To determine the role of ultrasonography in diagnosis of scrotal disorders.This study was carried out after institutional review board approval was granted, and informed consent was waived. Between January 2005 and January 2007, 144 patients aged 12 years and older with scrotal symptoms, who underwent scrotal ultrasonography (US), were retrospectively reviewed. The clinical presentation, outcome, and US results were analysed. The presentation symptoms were divided into three groups including scrotal pain, painless scrotal mass or swelling, and others. Surgery was performed in 32 patients.Of 144 patients, 110 had clinical follow-up and constituted the material of this study. The patients ranged in age from 13 to 82 years (mean 38.6 years). Of 110 patients, 84 (76.4%) presented with scrotal pain, 21 (19%) had painless scrotal mass or swelling and 5 (4.5%) had other symptoms. Of the 84 patients with scrotal pain, 52 had infection, 4 had testicular torsion, 7 had testicular trauma, 10 had varicocele, 4 had hydrocele, 1 had epididymal cyst, 1 had scrotal sac and groin metastases, and 5 had unremarkable results. Of the 21 patients who presented with painless scrotal mass or swelling, 18 had extratesticular lesions and 3 had intratesticular lesions. All the extratesticular lesions were benign. Of the 3 intratesticular lesions, one was due to tuberculous epididymo-orchitis, one was non-Hodgkin’s lymphoma, and one was metastasis from liposarcoma. Of the 5 patients who presented with other symptoms, 4 had undescended testes, and 1 had gynaecomastia. US gave incorrect diagnosis in only one patient with scrotal pain.The most common cause of scrotal pain was infection. The most common cause of scrotal mass or swelling was extratesticular lesion. US plays an important role in the diagnosis of scrotal disorders and in planning for proper management. A wide variety of disease processes involving the scrotum may have similar clinical manifestation . Differentiation of these processes is important for proper management. High-resolution ultrasonography (US) combined with colour Doppler ultrasonography (CDUS) has become the imaging modality of choice for evaluating scrotal diseases . ScrotalInstitutional review board approval was granted, and informed consent was waived. Between January 2005 and January 2007, 144 patients aged 12 years and older with scrotal symptoms underwent US at Maharaj Nakorn Chiang Mai Hospital. The presenting symptoms were divided into three main groups including scrotal pain, painless scrotal mass or swelling, and others such as undescended testes. Medical records of these patients were reviewed to determine the age, presenting symptoms, US results, treatment and pathological results. Gray-scale and colour Doppler US were performed on all the patients using either high-resolution US units 3000HDI or 5000 HDI  with a 10-12 MHz linear transducer.Of 144 patients, 110 had clinical follow-up and constituted the material of this study. The patients ranged in age from 13 to 82 years (mean 38.6 years). Of 110 patients, 84 76.4%) presented with scrotal pain -4, 21 1-7 and 5 6.4% presTesticular torsion was found in only 4 patients with a mean age of 17.2 years. Two of these 4 patients presented early, between 1 and 4 hours after the onset of pain. US gave correct diagnosis leading to prompt surgical correction and the testis was salvaged in both patients. The other 2 patients came late, between 4 and 7 days after their symptoms. Orchiectomy was performed after diagnosis of missed torsion. US gave incorrect diagnosis in only one patient with scrotal pain. This patient was a 23-year-old who presented with scrotal pain. US showed mild enlargement of right epididymis and testis with absent vascularity. He was diagnosed to have testicular torsion . OrchiecIn the 7 patients who had history of scrotal trauma, US detected testicular rupture in 4 patients, scrotal haematomas in 2 patients and no abnormality in 1 patient. All 4 patients with ruptured testes underwent operation. Three had partial orchiectomy and one had total orhiectomy.Common scrotal problems in adolescent and adult male patients that require medical care are scrotal pain and painless scrotal mass or swelling. Bacterial epididymitis or epididymo-orchitis are the most common causes of scrotal pain in adults while torsion is more common in a younger age group , 2, 4, 5In our study, scrotal pain is more common than painless scrotal mass or swelling. The most common cause of scrotal pain is infection 52/84), which was mostly found in middle-aged men (mean age 40.9 years). Testicular torsion was found in only 4 patients with a mean age of 17.2 years. Two of these 4 patients presented early, between 1 and 4 hours after the onset of pain. US gave correct diagnosis leading to prompt surgical correction and the testes were salvaged in both patients. The other 2 patients came late, between 4 and 7 days after their symptoms appeared. Orchiectomy was performed after diagnosis of missed torsion. The testicular salvage rate is 80% to 100% if surgery is performed within 5 to 6 hours, but the rate decreases to approximately 20% if detorsion is performed after 12 hours following the onset of symptoms [/84, whicScrotal trauma results in contusion, haematoma, fracture or rupture of the testis. Prompt diagnosis of testicular rupture is important because the surgical testicular salvage rate drops from approximately 90% to 45% after 72 hours of onset , 2, 4, 5Other causes of scrotal pain include varicocele, hydrocele, epididymal cyst, and metastases to scrotum and groin in case of supraglottic squamous cell carcinoma. These patients presented with scrotal pain, so they were initially classified in the scrotal pain presenting group, although clinical examination later revealed scrotal mass. They were treated according to their findings. In 5 patients who presented with scrotal pain, and no detectable abnormality on US, this could have been due to prior antibiotic treatment before the US study.In patients with painless scrotal mass or swelling in this study, extratesticular lesions were much more common than intratesticular lesions. All extratesticular lesions were benign. In the 3 patients with intratesticular lesion, one was TBEO, one was NHL, and one was metastasis from liposarcoma at thigh. There was no primary testicular tumour during the study period. TBEO may present with painless scrotal swelling and can mimic carcinoma. US is helpful in differentiating TBEO from carcinoma. Epididymal enlargement and skin thickening almost always occur in infection but carcinoma rarely involves skin and epididymis , 7, 10. The other presenting symptoms were undescended testes and gynaecomastia. US is the initial imaging modality to detect the location of undescended testes, which most commonly occurs at the inguinal region. The US appearance of undescended testes is similar to one lying within the scrotum, although it is frequently atrophic and small , 2. In tThe most common cause of scrotal pain is infection. The most common cause of scrotal mass or swelling is an extratesticular lesion. US plays an important role in the diagnosis and proper management planning of the scrotal disorders.


Burn wounds are severely stressful events that can have a significant impact on the mental health of patients. However, the impact of burns on individuals with different personality traits can be different. The present study aimed to investigate the impact of dispositional optimism on the subjective well-being of burn patients, and mainly focused on the confirmation of the mediator role of psychological resilience. 410 burn patients from five general hospitals in Xi'an accomplished the revised Life Orientation Test, Connor-Davidson Resilience Scale, and Subjective Well-Being (SWB) scale. The results revealed that both dispositional optimism and psychological resilience were significantly correlated with SWB. Structural equation modelling indicated that psychological resilience partially mediated the relationship between dispositional optimism and SWB. The current findings extended prior reports and shed some light on how dispositional optimism influenced SWB. Limitations of the study were considered and suggestions for future studies were also discussed. With the gradual shift from biomedical models to biopsychosocial models, the interest in on patient well-being as a research area has increased, and modern medicine now is now focused on improving the quality of life while prolonging the lifespan of patients Originally proposed by Carver and Scheier, dispositional optimism is viewed as a stable psychological quality and a positive personality trait. It refers to an individual's positive expectations for the future Researches on psychological resilience began with the study on the responses to traumatic events. Research conducted by developmental psychopathologists on the formation and development of psychological resilience in the face of adversity has contributed to our understanding of why individuals do not succumb to stressful phenomena In summary, there are enough reasons to believe that dispositional optimism and psychological resilience are positive predictors of subjective well-being, and that the two variables are positively correlated: It is usually the case that an optimistic person also has high psychological resilience. However, the trilateral relationship among the three variables remains unclear at present. Dispositional optimism is a stable psychological quality, psychological resilience is the ability to adapt to changing environments and recover from stressful situations, while subjective well-being is the overall affective and cognitive evaluation of quality of life. We hypothesize that people who have positive expectations for the future will have a stronger ability to withstand pressure and hence have a more positive evaluation of life. Using burn patients as research subjects, this study attempts to explore the impact of dispositional optimism and psychological resilience on post-traumatic subjective well-being.Participants were 410 burn patients (309 men and 101 women) from five general hospitals in Xi'an. All burns were due to scalds and second-degree burnt area covered 20–40%. Patients with head and face burns were excluded. The ages of burn patients ranged from 17 to 35, with a mean of 25.24 (SD = 2.76). Questionnaires were distributed at the second time when patients came to the hospital and participants completed the questionnaires in a separate room. Participants were told that they were engaging in a psychological investigation in which there were no correct or incorrect answers. Date collection lasted three months, from March to May, 2013. All participants provided informed consent before completing the measures  and received ¥50 in compensation. The research described in this paper meets the ethical guidelines of Xijing Hospital and has been approved by the ethics committee of the Fourth Military Medical University.LOT-R, developed by Scheier, Carver and Bridges, is a 6-item measure (plus 4 filler items) of individual differences in dispositional optimism and pessimism. Items are rated from 1(strongly disagree) to 5(strongly agree) The Connor-Davidson Resilience Scale  is viewed as people's cognitive appraisal and emotional experience of life 2), (b) the Standardized Root Mean Square Residual (SRMR), (c) the Root Mean Square Error of Approximation (RMSEA), and (d) the Comparative Fit Index (CFI) To be sure of the structural relations of the latent structured model, a two-step procedure introduced by Anderson and Gerbing was adapted to analyses the mediation effect The mediating effect in the current study was tested for a significance by adopted the Bootstrap estimation procedure in AMOS. The reason for not using Sobel test, the commonly employed method for examining the statistical significance of a mediation effect, which involves computing the ratio of products of direct effects to their estimated standard error 2  = 124.457, P<0.001; RMSEA = 0.07 and CFI = 0.957. All the factor loadings for the indicators on the latent variables were significant (P<0.001), indicating that the latent construct was well represented by its indicators.Confirmatory factor analysis was used to exam whether the measurement model fit the sample data adequately or not. The measurement model included three latent constructs and 11 observed variables. An initial test of the measurement model came into being a satisfactory fit to the data: χFurthermore, as shown in 2  = 136.929, P<0.001, RMSEA = 0.076, SRMR = 0.050 and CFI = 0.936. However, examination of parameter estimates revealed that the standardized path coefficient from dispositional optimism to SWB and psychological resilience, and from psychological resilience to SWB were all significant. Thus, according to the modification indices in the model 1, model 2 was created by add the correlations of residual terms between resilience1 and resilience2, resilience1 and resilience2.In the first step, the direct effect of the predictor variable  on the dependent variable (SWB) without mediators was tested. The directly standardized path coefficient was significantly, β = 0.48, P<0.001. Then, a partially-mediated model (model 1) which contained mediators  and a direct path from dispositional optimism to SWB was tested. The results showed that the model not very good fit to the data, χ2  = 90.246, P<0.001; RMSEA = 0.058; SRMR = 0.043; and CFI = 0.964. Taken together, those results showed the important role of psychological resilience in the relationship between dispositional optimism and SWB. The effect of dispositional optimism on SWB through psychological resilience was 17.9%.After adding the correlations of the residual terms, the final meditational model, as shown in Then the mediating effect was tested by adopted the Bootstrap estimation procedure .As shown in This study investigated the concurrent effect of dispositional optimism and psychological resilience on subjective well-being, and examined the mediator effect of psychological resilience on the relationship between dispositional optimism and subjective well-being of burn patients. This study found a positive relationship between optimism and SWB. This finding suggests that burn patients with high optimism are more likely to be capable of recovering from stressful situations and possess high subjective well being.The finding that dispositional optimism and psychological resilience can positively influence subjective well-being is consistent with those of previous studies Based on prior findings, this study mainly focused on the confirmation of the mediation effect of psychological resilience between dispositional optimism and subjective well being. Dispositional optimism and psychological resilience have always been found to be associated; in particular, optimistic individuals are generally known to be capable of recovering from frustrations Burn patients were recruited as participants in the present work because their mental health is known to be influenced greatly by the stress resulting from their burn wounds. The results suggest that although burn patients experience the same traumatic event, those with higher dispositional optimism and stronger psychological resilience will feel little mental suffering and are more likely to recover. To improve the subjective well being and life quality of burn patients, we should adopt interventions that primarily focus on increasing the dispositional optimism and psychological resilience of these patients.In sum, this study provides insights into the relationships among dispositional optimism, psychological resilience and subjective well being. Dispositional optimism acts as a protective factor by increasing the ability of an individual to recover from frustrations. Such ability has a beneficial effect on SWB. Nevertheless, this study has certain limitations. First, personality is always dependent on culture. As all measures used in this study originate from western countries, some confounding factor caused by cultural difference may be induced. Second, some recent studies have suggested that dispositional optimism is bidimensional and consists of optimism and pessimism factors


Objectives: The present study was designed to evaluate the usefulness of deep dry needling in the treatment of temporomandibular myofascial pain. Study Design: We selected 36 patients with myofascial pain located in the external pterygoid muscle . We studied differences in pain with a visual analog scale and range of mandibular movements before and after intervention. Results: We found a statistically significant relationship  between therapeutic intervention and the improvement of pain and jaw movements, which continued up to 6 months after treatment. Pain reduction was greater the higher was the intensity of pain at baseline. Conclusions: Although further studies are needed, our findings suggest that deep dry needling in the trigger point in the external pterygoid muscle can be effective in the management of patients with myofascial pain located in that muscle. Key words:Temporomandibular joint, myofascial pain, external pterygoid muscle, trigger point, deep dry needling. Temporomandibular joint (TMJ) is a bilateral diarthrosis located between the glenoid fossa-temporal eminence complex and the mandibular condyle. Its involvement is multifactorial, and is commonly known by ambiguous terms such as temporomandibular disorder or TMJ pain-dysfunction syndrome. This condition is highly prevalent, and usually has varied clinical presentations characterized by pain in the preauricular area and alterations in the dynamic of open-close mouth movements. Painful hypersensitivity is often observed in the masticatory muscles as origin of myofascial pain syndrome, being the external pterygoid muscle one of the most frequently affected. External pterygoid muscle  is a short, thick and flattened transversely muscle, located in the pterygomaxillary fossa roof that extends from the pterygoid process and greater wing of sphenoid to the neck of the mandibular condyle, being essential to the protrusive and lateral movements of the mandible ,2.Most authors agree that the current treatment of nonspecific myofascial pain is multidisciplinary and must be approached from several perspectives. Myofascial pain must be suspected in patients with pain in masticatory muscles located in the preauricular or mandibular area, frontal or temporal regions, or in the ear, along with the existence of painful trigger points (TPs) on palpation. Usually, it is associated with pain provoked by mandibular function and with limitation of interincisal opening (opening <40 mm) -9.Our study had the purpose of aiding to determine the possible importance of myofascial TPs in temporomandibular pathology, and evaluate the usefulness of the deep dry needling (DDN) in the treatment of myofascial pain of the external pterygoid muscle.We studied 36 patients with myofascial pain located in the external pterygoid muscle consecutively selected in the outpatient clinic of the Oral and Maxillofacial Surgery Department of “Virgen del Rocio” University Hospital of Seville (Spain), between May and September 2008, to compare differences in pain with a visual analog scale and range of mandibular movements before and after application of needles for needling the external pterygoid muscle. Patients were included in a diagnostic protocol based on clinical signs and imaging techniques (panoramic radiograph and MRI). The study received prior approval from the Committee for Research and Clinical Ethics of the Hospital, and informed consent was obtained from all patients before inclusion in the study. We included patients older than 18 years of age with temporomandibular pain for more than six months and moderate limitation in mandibular movement , and with a palpable taut band or hypersensitive nodule in the external pterygoid muscle mass by intraoral palpation. We excluded patients under 18 years and those with TMJ internal derangements with anterior disk displacement, degenerative joint disease (osteoarthritis/osteoarthrosis), history of jaw trauma, vascular diseases, migraine and tension headaches, and history of infectious-inflammatory conditions of odontogenic origin.Sterile stainless steel needles with a plastic cylindrical guide, 40 mm in length and 0.25 mm caliber distributed in Spain by Agu-punt®, have been used for the therapy with DDN. A total of 3 sessions were performed per patient at an interval of 1 week, and clinical assessments at 2 weeks, 1 month, 2 months and 6 months after finishing the treatment. The needle was applied after asepsis of the preauricular area with alcohol 90%, manual location of the intra-extraoral mass of the external pterygoid muscle Fig. , followeOf the 36 patients studied, 30 (83.3%) were women and 6 (16.6%) men. The mean age was 27 years (SD ± 6.5). Clinical signs were: preauricular pain  with a mean value of 8.45 ± 1.46 in visual analog scale, joint noise sounds in mouth opening (in 5 cases), and reduction in the range of mandibular movements . Before DDN, mean mandibular movements values were: mouth opening of 2.90 (± 1.10), laterality of 0.20 (± 0.01), and protrusion of 0.1 (± 0.00). Radiographic findings showed no alteration in the morphology of the articular surfaces. MRI studies revealed no significant changes in static and dynamic position of the articular disk in any of the cases studied.By analyzing the correlation between pain assessment before the start and the end of treatment, we observed that greatest reductions in pain were achieved in those patients who had high baseline values in visual analog scale before starting treatment. On the contrary, when patients had low values of pain in visual analogue scale, less pain reduction was achieved. The pain response to DDN therapy was observed as early as 2 weeks after DDN, and remained stable without significant changes during the control patient period . Also, tTemporomandibular pain of myofascial origin is a condition often referred for evaluation to outpatient clinics of Oral and Maxillofacial Surgery Departments. In more than 90% of cases no underlying cause is found, that is why they are diagnosed as nonspecific or uncomplicated pains, whose treatment is still under study ,6,11.Vazquez-Delgado et al. have reviewed the pathophysiologic, clinical and therapeutics aspects of the myofascial pain syndrome ,13. UsuaClinical guidelines and protocols about temporomandibular disorders recommend the management of myofascial pain from a multidisciplinary approach ,4. HowevSince by stretching techniques and manual handling is difficult and complicated to access to the external pterygoid muscle, needling of TPs may be necessary. The critical importance of this muscle as origin of temporomandibular myofascial pain makes it worthwhile to develop the necessary skills for invasive treatment by TP needling. The external approach  allows the needling of the central TPs in the muscle bellies of the two divisions of the muscle and in the insertional TPs of posterior myotendinous junctions of both divisions. The correct location of the muscle mass is essential for the technique we use, so interference factors represented by the nearby bony structures  must be eliminated. That is why there is no need to carry out the electromyographic control described in Koole et al. study , which iIn our patients we did not use a intramuscular puncture technique to inject local anesthetics, corticosteroids or botulinum toxin because DDN is just as effective in the myofascial pain caused by TPs in the pterygoid muscle, and this way myotoxic effects of infiltration with such drugs are avoided. Myotoxicity is strongly related to the concentration of anesthetic injected, especially by long-lasting anesthetics. The use of epinephrine in concentrations of 1:100,000 or more can increase muscle damage caused local anesthetics. The myotoxicity of the botulinum toxin type-A is irreversible by binding to the presynaptic cholinergic nerve terminals and interrupting any neurogenic contraction of muscle fibers mediated by the affected motor plates. This chemical denervation maintains the paralysis of the muscle for a period of 3 to 6 months until new axons sprout from a motor nerve and form new synaptic contacts to restore a normal neuromuscular junction function of affected muscle fibers .For the treatment of symptoms associated with TPs, the DDN is a technique as effective as the infiltration of anesthetics if it causes local twitch response, which occurs when the needle had inserted in the muscular active loci of the TP. The reverse is also true and, if there is no local twitch response, the DDN or the infiltration of anesthetics are equally ineffective. Another reason to prefer the DDN before using local anesthetics is because dry needling allows the location of all TPs from one area by preserving pain reaction to palpation.The results of our study have shown that the greatest reduction in the magnitude of pain was achieved when patients had started from a more unfavorable clinical situation with intense pain, so it was expected that pain improvement would be more evident in these patients. We have observed that in those patients who had significant pain before starting treatment , it was common that they had a reduction of 6 points, while those that started with mild pain  the expected reduction of pain was 4 points or less. These findings are consistent with the results published by other authors that performed intramuscular infiltrations after muscle needling ,19. FernIn conclusion, the results of our study suggest that patients with painful temporomandibular disease due to external pterygoid muscle involvement treated selectively with needles for dry needling showed a significant improvement in pain and, as consequence, an improvement of functional limitation which persisted up to 6 months after finishing the treatment. Pain reduction was greater the higher was the intensity of pain at baseline.


The Australian Whiplash Disability Questionnaire (WDQ) was cross-culturally translated, adapted, and tested for validity to be used in German-speaking patients. The self-administered questionnaire evaluates actual pain intensity, problems in personal care, role performance, sleep disturbances, tiredness, social and leisure activities, emotional and concentration impairments with 13 questions rated on an 11-point rating scale from zero to ten.In a first part, the Australian-based WDQ was forward and backward translated. In a consensus conference with all translators and health care professionals, who were experts in the treatment of patients with a whiplash associated disorder (WAD), formulations were refined. Original authors were contacted for clarification and approval of the forward-backward translated version. The German version (WDQ-G) was evaluated for comprehensiveness and clarity in a pre-study patient survey by a random sample of German-speaking patients after WAD and four healthy twelve to thirteen year old teenagers.In a second part, the WDQ-G was evaluated in a patient validation study including patients affected by a WAD. Inpatients had to complete the WDQ-G, the North American Spine Society questionnaire , and the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) at entry in the rehabilitation centre.In the pre-study patient survey (response rate 31%) patients rated clarity for title 9.6 ± 0.9, instruction 9.3 ± 1.4 and questions 9.6 ± 0.7, and comprehensiveness for title 9.6 ± 0.7, instruction 9.3 ± 1.4 and questions 9.8 ± 0.4. Time needed to fill in was 13.7 ± 9.0 minutes.In total, 70 patients  were included in the validation study. WDQ-G total score was 74.0 ± 21.3 points (range between 15 and 117 points). Time needed to fill in was 6.7 ± 3.4 minutes with data from 22 patients. Internal consistency was confirmed with Cronbachs’s α = 0.89. Concurrent validity showed a highly significant correlation with subscale pain and disability (NASS) at r = 0.74 and subscale pain (SF-36) at r = 0.71.The officially translated and adapted WDQ-G can be used in German-speaking patients affected by a WAD to evaluate patients’ impairments in different domains. The WDQ-G is a self-administered outcome measure showing a high internal consistency and good concurrent validity. Neck pain can pose a substantial limitation in daily life and profession for affected individuals and family members. Globally, about 180 of 1000 people experience neck pain at least one day a year . That meet al. introduced a new conceptual model of neck pain based on the work of the Task Force on Neck Pain and Associated Disorders during the Bone and Joint Decade 2000 to 2010 [et al.’s evaluation highlights the need for a disease-specific questionnaire. Therefore, the Whiplash Disability Questionnaire (WDQ) was specifically developed for individuals suffering from a WAD by Pinfold and colleagues and published in 2004 [et al.’s study [Guzman  to 2010 . The mod to 2010 ,6. In a  to 2010 . Partici in 2004 . The dev’s study , b) prelTwo systematic literature reviews on neck pain questionnaires critically appraised their quality and availability in different languages ,10. AuthCurrently, the officially translated North American Spine Society questionnaire (NASS) and the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) have been used to evaluate treatment effects of patients with neck pain -21. Cons1) to establish a German version of the WDQ following recommended guidelines,2) to test the concurrent validity with the subscale pain and disability of the German NASS for cervical spine and with the subscale bodily pain of the German SF-36, and3) to examine internal consistency of the German WDQ.It is hypothesised that a German WDQ will highly correlate with the subscale pain and disability of the German version of the NASS for cervical spine and with the subscale bodily pain of the German version of the SF-36.et al. (2000) [Translation and trans-cultural adaptation guidelines for self-administered outcome measures of Beaton . (2000)  was usedThree German speaking translators produced independent forward translations of the WDQ. One was done by an officially recognised translator with a history of low back pain, the second one by an English teacher, who experienced a WAD, the third one by a physiotherapist, who is specialised in neurological rehabilitation and has worked in an English speaking country for several years.Forward translations were synthesised into one German version by the project leader.The synthesised forward translated version was then backward translated into English by three independent translators: a bilingual physician, a bilingual financial analyst, and an English native-speaking housewife living in the German part of Switzerland for more than ten years. The backward translations were again synthesised by the project leader.In a two-hour long consensus conference all forward and backward translators, two occupational therapists, an additional physiotherapist, an additional physician, and the project leader reviewed the synthesised forward translated German and the backward translated English version. All healthcare professionals were experts with experiences in the treatment of patients with a WAD. A consensus version was produced, representing the preliminary German version of the WDQ, termed WDQ-G. The conference lasted for about two hours.A randomly selected sample of former inpatients (60 out of 1019 patients between 1999 and 2005 of a Swiss rehab centre) diagnosed with WAD received the preliminary WDQ-G version by postal mail. Patients were asked to fill in the questionnaire and rate clarity and comprehensiveness of the title, questionnaire instruction, and questions on two eleven-point visual analogue scales (VAS), ranging from zero to ten (where ten indicated the highest level). Furthermore, all patients were asked to report the time needed to fill in the preliminary WDQ-G. The preliminary WDQ-G was moreover rated by four healthy twelve to thirteen year old teenagers for clarity and comprehensiveness.The preliminary WDQ-G and all forward and backward translations were sent to the original authors, asking for approval to use the WDQ-G in a patient validation study.After receiving permission from the original authors to use the pre-final WDQ-G, a patient validation study was carried out. Inpatients were asked to fill in the questionnaires at entry. The study was approved by the responsible ethics committee in Aarau (reference number: 2005/039) and carried out in accordance with the Declaration of Helsinki.et al., data on influential factors  were collected from each patient [Based on the synthesis report by Frinking  patient .Patients completed the preliminary WDQ-G, one cervical problem-specific questionnaire and two generic instruments, which had been validated in several previous studies ,24-29. AThe WDQ has been developed based on items of the existing NDI and semi-structured interviews conducted with 83 patients by Hoving and colleagues . PatientThe NASS consists of two subscales: 1) pain and disability (11 questions) and 2) neurogenic symptoms (8 questions). Subscale pain and disability addresses perceived impairment in everyday life , at work , or during leisure activities (e.g. while travelling) . SubscalThe SF-36 serves to determine perceived general health and quality of life . WorldwiAdditionally, participants were asked to rate their actual subjective pain intensity on a Visual Analogue Scale (VAS). Pain is indicated on a horizontal 10-cm straight line anchored by two extremes of pain: “no pain” and “pain as bad as it could be” .Anonymised and completed SF-36 and NASS questionnaires were scanned to upload by secure data transfer to an independent company  for data assembly and subsequently returned for in-house analysis. Questionnaires for demographic and descriptive statistics as well as VAS and WDQ data were recorded manually within the clinic using Microsoft Excel 2003. All data were eventually assembled for statistical examination with the Statistical Package for Social Sciences (SPSS).Patients referred to inpatient rehabilitation were asked to participate when they fulfilled the following selection criteria: German speaking females and males with an acceleration-deceleration event of the head with or without a mild traumatic brain injury (MTBI), being older than 18 years, understand the aim and procedure of the study, and given written informed consent. Patients were excluded if they had additional neurological or psychiatric diseases, if they needed supporting devices for walking, e.g. walking sticks, or if they had additional systemic diseases, e.g. Fibromyalgia.Patient and questionnaire descriptive data were calculated representing frequencies, means and standard deviations or confidence intervals. Concurrent validity was estimated by computing the Pearson Product–Moment Correlation Coefficient (r) between WDQ-G total score and subscale pain and disability of the NASS questionnaire, and between WDQ-G total score and subscale bodily pain of the SF-36. Internal consistency was computed using data from the first measurement event at study entry. Additionally, the inter-item correlation matrix was observed to detect very high correlation indicating item redundancy. All analyses were performed with SPSS version 16, 2007  with p ≤ 0.05.During the translation stages 1 (forward) and 3 (backward) three different German and English versions were produced. In particular, the wording of the first parts of the questions on “How much do your whiplash symptoms interfere…” or “How much pain/ sadness/anger/ do you…” was not congruently translated. The synthesis (stage 2) was necessary to agree on a sole German version providing the basis for the backward translations conducted by three independent translators. During the consensus conference (stage 4) the wordings at the beginning of questions 1, 3, 6, 10, 11, and 12 were again modified to avoid the implication that patients have to have pain after whiplash injury, and if so that it should be on a high level, e.g. question 3: the original WDQ asks: “How much do your whiplash symptoms interfere…”. For the German WDQ this had to be adapted to: “To what extent do your whiplash symptoms impair…”. Furthermore, the scale descriptions on the lower and higher ends were shortened to minimise ambiguity.In agreement with the authors of the original Australian WDQ it was decided to modify the description on how to fill in the questionnaire for two reasons: 1) to emphasise the scale (zero to ten) and 2) to minimise the risk that patients miss out items.Original Australian version: “Please circle a number in each section to indicate how you have been affected by the whiplash injury and symptoms. If one or more questions are not relevant to you, please leave that section blank.”Agreed German version: “For each question please circle on a scale from 0 to 10 the number corresponding to the extent to which you are affected by your whiplash symptoms. If one or more questions are not relevant, please cross them out”.Only 47 of 60 randomly selected patients could be contacted by postal mail for the pre-study patient survey. The response rate was 31% representing 16 patients , who filled in the preliminary WDQ-G. Clarity of title 9.6 (± 0.9), instructions 9.3 (± 1.4), and questions 9.6 (± 0.7), as well as comprehensiveness of title 9.6 (± 0.7), instructions 9.3 (± 1.4), and questions 9.8 (± 0.4) was rated by 15 patients. Time needed to fill in the WDQ-G was 13.7 (± 9.0) minutes ranging from 1.2 to 30.0 minutes as reported by 14 patients. WDQ-G total score of all 16 patients was 69.4 (± 24.0) ranging from 6.0 to 103.0 points.The participating teenagers had no problems in understanding the content and aim of the questionnaire, wording of all questions and scale descriptions.The validation study was conducted between June 2006 and September 2008 in a midsize rehabilitation centre in the German-speaking part of Switzerland. During this time period subsequently referred patients (159) were screened for study eligibility. Exclusion reasons for 81 patients were: additional psychiatric (N = 9), neurological (N = 2), or systemic (N = 2) disease, insufficient language skills (N = 16), incomplete questionnaire return for first measurement event (N = 8). Further reasons for exclusion were (N = 52): necessity of walking aids, no written consent, early discharge, recent bone fracture, no WAD, and arthroscopy of the knee.Eventually, a consecutive sample of 70 WAD patients  could be recruited. Average time since injury was 1.5 ± 2.6 years on average . Table Figure et al., no redundancy was found when considering inter-item correlation, which did not exceed 0.75 [Based on the inter-item correlation, internal consistency (Cronbach’s α) of the German WDQ was α = 0.894 (N = 67). Similar to Pinfold In relation to the second study aim, concurrent validity of the WDQ-G was determined with the subscale pain and disability of the NASS questionnaire (r = 0.74) and with the bodily pain subscale of the SF-36 (r = 0.71). Both correlations were determined highly significant with p < 0.01. Table The study described a guideline-driven German translation, cross-cultural adaptation and validation process of a disease-specific questionnaire for WAD patients: the Whiplash Disability Questionnaire. In six predefined stages the Australian-based WDQ was forward and backward translated, approved by the original authors, evaluated by WAD patients, and tested for its quality criteria. As hypothesised, the WDQ-G correlated highly significant with the NASS subscale pain and disability and the SF-36 subscale bodily pain showing a good concurrent validity. Furthermore, the WDQ-G presents a high internal consistency. As a further development of the NDI, the WDQ covers specific aspects of impairment for WAD patients: role performance, tiredness, social and leisure (sporting and non-sporting) activity, emotional and cognitive impairments that can be evaluated on an eleven point rating scale .In clinical trials, treatment effects and calculated effect sizes as well as recommended treatment guidelines are based on subjective and objective outcome measures. Those outcome measures are vital elements in the trial methodology. Therefore, it is essential to translate outcome measures in a standardised way into different languages to remain the original construct assessed and adopt it to the target country specific language, traditions, and customs. Furthermore, it is crucial to evaluate the quality criteria of the translated and adapted measurement ,22. The Difference for time needed to fill in the questionnaire between pre-study sample (13.7 minutes) and the validation study sample (6.7 minutes) could be explained by the additional task assigned to the pre-study sample to also evaluate the WDQ-G’s clarity and comprehensiveness, whereas inpatients in the validation study sample only had to fill in the questionnaire.et al.’s study with 4.3:1 [et al. ranging between 1:1 to 2:1 [The present patient validation sample showed a different gender distribution of 1.4:1  compared to the patient sample in Pinfold th 4.3:1  but simi1 to 2:1 . General1 to 2:1 ,30,37 or1 to 2:1 ,38. Demo1 to 2:1 .et al.[Patients in the validation study showed the highest score for item 8  and the lowest for item 2 . The average score for all 13 questions was 74.4. Those scores are almost identical to the results from Pinfold et al.[The translation and cross-cultural adaptation process followed the guidelines proposed by Beaton et al.. Stage 2et al.. FurtherTo answer question four (driving or using public transport) patients differentiated between being the driver, the co-driver, or a passenger in a public transport vehicle. All three alternatives could be impaired on different severity levels after a whiplash injury. If a patient in the present validation study raised the question, which aspect should be evaluated, they were asked to indicate the impairment level for the most unpleasant situation. It is assumed that the differentiation can occur in all patients filling in the WDQ independent from different languages. Therefore, further research is needed to define a more precise patient instruction or add further questions to evaluate all three alternatives separately.For a trustworthy questionnaire use in clinical routine or research it is important to determine quality criteria of the instrument including validity, reliability, and responsiveness. The present study focussed on the standardised translation process and data collection to determine concurrent validity and internal consistency. Meanwhile the paper was published.et al.[et al.[The presented study aimed to produce a robust German version of the WDQ by following strict guidelines published by Beaton et al.. Howeverl.[et al.. The twol.[et al.. ReliabiIn general, validity tests for self-administered questionnaires are difficult to implement and to compare with a gold standard, in particular as there is no gold standard for WAD. In the case of the present investigation, it was chosen to determine concurrent validity with the subscale pain and disability (NASS) and subscale bodily pain (SF-36) to approach a close conceptional association to established related questionnaires.et al. suggest a sample of 20 for reliability studies and a sample of 80 or more for validation studies in neurology [et al. proposed a sample size of 50 to determine reliability for measures with a five-point Likert scale [In the validation study, data from 70 patients was analysed to determine validity. It could be argued that the sample size was too small for a final validity analysis. However, in other publications on translation and validity studies sample sizes varied distinctly ,41-43. Reurology . Javali rt scale . So far,Sample size was also the limiting factor to conduct factor analysis. It is recommended to have a case:item ratio of 10:1 requiring at least 130 cases for a WDQ-G factor analysis . In someThe WDQ-G is a self-administered disease-specific outcome measure showing a high internal consistency and good concurrent validity. After the official translation and cross-cultural adaptation process the WDQ-G represents preliminary validity evidence and can be used with German-speaking WAD patients to evaluate patients’ impairments in different domains: activities of daily living, career, leisure activities, social life, and care for others. Further research should include a factor analysis to confirm the unifactorial structure of the questionnaire.The German version of the WDQ can be obtained free of charge from the first author: Dr. Corina Schuster: c.schuster@reha-rhf.ch.α: Cronbach’s alpha; MTBI: Mild traumatic brain injury; N: Sample size; NASS: North American spine societies questionnaire for neck pain; NDI: Neck disability index; NPQ: Northwick park neck pain questionnaire; r: Pearson product–moment correlation coefficient; RAQoL: Rheumatoid arthritis quality of life questionnaire; SF-36: The medical outcomes study 36-item short form health survey; SPSS: Statistical package for social sciences; VAS: Visual analogue scale; WAD: Whiplash associated disorders; WDQ: Whiplash disability questionnaire; WDQ-G: German version of the whiplash disability questionnaire.The authors declare that they have no financial or non-financial competing interests.th Word Conference on NeuroRehabilitation in Brasilia 2008 and at the 16th World Congress for Physical Therapy in Amsterdam 2011.The preliminary results have been presented as a poster at the 5CS was the project leader. She wrote the study protocol and was involved in the translation and validation process, data collection, analyses and interpretation, and manuscript writing. MM was involved in data analysis and interpretation, and he critically reviewed earlier versions of the manuscript. TE was involved in study design, data interpretation and he critically revised the manuscript. All authors gave final approval of the manuscript.


Cluster headache (CH) is an extremely severe and debilitating trigemino-autonomic pain syndrome.About 10% of patients with CH manifest a chronic form CH (CCH). Extracts of Boswellia serrata have been clinically studied for the treatment of many inflammatory conditions such as osteoarthritis and rheumatoid arthritis (3). The resin from Boswellia Serrata contains a number of biological actives called pentacyclic triterpene acids, which give the extract its anti-inflammatory and analgesic properties, with boswellic acid the major active ingredient (4). These acids have been demonstrated to interfere with the body’s natural inflammatory response by inhibiting cytokines and leukocyte activity. The present study aims to evaluate the long-term efficacy of Boswellia Serrata  on headaches and disturbed sleep in patients with CCH.In an open-label study, 4 patients with CCH and disturbed sleep received oral Boswellia Serrata.The effects were long-lasting in 3 patients (mean 15 months) and transient (6 months) in one patient. The rapid improvement of nocturnal pain within weeks is similar to the analgetic effect observed in recent trials using Boswellia Serrata in cancer pain The mechanisms of how Boswellia Serrata reduces pain in CCH remain unclear. Boswellic acids, constituents of Boswellia extract have subsequently been identified as selective redox independent noncompetitive inhibitors of both 5-lipoxygenase, the key enzyme in leukotriene biosynthesis and human leukocyte elastase. Proinflammatory cytokines, such as leukotrienes, are known to play a role in the pathophysiology of CH. This study provides Class IV evidence that oral Boswellia Serrata  reduces the intensity and frequency of headaches in patients with CCH.None


Low-level laser therapy (LLLT) has been widely used as adjuvant strategy for treatment of musculoskeletal disorders. The light-tissue interaction (photobiostimulation) promotes analgesic and anti-inflammatory effects and improves tissue healing, which could justify the recommendation of this therapy for patients with fibromyalgia, leading to an improvement in pain and possibly minimizing social impact related to this disease. The present study proposes to evaluate the effect of LLLT on tender points in patients with fibromyalgia, correlating this outcome with quality of life and sleep.t test will be performed to test within-group differences. The level of significance for the statistical analysis will be set at 5% (P ≤0.05).One hundred and twenty patients with fibromyalgia will be treated at the Integrated Health Center and the Sleep Laboratory of the Post Graduate Program in Rehabilitation Sciences of the Nove de Julho University located in the city of Sao Paulo, Brazil. After fulfilling the eligibility criteria, a clinical evaluation and assessments of pain and sleep quality will be carried out and self-administered quality of life questionnaires will be applied. The 120 volunteers will be randomly allocated to an intervention group  or control group . Patients from both groups will be treated three times per week for four weeks, totaling twelve sessions. However, only the LLLT group will receive an energy dose of 6 J per tender point. A standardized 50-minute exercise program will be performed after the laser application. The patients will be evaluated regarding the primary outcome (pain) using the following instruments: visual analog scale, McGill Pain Questionnaire and pressure algometry. The secondary outcome  will be assessed with the following instruments: Medical Outcomes Study 36-item Short-Form Health Survey, Fibromyalgia Impact Questionnaire, Berlin Questionnaire, Epworth Sleepiness Scale and polysomnography. ANOVA test with repeated measurements for the time factor will be performed to test between-groups differences (followed by the Tukey-Kramer post hoc test), and a paired The protocol for this study is registered with the Brazilian Registry of Clinical Trials – ReBEC (RBR-42gkzt) According to the American College of Rheumatology (ACR), fibromyalgia is a chronic musculoskeletal condition characterized by generalized pain for at least three months in combination with sensitivity in 11 or more of the 18 points sensitive to palpation in different parts of the body, known as tender points . FibromyThe most widely accepted theory is that fibromyalgia is caused by an abnormality in pain modulation mechanisms - a central nervous system disorder in regulating sensitivity to pain. Thus, an individual may exhibit a reduction in serotonin (neurotransmitter of the inhibitory descending system) and in increase substance P (neuroexcitatory substance involved in the conduction of pain) in the central nervous system .Fibromyalgia is often associated with other syndromes, such as fatigue, sleep disorders, morning stiffness and psychological disorders, such as anxiety and depression. Sleep disorders are closely linked to somatic symptoms in patients with fibromyalgia and not to their personality. The most common complaints are difficulty falling asleep, frequent awakening during the night, difficulty getting back to sleep, restless superficial sleep and early rising, the consequences of which are nonrestorative sleep and a sensation of weariness, which contribute toward a poor quality of life. Thus, non-restorative sleep is an important aspect among the manifestations of fibromyalgia, which makes the investigation into primary sleep disorders essential to the assessment of affected individuals ,6. The cet al. [There are several treatment options for fibromyalgia, such as drugs ,8, psychet al. , the anaet al. . The noret al. .In last ten years, important advances have occurred in the therapeutic use of photobiostimulation with low-level lasers. Such advances have occurred due to a greater understanding of the mechanisms of action involved as well as technological developments and the publication of relevant studies and research related to the advantages obtained with the use photobiostimulation in clinical practice. However, the lack of consensus regarding therapeutic protocols hinders multicenter comparisons of the many clinical trials published. Thus, a number of scientific papers have been drafted to establish a therapeutic protocol for the use of photobiostimulation with regard to exposure time, intensity, energy density, application mode and application site.A considerable number of studies have demonstrated the remission of pain in patients with fibromyalgia through the use of LLLT. However, this is not yet a well-established therapy and comparisons of controlled clinical trials are rare. Moreover, there are problems regarding the standardization of treatment ,14,17,18The aim of the proposed study is to assess the analgesic effect of LLLT on tender points in patients with fibromyalgia and establish correlations with quality of life and sleep.A double-blind randomized controlled trial will be carried out at the Sleep Study Laboratory of the Post Graduate Program in Rehabilitation Sciences of the Nove de Julho University (UNINOVE) and the UNINOVE Integrated Health Center, located in the city of Sao Paulo, Brazil. Figure The sample will be comprised of 120 patients with fibromyalgia with a clinical diagnosis based on the ACR criteria. The subjects will be screened at the UNINOVE Rheumatology Clinic.et al. [The required sample size was determined for the primary outcome variable, that is, overall score of the Fibromyalgia Impact Questionnaire (FIQ). According to Bennett et al. , a cliniThe following criteria will be adopted as requirements for inclusion in the study:•A clinical diagnosis of fibromyalgia based on ACR criteria;•Cognitive level sufficient for understanding the procedures and following the instructions;•Agreement to participate in the study and the signing of a statement of informed consent after receiving clarifications regarding the objectives of the study.Patients with the following will be excluded from the study:•Psychiatric disorders, history of drug abuse or other behavior that requires psychiatric medication intervention;•Development of situations beyond clinical control that do not allow participation in aerobic training activities, exertion or group activities;•Severe physical disability;•Co-morbid condition ;•Uncontrolled endocrine disorders;•Although there is no description of serious complications in individuals submitted to LLLT, those with a history of epilepsy, seizures, heart disease, arrhythmia, pacemaker, undiagnosed pain, pregnancy and malignant tumors will be excluded from the study.After the initial evaluation, the 120 volunteers will be randomly allocated to an intervention group  or control group . Randomization numbers will be created using a randomization table at a central office, where a series of sealed, opaque, numbered envelopes will be used to ensure confidentiality. Each envelope will contain a card indicating the group in which the patient will participate. After fulfilling the eligibility criteria, a clinical evaluation and assessments of pain and sleep quality will be carried out and self-administered quality of life questionnaires will be applied . After the volunteer signs the statement of informed consent, she will randomly select one of the envelopes. This study received approval from the UNINOVE Human Research Ethics Committee (protocol number 474921). Additionally, the study is registered with the World Health Organization Universal Trial Number (UTN) U1111-1125-5007 and the Brazilian Registry of Clinical Trials (number - RBR-42gkzt).A single examiner with the necessary skills will perform the evaluations in order to achieve reproducible examinations and more reliable results. A second examiner will be trained to administer the laser and conduct the exercises. A third examiner will perform the re-evaluations of the two groups. The groups will not be identified in order to avoid ‘unmasking’ during the study.The evaluations will occur prior to and at the end of the therapeutic program by a researcher with no knowledge regarding the type of treatment to which the subjects will be submitted. All subjects in both groups will be submitted to the same evaluation protocol, which will include the aspects listed below.Age (in years), body mass (in kilograms), height (in meters), profession, schooling  and marital status.Duration of pain, sites of pain in decreasing order of intensity, period of day in which pain is more intense, factors of improvement and worsening of pain, sleep quality, type of mattress and pillow.A visual analog scale will be used for the assessment of pain intensity, consisting of a straight line measuring 10 centimeters, with no numbers displayed and on which the words ‘no pain’ appear on the left extremity and ‘unbearable pain’ appear on the right extremity. The patient will be instructed to mark a point on the line that indicates the intensity of pain she is feeling at the time. Higher scores denote greater pain intensity.2) attached to a pressure (force) gauge. The gauge displays values in kilograms. Because the surface of the rubber tip is 1 cm2, the readings are expressed in kilogram per square centimeter (kg/cm2). The range of the algometer is 0 to 10 kg and records in 0.1 kg divisions. At one end of the device, perpendicular pressure is applied to the surface of the skin and recorded using a manometer. The algometry of the pain threshold on the tender points will be performed based on the fibromyalgia classification criteria of the ACR, following the procedures described below:A pressure algometer  is a device that assesses the pain threshold. This device consists of a round rubber disk  will be used. The FIQ is a quality of life assessment tool specific to fibromyalgia. The questionnaire has items addressing functional capacity, professional situation, psychological disorders and symptoms, for which higher scores denote a greater impact from fibromyalgia on quality of life.et al. [The version of the SF-36 translated into Portuguese and validated by Ciconelli et al.  will be The McGill Pain Questionnaire (MPQ) adapted to the Portuguese language will be used . The queAs some patients may have difficulty reading and understanding the instructions of the questionnaires , the reading will be performed together with the researchers.The sleep studies will be carried out at the Sleep Laboratory of the Post Graduate Program in Rehabilitation Sciences (UNINOVE) through complete nocturnal standard level I polysomnography using the Somnologica Studio , composed of 16 channels for the monitoring of electroencephalogram, electrooculogram, electromyography of the submentum and tibialis anterior muscles and electrocardiogram, including channels for digital oximetry, nasal pressure (canulla), pressure transducer, respiratory movements  and body position. The assessments will be performed manually by a specialized reader following the guidelines of the American Academy of Sleep Medicine , and theRegarding the performance of the examinations and procedures during the sleep study, the patients will be instructed to remain as relaxed as possible and sleep naturally as if at home. All signals will be recorded continuously throughout the entire sleep period of each subject.The educative session will be individual and carried out following the initial evaluation. The subject will be informed with regard to the nature of fibromyalgia, symptoms, treatment (stressing the importance of exercise) and consequences for activities of daily living. Some exercise strategies will be taught, such as extra body weight loading and adequate positions for the performance of activities of daily living and practice (work). A basic exercise program will then be taught, composed of 11 exercises for stretching the gluteus, paravertebral, hamstrings, pectoral, scalene, intercostals and trapezius muscles. The patients will receive a chart with all the information on fibromyalgia as well as illustrations and descriptions of the exercises to perform. The chart will be furnished to all patients in order to increase compliance with the at-home exercise program.The Twin Laser  will be employed, the active medium of which is made up of a Gallium-Aluminum-Arsenide semiconductor diode, with emission in the 780 nm near infrared wavelength (invisible) and variable power values in the continuous emission mode. The display provides the doses according to the power and application time. The laser will undergo verification of functioning, energy source, points of application and measurement of power.To provide the ‘blinding’ of the study, the laser equipment has two identical application points furnished by the manufacturer - one active and the other a placebo (that does not emit energy); both have a sound device and guide light. The points will be named A and B by a researcher who will not participate in the treatment or evaluations. The researcher performing the applications and the evaluators will be unaware of which points received the effective dose and which received the placebo. The patients will also not have access to information regarding to which group they belong. The points will be identified only at the end of the data acquisition phase.Both groups will receive three laser applications per week for four weeks, totaling twelve sessions. The applications will be performed in spot form with direct contact between the laser probe and the skin. However, only the patients in the effective radiation group with receive an energy dose of 6 J per point. The application points will be performed at the tender points identified prior to each session.Both groups (LLLT and control) will undergo a 50-mintue exercise program following the application of the laser or placebo, which will consist of 10 minutes of warm up and stretching, 30 minutes of aerobic exercise on a treadmill and 10 minutes of relaxation and stretching, three times a week throughout the four weeks of the study.The intention-to-treat analysis will be followed. The patients will be evaluated with regard to the primary outcome (pain) using the visual analog scale for pain, the McGill Pain Questionnaire and pressure algometry. The secondary outcome  will be assessed using the SF-36 and FIQ. The use of medication will be controlled throughout the study. The data on the use of analgesics and daily dosage of adjuvant therapy, such as antidepressants and muscle relaxers, will be recorded and tabulated.t test will be performed to test within-group differences. The level of significance for the statistical analysis will be set at 5% (P ≤0.05).ANOVA test with repeated measurements for the time factor will be performed to test between-groups differences (followed by the Tukey-Kramer post hoc test), and a paired According to data obtained from World Health Organization, a large number of people around the world suffer with chronic pain and it reflects in physical incapacity related to work activities. Furthermore, chronic pain represents a limiting factor in quality of life in modern society. Recent studies have shown that 10% of world population suffers with diffuse chronic pain, and 2 to 5% of these cases are related to fibromyalgia -28.Billions of American dollars are expended around the world every year in diagnostics, treatment, lost workdays and judicial process due chronic pain. In some cases, the cause of pain can be due fibromyalgia. Therefore, the development of efficient therapies can also represent an important decrease in financial costs in relation to chronic pain related to musculoskeletal disorders -31.LLLT has been widely used in treatment of skeletal muscle disorders with positive results -35. The Finally, with the development of the protocol of this study, it is expected that the group treated with LLLT will present with significant reduction of pain intensity on the visual analog scale, increase in the pressure pain threshold, and improvement in the overall quality of life and quality of sleep.At the time of manuscript submission the patients are being recruited to trial.The authors declare that they have no competing interests.All the authors contributed to the conception and design of the study. LVFO, ACA and PTC provided the idea for the study, established the hypothesis and wrote the original proposal. ECPLJ and PTC significantly contributed to writing this paper, while CSMR,RA, LMMS and CSO were involved in critically revising the manuscript. PTC and ACA wrote this protocol paper with input from all co-authors. All authors read and approved the final manuscript.


The Oxford elbow score (OES) is an English questionnaire that measures the patients' subjective experience of elbow surgery. The OES comprises three domains: elbow function, pain, and social-psychological effects. This questionnaire can be completed by the patient and used as an outcome measure after elbow surgery. The aim of this study was to develop and evaluate the Dutch version of the translated OES for reliability, validity and responsiveness with respect to patients after elbow trauma and surgery.QuickDASH, the visual analogue pain scale (VAS) and the Mayo Elbow Performance Index (MEPI) were also completed to examine the convergent validity of the OES in group A. To calculate the test-retest reliability and responsiveness of the OES, this questionnaire was completed three times by 43 different patients (group B). An average of 52 days elapsed between therapy and the administration of the third OES (SD = 24.1).The 12 items of the English-language OES were translated into Dutch and then back-translated; the back-translated questionnaire was then compared to the original English version. The OES Dutch version was completed by 69 patients (group A), 60 of whom had an elbow luxation, four an elbow fracture and five an epicondylitis. QuickDASH were -0.43, -0.44 and -0.47, respectively, and the Spearman's correlations with the VAS were -0.33, -0.38 and -0.42, respectively.The Cronbach's α coefficients for the function, pain and social-psychological domains were 0.90, 0.87 and 0.90, respectively. The intra-class correlation coefficients for the domains were 0.87 for function, 0.89 for pain and 0.87 for social-psychological. The standardised response means for the domains were 0.69, 0.46 and 0.60, respectively, and the minimal detectable changes were 27.6, 21.7 and 24.0, respectively. The convergent validity for the function, pain and social-psychological domains, which were measured as the Spearman's correlation of the OES domains with the MEPI, were 0.68, 0.77 and 0.77, respectively. The Spearman's correlations of the OES domains with The Dutch OES is a reliable and valid 12-item questionnaire that can be completed within several minutes by patients with elbow injuries. This Dutch questionnaire was useful as an outcome measure in patients with elbow trauma. QuickDASH questionnaire  is used to measure the state of the upper extremities before and after therapy [QuickDASH questionnaire is a shortened version of the 30-item DASH questionnaire, which was designed to measure physical function and symptoms in patients with musculoskeletal disorders of the upper limbs. Both DASH and QuickDASH have two four-item optional modules, one related to performing sports and/or playing a musical instrument and one related to work. The test-retest reliability of QuickDASH in a study of 101 patients was 0.90 [QuickDASH questionnaire also differs from the OES because it only asks patients about their experiences during the preceding week, whereas the OES asks patients about the preceding four weeks. The OES includes three domains: an elbow function domain, a pain domain (severity and time of day when the pain occurs) and a social-psychological condition domain; each domain is assessed using four questions. The answers are recorded on a five-point Likert scale. Every domain score is calculated to a final score that ranges from 0 (worst) to 100 (best) [Patient-reported outcome measures (PROMS) quantify the patients' or populations' subjective experience in relation to a health condition and its therapy . It is i therapy . The 11-was 0.90 . The DASwas 0.90 , and in was 0.90 . The Qui0 (best) . The difThe aim of the present study was to develop and evaluate the reliability, validity and responsiveness of the Dutch language version of the OES.1. The OES was translated into Dutch by four clinicians involved in orthopaedic trauma surgery. One clinician was an epidemiologist with experience in clinimetrics. The four translated versions were compared, and the differences were resolved by discussion. The Dutch version of the OES was then back-translated to English by a certified English translator (and native English speaker). The four clinicians compared this back-translation with the original English version of the OES, and they edited the Dutch translation to make it more accurate. After the translation process, mistakes were encountered in the tense of the Dutch version of questions seven and eight, which referred to pain during the past four weeks. These mistakes were found after the back-translation and were corrected.The 12 items of the OES were translated into Dutch according to the generally accepted rules for translation of non-Dutch questionnaires -111. TheQuickDASH, the Mayo Elbow Performance Index (MEPI) [The OES was validated by calculating the Spearman's rank correlation with x (MEPI)  and the x (MEPI) . The MEPx (MEPI) . This inx (MEPI) . The MEPx (MEPI) .QuickDASH, and 58 patients completed the VAS for pain.To validate the Dutch OES, the present study examined a cohort of 69 patients (group A) who were seen for elbow trauma at four clinical sites. Patients 15 years of age or older with a simple or complex elbow dislocation (n = 60), epicondylitis (n = 5) or fracture in the elbow region (n = 4) were included from four hospitals . The patients with previous elbow dislocations were in a chronic stage with a mean follow-up of 3.3 years, and the other nine cases were in an acute stage. Patients younger than 15 years and patients unable to read Dutch were excluded from the study. The elbow dislocations were treated either with plaster or with a sling for two weeks. The elbow fractures were reduced and internally fixated. The patients with epicondylitis were injected locally with platelet-rich plasma. Sixty-nine patients completed the OES and The MEPI was completed by the physician for 49 patients, and four domains were assessed: pain (maximum score of 45 points), ulnohumeral movement (maximum score of 20 points), stability (maximum score of 10 points) and the patient's ability to accomplish five functional tasks (maximum score of 25 points). The five functional tasks were 1) the ability to comb one's hair, 2) the ability to feed oneself, 3) the ability to perform personal hygiene tasks, 4) the ability to put on a shirt and 5) the ability to put on one's shoes.The patient's pain level was assessed with the following question, "How much pain do you have in your elbow?" This question was scored using a 10-point VAS for pain, with 0 indicating no pain and 10 indicating the worst possible pain imaginable.QuickDASH is a standardised and validated questionnaire that assesses a patient's symptoms and disabilities at work and during leisure activities [QuickDASH questionnaire can be downloaded free of charge from the following website: http://www.dash.iwh.on.ca. This questionnaire, which assesses the entire upper extremity, was completed by the patients themselves. The QuickDASH questionnaire consists of three modules. The first module includes 11 questions about symptoms and the ability to perform certain activities. The second and third modules, which are both optional, contain four questions each. The first optional module asks questions about how the patient is affected at work, and the other module asks questions about how they are affected while playing sports or a musical instrument. All of the questions are scored on a five-point scale. The total score of each of the three modules is summed and corresponds to an overall score on a scale of 0 (no disabilities) to 100 (severe disabilities). All three of the modules were used for the present analysis. Lastly, the validity of the Dutch OES was measured by calculating the correlation between the Dutch OES, QuickDASH, the VAS for pain and the MEPI.tivities ; the QuiIn a separate cohort (group B) of 43 patients, the OES was administered three times. The elbow dislocations in this second group B were either treated with plaster or with a sling for three weeks. The elbow fractures were reduced and internally fixated. After the operation patients were allowed to exercise. The patients with epicondylitis were injected locally with platelet-rich plasma. The timing of the administration of the second OES differed between patients and was performed after a median time-period of one day (interquartile range = 6.0). The second test allowed us to calculate the test-retest reliability.The OES test was also administered a third time to the patients of group B; this third administration allowed us to analyse the ability of the OES to detect changes in patient status . An average of 52 days elapsed between therapy and the administration of the third OES , as clinically detectable changes were expected after the treatment of the elbow fractures and dislocations. The first administration of the OES in group B was performed during the acute stage of the disorder, with a mean of 16.6 days  after the therapy to increase the possibility of observing a change between the first administration and third administration of the OES. The OES refers to the period of "the past 4 weeks", and the interval between the trauma and the administration of the OES reduced the possibility of problems for those patients with an acute trauma to complete the questionnaire.The questionnaires were imported into the PASW Statistics 18.0 software package and analysed using the same computer program. The test reliability was analysed by calculating the Cronbach's α coefficient and the intra-class correlation coefficient (ICC). As a measure of test-retest agreement for each domain, the standard error of measurement was calculated by dividing the mean difference in score between the initial test and the retest by the square root of two . Using tQuickDASH, the VAS for pain and the MEPI. Spearman's correlation coefficients were used because the data of the questionnaires were not normally distributed.The convergent validity was estimated by calculating the Spearman's correlation coefficients among the OES scores and those for The ability of the OES to detect changes in patient status  was calculated by determining the effect size and the standardised response means. The effect size was calculated by dividing the difference in patients' scores between the first administration and third administration of the OES by the standard deviation of the score from the first administration. The mean standardised response was calculated by dividing the mean change in score by the standard deviation of the change in scores.The percentages of scores below 25 and above 75 for the three domains of the OES were calculated to assess floor and ceiling effects.The patient characteristics are presented in Table The outcomes of the OES analysis are shown in Table QuickDASH, the VAS for pain, and the MEPI  are shown in Table The Spearman correlation coefficients among the three domains of the OES and In the present study, the reliability  and the test-retest reliability of the Dutch version of the OES were both high for all three of the domains. In a study by Dawson et al., the Cronbach's α coefficients for the three domains were also found to be high: for the elbow function domain, it was 0.90; for the pain domain, it was 0.89; and for the social-psychological domain, it was 0.84; the ICC values for each domain in this study were 0.89, 0.98 and 0.87, respectively .The effect sizes and standardised response means, which are a measure of the test's responsiveness or its ability to detect changes in patients' conditions, were moderate. This finding was in contrast to the study of Dawson et al., which found that the English OES domains had large effect sizes  ,8. TerweThe distribution of the domain scores showed that a high percentage of patients had superior scores above 75. This finding could point to a ceiling effect of the OES, which is a failure to detect differences between patients with a high score; differences at the high end of the scale could be too small to reliably distinguish individuals. But it is usual to obtain skewed scores in opposite directions for pre and postsurgical interventions in orthopaedics and ceiling effects are more relevant to item level rather than to the overall score analysis.QuickDASH questionnaire was moderate. Dawson et al., however, have found a high degree of correlation between the 30-item DASH and the function domain of the OES (-0.84) but only a moderate degree of correlation between the DASH and the pain (-0.66) and social-psychological domains (-0.59) [QuickDASH can be attributed to the difference in time recall because the QuickDASH questionnaire asks patients about the preceding week, and the OES addresses the past four weeks. The VAS for pain had a moderate correlation with the OES, which was probably because the OES assesses a patient's pain under specific circumstances, such as during the night. In contrast, the VAS for pain assesses a patient's mean overall pain intensity at the present moment and does not ask if the degree of pain changes under specific circumstances.The correlation between the three domains of the Dutch version of the OES and the MEPI was high, which indicates that the OES has a good convergent validity. The MEPI score was mainly determined by the contribution of elbow pain (45%) to the patients' overall elbow functioning. Doornberg et al. have concluded that pain has a large influence on questionnaires that assess elbow function, both those that are completed by physicians and those that are completed by the patients ; howevere OES -0.4 but onlThis study had several limitations, including the small sample sizes and a homogeneous patient population  in the two studied cohorts. The reliability of a measuring instrument in classical test theory is characteristic of the sample tested. Another limitation of this study was the variation in the time that elapsed between the first administration and second administration of the OES as well as between the first administration and third administration. The OES refers to the preceding four weeks, and, during this period, the patients were treated for their elbow dislocation with a plaster or sling, which could have interfered with their movements that were addressed by the questions of the OES. This problem could have affected the correlations with the other instruments which used different periods of recall. The variability in time between the administrations could have lowered the ICCs of the OES domains. In addition, the variability in the length of time between the OES administrations could have influenced the standard error of the measurements, the MDC and the effect size measures.Because our patient population included a relatively homogeneous group, future studies should examine OES results in patients with other types of elbow disorders. An analysis of the OES via modern test theory would also be necessary to examine the ordering of the five scoring categories.The Dutch OES is a reliable and valid 12-item questionnaire that can be completed within several minutes by patients with elbow injuries. This Dutch questionnaire was useful as an outcome measure in patients with elbow trauma, and the Dutch language version can now be applied in the Dutch population.Future studies will use this Dutch OES in a randomised controlled trial for the evaluation of the functional treatment of simple elbow dislocations . In addi© Isis Innovation Limited, 2008. All rights reserved.Oxford Elbow ScoreThe authors, being Professor Ray Fitzpatrick and Dr. Jill Dawson, have asserted their moral rights.The authors declare that they have no competing interests.JDH, NWLS, HG, WET and DDH developed the study and drafted and revised the manuscript. WET performed the statistical analysis of the data. JDH, DDH and HG participated in patient inclusion and assessment. All of the authors have read and approved the final manuscript.


Fibromyalgia is a chronic disorder characterized by widespread pain and tenderness. Prior trials have demonstrated the efficacy of pregabalin for the relief of fibromyalgia symptoms, and it is approved for the treatment of fibromyalgia in the United States. However, prior to this study, there has not been a large-scale efficacy trial in patients with fibromyalgia in Japan.This randomized, double-blind, multicenter, placebo-controlled trial was conducted at 44 centers in Japan to assess the efficacy and safety of pregabalin for the symptomatic relief of pain in fibromyalgia patients. Patients aged ≥18 years who had met the criteria for fibromyalgia were randomized to receive either pregabalin, starting at 150 mg/day and increasing to a maintenance dose of 300 or 450 mg/day, or placebo, for 15 weeks. The primary efficacy endpoint was mean pain score at final assessment. Secondary endpoints included Patient Global Impression of Change (PGIC) together with measures of sleep, physical functioning and quality of life.n = 250) or placebo (n = 248). Pregabalin significantly reduced mean pain score at final assessment  and at every week during the study (P <0.025). Key secondary endpoints were also significantly improved with pregabalin treatment compared with placebo, including PGIC ; pain visual analog scale ; Fibromyalgia Impact Questionnaire total score ; and quality of sleep score . Treatment was generally well tolerated, with somnolence and dizziness the most frequently reported adverse events.A total of 498 patients  were randomized to receive either pregabalin (This trial demonstrated that pregabalin, at doses of up to 450 mg/day, was effective for the symptomatic relief of pain in Japanese patients with fibromyalgia. Pregabalin also improved measures of sleep and functioning and was well tolerated. These data indicate that pregabalin is an effective treatment option for the relief of pain and sleep problems in Japanese patients with fibromyalgia.NCT00830167ClinicalTrials.gov:  Fibromyalgia (FM) is a common chronic pain disorder characterized by widespread pain and tenderness -5. Assoc2δ ligand with analgesic and anticonvulsant activity Results from the current study in Japanese patients were broadly consistent with those from previous trials, in which reductions in mean pain score (vs placebo) ranged from -0.47 to -0.98 ,12-14, cWhile the primary objective of this trial was to assess the effect of pregabalin on the symptomatic relief of pain, the study also assessed the broader effects of pregabalin on overall health status and quality of life. Measures such as PGIC allow patients to provide their own assessment of their overall health status, taking into consideration pain and other symptoms together with physical and emotional functioning, and any adverse effects. This study demonstrated a significant improvement in PGIC with pregabalin compared with placebo, with 38.6% vs 26.7% of patients reporting that their symptoms were either "very much improved" or "much improved". These results were consistent with prior trials, in which the percentage point difference between pregabalin and placebo in PGIC ranged from 6.2 to 26.0 ,12-14. SSleep disturbance is one of the key clinical domains in FM . There iThere were no serious or severe treatment-related AEs observed in this study, although not all patients tolerated pregabalin and discontinuations and dose reductions were more common with pregabalin than placebo. The majority of discontinuations were due to somnolence or dizziness. The NNH, based on discontinuations from the study, was higher in this trial (16) than in previous trials of 450 mg/day pregabalin in FM patients (in which it ranged from 9 to 11) ,13,14, pOverall, the safety profile of pregabalin in this population was consistent with prior clinical trials; the most common treatment-related AEs with pregabalin being somnolence and dizziness. Nevertheless, further trials are needed to assess the long-term safety and tolerability of pregabalin in Japanese patients with FM. In order to address this, this trial has been extended into a 52-week, open-label study (the results of which will be reported elsewhere).In this, the first clinical trial in FM patients in Japan, pregabalin demonstrated significant efficacy in pain reduction and also improved measures of sleep and functioning. The drug was generally well tolerated, and AEs were consistent with prior trials and current product labeling. These data suggest that pregabalin may be an effective treatment option for the relief of pain and sleep problems in Japanese patients with FM.ACR: American College of Rheumatology; AE: adverse event; CI: confidence interval; C-SSRS: Columbia Suicide Severity Rating Scale; FM: fibromyalgia; FIQ: Fibromyalgia Impact Questionnaire; HADS: Hospital Anxiety and Depression Scale; LOCF: last observation carried forward; LS: least squares; MMRM: mixed-effect model repeated measure; MOS: Medical Outcomes Study; NNH: number needed to harm; NNT: number needed to treat; NSAIDs: nonsteroidal anti-inflammatory drugs; PGIC: Patient Global Impression of Change; SF-36: 36-Item Short Form Health Survey; VAS: visual analog scale.HOhta, MO and MS are employees of Pfizer Japan, Inc. KN and HOka received a consultancy fee from Pfizer Japan, Inc. for their participation in this study. CU declares no competing interests. KN, HOka and CU were not compensated for their work on this manuscript.KN, HOka, HOhta, MO and MS contributed to the design of the study. HOka was a principal investigator and KN and CU were sub-investigators on the study. MO conducted the statistical analysis of the data. All authors had full access to the study data, contributed to the drafting and critical review of the manuscript and read and approved the final version.


The aim of this study was to assess the severity of pain and its impact on the quality of life (QoL) in untreated patients with head and neck squamous cell carcinoma (HNSCC).A study group of 127 patients with HNSCC were interviewed before antineoplastic treatment. The severity of pain was measured using the Brief Pain Inventory (BPI) questionnaire, and the QoL was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) and the head and neck module (QLQ-H&N35).The mean age of the patients was 57.9 years, and there was a predominance of men (87.4%). The most frequent site of the primary tumor was the oral cavity (70.6%), and the majority of the patients had advanced cancers (stages III and IV). QoL in early stage of cancer obtained better scores. Conversely, the patients with advanced stage cancer scored significantly higher on the symptom scales regarding fatigue, pain, appetite loss and financial difficulties, indicating greater difficulties. Regard to the severity of pain, patients with moderate-severe pain revealed a significantly worse score than patients without pain.The severity of pain is statistically related to the advanced stages of cancer and directly affects the QoL. An assessment of the quality of life and symptoms before therapy can direct attention to the most important symptoms, and appropriate interventions can then be directed toward improving QoL outcomes and the response to treatment. Approximately 40% of these tumors occur in the oral cavity, 15% occur in the pharynx, and 25% occur in the larynx; in 90% of the cases, the most common histologic type is squamous cell carcinoma [Head and neck cancer (HNC) comprises a group of tumors that arise in the oral cavity, pharynx and larynx. It is the 6Pain is one of the several symptoms of cancer that create a poor quality of life (QoL) because pain affects physical functions and has an emotional impact -5. In HNThe complaint of pain has been reported in all clinical stages of oral cancer, with 88.1% of the cases occurring in stages III-IV. Some studies have shown a correlation between pain and tumor staging, with pain being the initial symptom in approximately 20% of the patients with oral squamous cell carcinoma ,6.Cancer pain is multidimensional and is directly associated with QoL . The assFor cancer patients, pain and symptom control are the best predictors of overall QoL scores because the effects of unrelieved pain and poorly managed symptoms have been shown to interfere with the activities of daily living, mood, mobility, and independence. Therefore, when the control of symptoms is not attended to, the QoL tends to be reduced ,10. AddiWe hypothesized that patients with HNC who experienced moderate to severe pain before antineoplastic treatment would report more interference with QoL scores than those patients without pain. Therefore, the purpose of this study was to assess pain severity and its impact on the QoL in untreated patients with head and neck squamous cell carcinoma (HNSCC), and assess QoL of these patients with respect to pain severity, clinical stage of the primary tumor, and lymph nodes involvement.This study is prospective and controlled and it was approved by the Research Ethics Committee of the Espirito Santo Federal University (Protocol n° 99.242/2012). We interviewed 127 outpatients with primary head and neck squamous cell carcinoma consecutively who had undergone medical examinations in 2012 at the Santa Rita de Cassia Hospital-AFECC, Vitoria, ES, Brazil. The cancer patients were distributed into groups with no pain (N = 52), mild pain (N = 47), and moderate to severe pain (N = 28). Inclusion criteria were patients with untreated HNSCC aged over 18 years and both gender. The exclusion criteria were patients who had already been treated for HNSCC, had recurrent malignant disease, were unable to speak Portuguese or had a functional status sufficiently impaired to prevent answering the questionnaires. Clinical data  were obtained from medical records.The pain was measured using the item of “average pain” during the last 24 hours in the Brief Pain Inventory (BPI) , which wThe QoL was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) version 3.0 , which wThis is a 30-item questionnaire that consists of 5 functional scales , 3 symptom scales , a global health status/QoL scale, and a number of single items assessing additional symptoms commonly reported by patients with cancer . The patients were asked to rate each item on a 4-point scale and the global health status/QoL scale item on a 7-point scale .The Quality of Life Questionnaire Head and Neck Cancer Module (EORTC QLQ-H&N35)  has 35 sAll scales and single items were linearly transformed to provide a score ranging from 0 to 100; a high score on the functional scale and for global quality of life (QoL) was representative of a high level of functioning and a high QoL. However, a high score on the symptom scale represented a high level of symptomatology and problems . The insp < 0.05.The scores from the EORTC QLQ-C30 and EORTC QLQ-H&N35 were interpreted according to the EORTC scoring manual . InternaThe main features of our series of 127 patients with HNSCC are summarized in Table The reliability coefficients (Cronbach’s α), means, and SDs for the EORTC QLQ-C30 scales are listed in Table The reliability of the BPI was evaluated according to the internal consistency (Cronbach’s α coefficient). The mean score of item “average pain” during the last 24 hours in the BPI was 4.1. We separately calculated alpha coefficients for pain severity and pain interference. The internal consistency of the pain severity dimension was 0.82 and for the pain interference dimension was 0.92, indicating a satisfactory internal validity (>0.70).p = 0.025; N, p = 0.024), role functioning  and social functioning , indicating better functioning. Conversely, the patients with an advanced-stage tumor scored significantly higher on the symptom scales with regard to fatigue , pain , appetite loss  and financial difficulties , indicating greater difficulties , swallowing , social eating , social contact , teeth , sticky saliva , pain killers  and weight loss , indicating greater impairment  and lymph node involvement (N) indicated that the patients with an early stage tumor scored significantly higher in physical functioning , role functioning , emotional functioning , cognitive functioning , social functioning  and global quality of life  , insomnia , appetite loss  and constipation  scales  and financial difficulties  scales when compared with the cancer group with no pain.Significant differences in the EORTC scales were found with regard to pain intensity. On the EORTC QLQ-C30, the cancer group without pain had better scores on all of the functional scales: physical functioning , speech problems , social eating , social contact , teeth , opening mouth , dry mouth , sticky saliva , feeling ill , pain killers  and weight loss  scales for the cancer group with moderate-severe pain  and less sexuality  scales.The EORTC QLQ-H&N35 questionnaire also demonstrated significantly worse scores on the swallowing . Analyzing the tumor classification, the group with T1 tumors had more patients with no pain (p < 0.001), conversely, patients with T4 tumors indicated a greater intensity of pain (p = 0.003). The absence of lymph node involvement (N0) revealed a difference in the percentage of patients without pain (p = 0.039)  and worse symptoms, which is in accordance with the results of earlier studies -21 and dThe HNSCC patients with moderate to severe pain reported higher levels of interference on all of the functioning scales, the global QoL and the 4 symptoms  on the EORTC QLQ-C30 scales, whereas patients without pain indicated better results on those scales. Thus, increasing pain is related to a reduced quality of life and increased symptoms. We found similar results with the EORTC QLQ-H&N35 because the 11-symptom scales revealed the worst scores (indicating a high level of problems) for patients with moderate to severe pain.In our study, although 66.9% of all patients reported that they had used analgesic medication for pain control, the number of patients with pain (59%) remained high, similar to what was found in an earlier study . While wNormally, cancer pain is classified into three categories: pain caused by tumor growth, pain caused by treatment, and pain unrelated to cancer . TherefoA potential limitation of our study might be that we chose to use the BPI average pain intensity item as the pain intensity criterion, the study was performed with moderate sample, and patients’ recruitment was from one center. However, evaluating the level of pain experienced most frequently is more important for assessing pain’s interference than evaluating shorter periods with the highest/lowest pain intensities. Additionally, this criterion is in accordance with other studies -30, and Although head and neck cancer has the highest prevalence of pain , clinicaAssessing the quality of life and symptoms before therapy can direct attention to the most important symptom, such as pain, and thus, appropriate interventions can improve QoL outcomes and the response to treatment.QoL: Quality of life; HNC: Head and neck cancer; HNSCC: Head and neck squamous cell carcinoma; EORTC QLQ-C30: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30; QLQ-H&N35: Quality of Life Questionnaire Head and Neck Cancer Module; BPI: Brief Pain Inventory; SPSS: Statistical Package for the Social Sciences; T: Tumor size; N: Lymph node involvement; PF: Physical functioning; RF: Role functioning; EF: Emotional functioning; CF: Cognitive functioning; SF: Social functioning; QL: Global quality of life; FA: Fatigue; NV: Nausea/vomiting; DY: Dyspnea; SL: Insomnia; AP: Appetite loss; CO: Constipation; DI: Diarrhea; FI: Financial difficulties; HNSW: Swallowing; HNSE: Senses; HNSP: Speech; HNSO: Social eating; HNSC: Social contact; HNSX: Sexuality; HNTE: Teeth; HNOM: Opening mouth; HNDR: Dry mouth; HNSS: Sticky saliva; HNCO: Coughing; HNFI: Felt ill; HNPK: Pain killers; HNWL: Weight loss.The authors declare that they have no competing interests.KGO, SVVZ, NSB, SAG: contributed to the conception and design of the study, analysis of data and critically read the manuscript. JRVP, AS, EDS, JL: collected data and critical revision. All contributing authors have no disclosures to make. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2407/14/39/prepub