Improvements in software and design and reduction in cost have made virtual reality (VR) a practical tool for immersive, three-dimensional (3D), multisensory experiences that distract patients from painful stimuli.The objective of the study was to measure the impact of a onetime 3D VR intervention versus a two-dimensional (2D) distraction video for pain in hospitalized patients.We conducted a comparative cohort study in a large, urban teaching hospital in medical inpatients with an average pain score of ≥3/10 from any cause. Patients with nausea, vomiting, dementia, motion sickness, stroke, seizure, and epilepsy and those placed in isolation were excluded. Patients in the intervention cohort viewed a 3D VR experience designed to reduce pain using the Samsung Gear Oculus VR headset; control patients viewed a high-definition, 2D nature video on a 14-inch bedside screen. Pre- and postintervention pain scores were recorded. Difference-in-difference scores and the proportion achieving a half standard deviation pain response were compared between groups.P=.008). A total of 35 (65%) patients in the VR cohort achieved a pain response versus 40% of controls . No adverse events were reported from VR.There were 50 subjects per cohort (N=100). The mean pain reduction in the VR cohort was greater than in controls  Hospitalized patients frequently experience physical, emotional, and social distress that is exacerbated by a radical change in living environment, loss of customary rights and privileges, and a high prevalence of pain . Nearly Treatment of pain in the acute care setting is often focused on pharmacological management, which can yield inconsistent and suboptimal pain control . HoweverVirtual reality (VR) technology provides an immersive, multisensory, and three-dimensional (3D) environment that enables users to have modified experiences of reality by creating a sense of “presence” ,6. To daHowever, the evidence to date supporting VR for inpatient care has shortcomings. In a recent meta-analysis of randomized controlled trials of VR for medical inpatients, we found 11 previous studies testing VR versus control conditions . AlthougWe conducted a nonrandomized, comparative cohort study over a 6-month period to compare a 3D VR pain distraction experience (administered during the first 3-month recruitment period) with a 2D high-definition nature video on a 14-in screen placed in easy viewing proximity (administered during the second 3-month period), described further below. In both cohorts, we recruited adults (18+ years) admitted to the Inpatient Specialty Program at Cedars-Sinai Medical Center, a large, urban, tertiary care medical center. We excluded patients who could not consent, who were placed in contact isolation, or who had head wounds or bandages that interfere with the VR headset. In addition, because VR may cause motion sickness in some users , we exclWe administered VR using the Samsung  Gear Occulus headset fitted with a Samsung Galaxy S7 phone that delivers VR images and sound . We seleDuring the control period, we administered a 2D high-definition (1080p) video depicting relaxing nature scenes, including mountain lakes and running streams from Patagonian vistas presented with an audio track featuring Native American Shaman music. We selected this video because of its high-definition images, positively reinforcing music, and emotionally calming content. Patients watched the video on a 14-in high-definition computer screen placed in easy viewing proximity on a bedside or chairside table. We ran the video for its first 15 minutes—the same duration as the VR intervention.Patients in both study periods were informed that researchers were testing the effect of a distraction experience on the perception of pain. Because it was important for the research staff to exhibit equipoise when describing the potential benefits of the study intervention , we prepared a script that used neutral language regarding the study intervention. Once consented, patients rated their current pain using a standard 11-point numeric rating scale (NRS), ranging from 0 (no pain) to 10 (“the worst pain of your life”). The NRS is a validated measure of pain widely employed in clinical practice based on its ease of use, high compliance rates, and responsiveness to detect meaningful changes in pain . Althougt tests for continuous parametric variables and chi-square tests for categorical variables.We calculated descriptive statistics for key demographic and clinical characteristics between groups, including age, sex, race and ethnicity, primary reason for hospitalization, and baseline pain scores. We performed bivariate analysis to evaluate for significant differences between groups, including two-sample t tests) and then compared difference-in-difference (DID) pain scores between cohorts (using the rank sum test given nonparametric DID distributions). In addition, we classified each individual patient as a responder or nonresponder using the criterion standard of achieving an effect size of ≥0.5 standard deviation on the pain scale, a “medium” effect size using the rule of Cohen, and a value corresponding to the minimum clinically important difference (MCID) using the rule of Norman [We next compared pre- and postintervention pain scores within subjects , which can be interpreted as how much of the variation in the sample can be explained by the interaction.Because the study used a mixed factorial design, we used a repeated-measures analysis of variance (ANOVA), which incorporated both a between-subjects and within-subject factor (pretest-posttest). The Finally, to adjust for potential differences in patient characteristics between groups, we performed multivariable linear regression analysis to test the independent effect of VR on pain reduction, adjusting for demographic and clinical variables. To support a regression model with 5 covariates, and assuming at least 20 subjects per covariate, we required a total sample size of 100 patients. All analyses were conducted using Stata 14 (StataCorp).The Cedars-Sinai Institutional Review Board approved this study (Cedars IRB Pro00039751).There were 50 patients in each group (N=100). P<.001; percent reduction=24%) and the control patients , with a larger drop in the VR group than controls . Using a binary responder definition of a ≥0.5 standard deviation drop in pain, there was a higher proportion of responders in the VR group (65%) versus the control group . In the repeated-measures ANOVA, results showed that VR elicited a statistically significant difference in pain scores following treatment, F1,97=7.45, P<.001. The calculated η2 was .07, which Cohen considers equivalent to an effect size slightly greater than medium. In multivariable regression analysis adjusting for age, race, ethnicity, sex, and reason for hospitalization, VR remained a significant predictor of pain reduction . There were no differences in the effect of VR by age, race, ethnicity, sex, or reason for hospitalization.When focusing on within-subject changes in pain, there was a significant drop in pain in both the patients in the VR group  improvements in pain versus a control distraction video without triggering adverse events or altering vital signs. These results indicate that VR may be an effective adjunctive therapy to complement traditional pain management protocols in hospitalized patients.Whereas previous VR research has traditionally focused on specific types of pain ,12,25,26It remains unknown exactly how VR works to reduce pain perception across conditions. Most proposed mechanisms attribute the benefit to simple distraction . When thOur study has several important limitations. First, although we compared results between 2 well-characterized groups in this early phase VR study, this was not a randomized controlled trial. Nonetheless, we performed multivariable regression analysis to adjust for variations between groups and still found that exposure to VR was a significant predictor of reduced pain. Future research should randomize patients in a larger, prospective comparison trial. Second, the VR intervention was only 15 minutes long and included only one visualization; it is possible that pain may rebound after VR and/or longer-term benefits require more sustained and repeated exposure to varying content. Future research should evaluate the effect of altering the duration, intensity, frequency, and content of VR compared with control conditions. Third, because this was a onetime intervention we did not measure the impact of VR on use of pain medications, hospital length of stay, or postdischarge satisfaction scores. Nonetheless, this study is, to our knowledge, the first to measure the impact of VR on pain management versus a control condition among a diverse group of hospitalized patients. Fourth, it is impossible to know whether the greater effectiveness of the VR condition was due to presenting a 3D virtual environment (vs a 2D environment) or playing a highly involving, active game versus a passive distraction experience. It is not possible from this experimental design to determine definitively if the observed effect in pain reduction was due to the 3D versus 2D experience, active versus passive components, variations in visual and audio between conditions, or other attributes that measurably vary between arms. Our pragmatic trial is a first step along a path of additional investigations; future research should test other control conditions and visualization to understand whether there are unique benefits of the 3D VR experience over other control conditions. Finally, our protocol did not track the characteristics and reasons for patient ineligibility or refusal to use VR. However, our previous research found that many hospitalized patients are not eligible to use VR for various reasons, including active neurological symptoms, ongoing nausea or vomiting, injury to the face or neck, epilepsy, too frail or debilitated, or receiving mechanical ventilation. Moreover, we found that among those who are medically eligible to use VR, up to two-thirds are unwilling to try the technology, particularly older individuals. Taken together, these findings reveal barriers to widespread use of VR in hospitalized patients. Future research should study whether adoption rates are increasing and whether using VR is cost-effective for hospitals given variable patient uptake.These results indicate that VR is an effective, safe, and feasible intervention to aid with pain management among diverse hospitalized patients. Larger randomized clinical trials are needed to better characterize its impact on longer-term pain perception, resource utilization, and postdischarge outcomes.


Thoracic paravertebral block (TPVB) is used to reduce pain after breast cancer surgery (BCS), but the pain-reduction effects more than 1 year after surgery are unclear.p = 0.039). The pain score 3–6 h after surgery was significantly higher in the patients with chronic pain than without (p = 0.016). Bivariate logistic regression revealed that TPVB and pain score 3–6 h after surgery were independent predictive factors of chronic pain after BCS.Fifty-one patients underwent BCS at the Niigata City General Hospital from December 2009 through March 2010. To evaluate the long-term effects of TPVB in the reduction of chronic pain after BCS, we retrospectively reviewed the anesthesia charts and medical records of these patients and conducted telephone surveys regarding postoperative pain 13–17 months after surgery in 46 of these patients. Among the 46 patients enrolled in this study, 17 experienced chronic pain. There was a significant difference in the percentage of patients that received TPVB among those with and without chronic pain (patients with chronic pain 5/17 (29.4 %), patients without chronic pain 18/29 (62.1 %), These results indicate that TPVB has the potential to reduce chronic pain for more than 1 year after BCS. Breast cancer is the most commonly diagnosed malignancy in women, and the incidence of this condition is increasing , 2. BecaThoracic paravertebral block (TPVB) is a commonly used adjuvant analgesic technique in BCS, and previous study reported that TPVB reduces intraoperative analgesic requirements and suppresses acute postoperative pain , 13. HowWe hypothesized that TPVB combined with general anesthesia may reduce acute and chronic postoperative pain after BCS. We analyzed the association between the incidence of chronic postoperative pain after BCS and the use of TPVB combined with general anesthesia by using a retrospective chart review and telephone survey.This retrospective cohort study was performed at Niigata City General Hospital. This study was reviewed and approved by the Niigata City General Hospital institutional review board . Written informed consent was obtained from the patient, and we confirmed the consent for publication of this case series when we performed telephone survey to the patients. We reviewed the anesthesia charts and medical records of all patients who underwent BCS under general anesthesia with or without TPVB from December 2009 through March 2010. Patients who underwent bilateral BCS or simultaneous BCS and surgery involving another part of the body were excluded. The same anesthesiologist (HS) performed TPVB with general anesthesia in all patients. The director of the division (SD) assigned the anesthesia cases of the day to an individual anesthesiologist, and certain types of cases were not assigned to a specific individual.™ (BIS™) monitor . Target BIS values were set between 40 and 60. We adjusted the remifentanil dose to maintain systolic blood pressure of 80–140 mmHg, heart rate of 50–100 beats/min, and BIS values of 40–60. TPVB was performed under ultrasound guidance before induction of general anesthesia by administering 20-ml 0.375 or 0.5 % ropivacaine in one or two intercostal spaces between T2/3 and T4/5. Non-TPVB patients received fentanyl and flurbiprofen axetil as transitional analgesia.General anesthesia was induced with propofol and remifentanil and maintained with propofol or sevoflurane and remifentanil. The propofol infusion rate was regulated by target-controlled infusion (target blood concentration 1.8–4.0 μg/ml with Terumo TE372 TCI [Diprifusor]). The patients were monitored using an electrocardiogram, non-invasive arterial blood pressure (every 5 min), pulse oximeter, and bispectral indexThe medical records were reviewed by an anesthesiologist (HN) blinded to the anesthesia method to determine the intensity of postoperative pain at 0–3, 3–6, and 6–24 h after surgery according to a four-point verbal rating scale . Flurbiprofen axetil, loxoprofen, and acetaminophen were used as rescue analgesics.An anesthesiologist (HN) interviewed the patients by phone to determine the postoperative pain 13–17 months after surgery. Chronic pain was defined as pain in the surgical area or the ipsilateral arm, present at least 4 days a week, with an intensity of one or more on the four-point verbal rating scale, described as a typical neuropathic pain consisting of burning pain, shooting pain, pain evoked by pressure, and deep blunt pain . Demographic data were analyzed by paired Fifty-one patients underwent BCS during the study period. After exclusion of patients who underwent bilateral breast surgery or simultaneous surgery involving another body part, we identified 49 patients as a telephone survey conducted in May 2011. The telephone survey was conducted in May 2011 and 46 patients answered the survey completely . Therefore, we pooled the data for patients treated with the two concentrations of ropivacaine. The average dose of remifentanil was significantly lower in the patients with TPVB than in those without . However, there was no difference in the worst pain score within 24 h of surgery between the two groups (p = 0.33). The pain scores 3–6 h after surgery were significantly higher for those with chronic pain than those without. The pain scores 0–3 and 6–24 h after surgery were not significantly different between the two groups . Moreover, incidence of chronic pain was significantly lower in the patients who received TPVB than the patients who did not received (21.7 % [5/23] vs. 52.2 % [12/23]).The interval between surgery and the telephone survey ranged from 13 to 17 months. Seventeen of 46 (37 %) patients suffered chronic postoperative pain. We compared the demographic data, anesthetic method, postoperative pain score, and perioperative adjuvant cancer therapy between patients with and without chronic pain , resulting in comparable pain scores 0–3 h after surgery between the two groups(Fig. In conclusion, results of our study suggest that TPVB combined with general anesthesia may reduce the incidence of postoperative chronic pain for more than 1 year after BCS.


Studies to assess the effects of therapies on pain and masticatory muscle function are scarce.  To investigate the short-term effect of transcutaneous electrical nerve stimulation (TENS) by examining pain intensity, pressure pain threshold (PPT) and electromyography (EMG) activity in patients with temporomandibular disorder (TMD). Forty patients with myofascial TMD were enrolled in this randomized placebo-controlled trial and were divided into two groups: active (n=20) and placebo (n=20) TENS. Outcome variables assessed at baseline (T0), immediately after (T2) and 48 hours after treatment (T1) were: pain intensity with the aid of a visual analogue scale (VAS); PPT of masticatory and cervical structures; EMG activity during mandibular rest position (MR), maximal voluntary contraction (MVC) and habitual chewing (HC). Two-way ANOVA for repeated measures was applied to the data and the significance level was set at 5%. There was a decrease in the VAS values at T1 and T2 when compared with T0 values in the active TENS group (p<0.050). The PPT between-group differences were significant at T1 assessment of the anterior temporalis and sternocleidomastoid (SCM) and T2 for the masseter and the SCM (p<0.050). A significant EMG activity reduction of the masseter and anterior temporalis was presented in the active TENS during MR at T1 assessment when compared with T0 (p<0.050). The EMG activity of the anterior temporalis was significantly higher in the active TENS during MVC at T1 and T2 when compared with placebo (p<0.050). The EMG activity of the masseter and anterior temporalis muscle was significantly higher in the active TENS during HC at T1 when compared with placebo (p<0.050). The short-term therapeutic effects of TENS are superior to those of the placebo, because of reported facial pain, deep pain sensitivity and masticatory muscle EMG activity improvement. However, the influence of this therapy on the tonus of masticatory muscles should be further investigated, considering that the evidence regarding the improvement of clinical parameters, e.g., reported pain, jaw movement and electromyography (EMG) activity, are divergent and controversial,It is well established that TENS can reduce patient-reported pain intensity in acute pain conditionsOne study showed that the main effects of TENS on the muscular tonus of patients with TMD were: 1) reduction in muscle activity of the anterior portion of the anterior temporalis muscle, during resting posture of the jaw, and 2) increased muscle activity of the masseter muscles, during maximal voluntary contraction (clenching)Mandibular kinematics may be subjected to changes that may compromise the muscle and articular functions in TMD patientsBased on the above, the aim of this study was to investigate the short-term effect of TENS by examining pain intensity, PPT and EMG parameters in subjects with myofascial TMD. Our initial hypothesis was that TENS is as effective in reducing facial pain as it is in improving masticatory muscle EMG activity of TMD patients.Academic staff and undergraduate students of both genders from the Federal University of Sergipe were eligible. They underwent clinical evaluation for examination of signs and symptoms of TMD and, after the inclusion and exclusion criteria assessment, participants were divided into two groups: (1) TENS placebo (n=20) and (2) TENS active (n=20). The study design was a randomized placebo-controlled trial. One investigator (R1) who did not participate in data collection performed the randomization with the aid of computed-generated combinatorial analysis, which was used to generate the random sequence. A second investigator (R2) performed the eligibility assessment and the group allocation was made by sealed and opaque envelopes . Operational issues precluded masking of the researcher who applied the treatment. Then, the same investigator (R2) who performed the group allocation also performed the treatment. A third investigator (R3), blinded for group allocation, conducted the outcome assessments. Finally, a fourth investigator (R4) carried out the interpretation and analysis of results. It is important to note that the participants of this study were also blinded regarding the type of treatment.per group was determined based on pilot evaluations, which would be suitable to detect a pressure pain threshold (PPT) difference of 1.02 kgf/cm2, standard deviation (SD) of 1.12 kgf/cm2, considering the significance level of 5% (α), and sample power of 80% (β).Sample size of at least 20 subjects The Ethics Committee of the Federal University of Sergipe approved the study and the informed consent from each participant was obtained after full explanation of the research purposes and procedures.The inclusion criteria was the diagnostic of chronic painful TMD (at least six months of pain complaint) according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), categories Ia  or Ib Reported facial pain intensity and PPT (primary outcomes), as well as EMG activity (secondary outcome), were assessed.Visual analogue scale (VAS) was used to assess the intensity of current pain. VAS measures the painful experience using a straight line of 100 mm, with the left margin anchored by the term “no pain”, and the right, by the term “worst imaginable pain”®, Cotia, SP, Brazil) containing a rod with a circular flat surface of 1 cm2 coated with soft rubber. The patient was positioned comfortably in a sitting position, with muscles relaxed. The evaluator then placed the end of the circular surface of the algometer perpendicular to the skin and applied a steadily increasing pressure of 0.5 kg/cm2/second. The patient was instructed to verbalize the moment when the pressure exerted caused a painful sensation. The following sites were assessed: masseter muscles, anterior temporalis muscle, and sternocleidomastoid (SCM) and upper trapezius  muscles, in addition to the lateral pole of the jaw. The average of two trials was considered the PPT. There was a two-minute interval between the first and second measurements at the same muscle site, and a five-second interval between the measurements of one muscle site and the otherPPT was conducted using an algometer , with electrical isolation of 3,000 volts, high EMG signal representation across all channels (2000 samples/second per channel), rejection of 110 dB common mode and low noise level <2 LSB (Low Significant Bit). The acquisition of EMG signals was performed using Miograph software with a 2000 Hz sampling frequency, 20-500 Hz bandpass filter with interference eliminated by the Notch Filter® were used, with a 20 mm distance between the poles. The ground electrode was placed in the lateral epicondyle of the left elbow of all volunteers.The surface EMG record was obtained using a MiotecA muscle function test performed before placing the electrodes served to identify the center of the muscles to be analyzed. The electrodes were placed parallel to the muscle fiber of these muscles, equidistant from the muscle origin and insertion. Before the exam itself, subjects were asked to perform a maximum voluntary contraction (MVC), supported by a five-second isometric contraction of the masseter muscles and anterior temporalis muscle, in order to conduct normalization of the data, interpreted subsequently with the MATLAB.® gum was used for 20 chewing cyclesEMG signal was captured in three tasks: in the mandibular rest position (MR), during MVC and during habitual chewing (HC). In measuring HC, TridentAll evaluations were made in three assessment times: baseline (T0), immediately after (T1) and 48 hours after (T2) treatment. The participants were assessed according to the group allocation .The volunteer was positioned in dorsal decubitus with knees supported on a triangular pillow placed between the volunteer’s chest and head. Electrodes were placed on both the masseter muscles and the anterior temporalis muscle beams, considering the same references that were used for electrode placement of the electromyography surface exam.®, with two previously calibrated channels, and circular adhesive electrodes by Valutrode®, 3 cm in diameter. The parameters used in this study were: pulse duration only up to sensory activation (<100 us) and high intensities, but with an established limit to prevent muscle contraction and allow maximum comfort during the 50 minutes of therapy.Before muscle stimulation, all participants were informed of the different types of interventions being tested in the research and of the perceived sensation of paresthesia from the electrodes, ranging from unnoticeable to hardly noticeable or very noticeable. The TENS device used was model Neurodyn Sapphire Compact Line, by Ibramed,,,The total time of treatment was 50 min using variations of low and high frequency (VHF), with a sweep of 4 Hz (first 25 min) and 100 Hz (last 25 min). This application protocol was based on previous evidence, which report different and complementary analgesic mechanism when adopting high and low frequenciesPlacebo device was developed in the Electrical Engineering Laboratory of the Federal University of Sergipe (GPRUFS), Robotics Research Group. The placebo equipment allowed the passage of current to the participant for only a short period of time (40 seconds). The current was gradually reduced in such a way that the receiver would not be able to perceive the interruption in the stimulus. The placebo device had an internal resistance with values close to human body resistance. This system did not allow the electrical stimulation device to recognize that the current was not going through the individual, thus avoiding a false recording of non-contact electrodes.Placebo procedure was performed with the placebo group positioned in the same way as the test group (active TENS), and with the same current parameters used for the test group. All the patients were told was that they were participating in a study involving the possibility of a placebo treatment.Quantitative variables, i.e., age, body mass index – body mass divided by the square of the body height – (BMI), VAS, PPT and EMG at different tasks were presented as mean and standard deviation (SD). Variables were tested for data normality by the Kolmogorov-Smirnov test, and presented normal distribution (p>0.050).post-test. The significance level was set at 5%. In addition, the effect size of significant comparisons was computed according to Cohen’s kappa coefficient (d). Cut-off points can indicate small (d=0.20), moderate (d=0.50) and large (d=0.80) effectsThe effect of TENS on VAS, PPT and EMG activity at different tasks  within and between the groups over time  was computed using two-way ANOVA for repeated measures followed by Tukey’s The flow of participants is described in PPT values of the anterior temporalis (d=1.13), TMJ (d=1.23) and SCM (d=1.69), were significantly higher in the active TENS and at T1 when compared with placebo, but also for the masseter (d=1.05) and SCM (d=1.38) at T2 (p<0.050) . There wEMG activity of the masseter  and anterior temporalis  were significantly lower in the active TENS during MR at all assessment times when compared with placebo (p<0.050) . NeverthEMG activity of the anterior temporalis  was significantly higher in the active TENS during MVC at T1 and T2 when compared with placebo (p<0.050) . In addiEMG activity of the masseter (d=2.97) and anterior temporalis (d=2.49) muscle was significantly higher in the active TENS during HC at T1 when compared with placebo (p<0.050) . MoreoveThis study demonstrated that mostly of TENS hypoalgesic properties and improvement in EMG activity in subjects with myofascial TMD are not placebo effects. The main findings were: (a) short-term (T1 and T2) reduction in pain intensity; b) short-term increase in PPT values; (b) immediate (T1) reduction in MR EMG activity and short-term increase in MVC and HC EMG activity.The evidence is controversial regarding the TENS effects of pain reduction in chronic pain disorders, though electrical nerve stimulation modalities in general are considered an effective treatment for chronic musculoskeletal pain. In particular, TENS seems to be effective on reducing pain in TMD patients. However, positive outcomes are generally not reported immediately after the application, but rather they are proposed as cumulative effects. Our study presented both, immediate (T1) and cumulative effects of TENS application (T2), which could be partially explained by the use of high frequency TENS. Previous evidence has reported immediate effects on TMD pain when applying only high frequency TENS. However, as far as we know, there is no published study comparing high and low frequency TENS in TMD patients, which warrants further researches.A proper TMD evaluation would include muscle tenderness investigation, which can be done by manual palpation or with the aid of more standardized and reliable techniques, e.g., PPT assessment,The pain adaptation model,Such positive short-term effects of TENS on muscle pain and function could be related with the alternate frequencies protocol adopted in our study. This application protocol was based on previous evidence, which report different and complementary analgesic mechanism when adopting high and low frequenciesThe strengths of this study are mainly related with the systematic assessment of myofascial TMD pain and muscle function using valid and reliable methods. On the other hand, some limitations that can be highlighted in this study were: a) lack of a long-term assessment; b) lack of a control group without any treatment, since aspects related to fluctuation periods and pain remission in TMD patients must be considered before any final judgment is made regarding therapeutic efficacy, although ethical implications of such procedure should be considered; c) lack of a control group without TMD, which could also elucidate the effects of TENS on asymptomatic muscles; d) risk of treatment bias, because the researcher who applied the treatment was aware about the group allocations.Short-term therapeutic effects of TENS are superior to those of the placebo, because of the reported facial pain, deep pain sensitivity and masticatory muscle EMG activity improvement. Accordingly, we recommend the use of TENS as an effective option for short-term management of masticatory myofascial pain. However, further investigations are required to determine if this efficacy is also present in the long-term effects.


Shoulder pain (SP) represents a common musculoskeletal condition that requires physical therapy care. Along the years, the usual evaluation strategies based on clinical tests and diagnostic imaging has been challenged. Clinical tests appear unable to clearly identify the structures that generated pain and interpretation of diagnostic imaging is still controversial. The current patho-anatomical diagnostic categories have demonstrated poor reliability and seem inadequate for the SP treatment.The present paper aims to (1) describe the different proposals of clinical approach to SP currently available in the literature; to (2) integrate these proposals in a single framework in order to help the management of SP.The proposed clinical framework, based on a bio-psychosocial vision of health, integrates symptoms characteristics, pain mechanisms and expectations, preferences and psychosocial factors of patients that may guide physiotherapist to make a diagnostic triage and to choose the right treatment for the individual patient. Shoulder pain (SP) is a common musculoskeletal condition that can influence negatively the function of the entire upper limb . The preA large number of diagnostic categories have been developed: they are based on patho-anatomical classifications, such as tendinopathies, bursitis, labral tears, tendon tears, impingement, etc. . HoweverSchellingerhout  defined As consequence, we have thought it would be clinically useful to overcome the diagnostic difficulties by proposing a new pragmatic and symptoms-based model, coherent with a bio-psychosocial approach and closer to patient’s needs. Moving from this vision, this debate aims to: 1) describe the reasons for this diagnostic inconsistency; 2) present the different alternative proposals existing in the literature; 3) integrate the different proposals in a single framework, in order to provide physiotherapists with a helpful tool to deal with SP patients.In clinical practice, the assessment of a patient with SP is based upon an in-depth conversation  and a clinical assessment, which, in some cases, may be supported by imaging (e.g. magnetic resonance imaging [MRI] or ultrasound [US]). This approach is designed to enable a clinical diagnosis useful to guide the subsequent physiotherapy treatment .Physical tests are tools commonly used in clinical practice, created to help the physiotherapist to identify which anatomical structures are involved with the patient’s symptoms. They are non-invasive, quick, convenient, and provide immediate results . HoweverGreen et al. state that only few studies give information concerning the anatomical basis of the proposed tests . Only foThe Hawkins-Kennedy represents a well-fitting example of the confusion surrounding the anatomical construct of these tests. It has been developed to identify the presence of sub-acromial impingement . During Others researchers have questioned the clinical usefulness of the physical tests in SP. Hegedus et al. have published three literature reviews discussing this topic –19. Theye.g.US) [In clinical practice, diagnostic imaging  is considered to play an essential role during the assessment of patients with musculoskeletal disorders . They are.g.US) . Morphole.g.US) .Lenza et al. , stated In 2013 a Cochrane editorial debated the diagnostic accuracy of imaging ; it was .Usually, in patients with SP, there is uncertainty concerning the cause of pain and which risk factors are relevant to the onset of symptoms. Some authors suggest that the possibility of symptoms increases with the size of rotator cuff tear , while oThe lack of reliability of clinical tests and limited usefulness of diagnostic imaging led some authors to suggest the integration of different assessment strategies, more pragmatic and focused on the results of functional assessment –33. The These current approaches have evolved as a consequence of the uncertainty in biomedical model, but they still present some limitations that reduce their ability to interpret comprehensively all the features of SP. The STAR-shoulder classification and SSMP do not assess the contribution of central sensitization (CS) , 32. KliMoving from the existing proposals, we have tried to overcome the limits of exclusively mechanistic classification and to create a framework for assessment and treatment of SP that integrates and includes them in a bio-psychosocial perspective Fig. . AnamnesThe anamnesis is a milestone in the assessment of patients with musculoskeletal dysfunction . DiffereSpecific information regarding impairments and symptoms of SP must be investigated during the colloquium with the patient, including; onset, quality, 24 h behavior, localization, alleviating and aggravating factors . MoreoveThe features of symptom help physiotherapists to understand the underpinning mechanism behind patient’s pain presentation, such as nociceptive pain (NP) or CS. Potential indicators of NP are: the localization of pain in the area of injury/dysfunction, the description as intermittent and sharp during movement or constant dull or throbbing ache at rest, as well as a clear response consistent with aggravating and easing mechanical factors .Evidence suggests that CS phenomena are present in patients with SP , 41. PotIn addition to the anamnestic elements, physical signs of CS must be investigated during physical examination  . During Unfortunately, there is only preliminary discriminative validity of mechanism-based classification of musculoskeletal pain . The useDuring the anamnesis, it is essential to investigate the patient’s expectation, preferences and the presence of psychosocial factors (yellow flags) in order to guide the subsequent best treatment decisions and to reduce the patient’s risk for developing long-term disability .Recent evidence suggests that expectations and preferences about the physiotherapy treatment play an important role as influencers of musculoskeletal outcomes , 47 alsoMoreover, the predominance of specific psychological factors such as personal and environmental elements must be analysed. The physiotherapist should screen for older age more of 50 years), higher perceived pain intensity, longer duration of symptoms, previous injury, extensive sick leave, unemployment, co-morbidities, previous SP, poor perceived general health, avoidance of activity for fear of pain and harm, perceived high job demands and low job satisfaction, higher body mass index, poor social support, personal problems  , 50. years, hThe evaluation of the quality of active and passive shoulder and cervical spine movements , the ranPhysical assessment is also aimed to confirm the presence of CS signs suspected during anamnesis, such as swelling, weakness or stiffness of the affected segment, lack of correspondence between specific movements and pain , 42, whiFrom a clinical-pragmatic perspective, there is the need to modify the diagnostic labeling used for patients with SP , 17, 20.red flags, specific pain, non-specific pain. Firstly, the physiotherapist should exclude Red Flags, then distinguish patients, classifiable as specific shoulder pain, with signs and symptoms of musculoskeletal dysfunction for which is necessary the referral to an orthopaedic evaluation before establishing a physiotherapy treatment [non-specific shoulder pain [In our clinical framework, we propose a process of diagnostic triage that adopts a classification system similar to the one already adopted for other regions : rereatment , 58. FinRed flags are sign and symptoms alerting the physiotherapist on a possible presence of a non-musculoskeletal, life-threatening pathology, fracture, infection, tumor and inflammatory rheumatic conditions [Specific shoulder pain indicates that symptoms could refer to a pathology that has a clear structural, patho-anatomic or pathophysiologic origin . It requires referral to an orthopaedic specialist to clarify diagnostic aspects or surgical needs [specific shoulder pain, physiotherapists may refer to specific options for treatment available in literature  , explaining the pain mechanisms underpinning their symptoms, their favorable prognosis, the strategies of treatment that are intended to use proprioand the value of self-management and home exercise , 70, 71.Manual therapy is one of the possible interventions to reduce SP. Mechanical stimuli applied to the skin of the patients by manual therapy, determine several neurophysiological mechanisms  that improve pain. Because of this variety of effects sources, we can assume that manual therapy can be considered as a therapeutic intervention able to de-sensitize the neurologic system that supports pain perception –77. ManuWe considered as load every movement that could increase the ability to perform a limited/painful movement. The load is usually administered through exercise, thus playing an important role for this category of patients with SP . Indeed To organize the treatment of patients with non-specific shoulder pain provoked by shoulder movements, is advisable to adopt the same functional approach proposed by Klintberg et al., that seems to be flexible and easy to perform  Fig. 3)3). Once Different procedures are administered to the patient until he/she reports a satisfying improvement occurring during or after the intervention . Some auRegarding load management, the physiotherapist should play with an accurate tuning of the posology, in terms of specific target and modalities of execution (see Table Even if some authors choose the structure(s) to which target the exercises on the base of the effect of the previously performed procedure  , 87, 93,Patients with NP mechanisms: if the clinical condition is characterized by high level of reactivity, the therapeutic approach will be based on patient education , de-sensPatients with CS mechanisms: de-sensitization and load management are coupled with the therapeutic approach. The clinical conditions with prevalent CS features are managed by patient’s education and “time-contingent” exercise  in order to restructure the patient belief of association between pain-danger-harm (e.g. graded exposure/activity starting from the identification of painful tolerated exercise in terms of number of repetitions and pain granted during the execution) , 96–98. If symptoms reduction procedures resulted negative without influence patient’s SP, the load will be managed by exercise, according with prevalent mechanisms of pain elaboration showed by the patient:Concerning the prognosis, when a positive progressive improvement is obtained, an exercise training of 12 weeks duration is recommended , 92. MorIn this paper, we adopted an evidence-based approach to guide physiotherapists in the management of SP, thus proposing a framework inspired by the bio-psychosocial model  and aligExisting literature underlines the limits of a strictly anatomical model for the evaluation of patients with SP. The integration of the alternative purposes in that clinical framework could help to orientate physiotherapists towards a more bio-psychosocial and pragmatic approach. In the future, the category of non-specific shoulder pain and its peculiarities should be taken into account in diagnostic and prognostic research studies.


There have been few large-scale, real world studies in Spain to assess change in pain and quality of life (QOL) outcomes in cancer patients with moderate to severe pain. This study aimed to assess changes on both outcomes after 3 months of usual care and to investigate factors associated with change in QoL.Large, multi-centre, observational study in patients with lung, head and neck, colorectal or breast cancer experiencing a first episode of moderate to severe pain while attending one of the participating centres. QoL was assessed using the EuroQol-5D questionnaire and pain using the Brief Pain Inventory (BPI). Instruments were administered at baseline and after 3 months of follow up. Multivariate analyses were used to assess the impact of treatment factors, demographic and clinical variables, pain and other symptoms on QoL scores.1711 patients were included for analysis. After 3 months of usual care, a significant improvement was observed in pain and QoL in all four cancer groups (p<0.001). Effect sizes were medium to large on the BPI and EQ-5D Index and Visual Analogue Scale (VAS). Improvements were seen on the majority of EQ-5D dimensions in all patient groups, though breast cancer patients showed the largest gains. Poorer baseline performance status (ECOG) and the presence of anxiety/depression were associated with significantly poorer QOL outcomes. Improvements in BPI pain scores were associated with improved QoL.In the four cancer types studied, pain and QoL outcomes improved considerably after 3 months of usual care. Improvements in pain made a substantial contribution to QoL gains whilst the presence of anxiety and depression and poor baseline performance status significantly constrained improvement. Pain is a common and burdensome symptom in cancer patients  with datPain is clearly an important, specific outcome to monitor when assessing the results of cancer patient management in routine care. Quality of life on the other hand is a broad, multidimensional concept and a very relevant outcome for patients. In terms of monitoring the broader outcomes of care, studies have shown that health-related quality of life (HRQoL) questionnaires are a practical tool for this purpose . To dateStandardised assessment of pain and QOL in routine care can also help to identify patients who are at risk of poorer outcomes. Previous studies have identified various determinants of QoL in cancer patients including age, pain, appetite loss, fatigue, intestinal function, performance status, emotional functioning, presence of metastases, and treatment status –10. HoweThe C2 study was a large, exploratory study which aimed to assess changes in pain and QOL in cancer patients with moderate-severe cancer pain after 3 months of usual care and to investigate factors associated with change in QoL. Changes in pain and QOL were assessed and estimated using effect sizes and multivariate regression models were constructed to investigate prognostic variables predicting change in QOL. In this paper, we report results from four of the most commonly diagnosed cancers . Although the study was performed in Spain, the large number and heterogeneity of patients included and the investigation of factors contributing to change in pain and QoL outcomes should mean that the study is relevant to researchers more generally who are interested in pain and quality of life outcomes in clinical practice in cancer patients.The C2 study was a multi-center, prospective, longitudinal, observational study carried out in 150 oncology units throughout Spain. The present analysis was performed in a subset of the patients included in the study, i.e. patients with lung, breast, colorectal, or head and neck cancer. The C2 study protocol was approved by the Ethics Committee of the coordinating hospital “Hospital Universitario Puerta de Hierro Majadahonda”, file number 266. All patients provided written informed consent to participate.0-10 ≥4) for the first time while attending one of the participating oncology units. Patients were screened consecutively for enrolment during routine clinic visits. The patients included were predominantly managed in an out-patient setting. Patients were excluded if they had psychiatric or neurological disorders which, in the investigator’s judgement, meant they were unable to complete the study materials. Patients with stable psychiatric conditions who were able to complete the study questionnaires were eligible for inclusion.Patients were eligible for enrolment in the C2 study if they were ≥18 years or older and experiencing moderate to severe pain  and pancreas (n = 109) and the least frequent were brain (n = 7) and thyroid (n = 6).As the C2 Study was designed as an exploratory study, information on study refusal and screening rejection rates was not collected though in these types of study in Spain the refusal rate is normally low. Of the patients included at baseline, 19.5% (488 patients) did not attend the 3 month visit, most commonly because of loss to follow-up  and withdrawal of informed consent . Thirty-four patients (7%) were discharged and 2 patients died.Sample size for the C2 study as a whole was calculated based on determining the number of subjects required to assess the prognostic factors affecting evolution in QOL assessed using the EQ-5D questionnaire. For the purposes of this study, we defined an improvement in QoL as an increase ≥30% in EQ-5D Index and we initially considered 17 potential prognostic factors that meant individuals could be classified into one of 17 different distributions of values for these variables. After incorporating assumptions regarding the number of patients who would improve and the proportion of variance in the model that would be explained by the prognostic factors included and using an alpha error of 0.05 and a statistical power of 0.8, the final sample size for the C2 study as a whole was n = 3,008.Patients were followed for 3 months from study inclusion and made a total of 3 study visits . Pain and QoL were assessed at baseline and 3 months. The 1 month visit was used to collect data on aspects such as dose changes, intestinal function and pain, but data on QOL was not collected, so results from this visit are not included in the present analysis. Surveys were completed in person during routine clinic visits with support form health care personnel if needed. Participating centres followed their usual approach to patient management in all cases.Pain was categorised using the original version of the Edmonton Classification System for Cancer Pain (ECS-CP) . Pain seQuality of life was measured using the EQ-5D questionnaire  which meOther data collected included age, sex, primary tumour site, functional status (measured using the Eastern Cooperative Oncology Group performance status [ECOG]), time since diagnosis, presence and site of metastases, pain origin , intestinal function (measured with the Bowel Function Index–BFI- ), and trChange over time was assessed using paired t-tests or Wilcoxon tests. Effect sizes (ES) were calculated to help interpret the magnitude of change. An ES of 0.20 was considered to represent a small change, 0.50 a moderate change, and 0.80 a large change . MultivaThe demographic, clinical and treatment characteristics of the study population included for the current analysis are shown in Change in BPI scores from baseline to 3-month follow-up are shown in Changes in QoL are shown in The bivariate and stepwise selection process for prognostic variables eliminated 9 of the 21 variables originally tested leading to a total of 12 variables included in the final regression models, though not all of those were statistically significant for the four cancer types investigated.2 of 0.597, 0.699, 0.644, and 0.815, respectively, for lung, head and neck, colorectal, and breast cancer.The variables most commonly associated with change in QoL  were basIn the logistic regression model to test for factors associated with reporting extreme pain at month 3, only being in ECOG performance status 3–4 at baseline was statistically significant. Age and sex were not included in the model as they failed to meet the criterion for inclusion at the stage of bivariate testing and neuropathic pain and emotional distress at baseline, though included, were not statistically significant.In this exploratory study of outcomes in cancer patients treated in usual clinical practice in Spain, we observed substantial improvements in pain and QOL in the four cancer types studied. In terms of results on the pain measure (BPI), patients in all 4 groups showed similar magnitudes of improvement on the severity and interference sub-scales. The smallest improvement on the severity sub-scale was seen in the colorectal group, though the difference was small (change of 2.7 vs a mean change of 3.1 in the other three groups). All of the changes correspond to large effect sizes, indicating substantial improvement in pain in all four groups. As regards QOL, breast cancer patients showed the biggest improvement on the EQ-5D Index, followed by head and neck, colorectal, and lung cancer patients. Interestingly, the order was not the same on the EQ-5D VAS, where head and neck patients showed the biggest gains, followed by lung, colorectal, and breast cancer patients.Discrepancies between the EQ-Index and EQ-VAS have been reported previously  and may In regard to the head and neck cancer patients, the majority had pain secondary to the tumor or to treatment and were receiving curative treatment for localized cancer. Of note, these patients frequently show acute treatment-related toxicity including moderate to severe pain from surgery, mucositis related with radiotherapy, and drug-related neurotoxicity , 20. SomWhile improvements were observed in all four patient groups and in practically all EQ-5D dimensions, after 3 months of follow-up varying proportions of patients still reported extreme problems in EQ-5D dimensions. Notably, 15.4% of lung cancer patients and 20.3% of colorectal cancer patients reported being unable to perform their usual activities, 11.1% of colorectal patients still reported extreme pain/discomfort, and 12.9% of the same group reported extreme anxiety/depression. Patients reporting this level of problem on any EQ-5D dimension would presumably form a priority group for further investigation and potentially for more concerted clinical action. In the analysis to test for factors associated with reporting extreme pain at month 3, only being in ECOG performance status 3–4 at baseline was statistically significant. This result is coherent as the overall deterioration in health status manifested by the ECOG rating is associated with more advanced disease or greater morbidity and/or toxicity and part of that clinical picture would be the presence of higher levels of pain. These results also suggest that ECOG performance ratings can be used as a prognostic factor. An earlier study by Bradley et al  also fouIn terms of the factors associated with change in QoL in all types of cancer, the most relevant were baseline performance status, change on the BPI severity and interference sub-scales, EQ-5D Index score at baseline, and presence of anxiety/depression at both visits. An earlier study demonstrated the relationship between improvements in pain as measured by the BPI and improvements in QoL , though The regression analysis also showed that the presence of anxiety/depression substantially limited any gains in QoL. For example, based on the results of that analysis, colorectal cancer patients reporting anxiety/depression at baseline and at the final visit would have a much smaller improvement on the EQ-5D Index than those without anxiety/depression. The size of the difference (0.143 points) indicates that the presence of anxiety/depression likely affects several EQ-5D dimensions. These results are in line with others reported previously  and suggPrevious studies looking at predictors of QoL in head and neck cancer patients found that the presence of a feeding tube had the most negative impact on QoL, followed by medical comorbid conditions, presence of a tracheotomy tube, chemotherapy, and neck dissection. Hospital site, age, education level, sex, race, and marital status were also significant predictors of QoL . ClinicaAlthough we also found that presence of anxiety/depression was a predictor of smaller improvements in QOL in all patient types, we only found that treatment factors (chemotherapy) were predictive of change in QOL in the colorectal patients. It is of course possible that withdrawal of chemotherapy from some patients over the study period could have influenced results, as chemotherapy can be associated with pain, though other studies have shown that chemotherapy can help to alleviate the pain caused by the tumour itself –32. In tLikewise, the present study was not intended to explore change in pain and QoL outcomes associated with specific treatment patterns, rather it was intended to provide an overall picture of change in pain and QoL outcomes achieved in routine clinical care, in a wide variety of clinical and geographical settings and including curative and palliative treatment with chemo- or radiotherapy. It also provides information regarding the proportion of patients who may still report extreme pain after 3 months of usual care as well as the proportion of patients who are likely to need treatment for anxiety and depression, which can be useful for planning care.Strengths of the present study include the large sample size and the fact that patients were included from a total of 150 oncology units in a mix of settings from all regions of Spain. While it is not possible to ascertain how representative the sample is, its size and heterogeneity as well as the fact that it was drawn from Oncology Departments and pain clinics and therefore reflects the integrated management of patients with cancer, should provide a robust profile of pain and QOL outcomes for these patients in conditions of usual clinical practice.Limitations of the study include the relatively short follow-up period and the fact that we did not collect information on all potentially relevant variables, such as educational level, sleeping, drinking or smoking, for inclusion in the regression models. In the present analysis, we also did not use the data collected at the one month visit. However, for practical reasons it was necessary to limit the number of study variables collected and those analysed for this paper. Another limitation is the fact that we did not perform an analysis of drop-outs from the study, which could be considered in future studies of this type. It should also be noted that some correlation between measures used in the study is bound to occur, as the EQ-5D already contains a pain dimension, so it would be surprising if improvements on the BPI did not to a certain extent predict improvements on the EQ Index. However, pain/discomfort is only one of the dimensions of EQ-5D and, as shown in In conclusion, we found that after 3 months of usual care in oncology units QoL and pain improved overall in patients with different types of cancer and moderate or severe pain at baseline, though results varied to some extent by cancer type. Improvements in QoL were associated with improvements in pain, whilst poor baseline performance status and the presence of anxiety and depression over the study period severely limited improvements in QoL. The study results provide an overall picture of change on relevant outcomes in routine clinical care in these patient groups in Spain and can provide a reference point to reflect on how such outcomes could be further improved in the future.S1 Dataset(SAV)Click here for additional data file.


Ultrasound is increasingly used to evaluate shoulder pain, but the benefits of this are unclear. In this study, we examined whether ultrasound-defined pathologies have implications for clinical outcomes.n = 2322). Data collected included demographics, treatments received, current pain and function. The relationship between pathology-defined groups and clinical outcomes was examined.We extracted reported pathologies from 3000 ultrasound scans of people with shoulder pain referred from primary care. In latent class analysis (LCA), we identified whether individual pathologies clustered in groups. Optimal group number was determined by the minimum Bayesian information criterion. A questionnaire was sent to all patients scanned over a 12-month period (n = 1280), (2) bursitis with extensive inflammation (n = 595), (3) rotator cuff tears (n = 558) and (4) limited pathology (n = 567). A total of 777 subjects (33%) completed questionnaires. The median (IQR) duration post-ultrasound scan was 25 (22–29) months. Subsequent injections were most common in groups 1 and 2 ; surgery was most common in group 3 . Shoulder Pain and Disability Index scores were highest in group 3  and lowest in group 4 . Patients in group 4 who had surgery reported poor outcomes.LCA revealed four groups: (1) bursitis with limited inflammation elsewhere  contains supplementary material, which is available to authorized users. Shoulder pain is common, with an estimated worldwide incidence of 0.9% to 2.5% and point prevalence of up to 26% . ImportaRC syndrome, shoulder impingement syndrome, subacromial bursitis and RC tendinitis.The clinical diagnosis of shoulder pathologies is difficult, and evidence suggests poor levels of reliability and reproducibility amongst clinicians when examining shoulder pain , 10. RecUltrasound offers accurate detection of pathology, and, in the context of the reported diagnostic uncertainty, it is unsurprising that its use is increasing. From 2001 to 2009 in Australia, there was a fourfold rise in shoulder ultrasound scans . The numShoulder pain may have complex aetiologies, and pathologies often do not occur in isolation; some may respond to particular therapies better than others, which could complicate assessment of efficacy if they co-occur. Therefore, understanding patterns of shoulder pathology may help in targeting therapies more effectively. Given the uncertainty in clinical diagnosis, it seems reasonable to examine the potential of pathology-based diagnosis using ultrasound. If ultrasound cannot identify groups of patients who will achieve different outcomes, either in the current care pathway or in trials of targeted therapies, there would be limited justification for its continued use in this patient group. As a first step toward understanding the importance of a pathology-based classification, we aimed to determine whether distinct clusters of ultrasound-defined pathologies exist and whether there is any evidence that these have implications for long-term clinical outcomes.Ultrasound reports were retrieved for consecutive primary care patients referred to a single centre’s radiology department  for a scan of their shoulder. We included 3000 patients on the basis of estimated annual referrals and included scans between 2012 and 2013. Inclusion criteria were that patients be aged over 18 years, referred from primary care, referred for shoulder pain and attending for their first ultrasound scan. Patients were excluded if they had had previous surgery or had not been referred from primary care. These patients were identified by details on the referral card and electronic patient records.In our centre, guidelines advise that patients be referred from primary care for an ultrasound scan if they have moderate-severe painful abduction, have not improved after physiotherapy or have suspected acromioclavicular joint (ACJ) pain. However, clinical experience of the broad range of presenting symptoms and signs raises questions about adherence to these recommendations and may further highlight discrepancies in clinical evaluation of shoulder pain.Data from a single shoulder per patient were utilised, and, where identifiable, the first symptomatic shoulder was included. Eligible patient records were examined to identify the first ultrasound scan for a selected shoulder (even if the first scan fell outside the collection dates). Scans were obtained by musculoskeletal radiologists and sonographers. Previous work has shown that inter-rater reliability for shoulder pathologies between two of the radiologists is substantial  for full-thickness RC tear, calcification, impingement and tendon abnormalities . The folA postal questionnaire was sent to all eligible patients scanned in 2013. A second wave of questionnaires was sent to those who had not replied after 4 weeks. Data collected included demographics; characteristics of pain; previous treatment; Shoulder Pain and Disability Index (SPADI), a validated self-administered questionnaire used to measure pain and disability in the shoulder in the past week –20; Eurogroups) were then compared for age, sex, duration of pain , injection  and the presence of each pathology. To check for responder bias, these details were also compared between patients who completed the questionnaire and those who did not. Questionnaire responses were compared between the pathology groups using quantile, Poisson or binary logistic regression, according to the outcome type, adjusting for age and sex. Appropriate checks were made that the data satisfied the test assumptions. We used Stata version 13.1 software  for analysis.Latent class analysis (LCA) was performed  Table ; the othn = 2322). Of these patients, 777 completed questionnaires (33%), and we received replies from a further 233 (10%) who declined to participate. Responders and non-responders were similar in gender balance, age and ultrasound pathology findings (Table n = 87). Ultrasound findings did not show intra-articular synovitis in the RA-reporting group. Re-running the LCA in questionnaire respondents who did not report having RA (n = 690) resulted in very results similar to those of the full (n = 3000) LCA .Questionnaires were completed by 30%, 36%, 34% and 25% of patients in groups 1–4, respectively. Older patients were more likely to respond; there were no differences in adjusted response rates between groups , neck (33%), and knees either ipsilateral 27%) or contralateral 24%) to the target shoulder  and surgery (p = 0.015) (Table p = 0.014). Adjusted rates of physiotherapy did not differ between groups.There was descriptive evidence that treatment differed according to presence of certain individual pathologies  Table . Those ip = 0.048). The differences in total SPADI by surgery were negligible for group 1  and group 2 . In contrast, in group 4, total SPADI was substantively higher in the patients who had surgery   was more likely to still have pain at follow-up Table , and subp = 0.025). However, the nature of the association between symptoms, surgery and depression cannot be determined in this cross-sectional study. There were no substantive age- and sex-adjusted differences between the groups in shoulder activity level, EQ-5D index score, EQ-5D health VAS score, the number of comorbidities reported, or the odds of reporting difficulty standing from sitting (data not shown).Patients in group 4 who had surgery were more likely to report a diagnosis of depression than those who had not (adjusted probability [95% CI] 0.40 [0.15–0.66] vs. 0.09 [0.02–0.15]), whereas surgery was not associated with depression in the other groups  in group 4 had no pathology; some of these patients may have improved at the time of their ultrasound scan. Another explanation is that other pathologies were present that ultrasound could not detect. Ultrasound is as sensitive and specific as magnetic resonance imaging (MRI) in detecting RC disorders , but furAlthough we looked at associations between baseline pathologies and outcomes, the absence of baseline clinical data means we could not fully evaluate the predictive value of ultrasound. Previous attempts at identifying predictors of outcomes in people with shoulder pain have been made –40. PainThis study has a number of limitations. This study was undertaken in a single centre, though the sample size was large; the demographics of included patients seem similar to those of other large community cohorts , 43. TheThis study demonstrates, for the first time to our knowledge, that patients undergoing ultrasound scans for shoulder pain can be grouped according to pathologic patterns. Our data suggest that these groups may receive different treatment and have different outcomes. These preliminary data support further exploration of the potential benefits of a pathology-based classification for shoulder pain.Additional file 1:Supplementary materials, including ultrasound reporting definitions, LCA analysis and supplementary tables mentioned in the body of main text. (DOCX 33 kb)Additional file 2: Figure S1.Joint pain reported. (JPG 2553 kb)Additional file 3: Figure S2.Total SPADI by surgery. (JPG 2552 kb)


To evaluate the effect of naftopidil 75 mg once daily for ureteral double-J (DJ) stent-related discomfort after a ureteroscopic procedure using a multicenter, randomized, double-blinded, placebo-controlled study. 100 patients with indwelled retrograde DJ ureteral stents after ureteroscopic stone removal or retrograde intrarenal surgery (RIRS) were randomized 1:1 to receive either placebo or naftopidil during the stenting period. At the time of stent removal, the Ureteral Stent Symptom Questionnaire (USSQ), the International Prostate Symptom Score and the total amount of used analgesics were reported. Of the 92 patients who completed the study, 49 patients were enrolled in the placebo group, and 43 patients in the naftopidil group. USSQ urinary symptom scores  and USSQ body pain scores  were lower in the naftopidil group than in the placebo group, but the difference was not significant. Multivariate analysis showed that the use of a ureteral access sheath during RIRS was the only significant predictor of postoperative DJ-related pain . The use of naftopidil once daily did not significantly reduce DJ ureteral stent-related discomfort. Larger-scaled prospective studies should be conducted to evaluate the effects of naftopidil on DJ stent-related symptoms and surgeries. Although ureteral stents enable passive ureteral dilation and divert the flow of urine to the bladder, these stents have been associated with significant morbidity and have had negative effects on quality of life4. Previous studies have reported high incidences of urination frequency (50–60%), urgency (57–60%), dysuria (40%), incomplete emptying (76%), flank (19–32%) and suprapubic pain (30%), and hematuria (25%)7. Other reports have shown that stent-related urinary symptoms and pain have resulted in reduced quality of life (QoL) in up to 80% of patients4.Ureteral stenting has been an established urological procedure for maintaining the patency of ureters since 196716. However, these studies used tamsulosin or alfuzosin and not naftopidil. α1-adrenergic receptors are known to be present throughout the ureter, and the blockage of α1-adrenergic receptors inhibits basal smooth tone and hyperperistaltic frequency17. Among α1-adrenergic receptors, α1D-adrenoceptors are prevalent throughout the distal ureter to the detrusor muscle18. Because naftopidil has greater selectivity for the α1D-adrenoceptor19, there is a theoretical advantage in using naftopidil to reduce bladder irritation symptoms or pain due to ureteral stents.Many studies have sought to reduce ureteral stent-related discomfort by investigating the effect of α-blockers, which have shown some beneficial effects in reducing stent-related symptomsTo obtain higher-level evidence showing the effects of naftopidil on reducing double-J (DJ) ureteral stent-related discomfort, we conducted a multicenter, double-blind, randomized, controlled trial (RCT). To evaluate the effect of naftopidil on improving symptoms and quality of life in patients with indwelling ureteral stents, we used the validated Ureteral Stent Symptom Questionnaire (USSQ).www.clinicaltrials.gov under registry number- NCT01959074 . The methods were performed in accordance with approved guidelines.This study was a multicenter double-blinded RCT from 6 institutions. After obtaining institutional review board approvals from each institution, 100 patients were selected. This study design for use of naftopidil for patients with a ureter stone was approved by the Ministry of Food and Drug Safety . This study is registered at 2). The patients’ Informed consents were received before the study (enrollment and publication of results).The patients were selected based on the following inclusion criteria: patients ≥18 years age who underwent unilateral retrograde ureteral DJ stent placement only after ureteroscopic surgery (URS) and retrograde intrarenal surgery (RIRS). The following patients were excluded: (1) patients who underwent percutaneous nephrolithotomy, open ureteral surgery or laparoscopic ureteral surgery, including ureterolithotomy; (2) patients with persistent ureteral stones after ureterolithotomy; (3) patients with a febrile urinary tract infection (UTI); (4) patients who were pregnant or breast feeding at the time of surgery; (5) patients with a single kidney; (6) patients with hypersensitivity to naftopidil; (7) patients using α -blockers, calcium channel blockers, anti-muscarinic medication or corticosteroids within 4 weeks; (8) patients with moderate or severe cardiovascular or cerebrovascular disease; (9) patients with moderate hepatic dysfunction ; (10) patients with a prior history of pelvic surgery or irradiation; (11) patients with a prior history of transurethral surgery; (12) patients with significant active medical illnesses precluding protocol treatment and 13) patients with chronic kidney disease stage IV  and 11.9 (SD 10.1) in a group using an α-blocker and 28.4 (SD 6.2) and 19.1 (SD 10.9) in a group receiving placebo, respectively. A log-rank test with a two-sided significance level of 0.025 had 80% power to detect differences between the groups, with a sample size of 45 in each group. Fifty patients per group were randomized, which allowed for a maximum dropout rate of 15%.Sample size calculations were performed based on a previous meta-analysis investigating the effect of α-blockers in reducing ureteral stent-related symptomsThe patients were directed to take the study medication from the day after stent placement to the day of stent removal. The maximal stent indwelling period was 15 days after ureteral surgery (duration: 5–15 days). For acute intractable pain after ureteral stent indwelling, only aceclofenac 100 mg, a non-steroidal anti-inflammatory drug, was provided on demand. Patients were asked to keep a diary recording analgesic usage amounts, periods of absence from work, and the presences and types of side effects believed to be caused by the medication. Follow-up exams were performed on the day of stent removal. All patients completed the USSQ and IPSS scoring and reported a final analgesic usage amount. All patients completed IPSS preoperatively and the day of stent removal. The USSQ questionnaires were obtained in all patients on the day of stent removal. All questionnaires were collected by operating surgeon. The same double-J ureteral stent  was used in all patients. The stent diameter was 6 Fr, and the length was dependent on the somatometric characteristics of each patient. The stent was inserted under fluoroscopic guidance in all cases. Stent position after surgery was confirmed by radiography.The primary endpoints were the USSQ urinary symptom score and USSQ body pain score. The secondary endpoints were the USSQ general health score, USSQ work performance score, USSQ sexual matter score, IPSS score and QoL score, as well as total analgesic use.Statistical analyses were performed using SPSS version 18.0 on an intent-to-treat basis. Patients with major deviations from the inclusion criteria were excluded from the analysis. Stone size was measured preoperatively at maximal length. And in multiple stone, we calculated as the sum of the largest axis of each stone on computed tomography (CT). Fisher’s exact test was used to compare nominal variables, and the Mann–Whitney U test was used to compare continuous variables between the two treatment arms before ureteral stenting. To compare outcomes after ureteral stent removal, a Chi-square and non-parametric Wilcoxon 2-sample t-test were used. In the post-hoc analyses, multivariate logistic regression was used to predict the effective factors for higher USSQ body pain scores. Multivariate logistic regression analysis was also used to find the predictor of postoperative stent-related pain. A two-sided p < 0.05 was considered to be statistically significant.Figure Drug compliance was check by patients’ reports and envelope. There are 6 drug related complication. The abdominal discomfort was reported 3 patients in control group and 1 patient in naftopidil group. One patient in control group reported diarrhea, one patient in naftopidil group reported chest discomfort. All reported symptoms were recorded unrelated to drugs and there was no significant difference between two groups.The patient characteristics of each arm are shown in Table The overall results are listed in Table As shown in Table Multivariate analysis was used to determine the predictor of postoperative DJ stent-related pain score based on the USSQ body pain results Table . Based oTable Table This double-blinded multicenter RCT demonstrated the effect of naftopidil 75 mg once daily on DJ stent-related discomfort. The overall outcomes based on the primary endpoint  showed no significant effects on the aforementioned symptoms. However, we found that the surgical type, especially RIRS using a UAS, was a significant factor associated with postoperative pain. Significant differences were observed between patients who were and were not subjected to RIRS with a UAS. This is the first study to use naftopidil to investigate the effects of DJ-related discomfort.21. Additionally, relaxation of the bladder neck and the prostatic smooth muscle and, consequently, a reduction in voiding pressure and urinary reflux could reduce pain during voiding12. Through these mechanisms, the role of alpha-blockers in ureteral stent-related symptoms could be better focused .Stent-related discomfort, pain or urinary symptoms may be associated with ureteric spasm or trigonal irritation. Ureteric and local trigonal smooth muscle relaxation and reduced ureteric motility could reduce these symptomset al.12 studied tamsulosin 0.4 mg once daily in a RCT of 154 patients. Tamsulosin 0.4 mg decreased the USSQ urinary symptom score from 31.59 in the placebo group to 20.96 in the tamsulosin group (p < 0.0001) and the USSQ body pain score from 13.3 in the placebo group to 9.94 in the tamsulosin group (p = 0.04). Dellis et al.22 observed the effects of tamsulosin 0.4 mg and alfuzosin 10 mg in a 3-armed RCT of 150 patients. Both alpha blockers significantly reduced USSQ urinary symptom and body pain scores. More recently, Singh et al.23 showed that tamsulosin 0.4 mg had positive effects on urinary index and pain index scores in a small RCT (n = 60).Several RCTs have shown that alpha blockers reduce stent-related symptoms. Wang et al.24 showed that terazosin 2 mg twice a day reduced urinary symptoms and pain. Beddingfield et al.9 showed that alfuzosin 10 mg could not effectively reduce USSQ pain scores and USSQ urinary symptoms scores. Whereas these studies provided conflicting results, conclusive meta-analyses have shown that alpha-blockers significantly reduce USSQ urinary symptoms  and body pain index  scores25 and reduce urinary symptoms  and body pain 26.However, a few RCTs investigating the effects of alpha-blockers on stent-related symptoms have reported negative results. In a 104 patient RCT, Tehranchi 18. Naftopidil has a higher selectivity for the α1D-adrenoceptor, having approximately threefold and 17-fold higher potency for α1D than for α1 A and α1B, respectively19. Thus, there is a theoretical advantage in using naftopidil in studying DJ stent-related symptoms27.Recently, many studies have shown tamsulosin to effectively reduce DJ stent-related pain. The α1A- or α1D-selective blocker is effective over a wide predisposition of α1D adrenoceptors from the distal ureter to the bladder detrusor muscleet al.28 showed effectiveness of tamsulosin 0.4 mg and solifenacin 5 mg in relieving ureteral stents related symptoms, tamsulosin group and solifenacin group both improved the DJ stent related symptoms, however solifenacin had more effectively release the DJ stent related discomfort. Another reports from Liu et al.29 showed combination of tamsulosin and solifenacin had faster effect than monotherapy during initial period of DJ stent indwelling. However, Sivalingam et al.30 recently compared tamsulosin 0.4 mg plus eolterodine 4 mg and tamsulosin 0.4 mg alone, their results showed no significant difference in urinary symptoms, body pain and daily activity among patients who indwelled DJ stent. Therefore combination effect of α blocker and anti-muscarinic drugs should be necessary further evaluation. The study about combination of anti-muscarinic and naftopidil for the DJ stent related symptoms was not present, we should be focused these combinational effect in near future.Several studies showed their efficacy of anti-muscarinic agents or combination α blocker and anti-muscarinic drugs. El-Hahas To our knowledge, this is the first RCT using naftopidil to decrease ureteral stent-related symptoms. Unexpectedly, we observed that naftopidil 75 mg once daily could not effectively reduce urinary symptoms or body pain based on the USSQ. This observation could be due to the use of RIRS with a UAS. As shown in our multivariate analyses, surgery type (RIRS) was the main factor predicting postoperative DJ-related pain. Because we typically use a UAS with or without ureteral dilation during RIRS and because the typical UAS outer diameter is 14 Fr or 16 Fr, these larger diameter and longer ureteral dilation times could affect urinary symptoms and body pain. In the subgroup analysis among patients who underwent rigid URS not using a UAS, naftopidil 75 mg once daily treatment significantly decreased USSQ pain scores compared with the control group. However, the subgroup analysis included only 45 patients. These pain scores may have been different if the study had focused only on men who underwent rigid URS.This study had some limitations. First, a relatively small number of patients was sampled. Although the calculated sample size was sufficient, with a significance level of 0.025 and 80% power, eight patients were excluded from the final analysis. Second, the uneven allocation of patients to the placebo group (n = 52) and the naftopidil group (n = 48) was due to the simultaneous multicenter recruitment of patients. Finally, the surgery type was not consistent. We originally assumed that DJ-related pain was not associated with surgery type, such as RIRS. However, RIRS, which uses a large diameter UAS, may be an important factor affecting postoperative urinary and pain symptoms. Another RCT could be conducted to compare postoperative discomfort after rigid URS or RIRS.In conclusions, the use of naftopidil 75 mg once daily among ureteroscopic surgery patients could not effectively decrease DJ-related urinary and pain symptoms. Among the patients who underwent endoscopic stone surgery without UAS, naftopidil could be helpful to reduce DJ related pain. Future RCTs could assess the impact of surgery types.


The purpose of the study was to determine if clinician predicted prognosis is associated with patient outcomes.The study was a secondary analysis of data that were collected in 8 physiotherapy outpatient clinics. Nine physiotherapists with post-graduate training in manual therapy (mean 20.3 years of experience) were asked at baseline to project the outcome of the patients evaluated. In total, 112 patients with low back (74 %) or neck (26 %) pain were treated pragmatically with interventions consisting of manual therapy, strengthening, and patient-specific education. Outcomes measures consisted of percent change in disability (Oswestry or Neck Disability Index), self-reported rate of recovery (0–100 %), and percent change in pain . Hierarchical logistic regression determined potential factors (clinician predicted prognosis score (1–10) at baseline, dichotomised as poor (1–6) and good (7–10); symptom duration categorised as acute, subacute or chronic; same previous injury (yes/no); baseline pain and disability scores; within-session improvement at initial visit (yes/no); and presence of ≥ one psychological factor) associated with meaningful changes in each of the three outcomes at discharge .p = 0.02) and duration of symptoms  were associated with rate of recovery, whereas only clinician predicted prognosis was associated with disability improvement . No variables were associated with pain improvement.Clinician predicted prognosis (OR 4.15, 95%CI = 1.31, 13.19, Clinician predicted prognosis is potentially valuable for patients, as a good predicted prognosis is associated with improvements in disability and rate of recovery. Early prognosis is important for making clinical treatment decisions. Physiotherapists usually use a combination of decision making methods, including but not limited to hypothetico-deductive reasoning, intuition, and pattern recognition, when assessing prognosis and treatment , 2. PattN = 240). Prognosis assessment was performed at baseline and prior to treatment, and based on an 11 point scale . The authors found that physiotherapists were able to identify those who would have quicker resolution, although not with the same accuracy as a clinical prediction rule. Recently, Abbott and Kingan [N = 138). Physiotherapists formulated their opinion directly after performing a standardized physical examination and scored their prognoses on a 4 point Likert scale . Their investigation supported that physiotherapists were able to identify patients who had higher self-reported disability at 12 months.To our knowledge, the association between physiotherapist-predicted prognosis and various forms of patient outcomes has formally investigated in three studies. Hancock and associates  retrosped Kingan  prospectN = 157) at risk for having persistent disability (high score on Oswestry Disability or Neck Disability Indices). The authors [et al., [Lastly, Dagfinrud and colleagues  examined authors  also com[et al., , in thatet al., [The aforementioned studies –9 appearThis study was a secondary database analysis of a prospective cohort study  in whichAll data were gathered in one of eight outpatient physical therapy clinics in the United States. For eligibility to participate in the primary study, patients were required to be 18 years of age or older with mechanically producible cervical or lumbar spine pain which occurred during clinical examination movements. All subjects also had to have required care beyond a single visit and had to speak English. Clinicians were instructed to target consecutive patients with spinal pain for inclusion into the study.i.e., diminished muscle stretch reflex, or diminished or absent sensation to pinprick in any upper or lower extremity dermatome). Additional exclusion criteria included a history of neck or low back related surgery or current pregnancy.Exclusion involved the presence of any red flag  or signs consistent with nerve root compression that resulted in a radiculopathy  and practice settings were either hospital-based or private outpatient facilities. All were familiar with data collection in research projects and had experience collecting and recording data in two previous randomized controlled trials [The study included 9 orthopedically-oriented physiotherapists, all of whom had rigorous, extensive training in manual therapy principles, orthopedic manual therapy certification, or were Fellows of the d trials , 12.Prior to involvement, all physiotherapists participated in a standardized, mandatory 30-minute educational webinar that explained the primary purpose of the study, the data collection methods, and the requirements for participation. Physiotherapists were also made aware of the secondary purpose of the study, which was to evaluate their ability to predict the projected outcome.All physiotherapists performed a patient response-based examination  in whichThroughout the bout of care, treatment interventions were performed pragmatically to ensure ecological validity and almost exclusively consisted of manual therapy, strengthening, and patient-specific education. Specific interventions were not the purpose of the study thus the components of each patient’s treatment were not collected. The physiotherapists collected outcomes data for disability and pain at week two and at discharge collected these along with the rate of recovery. Patients were discharged when the physical therapist felt they had meet their maximal improvement, when the patients self-discharged, or when the two parties mutually agreed on discharge. Discharge was not delayed for the sake of the study, thus in rare cases patient-encounters were shorter than the 2 week follow up.e.g., age, race, gender, and diagnosis), duration of symptoms , baseline outcomes measures for pain  and disability (ODI or Neck Disability Index), previous history of a similar injury/sameness of symptoms(Yes or No), presence of a within-session change in pain or movement strategies , and presence of baseline psychosocial concerns (Yes or No).At baseline, each physiotherapist recorded demographics , or a poor projected prognosis (scored as 1–6).At the initial clinical encounter, each physiotherapist was asked to estimate each patient’s potential for a successful outcome, based on their professional appraisal. Operationally, the physiotherapists were instructed to evaluate lleagues , physiotPrimary disability measures included the ODI  or the NThe ODI was used to measure patient disability in the patients with back pain. The ODI is a scale of 10 questions with scoring of 0–5 for each question, and the ODI defines disability as the higher the score, the greater the disability . We usedThe NPRS was used for patient perception of pain intensity using a scale of 0 (“no pain”) to 10 (“worst pain imaginable”). The NPRS has been found to be reliable and responsive . We alsoSelf-reported rate of recovery was scored as (0–100 %) . PatientNumber of observations per variable was determined by using the recommendations of Homer and Lemeshow . For simAll analyses completed were performed using Statistical Package for the Social Sciences (SPSS), version 21.0 . Intention to treat analysis was used, and for missing data at any follow-up time point, the last observation was carried forward. Descriptive statistics were used to describe the full patient sample. Frequencies of physiotherapists’ prediction of prognosis scores were evaluated for each physiotherapist to determine variations among practitioners. Linearity of effect of continuous variables was evaluated by plotting to identify potential curvilinear relationships. If curvilinear relationships were found, categories were created and were entered as ordinal data with a set of indicators (dummies). Individual estimates were then plotted to visualize linearity and checked if there are significant differences in the individual estimates.r > 0.7 between independent variables was used to assess the potential of multicollinearity [To assess multicollinearity in the modeling and relationships among the 8 predictor variables, a correlation matrix was calculated for all independent variables. A correlational finding of inearity . Analyseinearity  characteP values, odds ratios and 95 % confidence intervals, and Nagelkerke values were reported. A Nagelkerke is a pseudo R square measure that investigates the usefulness of the model [2) in linear regression. The R2 statistics do not measure the goodness of fit of the model but indicate how useful the explanatory variables are in predicting the response variable and can be referred to as measures of effect size.Distinct hierarchical logistic regression analyses were performed for each of the dependent variables: percent improvement on patient-reported rate of recovery, ODI or NDI, and NPRS. Hierarchical models were used instead of stepwise modeling because automated stepwise models may sometimes lead to potential illogical conclusions and because the modeling used in this study was exploratory. For each analysis, individual he model . The valN = 64; 57 %), and the mean age was 54.3 years (SD = 13.4 years). Slightly fewer than 50 % (48.6 %) reported a previous history of this same spinal condition. The baseline ODI was 32.8/100 (SD = 17.8) whereas the baseline NDI was 32.7/100 (SD = 16.8). The baseline pain scores were a mean of 5.76 (SD = 2.1) and individuals were seen for a mean of 10.4 total visits (SD = 8.3). The average duration of symptoms reported at baseline was 11.9 weeks (SD = 19.3). Fifty-two (46.8 %) of the individuals qualified as acute spinal pain, 31.5 % were sub-acute and 21.6 % were chronic. Slightly over 41 % (41.4 %) responded yes to one or more of the seven psychosocial questions. A total of 86.6 % of the individuals exhibited a within-session change during the examination. The mean raw physiotherapist prediction of prognosis value was 6.94 (SD = 2.02). For individual physiotherapists, mean raw prediction of prognosis values ranged from a low of 2.3 (SD = 0.57) to a high of 7.7 (SD = 1.15). Using the dichotomised variables discussed earlier (a score of 7–10), physiotherapists projected that 74.8 % of the patients would have a good prognosis.The study enrolled 83 (74.1 %) patients with low back pain and 29 (25.9 %) with neck pain. Of the 112, nearly all were Caucasian (95.5 %), a majority were female (Average ODI percentage change scores for patients with LBP were 64.6 % (SD = 35.9), average NDI percentage change scores for those with neck pain were 64.1 % (SD = 37.8), and average NPRS percentage change scores were 71.2 % (SD = 28.8) for those with LBP and 63.4 % (SD = 36.6) for those with neck pain. Rate of recovery percentages were 83.5 % (SD = 19.6) for LBP and 79.7 % (SD = 23.9) for neck pain.When evaluating linearity of effect, only baseline pain demonstrated a non-normally distributed composition. However, when categorized, associations did not improve. Because there is a lack of an appropriate threshold within the literature for the categorization of the baseline measures used in the current study, the continuous variables collected at baseline were entered into the models without transformation.For the correlation matrix Table , small tTable The physiotherapists’ prediction of prognosis was also the only significant variable associated with a 50 % change in the disability status (ODI or NDI) with use of the logistic regression analysis. Patients identified by the physiotherapists to have a good prognosis were 4.28  times more likely to report a 50 % improvement in disability at discharge than those who were identified to have a poor prognosis  that the other prognostic variables used in our models. In contrast, Hancock et al.,  found thet al., –9. Theseet al., ; spinal et al., , 9; inflet al., ; and the[et al.,  found siet al., [i.e., 20 % improvement) from the raw baseline score. It is difficult to assess the comparability of our findings with Abbott and Kingan [et al., [et al., [et al. [The effect size of the physiotherapists’ prognosis in our study was larger than those previously reported. This may be reflective of 1) the differences in thresholds we used to determine success in our trial, 2) the skill set of our physiotherapists, or 3) the fact that we did not include a number of variables previously included in other studies. For the disability measures (ODI and NDI) we required a 50 % change from baseline measures to qualify as a success; a value that requires a notable overall improvement from baseline. Dagnifrud et al.,  requiredd Kingan  and Hanc[et al.,  because [et al.,  retained[et al.,  used num[et al.,   based on the initial assessment of each patient. The current study incorporated prognostic findings that were represented in past literature; however, it is possible that other factors not represented in the models influenced outcomes. Another limitation is the experience and skill sets of each physiotherapist. All physiotherapists had similar, structured training and it is possible that the prognosis prediction was actually a by-product of a structured decision making model used by clinicians from a similar background or training. Although the tool we used for measuring prognosis was the same as the tool used by Dagfinrud et al.  we were Physiotherapist prediction of prognosis is based on the theory that the physiotherapist can use previous knowledge obtained from multiple sources and experiences to come to an appropriate decision about the likely outcome of care. This study suggests that experienced physiotherapists’ prediction may be useful for determining prognosis.