Statement of the Problem: Trigeminal neuralgia (TN) presents with a shooting pain in maxillofacial region which compels the involved patients to visit many medical and dental physicians to relieve the pain. Hence, assessing the outcomes of different treatment modalities may help the patients and their clinicians choose a suitable practical method of treatment.Purpose: The study was aimed to evaluate the outcomes of different treatments of TN and to determine which surgical or non-surgical treatment is better for controlling the pain.Materials and Method: This study included 42 patients with trigeminal neuralgia. A questionnaire was completed for each patient in order to evaluate the pain control status of patients’ treatment with non-surgical  and surgical modalities. The questionnaire consisted of questions on an datasheet , concerning the duration of involvement with the condition, type and dose of the medication(s) used, the surgical technique administrated, patient satisfaction with the treatment modality and the intensity and frequency of the pain if present. The purpose of the study and the necessary information regarding the questions of the data sheet was given in detail to the patients for a careful completion of the questionnaires. Data was analyzed by adopting t-test using SPSS software.Results: The results showed that the patients treated with pharmaceutical modalities had relatively lower improvement rate than those treated with surgery combined with medication (p< 0.035). Carbamazepine was the most consumed medication for pain control and the microvascular decompression was the most performed surgical method in patients.Conclusion: Although medication therapy alone was less effective than surgery combined with medication, both treatment modalities were significantly effective in controlling the pain of patients. Trigeminal neuralgia (TN) is a known medical condition and its published reports date back to the first century. The condition is manifested as a shooting pain in the oral and maxillofacial region -2. The sDrug therapy, with Carbamazepine as the first choice, is usually considered the first line of non-surgical approach for the treatment trigeminal neuralgia . However42 patients with trigeminal neuralgia, who had referred to major treatment centers including private offices, state specialized treatment centers and the maxillofacial surgeons’ offices in Kerman, were recruited in this study. The demographic information of the participants was collected and then the patients were invited to the Department of Oral and Maxillofacial Surgery of the Faculty of Dentistry, Kerman University of Medical Sciences, for examination, interview and completion of a questionnaire. If a valid medical record was available, it was employed for tracking the course of the disease and for further evaluation. To be included in the study, the course of the disease should have been passed for 4 weeks (at least) from commencement of the condition, diagnosis and establishment of treatment .The participants were excluded from the study if:There were any doubts about the definitive diagnosis of TN, including patients with pain resulting from temporomandibular disorders (TMD) and burning mouth syndrome (BMS)   If the pain had not been alleviated by the treatments rendered, based on the criteria presented by Sweet: Sudden pain Pain elicited by mild palpation of the face (pain at the target point) Pain in the trigeminal nerve dermatome Unilateral painNormal facial sensation during clinical examination In order to assess the severity of pain after treatment, visual analog scale (VAS) test was enrolled and the patients were asked to mark the level of their perceived pain on a 100 mm, non -hatched VSA scale with one end marked as “no pain” and at the other end as “worst pain imaginable” .The pain severity was determined by the number of attacks (frequency of attack) as Mild (0-5 times a day), Moderate (6-10 times a day), Severe (11-15 times a day), and Very Severe (more than 15 times a day) .The data collected by the questionnaire consisted of patients’ age, duration of involvement with TN, the first treatment received, supplementary treatment received (if any), and severity of the present pain .To verify these data, an attempt was made to access patient medical files (if available) in order to record the therapeutic course. When the type of the supplementary  received by the patient was unidentified, the patient was excluded from the study. All the patients participating in the study were informed about the nature of the study in details and then deliberately signed informed written consent forms.Data were initially described by using frequency tables, graphs and central statistical parameters, including median, mean, and standard deviation.Type of painIn the present study, the most frequent type of pain was shooting pain with a frequency of 42.8%. Other types of pain are presented in Initiation of the first episode of painPain had initiated suddenly and spontaneously in 22 patients (32.4%) and after tooth extraction in 8 patients (19%). Other instances included initiation of pain after eating, palpation of the area, cold water, emotional stress, toothache, and trauma which are summarized in Duration of involvementDuration of involvement of 28 patients (66.7%) was less than 10 years and in 14 patients (33.3%) was more than 10 years. Other occasions are summarized in The affected sideThe right side of the face was more involved than the left side in the present study. The right and left sides were affected in 24 (57.1%) and 17 (40.5%) patients, respectively. Bilateral involvement was identified in only one patient (2.4%).Use of MedicationCarbamazepine 40 patients (95.2%) in the present study had taken Carbamazepine, with the routine daily dose of 200-1200 mg. The most prevalent dose was 400 mg/day in 9 patients (21.4%), followed by 600 and 800 mg/day in 8 patients (19%) each. Seven patients (16.7%) took 1200 mg/day and in 3 patients (7.1%) the dose was higher than 1200 mg/day. Phenytoin5 patients (11.9%) had taken Phenytoin to control pain with doses of 300 mg/day in 4 patients and 200 mg/day in 1 patient (2.4%). Baclofen8 patients (19%) had taken Baclofen; with 3 patients (7.1%) taking the highest does of 10 mg/day. The daily doses of 20 and 30 mg had been taken by 2 patients each (4.8%) and only one patient (2.4%) had taken a daily dose of 75 mg.GabapentinGabapentin had been taken by 4 patients (9.5%) at different doses.AmitriptylineOnly 1 patient (2.4%) had taken Amitriptyline at a dose of 25 mg/day.LamotrigineNo patient had taken Lamotrigine.Duration of the medication therapy32 patients had taken medications for 1 month to 5 years (76.1%) and 7 patients (16.6%) for 5-10 years. Only 3 patients (7.1%) had taken medications for 15-20 years. Surgical technique for the treatment of neuralgiaOf a total of 42 patients, 16 patients had undergone surgery; 14 patients (87.5%) had undergone MVD, 1 patient (6.25%) had undergone cryosurgery and 1 patient (6.25%) had received Botox injection. Satisfaction of patients with the treatment of neuralgiaFrom the total of 42 patients, 29 patients (69%) were completely satisfied with treatments  and ; 8 and 10 patients were fully satisfied with medication therapy and surgery, respectively. 11 patients (26.1%) were fairly satisfied; 6 patients (14.3%) were dissatisfied and 7 patients (16.66%) were very dissatisfied .Totally, 13 persons (30.95%) were dissatisfied. Severity of the painThe pain severity, measured on VAS, was 90-100 in 11 patients (26.1%); 10-20 in 3 patients (7.1%), and 60-70 in 3 other patients (7.1%). Other pain severities were less prevalent  had low pain severity and subsequently 6 (14.28%), 3 (7.14%), and 2 (4.8%) patients exhibited very severe, severe, and mild pain severity respectively.p< 0.035) (∂ =5%) revealed that fewer patients had recovered from TN by using medication therapy alone.Comparing medication therapy alone (carbamazepine) and the surgery combined with medication therapy, MVD with statistically significant differences  had completely recovered from TN with the treatments they had received and 26.1% had achieved relative pain relief, consistent with the results of a study published by Scrivani et al. [In the present study, medication therapy resulted in pain relief in 57.67% of patients with complete pain relief in 30.75% and partial pain relief in 26.92%. Moreover, 57.14% of patients experienced pain recovery by using carbamazepine; with complete pain relief in half of these patients (28.57%) and partial pain relief in the remaining half. These findings are in consistent with the results of some previously published studies -19. In aOn the other hand, the results of the present study are not in line with those of yielded by the study of Jun Sato et al. concerning the effect of medication therapy on the pain relief. In their study, 50 patients with TN were evaluated and their findings showed that Carbamazepine was effective for the treatment of TN and resulted in pain relief in 45 patients (90%). Moreover, Rockliff et al. studied the efficacy of anticonvulsive agents, especially Carbamazepine, and reported that the efficacy of the medications taken by their studied patients was 60-80% . The difOf all the patients treated with MVD surgical procedure in the present study, 85.5% achieved complete or partial recovery which is consistent with the results of previous studies. In a published study conducted by Olson et al., 93% of patients achieved complete recovery and 4% achieved partial recovery after MVD surgical procedure . ScrivanIn a research by Neto et al., smaller size of the foramen rotundum and foramen ovale on the right side were reported as the etiologic factors for TN. They reported a higher incidence of the condition on the right side. Their results showed that 83% of patients experienced recovery with the use of MVD surgical technique and the rest (17%) did not achieve pain relief and recovery with the surgical technique. They concluded it was attributed to other etiologic factors rather than pressure on the nerves and inappropriate treatment .In a study enrolled by Reuelta-Gutierrez et al., presence of blood vessels such as superior cerebellar artery and its pressure on the trigeminal nerve was not detected in 3.1-17% of patients and standard MVD surgical technique was introduced as a safe and efficient technique for the treatment of TN .Aryan et al.  evaluateThe results of a study by Hai et al.  on the eIn a study performed by Oh et al.  the treaApfelboum carried out a study on the long-term outcomes of MVD in patients with TN and reported excellent treatment results (66%) and good results (15%) in patients with mild pain .Regarding the outcomes of MVD in patients with TN, a study performed by Olson et al. demonstrated that 74% of patients achieved complete pain relief even 10 years after treatment .In the present study, 69% of patients achieved complete or relative relief of pain and the severity of pain decreased in these patients. This result is consistent with the results of a study by Campbell et al. . They evDespite the availability of various treatment modalities for TN, approximately 30% of patients require continuance of their treatment or an alteration in their treatment modality. Moreover, medication therapy alone was less effective compared to medication therapy combined with surgical procedures. Even though both treatment modalities were significantly effective in the recovery of patients, further studies for evaluating the different modalities of treatments are strictly recommended. We would also recommend employing IMMACT guidelines  in futur


Identification of prognostic factors for persistent pain and disability are important for better understanding of the clinical course of chronic unilateral lumbar radiculopathy and to assist clinical decision-making. There is a lack of scientific evidence concerning prognostic factors. The aim of this study was to identify clinically relevant predictors for outcome at 52 weeks.116 patients were included in a sham controlled clinical trial on epidural injection of glucocorticoids in patients with chronic unilateral lumbar radiculopathy. Success at follow-up was ≤17.5 for visual analogue scale (VAS) leg pain, ≤22.5 for VAS back pain and ≤20 for Oswestry Disability Index (ODI). Fifteen clinically relevant variables included demographic, psychosocial, clinical and radiological data and were analysed using a logistic multivariable regression analysis.At follow-up, 75 (64.7%) patients had reached a successful outcome with an ODI score ≤20, 54 (46.6%) with a VAS leg pain score ≤17.5, and 47 (40.5%) with a VAS back pain score ≤22.5.Lower age (OR 0.94 (CI 0.89–0.99) for each year decrease in age) and FABQ Work ≥34 (OR 0.16 (CI 0.04-0.61)) were independent variables predicting a successful outcome on the ODI.Higher education (OR 5.77 (CI 1.46–22.87)) and working full-time (OR 2.70 (CI 1.02–7.18)) were statistically significant (P <0.05) independent predictors for successful outcome (VAS score ≤17.5) on the measure of leg pain. Lower age predicted success on ODI (OR 0.94 (95% CI 0.89 to 0.99) for each year) and less back pain (OR 0.94 (0.90 to 0.99)), while higher education (OR 5.77 (1.46 to 22.87)), working full-time (OR 2.70 (1.02 to 7.18)) and muscle weakness at baseline (OR 4.11 (1.24 to 13.61) predicted less leg pain, and reflex impairment at baseline predicted the contrary (OR 0.39 (0.15 to 0.97)).Lower age, higher education, working full-time and low fear avoidance beliefs each predict a better outcome of chronic unilateral lumbar radiculopathy. Specifically, lower age and low fear avoidance predict a better functional outcome and less back pain, while higher education and working full-time predict less leg pain. These results should be validated in further studies before being used to inform patients.ISRCTN12574253. Registered 18 May 2005.Current Controlled Trials  Radiculopathy, or sciatica, is defined as radiating leg pain below knee level with neurological deficits in the distribution of the lumbosacral nerves ,2. The mThe natural course of radiculopathy also varies between studies, as do the success rates after treatment, both depending on the inclusion criteria and outcome measures used . For exaPrevious studies have assessed many possible predictors associated with the prognosis of radiculopathy, such as clinical, demographic, psychosocial and work-related risk factors, radiological findings and treatment modalities ,11. FemaTwo recent systematic reviews attempted to synthesize the evidence on prognostic factors for sciatica ,18. HeteTo study possible predictors for outcome, validated patient-reported outcome measures should be used with standardized cut-offs that distinguish between success and non-success . In thisIn summary, the reviews on predictors referred to above for the study of outcome of sciatica have identified a limited number of variables of clinical importance but the studies vary in the use of inclusion criteria and outcome measures, use unclear definitions of success criteria, and use statistical methods inconsistently. In the present study of chronic unilateral lumbar radiculopathy, we included a homogeneous patient sample selected with clear inclusion criteria in a specialized care setting, and clinically relevant outcome measures with well-defined cut-offs for successful outcomes. The aim of this study was to identify clinically relevant predictors for outcome among patients with chronic radiculopathy.The study was performed as part of a multicentre randomized controlled trial (RCT) on the treatment effect of caudal epidural injections for chronic unilateral lumbar radiculopathy , and as Eligible patients with suspected chronic unilateral lumbar radiculopathy, aged between 20 and 60 years, referred to outpatient multidisciplinary back clinics of five Norwegian hospitals, were consecutively assessed for inclusion. The inclusion period was 3 years, between 2005 and 2009. 461 patients with suspected chronic unilateral lumbar radiculopathy were assessed for inclusion: 376 (81.6%) were referred from general practitioners and 85 (18.4%) were internally referred in the participating hospitals.The inclusion criterion was chronic unilateral lumbar radiculopathy lasting more than 12 weeks. The intensity of the leg pain, radiating from the back to below the knee, had to be comparable to or worse than the back pain. A clinical examination was carried out by trained physicians and physiotherapists. The assessment included muscle strength, sensory loss, reflexes of the Achilles tendon and patella, and the straight leg raising test. The results of each clinical test were dichotomized as normal or abnormal as described previously . These iWe excluded 345 (74.8%) patients fulfilling predefined exclusion criteria according to the original RCT: 146 (42.3%) due to unspecific low back pain with referred leg pain, 105 (30.4%) due to radiculopathy improving during the last 2 weeks before the inclusion examination, 24 (7.0%) due to radiculopathy requiring necessary urgent referral to surgery, 16 (4.6%) because of back surgery prior to this study, 37 (10.7%) due to different medical conditions , and 17 (4.9%) because they declined to participate.At this point, 116 patients with chronic unilateral lumbar radiculopathy were included in the study. At all study sites the patients received standardized oral and written information about spine anatomy and function at baseline and follow-up. They were encouraged to engage in physical activity, and all patients received the brochure ‘Worth knowing about bad backs. What experts agree on’ . The decAt baseline, a questionnaire on sociodemographic factors, fear avoidance belief (FABQ), duration of low back pain and leg pain and outcome measures was completed by the patients.We used functional status assessed with the ODI as the primary outcome measure and leg pain and back pain as secondary outcome measures. At follow-up after 52 weeks the ODI score, the VAS leg pain and the VAS back pain were registered. A successful outcome score was set to ≤17.5 for VAS leg pain, ≤22.5 for VAS back pain and ≤20 for ODI, as recommended by Haugen et al. after Receiver Operating Curves (ROC) analysis of outcomes in 466 patients . Change The ODI contains 10 questions on limitations of daily living activities -39. EachTable We calculated means and standard deviations (SD) for continuous variables, and frequencies and proportions for categorical variables. Paired samples t-tests were used to test change scores between baseline and follow-up for patient-reported outcomes. ANalysis Of VAriance (ANOVA) was used to compare mean differences between groups. We used univariable and stepwise backward  multivariable binary logistic regression to analyse associations between predictors and outcome measures. Predictors with P value <0.20 from the univariable analysis were used in the multivariable analysis. In the analysis we adjusted for the baseline values. Odds ratios (ORs) with 95% confidence intervals (CI) were calculated. P values <0.05 were considered statistically significant. All analyses were performed using the Statistical Package for the Social Sciences (SPSS) software version 22 .In total, 116 patients with chronic unilateral lumbar radiculopathy were included. Their clinical and demographic characteristics are summarized in Table Table At follow-up, 75 (64.7%) of the patients had reached a successful outcome with an ODI score ≤20, 54 (46.6%) with a VAS leg pain score ≤17.5, and 47 (40.5%) with a VAS back pain score ≤22.5. These outcome values were used in the multivariable logistic regression analysis.Table Table Lower age (OR 0.94 (CI 0.90–0.99) for each year decrease in age) and working full-time (OR 2.77 (CI 1.02-7.56)) predicted a successful outcome (VAS score ≤22.5) for back pain, while FABQ Physical activity ≥15 (OR 0.31 (CI0.11-0.85)) predicted the contrary.Fifteen (13%) patients underwent surgical decompression of the clinically affected nerve root during follow-up, and outcome data for 12 of them were available. A subanalysis comparing operated and non-operated patients showed that the operated patients had significantly higher baseline scores for ODI, VAS leg pain and VAS back pain and improved significantly more. There were, however, no differences between the groups with regard to the ODI and the VAS leg pain and VAS back pain scores at 52 weeks follow-up Table .Table 4The main finding of this study is that lower age, higher education, working full-time and low fear avoidance beliefs each predict a better outcome of chronic unilateral lumbar radiculopathy. Specifically, lower age and low fear avoidance predict a better functional outcome and less back pain, while higher education and working full-time predict less leg pain.This study also shows that the prognosis for patients referred to multidisciplinary back clinics for chronic unilateral lumbar radiculopathy is good. A total of 75 (64.7%) patients at follow-up had an ODI score below 20, 54 (46.6%) had a VAS leg pain score below 17.5 and 47 (40.5%) had a VAS leg pain score below 22.5.Identification of prognostic factors predicting persistent pain and disability is important for better understanding of the clinical course – information that can be provided to patients and physicians – and decision-making in treatment and guidance of patients with radiculopathy. We identified higher age and reflex impairment as prognostic factors for non-success, and higher education, working full-time and low fear avoidance as prognostic factors for a successful outcome. These prognostic factors may be used by clinicians to inform patients about the one-year prognosis of chronic unilateral lumbar radiculopathy. In addition, studies show that high fear avoidance can be reduced with cognitive intervention with the prospect of improved outcomes -47.Prognostic research is aimed at using multiple variables to predict the outcome as accurately as possible . ReviewsTwo recent studies have explored prognostic factors for outcome of radiculopathy using a multivariable approach. A Norwegian prospective observational multicentre cohort study used the Maine Seattle Back Questionnaire, which is equivalent to the ODI, as the primary outcome measure . The autIn addition to the main findings in our study, the presence of muscle weakness at baseline predicted a better outcome on the secondary outcome measure VAS leg pain, while the presence of reflex impairment predicted the contrary. The study by Haugen et al.  observedSurgically treated patients had more complaints at baseline and improved more during follow-up than those treated non-surgically, but after 52 weeks there were no differences in outcomes between the two groups. Those who had intolerable symptoms seem to benefit from surgery due to rapid pain relief. In previous studies, patients selected for surgery had more disability and pain (higher baseline scores) and more rapid decline of symptoms than those not operated on ,50. HoweIt is a strength that we analysed multiple clinically relevant variables using a multivariable method. Our study is limited by a relatively small number of patients, which precluded explorative analysis of the effect of different combinations of predictors ,54. We cMany previous prognostic studies of chronic radiculopathy have focused on patients encountered in primary care or at the surgical units. The present study deals with patients referred to outpatient multidisciplinary back clinics. Our results should not be generalized to surgical patient populations or to patients from unselected primary care.We found that lower age, higher education, working full-time and low fear avoidance beliefs each predict a better outcome of chronic unilateral lumbar radiculopathy. Specifically, lower age and low fear avoidance predict a better functional outcome and less back pain, while higher education and working full-time predict less leg pain. These results should be validated in further studies before being used to inform patients. Unfortunately, comparison with results from two other recent studies conducted with similar methods was difficult because of minor differences in inclusion criteria and categorization of possible predictors. Accordingly, rigorous standardization of the methodology is necessary for future studies before reliable predictors can be identified across studies.


Objective. Comparing global postural reeducation (GPR) to a standard physiotherapy treatment (PT) based on active exercises, stretching, and massaging for improving pain and function in chronic low back pain (CLBP) patients. Design. Prospective controlled study. Setting. Outpatient rehabilitation facility. Participants. Adult patients with diagnosis of nonspecific, chronic (>6 months) low back pain. Interventions. Both treatments consisted of 15 sessions of one hour each, twice a week including patient education. Measures. Roland Morris Disability Questionnaire to evaluate disability, and Numeric Analog Scale for pain. A score change >30% was considered clinically significant. Past treatments, use of medications, smoking habits, height, weight, profession, and physical activity were also recorded on baseline, on discharge, and 1 year after discharge . Results. At T0 103 patients with cLBP (51 cases and 52 controls) were recruited. The treatment (T1) has been completed by 79 (T1) of which 60 then carried out the 1-year follow-up (T2). Both GPR and PT at T1 were associated with a significant statistical and clinical improvement in pain and function, compared to T0. At T2, only pain in GPR still registered a statistically significant improvement. Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage , 2. PainThe treatment of chronic LBP is still very controversial. International guidelines consider three groups of low back pain treatment options: medication, invasive, and conservative treatment. The conservative approach is generally recommended for chronic nonspecific low back pain: patient education, specific exercise, and spinal manipulation are claimed to be effective in the short term, but the magnitude of functional improvement and pain relief is generally low. Stretching, spine stabilization, and proprioception exercise are generally recommended with or without manual therapy or massage. According to a recent Cochrane review , exercisIn the rehabilitative treatment of low back pain many approaches are used around the world, requiring specifically trained physiotherapists but claiming long lasting benefits. Global postural reeducation (GPR) is an approach based on an integrated idea of the muscular system as formed by muscle chains, which can face shortening resulting from constitutional, behavioral, and psychological factors. The aim of GPR is to stretch the shortened muscles using the creep property of viscoelastic tissue and to enhance the contraction of the antagonist muscles , 10. TheThe scientific literature regarding the use of GPR for the treatment of chronic low back pain is scarce. A recent review of the literature identified 11 studies  about thOur pragmatic clinical study aims at describing the short and long term effects of GPR on patients with nonspecific cLBP, compared with a similar sample of control that received standard individual physiotherapy (PT).All patients signed their informed consent form to be included in the study. The Institutional Review Board approved the study protocol.All patients at the Don Gnocchi Foundation IRCCS Florence from June 2011 to February 2011 with a prescription of individual PT for persisting nonspecific low back pain were considered eligible. Diagnosis and prescription were given by community health specialists in physical medicine and rehabilitation: some specify the type of individual PT prescription  while others just provide a generic prescription of individual PT, leaving the choice of approach to the physiotherapist. For the purpose of our study, further inclusion criteria were 18–80 year old patients, and chronic LBP, defined as persisting from “very often” to “always” for at least 6 months. Exclusion criteria were neurological signs (irritation/deficit) and/or pain below the kneecap; severe osteoporosis; spondylolisis and spondylolisthesis; arthritis ; tumors; infections; previous spinal surgery; other debilitating and/or very painful musculoskeletal conditions; recent trauma (<30 days); acute illness; anticoagulant therapy or phenobarbital or radio/chemotherapy; psychiatric illness; and medical-legal disputes in progress; pregnancy. Eligible patients meeting the above criteria were invited to participate in the study and were asked for their written consent. The Institutional Review Board of the Don Gnocchi Foundation approved the study protocol. The patients who already had a specific prescription of individual PT-GPR were assigned to the GPR group, while those with a general prescription of individual PT and no contraindications to GPR  were either addressed to GPR or to PT to form a matched control group. Six qualified physiotherapists, with basic training and two courses of higher education in accordance with GPR Souchard and with at least 5-year experience, assessed and delivered the rehabilitation program, delivering either GPR or PT according to group assignment.For both interventions the program provided 15 sessions of 60 minutes each, two times a week. Therapist assessment was individually performed the day before the start of the treatment, while the final assessment was delivered immediately after the end of the last session. The exercise treatment protocol (PT) was formulated according to national and international guidelines on the treatment of persistent low back pain with exercises , 15 and In GPR group patients were subjected to a postural assessment according to the Souchard approach. Different body segments were observed in relation to patients and space, in order to identify possible disharmonies. Patient assessment is global and takes into account any changes in vision, dental occlusion, the support of the foot, visceral or psychological problems, past neurological or orthopedic problems, and a search for shortened muscle chains. According to specific assessment, appropriate “postures” were selected to correct identified muscle imbalances –18.At the beginning of the treatment, each patient, in both groups, received an informative brochure with evidence based standardized educational information on basic back anatomy and biomechanics, optimal postures, correct movements in daily living activities, and ergonomics. On discharge each patient received an individual short set of exercise programs to carry out at home. These were generally recommended as well as the regular practice of low-impact physical activity of low to moderate intensity, according to the clinical profile and preferences of the patients.Measures were taken at T0 (baseline), T1 , and T2 (twelve months from discharge). Baseline assessment was of general characteristics: age, sex, BMI, smoking, number of years or months of low back pain suffering, pain frequency in the last 6 months, pain related to the use of drugs, whether previous LBP treatments performed also with different approach , profession, number of work days lost due to back pain, and physical activity. The primary outcome measure was low back pain-related functional disability, assessed by the Roland and Morris Disability Questionnaire (RMDQ) .The Roland Morris score ranges from 0 to 24 ranging, respectively, from “zero” to “maximum” low back pain-related disability. We regarded as “respondent” patients with a minimal clinically important difference (MCID) in scores from the Roland Morris Disability Questionnaire (RMDQ), indicated by the literature as an improvement equal to or greater than 30% compared to baseline at both ends of the treatment and follow-up . In addiAfterwards, between December 2012 and February 2013 (T2), all the patients who completed the treatment were contacted for a follow-up interview, performed by an independent researcher, reassessing the RMDQ and NRS and enquiring about any medication or other treatment for CLBP received, about the practice of any regular physical activity, any changes in activity or profession in the previous year, and any adherence to a specific exercise program.The sample sizes were calculated with a priori sample size analysis. From data of previous studies , 21 hypoStatistical analysis was performed using the software STATA 7.0, from Stata Corporation .t-test for independent sample.for continuous variables such as age, weight, height, the Student's χ2 test.For categorical variables such as sex, smoke yes/no, use of drugs we used the Pearson For analyzing the differences between the two groups we usedFor analyzing the differences concerning the score of disability and pain before/after within the same group we used the Wilcoxon sign rank test.χ2 test.For analyzing the differences between groups concerning the score of disability and pain we used the Kruskal-Wallis rank test and Pearson In the text Tables -3 the scFrom June 2011 to February 2011, 103 patients diagnosed with persistent chronic low back pain attended our facility for rehabilitation treatment. 32 of them had a specific prescription of GPR, while 71 had a generic prescription of individual PT. All the patients were assessed as eligible with no contraindications for GPR and all of them met the inclusion criteria. Those with GPR prescription were assigned to GPR, while the others were alternatively assigned to GPR or to PT to form a paired control group. Of the 52 patients assigned to GPR and the 51 to PT only 79 patients (39 for the GPR group and 40 for the PT group) were part of the final sample at T1 because 13 eligible patients refused to participate in the study (7 for the FKT group and 6 for the GPR group) and 11 patients discontinued the treatment (5 for the PT group and 6 for the GPR group). Of the 79 patients recruited 19 did not complete the 1 year follow-up. The final sample to T2 was composed of 60 persons, 30 for each group .Demographic, clinical, and general characteristics of the two groups at baseline (T0) are summarized in No statistically significant differences were observed between the two groups in the examined variables. The distribution of the two sexes in the two groups was homogeneous. The two groups were not homogeneous regarding profession; in the GPR group, in fact, employees are 50% (=15 subjects) while in the PT group only 8 patients (26%) were employed.P < 0,001). Improvement equal or above 30% was considered a clinically significant difference, as indicated in literature both for NRS and for RMDQ scores [P < 0.02). Comparing responders in the two groups at T2, we found that their percentage was not significantly different between groups, either for NRS (P < 1.00) or RMDQ (P < 0.27) : In fact, during the year following the end of treatment, GPR patients reported that they were subjected to further physiotherapy treatments later in time than patients in the PT group.We found a statistically significant difference only for the time elapsed before receiving further treatment in follow-up.  we found an improvement in both NRS and RMDQ scores compared to T0 in both groups, but neither of the two scores was clinically significant. In our findings, discharge improvements were attenuated in time and were no more clinically significant in either group; however patients who received GPR still reported statistically significant pain relief compared to baseline and a lower frequency of pain which may indicate a longer-lasting effect of such treatment on pain.However, since we have evaluated patients not earlier than one year after discharge, we can not say if significant improvements were maintained longer in RPG because we could not assess whether improvements have been lost more in the first than in the second half after the end of treatment, as it suggests a recent study LBP. .In a randomized clinical trial in 2008, conventional stretching and muscle chain stretching in association with manual therapy were equally effective in reducing pain and improving the range of motion and quality of life of female patients with chronic neck pain, immediately after treatment and the results were maintained at a six-week follow-up, differing from our sample [The main limitation of our study was the assignment of patients to the two groups that were not possible to randomize. Although all our patients had a clinical indication for GPR, only those who had a general prescription could be casually assigned to either group, while the few that already came to our facility with a prescription of GPR were necessarily assigned to the GPR group. Although we verified that the two groups were similar for all relevant general and clinical characteristics, our findings do not have the strength of a randomized controlled study.LBP shows complex and variable clinical features. Further, in future studies, in order to give more solid proof to our thesis it would be interesting to divide the sample into subgroups with similar characteristics at clinical assessment and to subject the patients to single interventions, comparing these results to a control group , 25. In Since treatments provided similar clinically significant improvements in both pain and disability, without significant differences between groups, we can say that the two approaches were equivalent for our cLBP patients.This study compared the short and long term effects of GPR and individual PT on cLBP. Our result showed equivalent improvements both in function and pain: both outcomes presented short term improvements above the clinically minimal significant difference that were no more clinically significant at one year. Only in the GPR group was pain relief statistically significant at one year in frequency and intensity. Considering that GPR is more expensive in terms of the professional training by physiotherapists, our results do not recommend promoting its systematic application in cLBP. Nevertheless, our data suggest the possibility that GPR may have longer lasting effects compared to PT, which deserves further investigation by a randomized controlled trial.


The objective of this study is to describe the pain in the right low abdominal area, i.e. , in the right iliac fossa, as a signal and symptom findings in the physical examination in patients with food allergy.We studied the data of the physical examination of the right low abdômen área of 355 patients with food allergy, retrospective using the medical data from the medical records of the Brazilian Society of Food Allergy (SBAA).Our patients were 48% male and 52 % female, and those numbers are not different from those of the pertinent literature. The age was distributed according with the literature, similar to all tree groups: 42.8% were infants, 32.7% were children (3 to 13 years) and 24.5% were adolescents and adults.In anamneses of the GALT system, the abdominal pain was the most frequent complain, present in 15.6% of the patients, followed by diarrhea and vomits in 12.6 and constipation in 11.7%, next to them we had vomiting in 11.7% of patients studied.In the physical examination of the patients selected to the study, pain of the right inferior abdômen was present in 18% of patients followed by abdominal distension in 13.5%. Left abdominal pain was found in 3.3% .Epigastric pain and splenomegaly in 2.6%.One explanation for the RLAP in patients with food allergy is related to the ileal nodular lymphoidhyperplasia expressing the immunereaction at the Payers Patches in the terminal ileum. Another splanation to the pain is the degranulation of eosinophils in the mucosal or muscular structure of the bowel wall inducing pain.All physician doing physical examination in patients with the suspicious diagnosis of food allergy, have to do a careful examination of the right low abdomen, considering the presence of pain. The evidence of this signal will be very suggestive for food allergy.


Methods. Using a randomized double-blind crossover design, we assessed the effect of 5 weeks of pregabalin (versus placebo) on acute cardiovascular and subjective responses to moderate exercise in 19 FM patients. Blood pressure (BP), heart rate (HR), and ratings of perceived exertion (RPE) during exercise and ratings of pain, physical fatigue, and mental fatigue before, during, and for 48 hours after exercise were compared in patients on pregabalin versus placebo and also versus 18 healthy controls. Results. On placebo, exercise RPE and BP were significantly higher in FM patients than controls (p < 0.04). Pregabalin responders  had significantly lower exercise BP, HR, and RPE on pregabalin versus placebo (p < 0.03) and no longer differed from controls (p > 0.26). Cardiovascular responses of nonresponders (n = 7) were not altered by pregabalin. In responders, pregabalin improved ratings of fatigue and pain (p < 0.04), but negative effects on pain and fatigue were seen in nonresponders. Conclusions. These preliminary findings suggest that pregabalin may normalize cardiovascular and subjective responses to exercise in many FM patients. Pregabalin, an approved treatment for fibromyalgia (FM), has been shown to decrease sympathetic nervous system (SNS) activity and inhibit sympathetically maintained pain, but its effects on exercise responses have not been reported. Fibromyalgia syndrome (FM) is characterized by widespread pain in muscles, joints, and deep connective tissues for at least three months. Additionally, using the American College of Rheumatology (ACR) classification criteria, FM patients report painful hypersensitivity to pressure in at least 11 of 18 tender points during clinical examination . One exaα2-delta subunit of calcium channels in the central nervous system (CNS) that has analgesic and anxiolytic as well as anticonvulsant activity. Clinical trials of pregabalin have shown significant reduction of pain, improved sleep quality, and improved health-related quality of life in the majority of FM patients studied [Heterogeneity among FM patients is also reflected in their differing response to medications, including pregabalin, the first drug licensed by the U.S. Food and Drug Administration (FDA) specifically for treatment of FM . Pregaba studied –8. Howev studied  concludeIt is also notable that exercise therapy (both aerobic and strength training) has been shown to reduce pain ratings and increase function in FM patients –12. Howe post hoc that patients tested while on their normal medications that included pregabalin had lower pain and mental fatigue scores both at preexercise baseline and for at least 48 hours after acute exercise than patients on other treatments (unpublished data). In these studies, the acute exercise task consisted of 25 minutes of combined arm and leg cycling at 70% of age-predicted maximal heart rate. Using this information, we hypothesized that pregabalin treatment would decrease pain and fatigue symptoms in at least some patients both at preexercise baseline and following an acute exercise challenge. We further hypothesized that pregabalin treatment would partially normalize cardiovascular differences in response to exercise seen between FM patients and healthy controls, with the caveat that this beneficial effect might be seen only in those patients who are treatment responders and/or those patients without comorbid CFS.To our knowledge, no previous studies have used standardized exercise tasks with extended postexercise symptom monitoring to assess effects of pregabalin versus placebo on cardiovascular responses or symptom severity in patients with FM. The most similar investigation that we could find was a study of postexercise changes in pain ratings in CFS + FM patients, rheumatoid arthritis patients, and healthy controls on placebo versus paracetamol. That study found mixed responses in CFS + FM patients, with paracetamol associated with decreased pain immediately after exercise in some but not all of these patients . In our n = 18) were also recruited for participation in the exercise protocol as a comparison group. Data were collected between June 2011 and June 2013.Written informed consent approved by the University of Utah Institutional Review Board was obtained from all study volunteers before participation. Our objective was to recruit 20 patients aged 18–65 from a private fatigue clinic who met the 1990 ACR criteria for FM . HealthyThis pilot study utilized a double-blind, placebo-controlled crossover design to examine pre- and postexercise leukocyte gene expression changes induced by pregabalin (Lyrica) in patients with FM, patients with both CFS + FM, and healthy controls. Evaluation of symptom changes, subjective ratings of pain and fatigue, and responses to an acute exercise challenge were obtained in conjunction with treatment and placebo conditions. Here, we report on cardiovascular and self-reported symptom responses to exercise with respect to treatment effects, while the gene expression results will be reported in a separate paper . Pregabalin and identical appearing placebo were provided by Pfizer.Upon study entry, patients were examined (by Lucinda Bateman) at the Fatigue Consultation Clinic (FCC), where the diagnosis of CFS + FM or FM was confirmed. Patients were randomized to receive either pregabalin or placebo for 5 weeks, including a 2-week upward titration phase up to 450 mg/day. FM and CFS + FM groups were randomized in blocks in order to achieve similar numbers in each group who received pregabalin or placebo treatment first. FCC staff were not blinded to the treatment the patients received for safety reasons. At the end of 5 weeks, patients reported for exercise testing in the Department of Anesthesia at the University of Utah, as described below. All University of Utah research staff, including the PI, were blind to the diagnosis and treatment of the patients. Following a 2-week washout period supervised by FCC staff, patients then received the opposite treatment for another 5 weeks. At this time, patients again reported to the blinded staff at University of Utah and repeated the exercise task.The acute exercise challenges were conducted during the fifth week of both treatment and placebo phases. The exercise task consisted of sustained (25 min) submaximal exercise using the Schwinn Air-Dyne bicycle ergometer. For the first exercise task in week 5, work-rate was gradually increased during the first 5 minutes until each subject attained a heart rate corresponding to 65–75% of age-predicted maximum heart rate. Thereafter, work-rate was adjusted as necessary to maintain the target heart rate. For the second exercise task , we replicated the first exercise session so that work-rate was equivalent for both placebo and pregabalin conditions. Healthy controls completed one exercise session using the same protocol used for patients. During each exercise task, heart rate (HR) was recorded each minute, systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded at minutes 10 and 20, and rating of perceived exertion (RPE) was recorded every 5 minutes using a modified Borg Scale [Patients were classified as pregabalin responders or nonresponders prior to data analysis. Classification used the “Effects of Study Medication” questionnaire that patients completed after each treatment. The first question, “How satisfied are you with the study medication you have used most recently?,” was scored as 0 , 1 (somewhat), 2 (moderately), 3 (quite a bit), or 4 (very much). Then, patients circled symptoms that “got better” and symptoms that “got worse” from a list of 16 symptoms. We also recorded and tallied symptoms that were reported but not on the list.t-tests were utilized to determine whether FM and CFM + FM patients differed significantly for any exercise variable. Analyses of variance (ANOVAs) were used to compare controls to all patients while taking pregabalin and placebo. Repeated measures analyses with planned contrasts were used to examine treatment differences in exercise variables and subjective ratings of pain, fatigue, and exertion. Follow-up analyses examining responses in pregabalin responders and nonresponders were also performed. To ensure that differences in cardiovascular responses were not influenced by differences in physical work, these measures were adjusted for individual differences in work-rates. Significance was set at alpha <0.05.Initially, unpaired p = 0.03). FM patients achieved higher work-rates than CFS + FM patients on both placebo and pregabalin. On placebo, average work-rate for FM-only patients was 332 ± 58.7 kcal/hr while average work-rate was 252 ± 52.7 in CFS + FM patients. After pregabalin treatment, average work-rate was 328 ± 69.4 and 282 ± 56.6 kcal/hr for FM-only and CFS + FM patients, respectively. Data from these two groups were combined for subsequent analyses.The only variable that was significantly different between FM patients and CFS + FM patients was exercise work-rate (p > 0.27). All groups were composed mostly of females.A total of 20 patients (9 FM and 11 CFS + FM) volunteered to participate in the study. One FM patient refused to discontinue the original treatment and thus did not complete the second arm (placebo phase) of the protocol; this subject was excluded from analysis. Eighteen healthy controls served as a comparison group for the exercise task. As shown in p = 0.633). Patients with orthostatic intolerance were also present in both responder and nonresponder groups  on the first item of the “Effects of Study Medication” questionnaire and were classified as nonresponders. One patient who scored this item as 1 (somewhat satisfied) was also classified as a nonresponder based on the number of symptoms that got worse versus better on pregabalin (6 versus 3) while reporting 0 symptoms getting worse or better on placebo. Therefore, 12 were classified as pregabalin responders and 7 as nonresponders see . Importar groups .p < 0.01, Responders reported significantly higher treatment satisfaction and significantly more symptoms that improved during the pregabalin condition compared to placebo (p < 0.05) and mixed symptom responses during both conditions. Importantly, nonresponders reported more negative symptom responses while taking pregabalin compared to placebo, although this difference was only borderline significant (p = 0.06). Also, two nonresponders reported decreased muscle and joint pain while taking pregabalin, but their many negative symptoms outweighed the beneficial effects. The most common symptoms that became worse during pregabalin treatment were light-headedness (3 responders and 3 nonresponders) and mental fog (0 responders and 5 nonresponders).Nonresponders reported significantly lower treatment satisfaction during the pregabalin condition (p > 0.11)  , indicatp = 0.011). In patients, average exercise RPE was significantly lower during the pregabalin condition compared to the placebo condition . These ratings in responders on pregabalin were also similar to the RPE ratings of controls . The nonresponders exhibited no treatment difference for RPE , physical fatigue (p = 0.009), and pain . Physical fatigue and pain in nonresponders also trended toward worsening with pregabalin versus placebo  for physical fatigue, mental fatigue, or pain. When considered separately, responders had lower scores when on pregabalin versus placebo for mental fatigue , despite the fact that exercise work-rate was slightly higher during the pregabalin condition (p < 0.002).During pregabalin treatment, patients as a whole had significantly lower absolute HR and relative HR  during exercise compared to placebo (ondition . Patientp = 0.034). There were no differences in HR/WR between controls and patients on either treatment .When exercise HR was expressed relative to work-rate (HR/WR), HR/WR was significantly lower during pregabalin treatment compared to placebo in the whole patient group . Although for unadjusted DBP there were no significant treatment effects or differences between patients and controls, DBP expressed relative to exercise work-rate (DBP/WR) was significantly lower during pregabalin treatment (p = 0.037), as was SBP/WR (p = 0.002). For the whole FM patient group, both SBP/WR and DBP/WR during the placebo condition were significantly higher than controls . In nonresponders, there were no treatment effects  for either SBP/WR or DBP/WR.Analyses of responders and nonresponders revealed that during the placebo condition SBP/WR and DBP/WR were higher than controls only in responders  normalizes BP and HR responses to sustained moderate exercise in the subgroup of FM patients with a positive response to treatment. Also, pregabalin reduced these patients' exercise RPE and symptoms of pain and fatigue before and during exercise, as well as blunting their postexertional malaise for 48 hours after the task. In nonresponders, BP response was not affected, perceived exertion during exercise was not improved, and pre- and postexercise symptoms of pain and fatigue tended to worsen rather than improve with pregabalin. Strengths of this study include the randomized, double-blinded placebo-controlled crossover design and the statistical control for slight differences in exercise work-rate.Classification of pregabalin responders was based on subjective rating of overall satisfaction and whether symptom improvements outweighed negative symptom responses. Consistent with prior research on pregabalin treatment in FM –24, decrThe causes of chronic pain and fatigue in FM and CFS + FM are not well understood, but there may be common mechanisms underlying both symptoms, including increased signaling of pain and fatigue and sympathetic nervous system (SNS) dysregulation which may be a cause or effect of the increased signaling. FM has been described as a disorder characterized by enhanced SNS activity , 25, 26,Our findings showed that FM patients who were nonresponders to pregabalin differed physiologically as well as symptomatically from patients who were responders. Their HR and BP responses to exercise on either treatment regimen did not differ from controls and were not altered by pregabalin. Differences in cardiovascular responses to exercise from controls that were seen in the FM patient group as a whole were subsequently found to be due to those who were responders. Thus, there may be subgroups of FM patients who do versus do not exhibit the SNS dysregulation linked to altered cardiovascular exercise responses, and this dysregulation may be associated with response to pregabalin. Furthermore, on pregabalin, the symptom profile of nonresponders  actually tended to worsen, although the adverse effect was significant only for mental fatigue. This suggests that different physiological systems may be the primary ones that maintain the FM pain and other symptoms in this subgroup of patients. Further research is needed to identify what processes are dysregulated in these FM patients and to clarify treatments that may be more effective in reducing their pain without increasing side effects. Our findings further suggest that pretests of SNS function in untreated FM patients may be useful as biomarkers to help target the most effective pharmacotherapy for different subgroups of FM patients.The decreases in exercise HR and BP responses during pregabalin treatment observed in responders may be a secondary effect of decreased pain, especially pain in muscles, joints, and connective tissue that are active during such exercise. Because fibromyalgia pain is associated with elevated inflammatory and stress markers , 34, thiOur observations of blunted exercise HR and BP responses are consistent with pregabalin's use during presurgical intubation during which the hemodynamic pressor response is attenuated . AlteratAlthough our findings clearly demonstrate that not all FM patients will benefit from pregabalin treatment, those who were responders reported improvement of pain symptoms, better sleep, and lower perceived exertion during exercise. These effects may have enhanced the ability to perform daily life activities as evidenced by these patients' reports of increased energy and ability to do chores or have fun and decreased physical and mental fatigue. If these symptom improvements result in less sedentary activity and participation in more active pursuits, health and quality of life could be improved. Although both aerobic and strength training regimens are among the best documented nonpharmacological interventions to reduce FM pain , 11, onlLimitations. The primary weakness of this pilot study is the small sample size. This indicates the need for replication in a larger sample of people with FM and FM + CFS in order for the results to be generalizable to these populations. not associated with nonresponse to pregabalin. Future research to determine whether pretreatment of FM patients with pregabalin could reduce initial postexertional symptoms and enhance success in completing an exercise training program is recommended.FM patients who were responders to pregabalin were characterized by increased BP and HR responses to exercise compared to healthy controls. Pregabalin treatment normalized these cardiovascular responses to exercise and reduced perceived exertion in these patients. Nonresponders to pregabalin had normal exercise BP and HR responses on placebo, and these responses were not altered by pregabalin. In addition to expected benefits on pain and sleep quality, FM patients who were pregabalin responders demonstrated significant reductions in multiple fatigue-related symptoms, and the presence of comorbid CFS was


Restricted physical activity commonly occurs following acute musculoskeletal pain in older adults and may influence long-term outcomes. We sought to examine the relationship between restricted physical activity after motor vehicle collision (MVC) and the development of persistent pain.We examined data from a prospective study of adults ≥65 years of age presenting to the emergency department (ED) after MVC without life-threatening injuries. Restricted physical activity 6 weeks after MVC was defined in three different ways: 1) by a ≥25 point decrease in Physical Activity Scale in the Elderly (PASE) score, 2) by the answer “yes” to the question, “during the past two weeks, have you stayed in bed for at least half a day?”, and 3) by the answer “yes” to the question, “during the past two weeks, have you cut down on your usual activities as compared to before the accident?” We examined relationships between each definition of restricted activity and pain severity, pain interference, and functional capacity at 6 months with adjustment for confounders.N = 164), adjusted average pain severity scores at 6 months did not differ between patients with and without restricted physical activity based on decreased PASE score . In contrast, clinically and statistically important differences in adjusted average pain severity at 6 months were observed for patients who reported spending half a day in bed vs. those who did not . In adjusted analyses, both decreased PASE score and cutting down on activity were associated with functional capacity at 6 months, but only decreased PASE score was associated with increased ADL difficulty at 6 months .Within the study sample (Among older adults experiencing MVC, those reporting bed rest or reduced activity 6 weeks after the collision reported higher pain and pain interference scores at 6 months. More research is needed to determine if interventions to promote activity can improve outcomes after MVC in older adults. Chronic musculoskeletal pain causes more disability globally than any other condition  and is tOne mechanism leading to chronic pain in older adults is motor vehicle collisions (MVCs). MVCs are the second most common type of trauma among older adults and result in an estimated 250,000 emergency department (ED) visits in the United States annually . Due to Physical activity is a modifiable and potentially important risk factor for persistent pain and functional decline in older adults involved in an MVC. Promoting physical activity improves outcomes in patients with chronic low back pain and hip fracture, and encouraging a return to normal activities and neck exercises improves outcomes in younger adults with acute neck pain due to MVC (i.e. whiplash) –19. ExpeThe objective of this study was to evaluate the relationship between physical activity and persistent pain among older adults involved in an MVC. Specifically, we sought to assess associations between three measures of restricted activity in the first 6 weeks after MVC and persistent pain, pain interference, and decreased functional capacity at 6 months.We analyzed data from a multicenter prospective longitudinal study of patients aged 65 years and older who were evaluated in an ED within 24 hours of an MVC. Research assistants (RAs) assessed eligibility and conducted in-person ED interviews. All RAs completed an online course on the protection of human research subjects and study-specific training, including a practice interview prior to enrolling patients. Follow-up surveys were completed via mail or telephone interview 6 weeks and 6 months after the MVC. Patients were consecutively enrolled at eight EDs in four no-fault insurance states . No-fault insurance states were chosen to minimize the number of participants for whom on-going legal activity might promote symptom persistence . InstituN = 27) patients who were subsequently admitted to the hospital. None of these patients had life-threatening injuries. Recruitment took place between May 2012 and January 2015.Patients aged 65 years and older who presented to the ED within 24 hours after an MVC were consecutively screened for enrollment for at least 60 hours a week at each study site. Patients were excluded if they did not speak English; were cognitively impaired as defined by a Six-item Screener score of 3 or less , 29; hadIn addition to demographic information, the ED interview assessed pre-MVC disability, pain, sleep, depressive symptoms, and social support, as well as ED pain. Pre-MVC disability was considered present if patients reported at least some difficulty with one or more activities of daily living (ADL). Pre-MVC pain was assessed by asking participants to rate their average overall pain severity  during the month prior to MVC and was defined as present if pain severity was rated ≥4. Sleep was assessed by asking participants to report their average number of hours of sleep each day during the week prior to MVC, including overnight sleep and naps. Depression was assessed using two questions from the Primary Care Evaluation of Mental Disorders (PRIME-MD), which is a validated tool used to rapidly identify symptoms of depression. Participants were considered depressed if they answered “yes” to either: 1) feeling down, depressed, or hopeless much of the time during the past month, or 2) being bothered by little interest or pleasure in doing things much of the time during the past month . PerceivMVC characteristics assessed during the ED interview included vehicle damage, perception of the MVC as life-threatening, and vehicle speed prior to impact. Participants were asked to characterize the damage to their vehicle as none, minor, moderate, or severe. They were also asked “How life-threatening was your motor vehicle accident? Please rate how close you came to dying on a 0 to 10 scale, where 0 means your life was not threatened at all, and 10 means that you came very close to being killed, or could easily have been killed.” A life-threatening MVC was defined as greater than or equal to the median score of 5. We assessed perceived life-threat from the MVC because perceived threat correlates with the stress exposure from the trauma, which is understood to be an etiologic contributor to persistent pain and may also predispose patients to reduced physical activity . FinallyThe ED interview also collected baseline measurements of pain interference, ADL difficulty, and physical function. Baseline pain interference, assessed using measures from the Brief Pain Inventory , was ratRestricted activity was assessed using three different measures. First, pre-MVC physical activity was assessed in the ED and current physical activity was assessed at 6 weeks using the Physical Activity Scale for the Elderly (PASE), which provides a summary score of activity based on participant responses to 16 questions about activities during the past week , 37. TheOutcome variables included pain severity, pain interference, increased ADL difficulty, and decreased physical function 6 months after MVC. Pain severity was defined by the patient’s self-reported average MVC-related pain severity  in the past week, at the time of the 6 month interview. Increased ADL difficulty and functional decline were determined by subtracting the total score at 6 months from the total score at baseline , with larger values indicating a greater increase in ADL difficulty and decrease in physical function.We report percentages of patients with restricted activity overall and by subgroups of patients based on sociodemographics, pre-MVC health, and ED pain severity. Chi-squared tests were used to identify statistically significant differences in the frequency of restricted activity. Relationships between each of the three dichotomous measures of restricted activity are characterized using Pearson correlation (a.k.a. the mean square contingency coefficient). We then report 6 month outcomes for patients depending on whether they experienced restricted physical activity 6 weeks after MVC using each of the three measures of restricted activity. The primary outcome was average MVC-related pain in the past week. Secondary outcomes included the percentage of patients with moderate or severe pain (pain score ≥4) at 6 months as well as pain interference, increased ADL difficulty, and functional decline. Potential confounders of the relationship between restricted activity and 6 month outcomes were chosen based on prior research and clinical experience: age, sex, race, education level, pain severity in the ED, pain severity prior to MVC, depressive symptoms, whether or not a lawyer had been hired 6 weeks after MVC, and the estimated speed of the vehicle at the time of impact. Adjusted relationships were determined using the predxcat command, which fits multivariable linear or multivariable logistic regressions and estimates outcomes at the mean value for covariates. All analyses were conducted using Stata 14.1 .Of 389 eligible patients, 180 (46.2 %) consented to participate and 164 had complete physical activity data in the ED. Sociodemographic characteristics of the individuals who declined participation were similar to those of study participants: most were white (73.0 % vs. 81.1 %), female (58.1 % vs. 61.6 %), and had a similar median age (73 vs. 70). Among the 164 participants with complete physical activity data, 150  completed the 6 week follow-up, and 147 (89.6 %) completed the 6 month follow-up . Patients with low pre-MVC PASE scores were less likely to have a ≥25 point decrease in PASE score (p < 0.001); this relationship was not observed for the other measures of restricted activity. Bed rest in the past two weeks was reported by a larger percentage of patients who reported pre-MVC depressive symptoms vs. those who did not  and by patients with severe pain in the ED vs. those with mild or moderate pain in the ED . Cutting down on activities was reported by a larger percentage of patients who were age 75 or older vs. age 65–74 , patients with low rather than high social support , and patients with moderate or severe pain vs. those with mild pain .Six weeks after MVC, 46.7 % of all study participants had restricted activity based on a ≥25 point decrease in PASE. PASE scores decreased by at least 1 point for the majority of patients (68.0 %), and PASE scores decreased by 1 standard deviation or more (i.e. ≥72 point drop) for 20.7 %. One quarter of patients reported spending at least half a day in bed in the past 2 weeks, and 53.3 % reported cutting down on their usual activity in the past 2 weeks as compared to before the MVC  also had a ≥25 point decrease in PASE score, and 31 (38.8 %) reported bed rest. Of the 70 patients with a ≥25 point decrease in PASE score, 23 (32.9 %) also reported bed rest. Correlations between pairs of these three variables ranged from 0.18 to 0.35.p = 0.02).  Neither of the alternative cutoffs for PASE identified subgroups of patients with significantly different adjusted pain severity scores at 6 months: any decrease (n = 102) vs. no decrease (n = 48) in PASE = 2.04 vs. 2.51, p = 0.47; ≥72 point (i.e. one standard deviation) decrease (n = 31) vs. <72 point (n = 119) decrease = 3.10 vs. 2.00, p = 0.14. In adjusted analyses, neither of these alternative cutoffs were associated with either increased ADL difficulty or functional decline at 6 months.A PASE score decrease of ≥25 was not associated with pain severity or pain interference at 6 months either before or after adjustment for confounders Tables  and 4. Hp < 0.01). After adjustment, among patients reporting bed rest at 6 weeks, 41.6 % reported moderate or severe pain at 6 months; among those not reporting bed rest, only 18.8 % had moderate or severe pain at 6 months (p = 0.03). Bed rest was also associated with adjusted average pain interference with general activity  and with walking . Bed rest was not associated with either increased ADL difficulty or functional decline.In contrast, bed rest was associated with higher pain severity and pain interference at 6 months, and these relationships persisted after adjustment for confounders. Specifically, adjusted average pain severity at 6 months was 3.56 for patients reporting bed rest at the 6 week interview vs. 1.91 for patients who did not report bed rest (p = 0.07). The mean decrease in physical function score over the first 6 months after the MVC was also higher for patients who reported cutting down than for those who did not . Cutting down on activity was associated with greater pain severity and pain interference at 6 months, but the associations between cutting down on activity and pain severity and pain interference did not remain statistically significant after adjustment. After adjustment, among patients reporting cutting down on activities at 6 weeks, 31.0 % reported moderate or severe pain at 6 months, and among those not reporting cutting down on activities, 15.3 % had moderate or severe pain at 6 months , the ADL and physical function assessments ask individuals how easily they can take care of themselves and complete basic functional tasks. The observed association between decreased PASE scores and subsequent ADL difficulty and functional decline is consistent with the finding of a large, randomized trial that a physical activity program reduced disability better than a health education program in older adults at-risk for developing disability .Our findings are also consistent with recent work by Gill et al. , who repIn our sample, the percentages of patients with a decrease in PASE scores did not vary significantly according to age, education, pre-MVC pain, or symptoms of depression. Specifically, compared to those without symptoms of depression, participants with symptoms of depression prior to the MVC were almost equally likely to have a ≥25 point decrease in PASE scores (50.0 % vs. 46.2 %). In contrast, patients with depressive symptoms were substantially more likely to report spending at least half a day in bed during the past 2 weeks (44.4 % vs. 22.0 %). A possible explanation for this difference is that some of the patients reporting bed rest at 6 weeks were already spending at least half a day in bed prior to the MVC, and that the bed rest question identified a depressed phenotype prior to the MVC. Depressive symptoms were not associated with cutting down on activity, further supporting the findings from the PASE data that depression is not an important determinant of a reduction in activity following the MVC. A decrease in PASE score was less commonly observed among patients with a low level of physical activity prior to the MVC. The most likely explanation for this is that there is a floor effect on PASE scores: if you start out with a low score, it is relatively difficult to further decrease your physical activity score. This floor effect may partly explain why a ≥25 point decrease in PASE score in the first 6 weeks was not associated with pain outcomes at 6 months.Our findings suggest that assessing physical activity approximately 6 weeks after an MVC may be useful for identifying older adults at increased risk of persistent pain. Whether interventions that promote physical activity after MVC can improve outcomes for older adults is less clear. Exercise improves pain symptoms in patients with chronic musculoskeletal pain , and speThis study has several limitations. Of the 389 eligible patients, only 46.2 % consented to participate, which raises the concern of whether findings from this sample can be generalized to the population of older adults presenting to the ED after MVC. This concern is mitigated by several observations. First, participants had similar demographic characteristics as non-participants. Second, the percent minority within the study sample (18.9 %) is only slightly lower than the percent in nationally representative samples (24 %) . Third, Among older adults experiencing MVC, multiple methods of characterizing restricted activity 6 weeks after the MVC were clinically and statistically associated with different adverse health outcomes. Self-reported bed rest and cutting down on activity 6 weeks after the MVC were associated with 6 month pain severity and pain interference; the relationship between bed rest and pain severity and interference remained after adjusting for multiple confounders. PASE scores, which utilize a more detailed assessment of physical activity, were not associated with 6 month pain or pain interference but were associated with greater ADL difficulty and functional decline. These findings provide preliminary support for the hypothesis that promoting physical activity during the early recovery period after MVC may improve recovery among older adults.Institutional Review Board approval was obtained at each study site, and each participant provided written informed consent.https://osf.io/efxuk/]. Consistent with the ICMJE position on sharing clinical trial data, we ask that those using the data seek collaboration with our research group, and if collaboration is not possible, that they provide appropriate credit to our group for the collection of this data.The dataset supporting the conclusions of this article is available in the Open Science Framework repository [Older Adult CRASH;


Myofascial pain syndrome (MPS) of the shoulder girdle and cervical region is a common musculoskeletal problem that is often chronic or recurrent. Physical therapy (PT) and lidocaine injections (LI) are two treatments with demonstrated effectiveness compared to a control group, however little is known about their combined value. The objective of this study was to determine whether LI into trigger points combined with a PT program would be more effective than each separate treatment alone in improving pain, function, and quality of life in a group of patients with MPS of the shoulder girdle and cervical region.A single-blind, randomized, controlled clinical trial (RCT) was conducted with three parallel groups in the Departments of Physical Medicine and Rehabilitation of two urban hospitals in Medellin, Colombia. One hundred and twenty seven patients with shoulder girdle MPS for more than 6 weeks and pain greater than 40 mm on the visual analog scale (VAS) were assigned to 1 of 3 intervention groups: PT, LI, or the combination of both (PT + LI). The primary outcome was VAS pain rating at 1-month post-treatment. The secondary outcomes included VAS pain rating at 3 months, and, at both 1 and 3 months post-treatment: (a) function, evaluated by hand-back maneuver and the hand-mouth maneuver, (b) quality of life, as measured by sub-scales of the Short Form – 36 (SF-36), and (c) depressive symptoms, as measured by the Patient Health Questionnaire – 9 (PHQ-9). Independent t-tests were used to compare outcomes between groups at 1 month and 3 months post-treatment.p = 0.560 and vs. LI, 44.2 [24.9], p = 0.545. There were also no differences between groups on secondary outcomes except that the PT and PT + LI groups had higher right upper limb hand-back maneuver scores compared to the LI alone group at both 1 and 3 months (p = 0.013 and p = 0.016 respectively).In the per protocol analysis, there were no significant intergroup differences in VAS at 1 month PT + LI, 40.8 [25.3] vs. PT, 37.8 [21.9], The results of this RCT showed that no differences in pain ratings were observed between the individual treatments (PT or LI) compared to the combined treatment of PT and LI. In general, no difference in primary or secondary outcomes was observed between treatments.NTC01250184 November 27, 2010. Myofascial pain syndrome (MPS) is a major cause of chronic musculoskeletal pain and is characterized by the presence of hypersensitive areas and myofascial trigger points (MTrPs) in a muscle or its fascia that, when palpated, may trigger a characteristic referred pain, tenderness and autonomic phenomena .The prevalence of MPS varies from 21 % in orthopedic clinics to 30 % in general practice, and between 55 and 95 % in specialized pain management centers . MyofascThe concept of MTrPs can be considered to be controversial because some researchers argue that the key phenomenon of muscle tenderness demands a robust plausible explanation based on neurobiology . In respThe diagnosis of MPS can also be considered controversial. Some researchers suggest that focal areas of muscle pain defined as associated with MTrPs cannot be reliably identified. Although inter-observer variability does exist, research shows that, after implementing a training program to ensure systematic physical examinations, an appropriate percentage of agreement between different examiners can be achieved, especially when palpating the trapezius, gluteus maximus and quadratus lumborum trigger points –18. VariThere are many different treatments for MPS. Non-invasive treatments include therapeutic exercise, ultrasound, and massage and stretching the affected muscle with aerosolized fluoromethane. A systematic review of 21 randomized controlled trials (RCTs)  showed mInvasive treatments have also been used to treat MPS, including dry-needling or medications, such as local anesthetics, corticosteroids, or botulinum toxin . Dry neeBecause of the lack of research examining which treatments, or combination of treatments, are more effective for MPS, the objective of the present study was to determine whether lidocaine injection (LI) into MTrPs combined with a physical therapy (PT) program was more effective than each separate treatment alone on the outcomes of pain, function, and quality of life in a group of patients with MPS of the shoulder girdle and cervical region.A single blind, randomized, controlled clinical trial (RCT) was conducted in two different city hospitals in Medellín, Colombia (IPS Universitaria and Clínica Las Americas) between January 2009 and October 2011. Approval was obtained from the Ethics Committee of the University of Antioquia.Using the patient databases of two general and specialized medical institutions, 762 patients were identified to have non-specific myalgia or muscle disorders diagnoses. These diagnoses were chosen because the International Classification of Disease Version 10 (ICD-10) does not have a specific code for MPS. The inclusion/exclusion criteria were: 1. To be older than 18 years of age. 2. To have MTrPs in one or more of the following muscles: the trapezius, the infraspinatus, and/or the levator scapulae , diagnosed by neck or shoulder pain, which may or may not be accompanied by the typical pattern of referred pain in the compromised muscle. 3. To have had neck or shoulder pain over the prior 6 weeks . 4. To have a minimum pain score of 40 mm on the visual analog scale (VAS). 5. To not have moderately severe depression, as indicated by a score of higher than 15 on the Patient Health Questionnaire (PHQ-9) measure of depressive symptoms, and/or presence of a psychiatric or bipolar affective disorder. 6. To not have comorbid conditions such as Fibromyalgia according to the criteria of American College of Rheumatology , 31, polA nurse with 10 years of research experience conducted a phone screen of 762 patients to assess the inclusion and exclusion criteria. If the patients were older than 18 years of age, had neck pain or shoulder girdle pain, and had not received treatment in the last month, the patient was given an appointment for a medical evaluation. Two hundred and sixty seven patients were excluded during the phone screen for having a non-MPS diagnosis, MPS of less than 6 weeks duration, or in current treatment for MPS. Four hundred and ninety-five patients were given an appointment at the hospital for a clinical assessment. At the appointment, two medical physiatrists (LHL and JAP) with over 10 years of research experience performed a clinical evaluation of the MPS patients and reviewed their medical history in order to verify inclusion and exclusion criteria. At this stage, 360 patients were excluded due to: moderately severe depression with a score higher than 15 on the Patient Health Questionnaire (PHQ-9) measure of depressive symptoms and/or presence of psychotic or bipolar affective disorder and/or existence of comorbid conditions listed in the inclusion/exclusion criteria. The selected muscles  were carefully palpated using a gel and manual detection of trigger points. Patients were observed and asked if they experienced pain. If they responded affirmatively, they were asked if that pain was located in the same palpation point or in a different point. In addition, patients were also asked to indicate the location of the pain on a form with drawings of the muscles and their trigger points.All eligible patients were invited to participate in the study. The patients were informed of the study before the first assessment and signed a written, informed consent statement.The final sample consisted of 135 patients, with 45 patients were randomly allocated to each of the three groups: Physical Therapy (PT) + Local Injection (LI), PT only, and LI only. After randomization, 2 patients in the PT + LI group were excluded (one of them with VAS < 40 mm and the other with PHQ-9 > 15), 4 patients in the PT group (for having VAS < 40 mm), and 2 patients in the LI group (one because of breast cancer and the other due to VAS < 40 and PHQ-9 > 15)  or strumming (pressure applied perpendicularly across the muscle fibers). Then muscle-stretching and strengthening exercises were performed for the cervical and shoulder girdle and specific for trapezius, infraspinatus, and the levator scapulae muscles for a total of 30 min, followed by exercises to improve joint range of motion for 10 min more. This was protocol was standardized by LHL based on various publications and recommendations .At baseline, patients in each group had similar VAS pain scores, similar PHQ-9 scores as a measure of depressive symptoms, and similar QoL on the all the dimensions of the SF-36 except in the general health domain in which those in the PT group reported significantly worse general health QoL compared to the PT + LI and LI groups  or the LI group .As shown in Table p = 0.03]. The LI group mean on this item was 67.8 (16.1) and not significantly different from the PT + LI group mean (p = 0.49).At 1 month, there were also no significant differences between groups in their PHQ-9 depression scores or on any of the quality of life dimensions measured by the SF-36 sub-scales (see Table The 3-month outcomes are shown in Table p = 0.013 and p = 0.016 respectively). The left upper limb hand-back maneuver and right and left hand-mouth maneuvers were not significantly different between groups.Regarding function, at 1 month and 3 months, the PT and PT + LI groups showed higher right upper limb hand-back maneuver scores compared to the LI alone group (p = 0.10); 36.6 % of the PT + LI group used took analgesics, while 53.0 % of the PT group and 51.2 % of the LI group used these supplementary medications.There were no significant differences in analgesic use between groups (n = 84) the complication rate was 2.66 %. There were no complications in the PT group.There were complications documented for six patients. In the PT + LI group, four participants had localized hematomas. In the LI group, two participants had localized hematomas and one participant had minimal bleeding. In total, for the number of injections performed . There were no statistically significant differences between the combination group and the individual treatment alone groups in VAS pain ratings, PHQ-9 depression scores, or SF-36 QoL domains at neither 1 nor 3 months.There are no studies in the literature that evaluate head-to-head whether lidocaine injection into MTrPs combined with a PT program might be more effective than each separate treatment alone in improving pain, function, and quality of life in patients with MPS of the shoulder girdle and cervical region. However, in a recent Cochrane review of treatments for chronic neck pain, moderate quality evidence supports cervico-scapulothoracic and upper extremity strength and endurance exercises and combined cervical, shoulder and scapulothoracic strengthening and stretching exercises to improve pain and function . The preMassage, another technique incorporated into the PT treatment group of the present study, has been shown to be effective in reducing pain compared with inactive therapies, such as usual care; however, massage alone has not been found to be more effective than active therapies, such as exercise . In one Regarding lidocaine injections, in this study, using lidocaine injections alone was found to be similarly effective to lidocaine plus physical therapy. Similarly, in an RCT conducted with a smaller sample size of 80 patients, both dry needling and an injection of lidocaine improved pain ratings, but there were no differences between the groups . In the In a systematic review of needling therapies in the management of MTrP pain, the effect of MTrP injections was independent of the injected substance, which in most studies was an anesthetic such as lidocaine, bupivacaine, or procaine. No trials were of sufficient quality or design to test the efficacy of any needling technique beyond placebo in the treatment of myofascial pain. In another systematic review with meta-analysis, there was no significant difference between dry needling and lidocaine in the management of MTrPs in the neck and shoulder region. The quality of evidence for the studies was limited .In another study, TrP pain pressure values were significantly higher in lidocaine group than dry needle and pain scores were significantly lower than in both the botulinum toxin type A (BTX-A) and dry needle groups. The Canadian Agency for Drugs and Technologies for Health (CADTH) conducted a Rapid Response and synthesized evidence from identified one systematic review and five RCTs. They concluded that evidence cannot support the use of botulinum toxin type A (BoNTA) injection in MTrPs for myofascial pain, given that four out of five included trials reported that BoNTA had no statistically significant effect on pain. Therefore, BoNTA was not considered to be effective for the treatment of MPS . In summThere are a number of limitations of the present study. Because there were three different physical therapists who conducted the PT intervention, it is possible that inter-therapist effects may have influenced the findings. However the PT sessions were standardized via a protocol to minimize this potential confounder. Similarly, there were various medical specialists who performed the injections, but all had more than 5 years of experience in the field with MPS patients. Additionally, no validated functional measure centered on the patient, such as the DASH, was used. Future studies should include a validated measure of function and a measure of the impact of the condition on work performance, as well as an evaluation related to patient occupation and physical activity. In the current study, patients were only followed for 3 months, and additional research with longer follow-ups and a more comprehensive evaluation of outcomes is needed to assess how much of the improvement is maintained, the likelihood of relapses, and the need for further consultation and treatment. Finally, it is known that studies of the efficacy of MTrPs interventions have shown marked statistical heterogeneity that make it is difficult to evaluate outcomes . TherefoMyofascial pain is often chronic and treatment with any of the interventions studied produced similar outcomes, except for a slight advantage of those receiving interventions with PT showing better right limb hand-back maneuvering function compared to the LI only group. These findings suggest that PT treatment involving the use of hot packs and ultrasound, manual compression, deep stroking or strumming, and muscle-stretching and strengthening exercises could play a role in improving upper limb function, although more research is needed. Lidocaine injections, which produced similar outcomes in the MPS patients studied, are an inexpensive treatment even in repeated over time. Other studies have found that botulinum toxin is no more effective than injections with local anesthetic and is more expensive , 45–47. Approval was obtained from the Ethics Committee of the University of Antioquia. All participants provided informed consent.Not applicable.The dataset supporting the conclusions of this article is available in the gruporehabilitacionsalud@udea.edu.co in the University of Antioquia.