Chronic low back pain is the most frequent medical problem and the condition with the most years lived with disability in Western countries. The objective of this study was to assess a new treatment, Medi-Taping, which aims at reducing complaints by treating pelvic obliquity with a combination of manual treatment of trigger points and kinesio taping in a pragmatic RCT with pilot character.One hundred ten patients were randomized at two study centers either to Medi-Taping or to a standard treatment consisting of patient education and physiotherapy as control. Treatment duration was 3 weeks. Measures were taken at baseline, end of treatment and at follow-up after 2 months. Main outcome criteria were low back pain measured with VAS, the Chronic Pain Grade Scale (CPGS) and the Oswestry Low Back Pain Disability Questionnaire (ODQ).p = 0.10; ODQ 2.35  p = 0.14; CPGS − 0.19  p = 0.64) and at follow-up. Health-related quality of life was significantly higher (p = .004) in patients receiving Medi-Taping compared to controls.Patients of both groups benefited from the treatment by medium to large effect sizes. All effects were pointing towards the intended direction. While Medi-Taping showed slightly better improvement rates, there were no significant differences for the primary endpoints between groups at the end of treatment .https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017051.URL of trial registry record:  Chronic low back pain (CLBP) is one of the most frequent medical problems in Western countries. Lifetime prevalence rates of about 75% and point prevalence rates between 32 and 49% have been documented by epidemiological studies in Germany , 2 and aThe etiology of CLBP is unclear in most cases. We know in general terms that in some patients central hypersensitization as well as pain memory on the level of the spinal cord ganglia can play a role. But in most cases, many factors contribute to generating and sustaining a chronic pain problem . Local oThis was one of the starting points for our therapeutic rationale: In the clinical experience of one of the authors (DS) pelvic obliquity might be a potential co-factor in a multicausal network of factors contributing to the genesis of CLBP, resulting in chronic tension and painful trigger points that radiate out or induce pain through secondary reflex systems such as the Head zones , 21. ThuMedi-Taping. So far, there are no studies assessing the effectiveness or efficacy of this approach.The method of using kinesio tape in our study is contingent on DS’s model of pelvic obliquity and secondary trigger points. Thus, in our treatment model those trigger points are treated by acupressure and massage first and the muscular reflex patterns are disrupted by placing kinesio tape along those muscles that are thought to be responsible for triggering and supporting the pain processes. This combined treatment approach is termed We designed this pragmatic trial in order to evaluate whether this particular type of kinesio taping used as a supportive treatment for correcting pelvic obliquity  warrants further research. To the best of our knowledge, this is the first RCT assessing the effect of kinesio taping used in this way. Consequently, our trial has some characteristics of a pilot study, although its main objective is to assess clinical efficacy.More specifically, our trial assessed the clinical effects of correcting pelvic obliquity and trigger points with short acupressure and massage and applying kinesio tape to the respective muscles. We compared this new modality to best-practice physiotherapy, a strong control as its use as a treatment is supported by guidelines for treating CLBP due to evidence of effectiveness , 36. Sin1), after the end of the respective treatment  and at follow-up 2 months after the end of treatment .We conducted a pragmatic, assessor-blinded, randomized controlled trial at two different study centers in Germany. Patients with CLBP were randomly allocated to either Medi-Taping or a standard treatment for CLPB consisting of patient education and physiotherapy for 3 weeks. Measurements were taken at baseline . Patients allocated to Medi-Taping were treated within the outpatient center while patients randomized to physiotherapy were treated in a larger private physiotherapy center . The second center was the clinic for general medicine of the author DS in Bad Odesloe in the northern part of Germany (Study Center North). DS is the physician who developed Medi-Taping method . Here patients allocated to Medi-Taping were treated within the clinic of DS, patients receiving physiotherapy were sent to a physiotherapy center .The RCT was approved by the ethics committee of the Medical Center, University of Freiburg. All patients gave written informed consent before inclusion into the trial.Criteria for the inclusion in our trial were unspecific low back pain for more than 12 weeks, a rating of at least 4 cm on a 10 cm Visual Analog Scale (VAS) for the back pain, age between 18 and 80 years, and the ability to read and communicate in German.Patients fulfilling any of the following criteria were excluded from the trial: neurological malfunction at the lower extremities related to CLBP; a rating larger than 8 cm on the VAS for back pain; back pain due to infection, tumor, osteoporosis, or stenosis of the cerebrospinal canal; slipped vertebra/e; vertebral fractures; spinal disc herniation; surgery of vertebra, spinal disc or sacroiliac joint; allergy to tape; pregnancy; current cancer diagnosis; addictive disorder; severe psychiatric disorder; significant impairment due to memory problems or brain disorders; artificial hip ankle or knee joint; participation in other RCTs.All patients received an active treatment for 3 weeks. This was either Medi-Taping or a standard treatment of a combination of patient education and physiotherapy.Patients received three treatments within 3 weeks on average, i.e., one treatment per week. The procedure within a session was standardized and manualized. According to this protocol the sessions started with an assessment of leg length difference. Patients were asked to lie on their back and the legs were slightly stretched by a soft pull at the ankles. Next, a continuous horizontal line was drawn on the inside of both calves indicating the position of the calves relative to each other. Then the patient was asked to sit up with the legs remaining outstretched. This procedure results in a shift of the line between the two calves for most people. This shift was measured in millimeters as leg length difference.The patient was then asked to stretch out, lying supine, and the therapist palpated any myogeloses  and tense muscles areas that could be found next to the cervical spine between the base of the skull and seventh cervical vertebra on both sides. After this treatment the leg length difference assessment was repeated. If there was still a substantial difference. The same treatment was also performed on the thoracic and lumbar spine. Also, the mandibular joint was assessed for tense muscles and, if necessary, treated by palpation.Next, the leg length difference was assessed again and several tapes were applied as follows: First, two parallel tapes were fixed on both sides of the spine above the erector spinae muscles ranging from the base of the skull to the sacrum. For the application patients were asked to bend forward and to lean on a bench. This position stretches the back and its anatomical structure before applying the tape and thus provides the tape with tension before fixing it. Next a star-shaped pattern of tape (three stripes meeting in one point) was placed on the lower back while the patient was still in the same bent position. Thus, the star tape covered the area of the patient’s maximum pain and additionally stabilized the sacroiliac joint. This tape was placed with maximum tension in the middle section by stretching the tape before application, with the ends (approx. 5 cm) applied without tension. If after this procedure there was still residual pain, a third tape was placed at the gluteus maximus muscle. This tape was first fixed distally from the greater trochanter then stretched up to approx. 80% of the possible tension before the other end was placed on the sacrum. On average six tapes were applied for the gluteus tape.Patients were instructed to keep the tapes on as long as they stuck to the skin. If the patients had recurring low back pain (LBP) within the same week, they were asked to see the therapist again immediately. Otherwise, the second and the third treatment were scheduled once a week for the following 2 weeks, respectively.Overall, three therapists delivered the intervention: CS and NW at Freiburg and DS at Bad Oldeslohe. NW and CS received training and visited courses on the intervention by DS. Before the start of the study DS supervised the work of NW and CS with several patients in pilot sessions.Patients allocated to the control or standard group received a patient education booklet containing information for patients with low back pain. This 100 page booklet was published by the commission that produced the German national guidelines for the treatment of low back pain . It giveThe following outcome measures were applied.Average low back pain within the previous 2 weeks was assessed by a Visual Analog Scale (VAS) of 10 cm length with the anchor points at 0 cm ‘no pain at all’ and at 10 cm ‘worst possible pain’ , 40. A dFunctional limitations due to CLBP were assessed using the German version of the Oswestry Low Back Pain Disability Questionnaire (ODQ) , 43. TheThis instrument consists of 6 numeric rating scales and a single question . The firThe distance between fingertips and floor (FTF) is a measure of the flexibility of the spine. It is measured by bending forward with stretched legs as far as possible. The distance between fingertips and floor is measured by a scale fixed to the wall. Individual scores have a limited validity but repeated measures are an appropriate clinical indicator for the mobility of the spine.The Schober Sign (SS) is another method to assess spinal mobility , originaLeg length difference was measured as an indicator of pelvic obliquity. The procedure of measuring leg length difference is described above (see Treatment). A line indicating the position of both legs is drawn connecting the calves of a patient lying on their back. Next the patient is asked to sit up with the legs outstretched. The shift between the two lines in this sitting position indicates the leg length difference.The Quality of Life Profile for the Chronically Ill is a health-related quality of life inventory especially designed for patients with chronic conditions and validated in German . It consWe predefined changes at t2 for pain (VAS and Korff pain grade), and functional limitations (Oswestry Disability Score) as primary outcomes. Secondary outcomes were changes in quality of life (PLC), spinal mobility (SS and FTF) and leg length difference (as indicator of pelvic obliquity) at t2 and all changes at t3.Patients contacted the study center and were screened for eligibility. Next, they were invited to the respective study center and a clinical examination regarding inclusion/exclusion criteria was performed by CS (Freiburg) or DS (Bad Oldesloe). Patients were informed about the study and gave written informed consent. Having consented, patients filled in the questionnaires. After baseline measurements were completed patients received their group assignment. Patients assigned to Medi-Taping received their first treatment immediately after the assignment and appointments were scheduled for the following 2 weeks. Medi-Taping treatments lasted approx. 15 min. Patients assigned to standard treatment received the booklet on low back pain and were connected with the respective physiotherapy center in order to schedule six sessions of physiotherapy of 20 min duration. Patients receiving pharmacotherapy for their back pain were allowed to continue with this treatment as they wished.Patients returned to the study center 1 week after the end of treatment (t2), were assessed again clinically  and filled in questionnaires . The same assessment was repeated at t3, approx. three months after baseline. Clinical examinations at t2 and t3 were made by trained examiners who had not been interacting with the patients and who were blinded against treatment allocation. One examiner was used at each center. Both examiners were trained by the three therapists interacting with the patients .After follow-up measurements patients in the standard treatment arm were offered the opportunity to receive Medi-Taping therapy if they so wished, free of charge.There is no prior study for the estimation of an effect size of an approach combining manual therapy in order to reduce pelvic obliquity in combination with taping for CLBP. Thus, a clinical-pragmatic approach was taken. Based on reports of practitioners and patients a superiority effect of more than half a standard deviation was assumed. With an effect size of d = 0.6–0.7 and an objective to recruit at least 100 patients in total, power ranging from 70%  to 85%  was achieved.Randomization was performed by using the random number generator of IBM SPSS 22 and allocation was blinded. Patients were randomized in blocks of 20. At first five Blocks of 20 were randomized at once. With ongoing recruitment, a sixth block of 20 patients was randomized. Finally, for the inclusion of the last patients a seventh block was randomized with only ten patients. Blocks were separated by study center. Study center North received 60 envelopes, South 70. The result of the randomization was printed on a result sheet that was sealed in an opaque envelope. The envelopes had consecutive numbers starting with one. The result sheet contained again the consecutive number, the group assignment and space to fill in date and time of opening, patient ID and name, name of person handing over the group assignment and their respective signature. Randomization was performed by SS who had no direct contact with patients otherwise. He ran the random number generator and sealed the envelopes that were then handed over to the respective clinician. The envelopes were opened in the presence of the respective patient in subsequent order. This process was documented by filling in the above result sheet.All measurements at baseline took place before group assignment and were thus blinded. The patients themselves knew whether they received Medi-Taping or standard care and were thus not blinded. Measurements at t2 and t3 were performed by MDs who had no prior contact with the patients and who were blind to the group assignment. Patients were asked not to reveal any information regarding the therapy received to the examiner in order to maintain the blinding.The study was evaluated according to the intention to treat approach. Missing data on questionnaire scales up to 20% of the total item number of the scale were replaced by means of the other items of the respective scale. All other missing data were replaced by regression-based imputations. Predictors for the imputation were the respective baseline value as well as age, gender, education, VAS at baseline, and chronic pain severity grade at baseline.For the assessment of the primary and secondary outcome at post-treatment (t2) general linear models were applied with group and study center as dichotomous and baseline measure (t1) as continuous predictors. Data that followed a Poisson distribution  were evaluated with a linear model using a Poisson distribution, with baseline measure as continuous predictor and group and center as categorical predictors. Data that were continuous but deviated from a normal distribution (Oswestry Disability Questionnaire) were log-transformed prior to analysis. Since three primary outcome variables were applied we applied a correction for multiple testing according to Holm, which uses alpha/3 for the first criterion, alpha/2 for the second, alpha/1 for the third criterion .group assignment and study center as between-subject factor was performed. Here the interaction term time x group was the focus of the analysis. Degrees of freedom were corrected for sphericity according to Greenhouse-Geisser. Regarding effect sizes we report partial η2 from the respective analyses. However, in order to compare our findings we also computed Cohen’s d for the changes from baseline to end of therapy (t1-t2) and from baseline to follow-up (t1-t3), by subtracting the means and dividing them to the mean of the respective standard deviations. All analyses were conducted with IBM SPSS 23 or Statistica V. 8.For the assessment of the follow-up data a repeated measurement ANOVA with t1, t2, and t3 as within-subject factor and Recruitment took place between June 2015 and March 2016 and was terminated when the specified number of patients was reached. Overall, 561 patients were screened either per telephone or per email between June and October 2015. One hundred forty-seven patients were invited for a clinical examination, 119 patients showed up and finally 110 patients started with the intervention and were included into the intention to treat analysis. Of these 110 patients, 59 were treated at the study center South and 51 at the study center North. The exact patient flow can be seen in Fig. Table N = 59) and North (N = 51). Samples were comparable for all variables except pain (VAS) and leg length difference (LLD), with the South sample reporting significantly more pain than the North one . Leg length difference was smaller in the South center  than in the North center . This difference was highly significant .We also compared the baseline data for the two study centers South . Table All analyses in the results section are based on the ITT-sample with The results of the linear models testing group differences at post-treatment (t2) for the three primary outcome variables can be seen in Tables time x group. With VAS-Pain rating there was a significant interaction between time and center  indicating that patients in one center did better over time than in the other. No other interactions between center and time were detectable. Figure For the assessment of the follow-up data we computed a repeated measurement ANCOVA over the post-treatment and follow-up measurement points with baseline as covariate. The results for both primary and secondary outcomes can be seen in Table For the Poisson-distributed variables we computed Poisson-based linear models for the follow-up score as dependent variable with the baseline and post-treatment score as covariates and group and center as categorical predictors Table .Table 6time x group interaction can be seen . This illustrates that our a-priori effect size assumption was too optimistic and the study suffered from a power problem.The interaction plots Fig. a-c illusWith respect to the minimum clinically important differences (MCID) of 2.0 cm for VAS or 10 points for ODQ no effects of clinical significance were found between groups . Regarding within-group differences, pain (VAS) in the Medi-Taping group nearly reached the MCID from baseline to post treatment (1.86) and from baseline to three-month follow-up (1.87), but not for the difference from post-treatment to three-month follow-up (− 0.01). For the ODQ, the maximum change reached in within-group changes was 7.11 (Medi-Taping from baseline to three-month follow-up), from baseline to post-treatment the respective difference was 5.53, from post-treatment to three-month follow-up 1.58.This pragmatic, examiner-blind randomized controlled trial of Medi-Taping versus physiotherapy in patients with chronic low back pain was the first of its kind. It was powered to detect medium-sized between-group effects in favor of Medi-Taping. All effects were pointing in the anticipated direction with patients in the Medi-Taping group doing better than controls. But our primary analysis failed to confirm this difference, as none of the primary outcomes showed a clearly statistically or clinically significant effect in favor of the experimental treatment. Some of the secondary outcome variables showed an effect: Quality of life improved significantly more in the Medi-Taping group with a small- to medium-sized effect of about 7% variance explained. And the finger-to-floor distance, which measures functionality, improved clearly and significantly more in the Medi-Taping group with a rate ratio of 1.29, indicating that a patient in the Medi-Taping group had on average a 29% better chance of improvement. This result was confirmed by the secondary analysis, a repeated measure analysis of variance of all variables, where the Oswestry Disability Score and the Quality of Life Score (PLC) just missed significance, and the Finger-to-Floor Distance was also highly significant. The trend illustrated by the interaction plots  would require 155 patients in each group to meet a power goal of 90% statistical power in a superiority trial. Thus, a fully powered trial would require more than 300 patients and would have to be three times as large as this trial.The trial was pragmatic. Although all results provided by clinicians are blind, patients could not be blinded, and the taping treatment would not lend itself easily to any form of blinding control. Hence one might suspect reporting bias in the patient outcomes. However, as patients knew that they would be receiving one of two potentially effective treatments and clinicians were blinded, we believe that reporting bias was not a problem, especially since the difference between groups in self-reported measures was not larger than in clinician-reported outcomes. The patients in our study were certainly comparable to patients in general practice. They had a chronic problem. Their pain was partially disabling them in their function and it was of medium severity. Hence, our trial can be generalized to a community sample, and both treatments can be considered useful for chronic pain.The most sensitive outcome proved to be finger-to-floor distance. This is a validated robust and objective measure of functionality . For a fThe intervention studied here is different from other effective chronic pain treatments. The physiotherapy offered here was a strong multimodal package with elements of mobilization and patient education. This is testified by the large pre-post effect sizes. There are almost no studies in the literature that compared kinesio taping with physiotherapy. Most studies provide physiotherapy to both groups and the experimental group then receives kinesio taping as add-on. In such comparisons, a recent review found an improvement in VAS of 0.62 and 5.15 points in the ODQ respectively .It was the first of its kind and hence the study was designed based on educated guesses and clinical impressions, which are notoriously unreliable, as documented by our over-optimistic power calculation. While we operated with two centers and thus had the benefit of a limited generalizability, ideally more centers should have been included. Perhaps a more realistic design would have been a non-inferiority trial, which, however, would require a considerably larger sample size , 55. OneAnother limitation was that we did not assess treatment adherence by the therapists. However, we had only three therapists, who were trained together and developed the treatment manual of the study during this training. In this context we are confident that there was only minimal variance in treatment delivery. Finally, our trial was only registered retrospectively. Thus, selection and reporting of outcomes and analyses cannot not be demonstrated to be prespecified. However, we submitted a detailed study protocol to the ethics committee before the start of the trial that contains all relevant details and can be obtained on request.We conclude from our pragmatic, partially-blinded randomized study that Medi-Taping, a purported way of correcting pelvic obliquity and chronic tension, is a treatment modality similar in effectiveness in treating chronic low back pain to a complex physiotherapy and patient education program with respect to pain, function and quality of life. There are indications that 2 months after the end of treatment Medi-Taping improves quality of life more than standard physiotherapy, but these indications are tentative and require replication in an adequately powered study.


Pain, pressure-pain threshold, range of motion, functionality and quality of life were measured before treatment, at the end of treatment, and at one-month and three-month follow-ups. Both groups received 15 therapy sessions over 5 weeks. Statistically significant differences in favor of the VT group were shown in the results. In conclusion, the intervention based on myofascial vacuum therapy improved pain, mobility, pressure pain threshold, functionality and quality of life.Non-specific low back pain is defined as pain located in the lumbar region; this condition is the most frequent musculoskeletal disorder. Negative pulsed-pressure myofascial vacuum therapy (vacuum treatment (VT)) devices mobilize tissue according to previously programmed parameters of force, time and frequency. The purpose of this study was to compare the effects of VT combined with core therapeutic exercise versus a physical therapy program (PTP) based only on core therapeutic exercise. Fifty participants with chronic non-specific low back pain were randomly assigned to two treatment groups, the VT group ( Non-specific low back pain is defined as the presence of painful symptoms located in the lumbar region, which is between the lower margin of the ribs and the lower limit of the buttocks ,2. This Currently, low back pain (LBP) is the most frequent musculoskeletal pathology  and reprIt is noteworthy that individual lifestyles may predispose the appearance of low back pain; sedentary behaviors are a risk factor in themselves  and are Another aspect to consider is that within physical therapy treatment, it is possible to combine active treatment based on physical exercise with other techniques such as electrotherapy devices  or manuaThese techniques have important releasing effects on vessels and nerves, leading to improved vascularization, reduced neuropathic pain, normalization of myofascial tension, and, as a consequence of the above, a reduction of pain and an increase in mobility ,20. In s2. Negative pressure can be preset from 25 to 250 millibars. The digital control of a wide range of parameters allows treatment to be tailored to each individual patient, thus avoiding the side effects of traditional cupping therapy [In order to address this problem, mechanical devices with digital parameterization have been developed in recent years. Negative pulsed-pressure myofascial vacuum therapy (Physium® Vacuum Treatment (VT)) is a pulsed negative-pressure therapy device that mobilizes tissue according to previously programmed parameters of force, time and frequency. It allows manual application by a therapist or static application by means of an articulated arm with a polypropylene treatment head at its end. Treatment head sizes vary from 20–100 cm therapy ,20,22, aThe innovative character of this therapy, which could allow the mechanic stimulus applied to be controlled and quantified, might avoid the side effects of traditional cupping therapy, as well as the uncertainty in relation to the applied parameters. Thus, VT may lead to establishing a warranty and effective myofascial treatment. Due to the above, jointly with the novelty of the VT approach, the present study aims to compare the effect of a therapy program based on the joint approach of VT therapy and therapeutic physical exercise versus the isolated performance of the same therapeutic physical exercise programe.The design of the present study was a prospective and longitudinal single-blind randomized controlled clinical trial. It has been performed in accordance with the Helsinki Declaration and the CONSORT statement for reporting clinical trials. The trial has been registered in the Clinical Trials Registry with the reference number NCT04534179, and it has been approved by the Ethics Committee of Research of Cádiz (Spain) with the reference number 1095-N-20. The sample size calculation was carried out taking into account the data obtained from Lauche et al. , employiThe criteria taken into account to include patients in the present study were: patients of both sexes, with an age range between 25 and 50 years old, diagnosed with CLBP  [All patients were recruited at the Santa María Clinic  by a clinician blinded as to group allocation. Each study group was composed through random allocation of the total sample with a 1:1 allocation ratio that was reported to patients by a different researcher, who was neither the one who performed the treatment nor the one who performed the evaluation, through an opaque envelope.The measurements of the study variables were made before the intervention, at the end of the intervention, and one month and three months after the conclusion of the treatment. Data were collected by an experienced physical therapist who was blinded as the evaluator.Pain was the main study variable. This was measured with the Spanish version of the Numerical Pain Rate Scale (NPRS) . This sc2 that is attached to a pressure pole. The measurements are expressed in kg/cm2, with the depression range from 0 to 10 kg/cm2. The PPT was measured bilaterally at the quadratus lumborum, piriformis, psoas and paravertebral muscles. The reliability and validity of such measurement in myofascial trigger points have been evaluated in numerous studies, determining that the algometer constitutes a reliable instrument for the quantification of pain sensitivity in patients with myofascial pain syndrome [The pressure-pain threshold (PPT) is the minimum applied force that induces pain. It is a validated method that presents reliability in the measurement with an ICC ranging from 0.78 to 0.93. The algometer consists of a disc of rubber with an area of 1 cmsyndrome ,31,32,33®, Maharashtra, India). The parameters taken into account for this purpose were flexion, extension, lateroflexion and rotation movements. The physical therapist asked the patient to perform the aforementioned movements from a standing position, and the data were recorded at the end of the range of motion of each movement required [Lumbar spine mobility was evaluated with a digital inclinometer  and mental (MC-SF12) factors of quality of life. In the Spanish population, the SF-12 questionnaire has demonstrated good reliability results  ,40.The development of the intervention in both groups lasted five weeks. Individuals in the experimental group were subjected to a treatment of three weekly sessions of VT during the five weeks and a therapeutic exercise program , while the participants in the control group received the treatment of the therapeutic exercise program ) with the same duration .The treatment time of each VT session was 30 min. The applied pressure ranged between 80 and 100 mb in search of an analgesic effect, placing the applicators intermittently on the quadratus lumborum, piriformis, psoas and paravertebral muscles ,20.The therapeutic exercise program was based on core exercise ,11,15,41The exercises included in the treatment program were: supine bridge (pelvic lift from supine position), prone bridge (front plank), side bridge , dead bug  and bird dog  ,11,15,41In this study, continuous variables were described through means and standard deviations, and the description of the categorical variables was performed through frequencies and percentages. The normality of the distribution, as well as the equality of variances of the continuous variables, were tested employing the Kolmogorov–Smirnov test and Levene’s test, respectively. In order to determine the possible between-groups differences at baseline in relation to the morphologic characteristics and the descriptive data, Student´s t-test was used for continuous variables, and the chi-squared test was used for bivariate variables. The treatment effect was analyzed through a 2 × 4 mixed model of repeated measures analysis of variance, with time-by-group interaction as the main hypothesis. In the cases where differences between groups at baseline were appreciated, the analysis of the differences in change scores was controlled by the effect of the mentioned variable at baseline. The analysis of covariance (ANCOVA) was selected to perform the analysis in these specific cases. To test the differences between the VT and PTP groups through time , Student’s t-test for pre-change/post-change scores was applied. 2), which could be considered the analogue of R2, the determination coefficient employed for experimental studies. It can be interpreted as the percentage of the between-group differences because of the treatment effect. In addition, Cohen’s d was chosen to evaluate the ES in the bivariate analysis, and it was calculated as the mean of the between-groups difference divided by the pooled SD of both groups. Following Cohen’s recommendations [2 was determined to be irrelevant when it was lower than 0.02, small when its value was between 0.02 and 0.15, medium when its value was between 0.15 and 0.35, and large when its value was over 0.35. The previous criteria also establish that a value of Cohen´s d < 0.2 could be considered irrelevant. Values of Cohen’s d between 0.2 and 0.49 were considered small, values between 0.5 and 0.8 were considered medium, and values >0.8 were considered large.The effect sizes (ES) for time-by-group interactions were calculated using eta-squared . For these variables, it was possible to observe medium ES values between 0.221 and 0.282. In addition, not only was an important enhancement in pain shown but this was also seen in algometry measures. All these results are shown in Statistically significant differences in favor of the VT group were shown by the analysis of the variance. It also revealed an ES between medium and large, as well as a statistical power between 0.657 and 0.996. All the variables related to mobility showed a significant improvement, except for flexion movement , where changes in the VAS scale are shown with therapeutic interventions with cupping versus other control techniques . NormallIn general, vacuum therapies are effective on lumbar symptoms, even when performed as a stand-alone treatment . It is nRegarding quality of life, improvements are obtained in the SF12 scale, implying that decompressive myofascial therapy with pulsed negative pressure contributes to improving the patient’s quality of life, as advocated in the study by Teut et al. (2018), which assessed quality of life by means of the extended version, the SF36 scale . Similarly, the results coincide with research carried out using decompressive myofascial therapy in other locations of the spine, such as studies that applied these techniques in cervical pathology, finding pain reduction, improvements in mobility, decreased pressure pain threshold ,53, and The fact that treatment parameters such as application time, pressure and vacuum intervals of the therapy can be controlled mechanically and digitally is a great advantage, representing the main strength of this research, since the intervention is reproducible, establishing general standardized action guidelines and making treatment conditions and parameters replicable. This possibility of quantifiable control of the intervention’s performance parameters is especially noteworthy, being the forte of our study since most of the research that develops treatments with vacuum therapies lack precise and quantifiable parameter controls . On the Therefore, in view of the results, it is possible to contemplate the combination of decompressive myofascial therapy with pulsed negative pressure with therapeutic physical exercise as a treatment of high value, capable of improving pain, mobility, pressure-pain threshold, functionality and quality of life in patients with non-specific chronic low back pain. Consequently, this combined treatment therapy may result in the reduction of socioeconomic costs derived from the medical care of individuals with chronic low back pain and could prevent and reverse the situation of overmedication that frequently accompanies these patients ,56, beinIn spite of the good results presented in this study, it is possible to find some limitations. It was not possible to include a placebo group, which would be advisable in order to evaluate the subjective influence of this treatment on patient pathology. Moreover, it was possible to observe a between-group difference in age. This aspect could be considered a limitation, but it is necessary to emphasize that the lifetime prevalence of low back pain is as high as 84%, depending on the case definition used, and no age group is spared, including children . FurtherMyofascial vacuum therapy with pulsed negative pressure together with therapeutic exercise is an option in the treatment of chronic non-specific low back pain. The intervention based on myofascial vacuum therapy improves pain, mobility, pressure pain threshold, functionality and quality of life.


Background: Few studies have focused on depressive symptoms among patients with chronic low back pain in China. The aim of this cross-sectional study was to assess the prevalence and associated factors of depressive symptoms in patients with chronic low back pain.Methods: From May to August 2021, 1,172 patients with chronic low back pain were recruited in China. Depressive symptoms were assessed through the Patient Health Questionnaire. Associations of demographic characteristics, clinical characters and social-psychological factors with depressive symptoms were investigated among patients with chronic low back pain.Results: The prevalence of depressive symptoms was 25.00%. Logistic regression analysis found that duration of pain in 1-5 years  and more severe pain  were associated with higher risks of depressive symptoms. Better family function  and higher pain self-efficacy  were associated with lower risks of depressive symptoms.Conclusion: Patients with chronic low back pain have a high prevalence of depressive symptoms in China. Duration of pain, pain severity, family function and pain self-efficacy were predictors of depressive symptoms among chronic low back pain patients in China. Early identification of the associated factors may be helpful for the timely management of depressive symptoms. Low back pain is a worldwide public health issue . And of Depressive symptoms are the most common mental health problem in patients with CLBP . And theChina has a large group of patients with CLBP due to its large population base. According to the literature, 67.3 million people in China suffered from CLBP in 2016, causing a heavy burden of disease . The resThe study was approved by the Ethics Committee of Ningbo No.2 Hospital, Zhejiang, China. All participants were voluntary and provided written informed consent before being involved in the study. All data of participants were kept anonymous and confidential.This study adopted the convenience sampling method to select a general hospital in Ningbo, Zhejiang province and Wuhan, Hubei province in China, respectively, as the study sites. Patients with CLBP admitted to Tongji Hospital in Wuhan and the Ningbo No.2 Hospital in Ningbo during May to August 2021 were invited to participate in this survey. The inclusion criteria included:  a nativen = n is the sample size, p is the proportion of depressive symptoms among CLBP patients, z is the normal deviation, and d is the margin of error. In order to control type I error, we took α as 0.05; therefore, z was equal to 1.96. Based on previous research on the depressive symptoms among CLBP patients, p was assumed to be 20.3%  was used to assess depressive symptoms, which consisted of 9 items . Each itTo control for the influence of potential confounding factors on depressive symptoms, we collected information on demographic characteristics, clinical characters (pain severity and duration of pain), family functioning, and pain self-efficacy. The demographic characteristics included sex, age, work status, marital status, educational level, monthly personal income, and medical insurance.The four-item Chinese version Brief Pain Inventory subscale on pain severity (BPI-PS) was used to assess pain intensity . The scaThe Chinese version of the Family Adaptation, Partnership, Growth, Affection, Resolve (APGAR) index was used to evaluate participants' satisfaction with current family function, which consisted of five items, namely, adaptability, partnership, growth, affection, and resolve , 21. EacPain self-efficacy was measured through the Chinese version of the Pain Self-efficacy Questionnaire (PSEQ), which has shown excellent validity and reliability in patients with CLBP , 25. PSEP < 0.05), continuous variables were showed by medians and quartiles. Categorical variables were showed by frequencies and percentages. We used Wilcoxon rank-sum test for continuous variables, and Pearson's chi-squared test for categorical variables to compare the demographic characteristics, pain-related variables, and family function between patients with or without depressive symptoms. The binary logistic regression was conducted to assess the association between outcomes and different explanatory variables. We also used stepped modeling approach to compare the fit of three sets of variables. Model 1 only contained individual characteristics; Model 2 contained both individual and pain-related factors; Model 3 was a full model which also included family function. Parameters including −2log likelihood, Akaike's information criterion (AIC) and Schwarz criterion (SC) were used to compare these multilevel models. The −2log likelihood, AIC and SC of Model 1, Model 2, and Model 3 became smaller, indicating that the fit of the models improved . The strength of association was interpreted using odds ratio (OR) and 95% confidence interval (CI). All P-values were two-tailed and significance level was set at 0.05. The statistical analysis was conducted using SAS 9.4 software.The normality of continuous variables was test by the Shapiro-Wilk method. Due to the distribution of all continuous variables did not satisfy the normality . The univariable analysis showed that age, educational level, monthly personal income, medical insurance, duration of pain, family function, the score of pain severity and pain self-efficacy were significantly different between patients with and without depressive symptom  and 3-5 years  were more likely to suffer from depressive symptoms than those with a duration of <6 months. Patients with CLBP who had higher scores of pain severity were at higher risk of developing depressive symptoms , while higher score of pain self-efficacy was associated with a decreased likelihood of depressive symptoms . Compared to those with severe family dysfunction, those with good family function  and moderate family dysfunction  were less likely to have depressive symptoms .The results of this study showed that the prevalence of depressive symptoms in patients with CLBP in China was 25.00%, significantly higher than that in Chinese community-dwelling population (12.30%) . This fiNotably, there is no significant association between medical insurance and depressive symptoms in CLBP patients in this study. This result is contrary to studies in some countries in Southeast Asia , 30. ThiPain-related factors were significant related to depressive symptoms in CLBP patients. Our study found that CLBP patients who had pain duration of 1-5 years were at higher risk of developing depressive symptoms, which was similar to previous studies , 33. TheThis study also found that family function was a significant protective factor for depressive symptoms –38. WhenTo our best knowledge, this study is the first to investigate the prevalence of depressive symptoms in Chinese patients with CLBP and to explore the influencing factors in terms of demographic characteristics, clinical characters, individual psychological factors and social factors, which provides evidence for the prevention and treatment of depressive symptoms in patients with CLBP. However, there are some limitations of this study. First, this was a cross-sectional study, and it was difficult to clarify the causal relationship between depressive symptoms and related factors. Second, the convenience sample was adopted in this study, which limited representativeness and generalizability of the results. Third, this study was conducted in two provinces of China, and thus, the generalizability of our results to patients with CLBP in other regions of China may be limited. Further large-scale studies are needed on a national scale.The prevalence of depressive symptoms is high among Chinese patients with CLBP. In the clinic, CLBP patients with pain duration of 1-5 years should be paid more attention. Moreover, pain should be actively managed to reduce pain intensity in CLBP patients. In addition to the treatment of somatic pathological changes, the psychological well-being of CLBP patients should also be promoted by enhancing patients' family function and pain self-efficacy.The original contributions presented in the study are included in the article/The study was approved by the Ethics Committee of Ningbo No.2 Hospital, Zhejiang, China. Participation was voluntary and all participants provided written informed consent before being involved in the study. All data of participants were kept anonymous and confidential.YH, ZY, and NG were responsible for the conception, design, and writing of the manuscript. YL and YX were responsible for the acquisition of data and literature research. MT and NJ were responsible for the analysis and interpretation of data. All authors read and approved the final manuscript.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Chronic pain remains or reappears for more than 3 to 6 months, and it is influencing 20% of the global population. The pain catastrophizing affects pain intensity and psychological conditions of patients with chronic pain. Rumination-focused cognitive-behavioral therapy (RFCBT) targets rumination as the key component of pain catastrophizing. The aim of this study was to determine the effectiveness of RFCBT on depression, anxiety, and pain severity of individuals with chronic low back pain (LBP).  In a randomized controlled trial, 30 patients aged between 20-55 years with diagnosed chronic LBP were chosen by convenience sampling and randomly allocated into intervention and control groups. All patients used their prescribed medications for pain management, but the intervention group received 12 weekly sessions of RFCBT, which was manualized psychotherapy to change unconstructive rumination to constructive rumination. Depression Anxiety and Stress scale-21 and chronic pain grade questionnaire were administered as pre-tests and re-administered after 3 and 6 months as post-test and follow-up assessments, respectively.  RFCBT significantly reduced depression , anxiety  and pain severity  in patients with chronic LBP.  RFCBT may offer benefits for treating patients with chronic low back pain when added to their usual pharmacological treatment. This benefit may be the result of targeting rumination as the key element of pain catastrophizing. The worldwide literature usually depicts pain as a symptom of modifiable disease, injury or trauma, and its presence is assumed to mirror a failure of worldwide health activities to address a fundamental cause . UsuallyFurthermore, rumination can predict disability  and is a To detect the difference between RFCBT and control groups with a two-tailed α of 0.05 and a (1-β) of 0.80, we needed 15 patients in each group. We allocated 20 patients in each group, considering 25%-30% anticipated dropout. In a randomized controlled trial with parallel groups, 40 patients with diagnosed CLBP who referred to physical medicine and rehabilitation clinic at Modares hospital in Tehran were selected by convenience sampling. Inclusion criteria were 20 to 55 years of age, reading and writing level of grade 6 at least, reaching minimum scores to be diagnosed with mild depression and mild anxiety in depression anxiety stress scale-21 . Also, participants with a history of bipolar disorders or psychotic disorders, substance dependence or substance-related disorders, and receiving any other psychotherapy during the study were excluded. All patients signed a written informed consent before participation.This scale contains three self-report subscales with 21 items and measures the emotional state of depression, anxiety, and stress. The severity rating includes normal, mild, moderate, severe, and very severe, and seven questions are dedicated to each subscale. Scores of each subscale need to be multiplied by two, and subscales may range between 0 and 42 . CronbacThis seven-item questionnaire provides a score to categorize patients with chronic pain into four classes according to the severity of their pain and the level of interference with daily life . All iteRFCBT was consisted of up to 12 sessions lasting 60 min scheduled weekly or fortnightly . This thFurthermore, patients utilize guided imagery to reproduce past mental states like memories of being fully absorbed in an activity , which works counter to rumination . Special All participants answered DASS-21 and CPG questionnaires. They were randomly allocated to RFCBT or control groups (20 patients in each group) after pre-treatment assessment. A computer-generated list of random numbers was used for the allocation of the participants. We assigned participants into RFCBT and control groups by simple randomization. Sequentially numbered opaque, sealed envelopes were used for allocation concealment. To prevent subversion of the allocation sequence, the name, date of birth, and national ID number of the participants were written on the envelope. Carbon paper inside the envelope transferred the information onto the allocation card inside the envelope. The envelopes were opened only after the enrolled participants completed all baseline assessments, and it was time to allocate the intervention. The admitting clerk was in charge of enrollment, and two independent medical residents in the physical medicine and rehabilitation clinic generated the random allocation sequence and assigned participants to interventions. All participants in both groups continued to use their prescribed medications for pain management during the study, but the intervention group received 12 sessions of RFCBT. Patients in both RFCBT and control groups conditions administered all questionnaires and scales after the last session of the RFCBT, and the follow-up was done three months later. At the end of the study, patients of the control group received 12 weekly sessions of RFCBT. The primary outcome was a reduction in depression, anxiety, and pain severity in patients with CLBP after receiving RFCBT for 12 weeks. All procedures performed in the present study involving human participants were following the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study. This trial was registered at the Iranian Registry of Clinical Trials (number: IRCT20190710044169N1), and was approved by the Research Ethics Committee of this university . Data were analyzed using SPSS 24. Mixed ANOVA was used to determine the effect of RFCBT on depression, anxiety, and pain intensity of participants. Normality, homogeneity of variance, and sphericity of the covariance matrix as ANOVA assumptions were tested before using mixed ANOVA to analyze data. Bonferroni was used as a posthoc test. Multivariate analysis of covariance was also used to analyze subscales of CPG, which showed a significant difference between RFCBT and control groups in at least one of the subscales. Fifty-five patients with CLBP were screened for eligibility . Ten pat Demographic characteristics of participants in both RFCBT and control groups are depicted in the  A mixed analysis of variance was used to determine the effect of RFCBT on depression, anxiety and pain severity in pre-treatment, post-treatment, and follow-up. Data were tested to meet mixed ANOVA assumptions. Independence assumption was met because the answers of participants were not affected by other participants. Shapiro-Wilk test was used to test the normality assumption. Distribution of scores were normal in both RFCBT and control groups for depression , anxiety , and pain severity . Homogeneity of variances and sphericity were checked by Levene’s test and Mauchly’s sphericity test, respectively. Homogeneity of variances assumption was met for depression , anxiety , and pain severity , but Mauchly’s sphericity test showed that sphericity assumption was not met for depression , , and pain severity . Since the sphericity criterion could not be met, Greenhouse-Geisser correction was used. Mixed analysis of variance showed that there was a significant difference between the mean scores of depression in the pre-test, post-test, and follow-up stages . Bonferroni test demonstrated that depression scores in post-test (P=0.001) and follow-up (P=0.001) were significantly reduced comparing pre-test. Furthermore, the mean scores of depression in the pre-test, post-test, and follow-up assessments were significantly different in RFCBT and control groups . The calculated F for between-group factor was significant , which illustrated that the mean of depression scores was significantly different in RFCBT and control groups . Mixed analysis of variance showed a significant difference between the mean scores of anxiety in the pre-test, post-test and follow-up assessment . Bonferroni demonstrated that anxiety scores in post-test (P=0.001) and follow-up (P=0.001) were significantly decreased comparing pre-test. Furthermore, the mean scores of anxiety in the pre-test, post-test, and follow-up were significantly different in RFCBT and control groups . The calculated F for between-group factor was significant , which showed the mean of anxiety scores was significantly different in RFCBT and control groups . Also, there was a significant difference between the mean scores of pain severity in the pre-test, post-test and follow-up assessments . Bonferroni test showed that pain severity scores in post-test (P=0.001) and follow-up (P=0.001) were significantly decreased comparing pre-test. Furthermore, the mean scores of pain severity in the pre-test, post-test, and follow-up were significantly different in RFCBT and control groups . The calculated F for between-group factor was significant  indicated that the mean of pain severity scores was significantly different in RFCBT and control groups . MANOVA This study aimed to determine the effectiveness of RFCBT on depression, anxiety, and pain severity in individuals with CLBP. The findings showed that RFCBT was effective for reducing depression, anxiety, and pain severity in patients with CLBP compared with the control group. Pain intensity and pain-related disability as two components of CPG were significantly reduced in the RFCBT group compared with the control group. Furthermore, comparing the mean scores of depression, anxiety, and pain severity in post-test and follow-up showed no significant difference, which indicates the persistence of the therapeutic benefits after three months. The effectiveness of RFCBT for depression and anxiety was consistent with the findings of Watkins et al. , which s Our findings indicate that RFCBT may offer benefits for treating patients with CLBP by reducing depression, anxiety, and pain severity when added to their usual pharmacological treatment. This psychotherapy can be considered as a high potential treatment for chronic pain. Comparing the effectiveness of RFCBT and another psychological treatment for CLBP and longer-term follow-up may improve the quality of future researches. This article has been extracted from the written thesis for a Ph.D. degree in the School of Medicine, Shahid Beheshti University of Medical Sciences (Registration No:M394). We thank the physicians and staff of shahid Modarres Hospital for their generous cooperation. The authors have no conflicts of interest in writing this article.


Background and Objectives: Correct assessment and a multidisciplinary approach appear to be extremely important in preventing peripheral neuropathy and its complications. The purpose of this study was to find the correlations and dissimilarities between different types of peripheral neuropathy, the occurrence of pain, and laboratory results. Materials and Methods: This retrospective study assessed 124 patients who were hospitalized in our neurology department due to various types of sensory or motor disturbances. The patients were eventually diagnosed with peripheral neuropathy, based on the electrophysiological study, anamnesis, physical examination, and laboratory results. The whole group was subjected to statistical analysis. Results: The mean age of patients was over 56 years, with a slight woman predominance. A statistically significant (p < 0.05) relationship between the place of residence and gender was seen, where more men than women live in the rural area, while more women than men live in the urban area. Most often we observed symmetric, sensorimotor, demyelinating, inflammatory, and chronic neuropathy. More than 40% of patients reported pain. A statistically significant correlation between the evolution/severity and the occurrence of pain was seen in subacute type (p < 0.05) and small fibre neuropathy (p < 0.01). Conclusions: A higher incidence of peripheral neuropathy in middle-aged people will become essential in the aging society with lifestyle and chronic disorders. Peripheral neuropathy is slightly more common in women than men and its occurrence may be influenced by work performed or internal and external factors. In the study group, more than 40% of patients reported pain, therefore the pain measurement for each patient should be implemented and repeated at every visit. An assessment of sodium level and, in women, markers of neuroinflammation level in the various types of peripheral neuropathy may be an interesting direction for the future. Peripheral neuropathies include all conditions that involve damage to the peripheral nervous system (PNS), which is prone to various types of damage, including mechanical, toxic, and metabolic origin. The clinical symptoms of peripheral neuropathy depend on its severity (evolution), distribution , affected the structure of the nerve cell  as well as the type of affected neurons  ,2. In clIt is assumed that based on the duration of the symptoms, peripheral neuropathy may be divided into acute (diagnostic emergencies) and chronic  type  or acutePNS is created by the somatic nervous system and autonomic nervous system, which allows us to distinguish in the classification different affected modalities: sensory, motor, autonomic, or mixed ,6. DiffeDisorders of toxic, metabolic, infectious, and hereditary etiology may affect the occurrence of damage in peripheral terminals of unmyelinated C, myelinated Aδ, and Aβ fibres or motor neurons, secondarily causing changes in their density and hyperexcitability ,14. The Also, axonal damage (as a result of pressure or hypoxia) and its consequences, can lead to the fibres degradation and changes in channel expression and composition, which may subsequently provoke defective transmission and ectopic discharges .The variety of symptoms and the multiplicity of etiology ,23,24,25When considering the occurrence of neuropathic pain in the context of decreased productivity at work or absenteeism, its social impact and connection to quality of life can be clearly seen. The emergence of sleep disorders, depression, or anxiety are also observed ,33,34. NResearch conducted by Barbosa et al. , confirmThe aim of this study was to find distinctive clinical features between different types of peripheral neuropathy, the occurrence of pain, and laboratory markers.This retrospective study included 124 patients, who were hospitalized in University Hospital in Lublin between 2019 and mid-2020 due to various types of sensory  or motor disturbances . Patients’ anamnesis, physical examination  as well as laboratory results were gathered from the subjects’ medical records. The patients were eventually diagnosed with polyneuropathy. The final diagnosis was based on an electrophysiological study including NCS and EMG, conducted by a trained neurophysiologist. Lumbar puncture and cerebrospinal-fluid (CSF) analysis were performed at the beginning of hospitalization and before administering medications. Protein level and cytosis were analysed. CSF protein was considered elevated when >45 mg/dL and cytosis > 15 cells/μL. Additionally, each patient had undergone an imaging examination . Taking into account parameters such as acuteness and time course of the clinical presentation but also comorbidities and laboratory results, we decided to divide our group into six types: acute , subacute , chronic (idiopathic and diabetic neuropathy), inflammatory , hereditary  and small fibre neuropathy. Furthermore, the group was categorised according to the type of nerve fibre involvement, distribution, and type of damage, the occurrence of pain was also taken into account. Afterwards, the obtained results were subjected to statistical calculations.2) was used to compare the relationships between variables expressed in the qualitative scale. To evaluate the differences between the subgroups of patients the unpaired two-sample Student’s t-test, Mann-Whitney test, one way ANOVA (with Tukey post-hoc test), and Kruskal-Wallis test were used. One-dimensional logistic regression was used to assess the impact of the variables on the risk of pain. The level of statistical significance was set at p < 0.05.Statistical analysis was performed using Statistica software . Data expressed on a quantitative scale was presented as mean with standard deviation (SD). Data expressed on a qualitative scale was presented as the number and percentage of the sample. The Chi-squared test  females and 49.19% (n = 61) males. Their age ranged from 23 to 86 years old, the mean age was 56.69 ± 14.7, for women 56.00 ± 14.48, and for men 57.35 ± 14.99 (p > 0.05). As regards the place of residence, the majority of respondents 70.16% (n = 87) came from the urban area, in comparison with the rural area 29.84% (n = 37). Furthermore, a statistically significant relationship (p < 0.05) between the place of residence and gender was seen, where more men than women live in the countryside (64% vs. 35%), while more women than men live in the city (54% vs. 42%), which is related to the demographic structure of Poland.In total, 124 patients were included in the analyses . We recep > 0.05), symmetrical manifestation was observed in 71.77% (n = 89), asymmetrical in 25.00% (n = 31), while asymmetrical with cranial nerve involvement—in 3.23% (n = 4) of responders.Taking into account the distribution of the symptoms (p > 0.05), axonal injury was diagnosed in 24.78% (n = 28), demyelinating in 51.33% (n = 58) and the mixed  in 23.89% (n = 27).Considering the type of the damage (n = 51) experienced pain (p > 0.05). The mean age of patients reporting pain was similar to patients without pain . Pain was 1.16 times more common in women and more than two times more frequent in patients living in the city (p > 0.05).Focusing on the occurrence of pain , of 124 p < 0.05) between the type of nerve involvement and the occurrence of pain, pain was reported in patients with sensorimotor and sensory neuropathy, while no patient suffering from motor neuropathy notified such symptoms. There was a statistically significant correlation (p > 0.05).In regards regards to the distribution of symptoms, in patients with an asymmetric manifestation, the risk of pain was found to be 1.99 times higher than in patients with a symmetric distribution, while in patients with an asymmetric distribution and cranial involvement this ratio/chance was 1.19 times lower (p > 0.05).Compared with axonal polyneuropathy, the risk of pain in patients with demyelinating and mixed polyneuropathy was lower by 2.44 times and 1.30 times respectively (p < 0.001). In comparison with inflammatory type, the risk of pain was 3.03 times higher in subacute type (p < 0.05), 5.31 time higher in SFN (p < 0.01) and 1.06 time higher in chronic type (p > 0.05).Also, a statistically significant correlation between the evolution/severity and the occurrence of pain was seen . No statistical significance was obtained for other parameters, however, an abnormal fasting glucose level displayed for each group, except demyelinating type, draws attention , at Kruskal-Wallis test (ttention ..p < 0.001). The other parameters did not differ significantly between gender nor patients with and without pain (It was demonstrated that the erythrocyte sedimentation rate (ESR) was higher in women compared to men (the mean 32.50 ± 28.47 vs. 12.28 ± 14.33), which is a statistically significant result (out pain .p > 0.05). Differences in CSF cytosis levels can be observed between the two groups 5.00 ± 10.71 for the pain-free group vs. 2.98 ± 4.48 for the group with pain. Patients suffering from pain have higher fasting glucose levels and visibly lower levels of vitamin B12 as compared to the pain-free group 102.08 ± 18.85 vs. 100.51 ± 14.04 and 921.81 ± 2384.84 vs. 1414.50 ± 2184.85, respectively (p > 0.05).The lumbar puncture was performed for 61 patients. Among them, pain was reported by 21 patients, including 14 women and 7 men. The concentration of proteins in CSF was slightly higher for the group with pain 58.51 ± 85.54 vs. 57.42 ± 31.26  ,51,52, wAnalysis of the cerebrospinal fluid allows us to observe biochemical changes taking place in the central nervous system (CNS). It contains numerous molecules and cells, whose modification and concentration inform about changes taking place in the CNS. The protein composition, derived from blood-brain barrier (BBB) filtration and drainage of interstitial fluid from the CNS, also includes proteins involved in other, more general, mechanisms, such as proteolysis, inflammation, signaling, or protein binding. It appears that the majority of “pain proteins” (pain-related proteins in CSF) take part in the same processes, but the essential proteins responsible for pain signaling are present in CSF at low concentrations. Views on this subject remain divided and require further research ,54. p > 0.05). Perhaps, this may be related to changes in the BBB permeability. The morphology and function of BBB can be influenced by a number of neurological diseases. An increase in the permeability of the BBB can lead to an influx of pro-inflammatory cytokines or immune cells into the CNS. It may be a response to long-term inflammation in the periphery or chronic pain [Assessing the concentration of proteins in CSF, the mean concentration of proteins in motor, sensorimotor and demyelinating polyneuropathy exceeded the accepted norm. Also, too high concentrations of proteins were observed for the pain and pain-free group, but the first one presented higher scores   but alsoThe prevalence of cobalamin deficiency increases with age, it was observed that in people over 60 years of age, almost 6% suffer from this deficiency ,62. ThisInterestingly, the group of women and the pain-free group showed very high levels of vitamin B12 (1369.31 ± 2819.98 vs. 1414.50 ± 2184.85), while the accepted norm in our laboratory is 211–911 pg/mL. The higher level of vitamin B12 in both groups may result from chronic pharmacological treatment, which could have been recommended by a family doctor before the patient was referred for further hospital diagnosis to prevent the onset of peripheral neuropathy.According to the available literature, in pain, cobalamin supplementation helps to regenerate nerves, increases nerve conduction velocity, upregulates brain-derived neurotrophic factor, and decreases pain signaling by inactivating vanilloid receptors. B vitamins seem to reduce homocysteine levels and thus increase the production of neurotransmitters ,64. MethFor preventive purposes, a quick and correct diagnosis of DN is fundamental. As prevention, change of lifestyle factors with weight loss, fall prevention, or foot care (in patients with DM) are mentioned . Pain inThe above confirms an important role of glycemia and its proper control in preventing the appearance of peripheral neuropathy and its complications.In our work, a statistically significantly higher level of sodium was demonstrated between motor and sensorimotor types of peripheral neuropathy. It seems that this may be an interesting direction for further research, however, it requires a larger group of respondents. In the available literature, we found no published studies on this topic. Meanwhile, we found many works whose authors lean on the role of voltage-gated sodium channels in peripheral neuropathy, specifically in the degeneration of axons, which can guide new therapeutic strategies in form of sodium channel blockers ,73.Some limitations to the present study should be discussed. The occurrence of neuropathic pain will be associated with an increase in inflammatory parameters, however, it is difficult to unequivocally assess all obtained laboratory results due to many factors (comorbidities and the patient’s lifestyle) but also a small size of the study group. Also, a small sample does not allow for an accurate estimation of population-based prevalence rates, because of a small sample. The next step would be to validate the results in a broader clinical setting.The analysis of patients was conducted retrospectively, for this reason, it was not possible to directly assess the physician’s decision-making and the implementation of all patients of the same laboratory test sets. Unfortunately, due to the inability to perform a required skin biopsy with IENFD, we could only suspect SFN and send the patient to a center capable of further evaluation.Our study showed that peripheral neuropathy is slightly more common in women than in men. Assessing the place of residence, more affected women live in the urban area, whereas more men suffering from peripheral neuropathy inhabit the rural area. This difference may be related to the work performed and external or internal factors influencing the manifestation of the disease. The mean age of the patients was over 56 years, which indicates a higher incidence of the disease in the middle-age and older. Most often we observed symmetric, sensorimotor, demyelinating, inflammatory, and chronic peripheral neuropathy. The pain was reported in patients with sensorimotor and sensory neuropathy and in types, such as inflammatory, subacute, and small fiber neuropathy. Pain screening is essential, because more than 40% of patients reported it. The pain measurement for each patient should be implemented and repeated at each visit. The variety of symptoms, the multiplicity of etiologies, but also multiple, often overlapping classifications, pose another challenge in making the correct diagnosis.There is a strong possibility that, in an aging society with lifestyle and chronic diseases affecting the occurrence of neuropathic problems, peripheral neuropathy will become one of the most important health problems all over the world. It seems that the assessment of sodium levels and, in women, markers of neuroinflammation in various types of peripheral neuropathy may be an interesting direction for further research.


To evaluate the relationship of postoperative cervical axial pain with different vertebral distraction methods used during ACDF procedures in cervical spondylosis patients.Ninety-four single-level cervical spondylotic myelopathy patients with significantly loss of intervertebral disc height who underwent ACDF surgery in our institute between January 2018 and January 2020 were enrolled. Cervical spine lateral radiographs were taken preoperatively, 3 days, 1-month, 2-month and 6-month after the surgery. The intervertebral disc height (IDH), interfacet distance (IFD), JOA (Japanese Orthopaedic Association) score, NDI (Neck Disability Index) score, nVAS  score and aVAS  score were measured. The correlation of clinical parameters and intervertebral disc height was evaluated. Then the correlation of clinical outcomes and different distraction method was evaluated. The patients were randomly divided into two groups, one uses Casper pin distractor system alone for distraction  and the other uses spreader assisted distraction method (Casper + spreader group). In biomechanical study, four cervical spine cadavers were selected for facet pressure measurements under different vertebral distraction methods, and the facet joint pressure was measured using force sensors.P = 0.11, P = 0.48) of the Casper + spreader group (3 days postoperation), and was associated with a better nVAS score at 2 months postoperation (P < 0.05). The biomechanical study in cervical cadavers also showed significantly and continuously decreased facet joint pressure in the spreader assisted vertebral distraction group (P < 0.01).Satisfactory cervical fusion and neurological recovery were achieved in all patients. No significant correlation of IDH, IFD, JOA, NDI or aVAS with nVAS score was found. No significant difference between the change in disc height and clinical outcomes was found. However, by comparing the clinical parameters of patients in different vertebral distraction groups, we found significant changes in the early nVAS and NDI scores (Spreader-assisted vertebral distraction method effectively alleviates postoperative neck pain in degenerative cervical spondylosis patients treated with ACDF. The mechanism may be related to the transient relief of facet joint pressure during the vertebral distraction procedure in ACDF. Anterior cervical discectomy and fusion (ACDF), as the most important and reliable anterior approach to treat cervical spondylosis, was first described in 1957 . Now, itDuring the standard ACDF procedure, vertebral distraction is routinely used to obtain fine surgical exposure and promote the implantation of intervertebral spacers or cages . HoweverAll study procedures were approved by the institute chancellor’s Human Research Committee in accordance with protocol 2015-0018. The cases of patients who underwent single-level anterior cervical discectomy and fusion (ACDF) for diagnosed cervical radiculopathy or myelopathy between January 2018 and January 2020 in our institute were enrolled. The inclusion criteria were (1) single-level cervical spondylotic myelopathy or radiculopathy resulting from a herniated intervertebral disc confirmed by MRI and CT scans, (2) ACDF occurring in the subaxial cervical spine, (3) more than 3 months of conservative treatment before admission to the hospital for surgery and (4) the intervertebral disc height of the responsible segment is significantly narrowed . The exclusion criteria were (1) a previous history of cervical spine surgery; (2) ACDF associated with cervical stenosis or cervical deformity resulting from spinal injury, tumour, infection, congenital disorders, OPLL or inflammatory arthritis (including ankylosing spondylitis and rheumatoid arthritis); and (3) Patients with neck and back pain due to inflammatory causes, visceral origin, systemic infections affecting spine, metabolic bone diseases, fractures in the vertebral column, past surgeries in the spine, and spinal tumours. Informed consent was confirmed, and each patient is blinded and randomly enrolled into the two surgical groups using the random number tables method. All patients enrolled must finish at least 1 year of follow-up to be included in this study, and a total of 94 patients  passed the criteria.Clinical assessment was performed by a spine specialist who was blinded to the patients’ information. The patients were asked to check their neck disability index (NDI) and grade their Japanese Orthopaedic Association (JOA) scores and neck and arm pain intensity before surgery and at routine postoperative intervals of 3 days and 1, 2, and 6 months. The NDI scores were expressed in a range from 0 (no disability) to 50 (maximum disability). Pain intensity was reported on a scale of 0 to 10 using the subjective visual analogue scale . During the follow-up period, the incidence and degree of neck pain (neck VAS score) were routinely checked, and any increment in the neck VAS score after the surgery was defined as postoperative axial pain.For radiological assessment, cervical spine anteroposterior, lateral, flexion, and extension X-ray radiographs were routinely taken preoperatively, 3 days postoperatively, 1-month postoperatively, 2-month postoperatively and 6-month postoperatively. Lateral radiographs of the cervical spine were taken with the patient’s supine head position and horizontal gaze maintained and were used for radiological assessment. The intervertebral disc height (IDH) and interfacet distance (IFD) of the operated segment were measured preoperatively and postoperatively. The IDH was measured using a modified three-point scale method (modified Lane's protocol), and significantly narrowed disc space was defined as a loss of disc height of 50% or more relative to the above normal disc. The increase in postoperative IDH (△IDH) was determined based on the difference between the preoperative and postoperative distances of the fusion segment , or distraction using a Casper-spreader-Casper sequence defined as Casper + spreader group .Four fresh-frozen human cadaveric cervical spines (C2–T1) were used in the biomechanical test. Examinations were first performed to exclude cervical trauma, deformities and other related diseases in these cadavers. Muscular and fascial tissues were removed, and the vertebrae, intervertebral discs, ligaments and facet capsules were entirely preserved. The distal (T1) end of the specimen was embedded in polymethylmethacrylate for stabilization. The facet contact force was tested with force-measuring sensors . After preparation, the sensors were placed into the facet joint capsule of C3–C4, C4–C5, and C5–C6 in all specimens. Then, the force sensor was calibrated and recorded on the computer during different distraction methods performed on C4–C5. The testing and data collecting was also divided into two groups according to the different distraction method. For Caspar alone group, we continuedly measured the facet joint force change after every 0.5 mm distraction made by the Caspar distractors. For Casper + spreader group, we first made a 2 mm distraction using the Casper distractor, then the intervertebral spreader was inserted into the posterior portion of the vertebrae, and made an additional 2 mm using the spreader, during which the facet joint force changes after every 0.5 mm distraction made by the distractors.P value < 0.05.Data analyses were performed using SPSS version 20 for Windows . Data are presented as the number of subjects in each group or the mean ± SD. Each independent variable was compared between the two groups using the Mann–Whitney U test for continuous variables and the χ2 test or Fisher exact test for categorical variables. Linear regression analysis was used to identify the relationship between factors and postoperative neck pain. ANOVA and Student’s t test were used to compare the pressure on the facet joint in the cadaver study. A statistically significant difference was set at a Between January 2018 and January 2020, 94 consecutive patients  underwent single-level ACDF for cervical spondylotic myelopathy or radiculopathy and completed the 1-year follow-up. The demographic, surgical profile and preoperative cervical alignment data of the patients are summarized in Table To determine the possible factors that influence the incidence of postoperative axial pain, we assessed the correlation between preoperative JOA, NDI and arm VAS scores and the neck VAS score at each follow-up time point using linear regression. Additionally, we assessed the correlation between the postoperative change in intervertebral disc height and postoperative change in interfacet distance with the neck VAS score at each follow-up time point. However, the results showed no significant correlation between these factors Table .Table 2Cn = 47) and a high △IDH group (n = 47) according to the mean intervertebral space increase of all patients . By assessing the differences in clinical parameters at each follow-up time point, we found that although NDI scores, JOA scores, and VAS scores for neck and arm pain were much improved, there were no significant differences between the two groups  and Caspar + spreader group (n = 47) group. Although no significant differences were found in the cervical JOA or aVAS scores between the groups, the nVAS and NDI scores showed significant differences in the early follow-up period . The NDI was significantly lower in the Caspar + spreader group than in the Caspar alone group at 3 days post operation but showed no significant difference at the later follow-ups. These results showed that the intervertebral-spreader-assisted distraction method could indeed alleviate postoperative axial pain.Next, we evaluated whether the use of an intervertebral spreader affected the clinical outcomes, especially postoperative axial pain. The patients were randomly divided into two groups: the Caspar alone group n = 7 and CasSince a report showed that facet joint pressure changes may cause postoperative neck pain, we assessed the facet joint pressure in cervical cadaver spinal segments using different distraction methods. To mimic the ACDF procedure, we first removed the C4/5 intervertebral disc and then placed the sensors into the facet joints of C3/4, C4/5 and C5/6 Fig. . By compAxial neck pain is a common complaint after ACDF during the follow-up period . Axial nACDF, as the most effective anterior approach, is widely used for the standard surgical treatment of cervical spondylosis. In the conventional ACDF procedure, vertebral distraction is the routine and vital method performed by vertebral distractors to further expose the intervertebral space to achieve complete decompression of the cord and nerve roots. The most common distractor used was the Caspar retractor system, which is based on distraction through pins fixed on vertebral bodies . HoweverThe intervertebral spreader was designed to spread the attached bones and is used in many stages. However, it was first used to spread the significantly narrowed disc space to open up enough space for decompression procedures in our institute. During practice, we found that the spreader distracts the vertebral bodies by concentrating the axial force on the posterior margin of the upper and lower end plates, which is more central to the middle column of the spine than with Casper distractors. This may lead to the maintenance of the biological structure by not angularizing the segments and causing pressure on facet joints Fig. . Based oPostoperative axial pain affects patients’ surgical outcomes, but there is still no effective way to fully avoid it, and the mechanism through which it occurs is still unclear. Zhou et al.  analysedAlthough the results in our study support that the use of intervertebral spreaders may lower the incidence of postoperative axial pain, there are still limitations to this study. First, the biomechanical experiments were carried out only on cadaveric cervical spine specimens because they cannot be performed during operations on living patients; therefore, the effect of muscles were not taken into consideration. Second, this was a retrospective analysis of patients at a single institution; therefore, there is a risk of selection bias. Furthermore, the precise mechanism by which the pressure on the facet joint affects postoperative axial neck pain is far from being fully revealed. Last, the exact normal value of the height of the posterior vertebral distraction is still not clear. We hope further in-depth clinical and biomechanical studies will be carried out to further explain the relationship between vertebral distraction and axial pain.This study describes that vertebral distraction using a Casper device significantly increased the load on facet joints, and the use of an intervertebral spreader could largely alleviate the pressure and lower the incidence of postoperative axial neck pain in single-level ACDF-treated patients. These results provide evidence supporting the use of a modified ACDF vertebral distraction procedure to lower the incidence of postoperative axial pain.