives will be assessed using linear regression models. To assess potential differences in treatment effect across sites, a treatment-by-site interaction term will be added to models. If the treatment-by-site interaction term approaches significance , the teThere is no compelling evidence of patient-related  factors that predict the outcome of SCS; however, in order to identify baseline characteristics that might have predictive effects on outcomes, exploratory analysis with regression models may be conducted including baseline covariates. For the analysis of secondary objectives, baseline assessments for pain score and the Oswestry Disability Index will be included in the regression models as covariates.Missing data are a potential source of bias. A rigorous study design and execution will help prevent the incidence of missing data from occurring. For the primary objective, patients with missing data at the end of Period I will be treated as nonresponders (failures). With this approach, we assume that nonresponders in both treatment groups have no change in their outcomes compared with baseline. This method has been chosen over more complex imputation methods, such as multiple imputation, because it has been empirically demonstrated in trials of chronic pain to produce conservative treatment effects . For thePeriod II is the long-term follow-up phase, which includes the possibility for patients to change from their original treatment assignment to the alternative treatment. The objectives of Period II are to compare within-patient changes  in each group. Because the study design allows patients to change from the randomized treatment group to the alternative treatment after 6 months of follow-up, the analysis of objectives in Period II will be based on the treatment patients actually received and not on the randomization assignment. Only completers will be included.P values will be reported. To maintain an overall type I error rate at 0.05, a fixed-sequence method for the multiplicity adjustment of hierarchical endpoints will be used to test the primary and secondary objectives. No multiplicity adjustment will be performed for evaluations of the additional study objectives. A validated statistical software package will be used for the analyses of the study results . These analyses are detailed in a statistical analysis plan.Unadjusted Economic analyses consider the costs and effectiveness of treatments. Costs will be calculated by multiplying units of healthcare use used by the cost of each unit. Effectiveness will be expressed as quality-adjusted life-years, with these data derived from patients’ responses to the EQ-5D-5 L.A within-trial cost-consequence analysis will include a disaggregated report of costs and quality-adjusted life-years and of other health outcomes observed in the two groups at 6, 12, and 24 months . Cost utEach investigation site’s Ethics Committee/Institutional Review Board (EC/IRB) will be required to approve the clinical investigational plan (CIP), the written patient information and consent form, any other written information to be provided to the patients, and, if applicable, product labeling and materials used to recruit patients. EC/IRB approval of the study must be provided in the form of a letter before commencement of the study at the investigation site. Site EC/IRB approvals at the time of submission 3 July 2013) of this protocol are listed in Additional file 013 of thEach principal investigator will ensure that no study-related activities occur prior to EC/IRB approval and will provide adequate oversight to ensure that the study is conducted in accordance with the outlined standards. Study conduct will be in accordance with the ethical principles that have their origin in the latest version of the World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (October 2008), Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice   and the Prior to site initiation or subsequent involvement in study activities, the sponsor will provide study training relevant and pertinent to the personnel conducting study activities, including investigator responsibilities and device training . Study-specific training will be documented prior to site initiation.Monitoring visits will be conducted periodically according to the requirements of the study monitoring plan. The monitoring plan will also define source data to be directly recorded on the electronic clinical report form. This information will be provided to the site during site initiation. After site initiation and training, monitoring visits will be conducted periodically to assess site study progress, the investigator’s adherence to the CIP, regulatory compliance , maintenance of records and reports, and review of source documents against patient electronic clinical report forms. Monitors will facilitate site regulatory and study compliance by identifying any findings of noncompliance and communicating those findings along with recommendations for preventative/corrective actions to site personnel. Monitors may work with study personnel to determine and recommend appropriate corrective action(s) and to identify trends within the study or at a particular site.The PROMISE Steering Committee consists of renowned specialists with expertise in the area of pain management and FBSS surgical procedures , statistics (RST), and health economics (LA). The committee will meet periodically to advise on trial design and to monitor enrolment, clinical site progress, and CIP compliance. The Steering Committee also meets with representatives of the sponsor  and is supported by a Medtronic statistician (YT) and by a consultant (JS). A data-monitoring committee will not be established for the study because no interventions intended to prolong life or reduce risk of a major adverse health outcome  are evaluated for which favorable or unfavorable study results might suggest study termination, and nor are there safety concerns suggesting the need for a data-monitoring committee.A publication committee will develop a publication strategy and oversee the development and review of publications related to the study. The publication committee will include members of the steering committee  and sponsor representatives . The publication committee will be responsible for overseeing and ensuring that the publication strategy is executed according to the established plan.An independent clinical events committee consisting of a minimum of three independent physicians will review adverse events to determine any relationship to the SCS therapy.The two published RCTs on the effectiveness of SCS have explicitly included only subjects with leg pain predominant or equaling low back pain ,10. Few The PROMISE trial seeks to provide clinical evidence on pain scores, function, health-related quality of life, and cost-effectiveness for FBSS patients with predominant low back pain being treated with SCS using the Specify® 5-6-5 multi-column lead.The PROMISE trial began patient recruitment in January 2013. Recruitment is expected to close in 2016. It is anticipated that primary endpoint findings will be available in 2017.CIP: Clinical investigational plan; EC/IRB: Ethics Committee/Institutional Review Board; EQ-5D-5 L: EuroQoL; FBSS: Failed back surgery syndrome; NPRS: Numeric Pain Rating Scale; OMM: Optimal medical management; RCT: Randomized controlled trial; SCS: Spinal cord stimulation.PR has received consultancy fees from Medtronic and honoraria for medical training from St Jude Medical. MJD has received consultancy fees from Medtronic Inc. and Kimberly-Clark. RBN’s former employers, Johns Hopkins University and Sinai Hospital, and the nonprofit Neuromodulation Foundation, of which he is an unpaid officer, have received funds from manufacturers of SCS equipment ; he has equity/consulting interest in Algostim. RST has received consultancy fees from Medtronic. LA has received consultancy fees from Medtronic and from Nevro Inc., and honoraria for lectures from Medtronic. CG, CVdA, and YT are full-time employees of Medtronic. JS’s employer (The Neuromodulation Foundation) has consulting agreements with and has received grants from companies that manufacture SCS equipment. KK works as a consultant to Medtronic Inc. and Boston Scientific and has received research grants from both these companies.PR is the overall study principal investigator. PR, MJD, RBN, RST, LA, CG, YT, CVdA, JS, and KK all participated in the study conception and design, contributed to the writing of the study protocol, drafting, and editing of this manuscript and read and approved the final manuscript.Is the Specify® 5-6-5 surgical lead technical description.Click here for fileIs a table presenting the Site Ethics/IRB approvals (as of 3 July 2013).Click here for file


This single-arm study evaluated feasibility, safety, and initial efficacy of electroacupuncture for thalidomide/bortezomib-induced peripheral neuropathy (PN) in cancer patients with multiple myeloma.Patients with neuropathy ≥ grade 2 received 20 acupuncture treatments over 9 weeks.worst pain in the last 24 hours, and pain severity  and continuing through week 13 . From baseline to week 13, additional significant improvements were seen as follows: postural stability ; coin test ; button test ; and walking test . No significant changes were seen with NCS.For the 19 evaluable patients, Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity (FACT/GOG/NTX) mean (SD) scores improved significantly between baseline and week 13 . Moderate effect size differences began on week 4, with the largest effect size differences found at week 9 for FACT/GOG/NTX scores, Acupuncture may help patients experiencing thalidomide- or bortezomib-induced PN. Larger, randomized, clinical trials are needed.NCT00891618.ClinicalTrials.gov Identifier:  Peripheral neuropathy (PN) is a common side effect of treatment for patients with multiple myeloma (MM) ,2. PN is2+ homeostasis, and dysregulation of neurotrophins [The pathogenesis underlying both bortezomib- and thalidomide-induced PN is unclear. For bortezomib-induced PN, previous studies have reported metabolic changes due to the accumulation of bortezomib in the dorsal root ganglia cells, mitochondrial-mediated dysregulation of Catrophins . For thatrophins . OverallThe current management of chemotherapy-induced PN focuses on treating its symptoms, generally with antidepressants, non-narcotic and narcotic analgesics, and anticonvulsants ,8,9. TheAcupuncture analgesia involves the integration of multiple processes at different levels of the nervous system . Manual Inherited genetic factors also play a role in individual response to acupuncture, and multiple molecules, such as opioid peptides , glutamate (NMDA and AMPA/KA receptors), 5-hydroxytryptamine, and cholecystokinin octapeptide, help mediate analgesia . The relOn the basis of promising findings from earlier studies ,27,28,32Participant flow throughout the study is shown in Figure Patient characteristics are provided in Table For neuropathy symptoms, 11 (58%) patients took pregabalin, and six (32%) took gabapentin during the study. For pain control, four (21%) patients took hydrocodone, three (16%) oxycodone, one (5%) morphine, and one (5%) hydromorphone. Two (10%) patients did not take opioids, pregabalin, or gabapentin for symptom management during the study.d = 0.4), with the largest effect size occurring between baseline and week 9 (Cohen’s d = 1.4). The effect size remained large at the one-month follow-up visit at week 13 (Cohen’s d = 0.9).Patient reported outcomes (PROs) are provided in Table severity and interference and worst pain in 24 hours at all time points (Table severity (week 9 = 1.1 and week 13 = 0.9) and worst pain in 24 hours . For pain interference, Cohen’s d effect size estimates were moderate .For Brief Pain Inventory-Short Form (BPI-SF) scores, there was a main effect of time for all subscales . Mean (SD) scores revealed significant improvements in pain ts Table  found foThe Functional Assessment of Cancer Therapy-General (FACT-G) scores revealed significant main effect of time for the physical well-being scale (p = 0.0004) with improvement from baseline to the end of treatment at week 9  and from baseline to follow-up at week 13 . No improvements were seen in social/family, emotional, or functional well-being ; button test ; walking test ; and postural stability . Marginal improvement was seen in fall risk, but it was not statistically significant ; thus, the acupuncture service provided was feasible.d = 1.4; p <0.0001) and remaining through the one-month follow-up at week 13 . Additionally, significant improvement was found for pain severity and interference and for worst pain experienced over 24 hours , with the largest improvement seen at the end of treatment at week 9  were chosen by a panel of expert faculty from the American College of Acupuncture and Oriental Medicine in Houston. Patients received acupuncture three times per week for 4 weeks followed by 1 week off (week 5) and then twice per week for 4 more weeks . Two licensed staff acupuncturists with over 30 years combined experience, and who were trained in the same masters’ degree program, provided all treatments.de qi  was experienced by the patient, electrical stimulation was applied bilaterally as follows: from LI4 (negative) to SI3 (positive) and from Lv3 (negative) to Gb42 (positive) at 2–100 Hz for 20 minutes. All needles were then removed.Standardized techniques for locating points and depth of insertion were utilized ,39 whileTo determine feasibility and safety, we tracked subject recruitment, attrition, compliance with treatment and follow-up regimens, and adverse events. Our criteria for success in terms of feasibility were that that at least 50% of the patients approached would agree to participate and fewer than 33% of the patients who gave consent to participate would drop out after recruitment.For efficacy, the FACT/GOG/NTX scale was used to assess the primary endpoint for PN, and patients had to complete at least 80% of the treatment sessions to be evaluable. The FACT-G survey and the Brief Pain Inventory-Short Form (BPI-SF) were also used to evaluate PROs. For objective outcomes, timed function tests  and NCS were performed. The NCS consisted of bilateral radial and sural sensory nerve conduction and bilateral tibial motor nerve conduction tests. We used previously established age-adjusted values to categorize sensory and motor nerve action potential amplitudes as normal or abnormal .t-test as well as the non-parametric signed rank test. Finally, in order to determine the strength of change due to the intervention, Cohen’s d effect size estimates were calculated for both the pain and neuropathy scores. Statistical analyses were performed using SPSS, v20 statistical software .Patient characteristics were assessed by frequency distributions, means, and ranges for relevant variables. For PROs, mean values/scores were calculated at baseline and weeks 4, 9, and 13 and compared for statistical significance. For variables with four time points, mixed model analyses were performed for time effect. Changes in function tests and NCS were compared from baseline to week 13. All comparisons were made using the paired Student’s The authors declare that they have no competing interests.All authors participated in approval of the final manuscript. MW obtained funding and was responsible for overseeing all aspects of the study. MG, LC, YG, MB, YC, and QW participated in data collection, management, analysis, and interpretation. ZY, YB, JC, RO, DW, JS, RA, ST, JR, RL, LZ, KD, and VG provided expertise during study development, design, data collection, interpretation, and writing of the manuscript.M. Kay Garcia and Lorenzo Cohen are co-first authors.


The identification of clinically relevant subgroups of low back pain (LBP) is considered the number one LBP research priority in primary care. One subgroup of LBP patients are those with back related leg pain. Leg pain frequently accompanies LBP and is associated with increased levels of disability and higher health costs than simple low back pain. Distinguishing between different types of low back-related leg pain (LBLP) is important for clinical management and research applications, but there is currently no clear agreement on how to define and identify LBLP due to nerve root involvement.The aim of this systematic review was to identify, describe and appraise papers that classify or subgroup populations with LBLP, and summarise how leg pain due to nerve root involvement is described and diagnosed in the various systems.The search strategy involved nine electronic databases including Medline and Embase, reference lists of eligible studies and relevant reviews. Selected papers were appraised independently by two reviewers using a standardised scoring tool.Of 13,358 initial potential eligible citations, 50 relevant papers were identified that reported on 22 classification systems. Papers were grouped according to purpose and criteria of the classification systems. Five themes emerged: (i) clinical features (ii) pathoanatomy (iii) treatment-based approach (iv) screening tools and prediction rules and (v) pain mechanisms. Three of the twenty two systems focused specifically on LBLP populations.Systems that scored highest following quality appraisal were ones where authors generally included statistical methods to develop their classifications, and supporting work had been published on the systems’ validity, reliability and generalisability. There was lack of consistency in how LBLP due to nerve root involvement was described and diagnosed within the systems.Numerous classification systems exist that include patients with leg pain, a minority of them focus specifically on distinguishing between different presentations of leg pain. Further work is needed to identify clinically meaningful subgroups of LBLP patients, ideally based on large primary care cohort populations and using recommended methods for classification system development.The online version of this article (doi:10.1186/s12891-016-1074-z) contains supplementary material, which is available to authorized users. To tackle the global burden of low back pain (LBP) , researcLeg pain can be classified as either radicular pain due to spinal nerve root involvement (NRI), or referred (non-specific) pain due to back pain that spreads down the leg from structures such as ligament, joint or disc but not involving a spinal nerve root . Leg paiThe majority of published guidelines on LBP  advocateA range of definitions and terms are used to describe LBLP due to spinal NRI , and various diagnostic criteria are used clinically and in the literature to define populations of LBLP –18. ThisDespite the implications to the patient, and the wider community, of having LBLP, its classification has received limited attention in the literature and guidelines, compared to LBP alone, especially in the primary care setting. A systematic review of the scientific literature was carried out to compile an up-to-date review of proposed classification systems for LBLP. The objectives of the review were to (i) describe the various ways LBLP is classified and the methods used to derive the classification systems (ii) appraise the classification systems using a specific tool and (iii) identify how leg pain due to NRI is described and diagnosed in the various systems.An electronic search was conducted in July 2013 of MEDLINE, EMBASE, CINAHL, AMED, PEDro, Web of Science, Cochrane library, DARE and HTA. All databases were searched from their inception. No date or language restriction was applied. An updated search was performed in August 2015. The Medline search strategy is shown in Additional file The eligibility criteria for study selection used in this review are summarised in Table purpose of the study; method of development referring to either a judgement based approach or using statistical methods; domain of interest referring to patient population and setting; specific exclusions for patients; categories within the system and whether additional dimensions (axis) to the condition were considered (e.g. severity or chronicity of symptoms); criteria used to assign patients to categories ; and training and personnel needed to perform the classification.The framework used to describe and appraise the identified classification systems was originally developed by Buchbinder et al.  and subsSeven criteria were addressed to appraise the methodological quality of the classification systems; these are described in Table The database search yielded 16,891 references, and an additional 21 papers were identified through hand searches of reference lists. 13,358 records remained after duplicate removal. Following initial screening by one reviewer to exclude papers that were clearly irrelevant, 417 remaining titles and abstracts were selected and subsequently screened independently by two reviewers. 122 articles were identified for full text review. From these, 50 were selected for inclusion which reported on 22 classification systems. A flow diagram summarising the systematic search and study selection process is given in Fig. Based on approaches used in previous LBP classification reviews –24, the Six papers described classification systems according to clinical signs and symptoms Table . They scThe QTFC has been extensively investigated and adapted. The first four categories, which do not involve information from advanced imaging such as magnetic resonance imaging (MRI), have shown good discriminative ability  with theWe did not identify any reliability studies for the QTFC system. Glassman et al.  establisThe purpose of the six pathoanatomical classification systems Table  was to iThe number of categories in all systems ranged from two  to twentPetersen et al.  detailedA group of Canadian chiropractors created a diagnostic classification system based on available evidence . They beThe four treatment-based classification systems Table  are desiIn the McKenzie system , also knHall et al.  describeAlbert et al.  classifiClinical guidelines published by the Orthopaedic group of the American Physical Therapy Association  proposedThree papers were grouped under screening tools and prediction rules Table , scoringThree pain mechanism classification system studies were identified Table  scoring Smart et al ‘s  system hThe three pain mechanism groups of nociceptive, neuropathic and central sensitisation are the basis of the third pain mechanism system  and, basA summary of the strengths and weaknesses of the 22 classification systems based on the quality appraisal scoring tool is presented in Fig. The terminology used for categories with NRI within the classification systems was listed to assess consistency of terms and the clinical criteria within these categories were explored. This is presented in Table Following a comprehensive systematic search of the literature, 22 systems were identified that classified patients with back and leg pain. Only three of the systems focused specifically on LBLP patients , 64, 65.The call to identify clinically relevant subgroups of LBP patients has been a top priority in primary care back pain research since the mid-1990s, and researchers have responded accordingly with a proliferation of subgroup studies . SeveralThe quality of the 22 systems varied, and those that scored higher on the appraisal tool were ones with evidence of more robust methods of development and more supporting published work on reliability, validity and generalisability. The majority of the systems used a judgement approach to development, ranging from authors opinion to expert consensus panels. Some systems used statistical methods to identify clusters of symptoms that best discriminate between patients, giving objective means of identifying subgroups of patients which helps to avoid author bias. Relying on statistical clustering in isolation can give rise to content validity issues, with subgroups not clinically recognisable or identifiable. Using a combined approach of judgement, preferably with group consensus and statistical methods to identify subgroups, is recommended  but onlyPathoanatomical classification systems generally scored low on the appraisal tool, primarily because development was mainly based on authors’ opinion. Many consider the pathoanatomical approach, which seeks to associate specific structures with symptoms, as outdated and unhelpful to patients. It is thought to lead to overuse of diagnostic procedures with subsequent implications on cost and patients’ expectations if findings do not match clinical symptoms . A revieThe treatment based approach classification systems included the McKenzie system which is a popular treatment based approach among clinicians, despite evidence that it is not superior to other treatments. An additional three papers were grouped under screening tools and prediction rules, where statistical methods were used to identify cluster of items to assist diagnosis or prognosis. Classification according to pain mechanisms is gaining popularity in musculoskeletal medicine and three papers applied this system to LBLP , 66, 75.Smart et al.  used staSchafer et al.  defined This is the first review that has focused specifically on classification of LBLP. The search identified over 13,000 citations for initial screening. This large number reflects the breadth of the search strategy and large number of databases searched with minimal restrictions. The broad search strategy was deemed necessary to include all possible terms that could be used to describe LBLP and classification and avoid missing any systems. The search strategy was supplemented by first author searches and hand searching reference lists. Identified systems were not excluded on the basis of quality and study appraisal was systematically and independently carried out by two reviewers. Other systems or supporting evidence may have been missed e.g. unpublished student studies or cases of publication bias if findings were unsupportive of the system.References were initially missed and 21 of the 50 papers in the systematic review were identified through supplementary search strategies. Despite the comprehensive search strategy which included up to 34 terms to describe LBLP, a possible reason for missing several papers is because of the vast nomenclature used to describe and identify LBLP.A primary aim of identifying groups of patients with similar characteristics or diagnostic entities is to guide management, as homogeneous groups may respond more favourably to certain management options. However, the first step is to be able to identify these groups with reasonable diagnostic certainty based on generally accepted characteristics.The classification of LBLP merits more attention, especially in primary care settings where most of these patients are assessed and managed. This should start with agreement on the criteria that reasonably distinguishes NRI from pain referred into the leg from structures in the back other than the nerve root. An approach that uses data from large, unselected groups of primary care patients to classify them according to relevant characteristics from self-reported measures, clinical examination findings and perhaps even demographic information, deserves more attention to appreciate the clinical characteristics of this subgroup of LBP patients. This methodology has been used more often in systems to subgroup psychosocial characteristics in chronic LBP patients  and it iA greater understanding of the profile of LBLP patients could help shape future research questions and directions in this subgroup of patients in terms of prognostic and effectiveness studies.Research involving animals: not applicable.Research involving plants: not applicable.Trial registration: not applicable. The systematic review protocol was not registered.Standards of reporting: The PRISMA guidelines for reporting systematic reviews were followed.Describing new taxa: not applicable.