The zygapophysial (facet) joint is the primary pain generator in one third ofchronic low back pain cases. Current treatment options include temporarilypalliative nonsurgical approaches, facet injections, radiofrequency denervation,and, rarely, lumbar arthrodesis. The purpose of this study was to assess thesafety and effectiveness of a minimally invasive implant intended to restore facetjoint function in patients with chronic lumbar facetogenic pain.This prospective, multi-center feasibility study enrolled patients with confirmedlumbar facetogenic joint pain at 1 or 2 levels who underwent at least6 months of unsuccessful nonoperative care. Patients received a minimallyinvasive implant  intended to restore facet joint function while preserving thenative anatomy. Main outcomes included back pain severity using a visual analoguescale, back-specific disability using the Oswestry Disability Index (ODI), andadverse events adjudicated by an independent Clinical Events Committee.Of 40 enrolled patients, 37 patients received the facet restoration implant and 34patients had complete 1-year follow-up data available. Over the 1-year follow-upperiod, back pain severity decreased 41% and ODI decreased 34%, on average.Freedom from a device- or procedure-related serious adverse event through1 year was 84%. Implant migration was observed in 3 patients and implantexpulsion from the facet joint occurred in 3 patients. In total, 2 (5.4%) patientsunderwent implant removal through 1 year post-treatment.A minimally invasive facet restoration implant is a promising treatment option inselect patients with chronic lumbar zygapophysial pain who have exhaustednonsurgical treatments, with therapeutic benefit persisting at 1 yearfollow-up. The basic anatomic unit of the spine is a three-joint complex comprised of anintervertebral disc and paired zygapophysial (facet) joints. The main function of thefacet joints is to limit movement in all planes of motion with a secondary role inweight bearing. Facet joints bear up to 25% of axial loads under normal conditions, andeven greater loads in the presence of decreased disc height . ResultsCurrent treatment options include temporarily palliative approaches such as conservativecare, medical management, corticosteroid injection, and radiofrequency denervation.Lumbar arthrodesis is typically reserved for patients with late-stage disease who haveexhausted nonsurgical treatments although no convincing evidence exists to support thisprocedure for facetogenic pain ¿14]. Th. Th14]. All experimental procedures performed in this study were in strict accordance with apre-defined protocol that was approved by all researchers and the local ethicscommittees  andEthics Committee of the Medical Association of Saxony-Anhalt .Subjects provided informed consent before study participation.This prospective, multi-center, feasibility study was conducted at four investigativesites in Germany and Brazil under a common study protocol. The protocol specifiedenrollment of 40 patients with chronic facet joint pain at one or two levels.Patients were grouped based on surgical history. Group 1 had no previous surgery(other than discectomy) at the index level or adjacent level. Group 2 had previoussurgery (other than discectomy) at the index level and/or adjacent level. Priorarthrodesis or facetectomy at the index level was contraindicated in both groups.Eligible patients underwent at least 6 months of nonoperative care and presentedwith radiographic (CT or MRI) evidence of facet disease at one or two levels from L1to S1, verified by at least one positive  intraarticular/periarticular facet injection in the last6 months. Additional inclusion criteria included surgical candidates age?18 years, pain severity ?60 mm (with predominantly back symptoms), andOswestry Disability Index (ODI) ?40%. Main exclusion criteria were active infection,morbid obesity, pregnancy, grade 3 or 4 osteoarthritis , osteopoPreoperative evaluation included demographics, medical history, back and leg painseverity, ODI, orthopedic examination, and imaging. The orthopedic examinationincluded palpation of the index facet joint and loading of the joint inflexion/extension and lateral bending. Imaging evaluations included MRI or CT and4-view x-rays within 6 months of study enrollment.The Glyder® Facet Restoration Device  isintended for treatment of patients with chronic facetogenic pain from L2 to sacrum,confirmed by diagnostic facet injection, due to degenerative facet joint disease ormechanical joint disease. The Glyder Device consists of a pair of PEEK-OPTIMA®wafers implanted in each facet joint. Each wafer has a smooth side to restore thesliding surface and a textured side that engages the articulating surface of thefacet to prevent migration. Each implant also contains a platinum/iridium markerencapsulated within the body to enhance implant visualization under radiographicevaluation. The device is intended to relieve facet joint pain by restoring facetjoint function, preserving the native anatomy without compromising future treatmentoptions.Close inspection of preoperative imaging is mandatory to inform proper accesstrajectory and identify possible structures that may interfere with implantation suchas large osteophytes, inadequate joint size such as <14 mm height and depth,or extreme posterolateral access angles that may result in occlusion by the iliaccrest. The patient is positioned prone on a radiolucent spine table with lordosismaintained and the skin is prepped and draped. Under oblique fluoroscopic guidance,the correct level is identified and the posterolateral entry point is marked. A2¿3 cm skin incision is made followed by blunt dissection to the facetjoint capsule. The joint line is radiographically identified and a small(3¿5 mm) incision is made along the joint line on the posterior aspect ofthe facet capsule to open the facet joint , depending on normality assumptions. Categorical variables were presentedas n (%). Longitudinal outcomes were analyzed with repeated measures analysis ofvariance; values were reported as mean ±95% CI. Missing values accounted for<5% of VAS and ODI data and were conservatively imputed using the last observationcarried forward (LOCF) technique .StatistA total of 40 patients  were enrolled at 4investigative sites in Germany and Brazil between November 2009 and January 2013. Onepatient was discontinued from the study due to a negative diagnostic facet injectionprior to the procedure. Two patients were discontinued when the procedure was abortedintraoperatively due to large osteophytes interfering with joint access. Ultimately, 37patients were implanted with the facet restoration device. Two enrolled patients hadgrade 3 or 4 osteoarthritis at the index level  patients. The CEC classified the events asrelated to the device 3), procedure (2), both (2), or neither (3)  and meticulous attention to device placement.Limitations of this study included lack of a control group and a somewhat heterogeneouspatient population. Arguably, use of ?20 mm improvement in VAS back pain severityas the criterion for a positive diagnostic injection in this study may be viewed asconservative with potential for false positives. Lessons learned from this feasibilitystudy have led to modifications in implant design, implantation procedure, and patientselection.A minimally invasive facet restoration implant is a promising treatment option in selectpatients with chronic lumbar zygapophysial pain who have exhausted nonsurgicaltreatments, with therapeutic benefit persisting at 1 year follow-up.KB, LM and JB are consultants to Zyga Technology, Inc.HM, KS, AL, KB, PS, and LP participated in the design of the study in patient enrollmentand treatment. LM performed the statistical analysis. LM and JB drafted the manuscript.All authors provided critical review of the manuscript draft and have given finalapproval of the version to be published.


The sacroiliac joint (SIJ) is frequently involved in low back and pelvic girdle pain. However, morphometrical and functional characteristics related to SIJ pain are poorly defined. Pelvic belts represent one treatment option, but evidence still lacks as to their pain-reducing effects and the mechanisms involved. Addressing these two issues, this case-controlled study compares morphometric, functional and clinical data in SIJ patients and healthy controls and evaluates the effects of short-term pelvic belt application.Morphometric and functional data pertaining to pelvic belt effects were compared in 17 SIJ patients and 17 controls. Lumbar spine and pelvis morphometries were obtained from 3T magnetic resonance imaging. Functional electromyography data of pelvis and leg muscles and center of pressure excursions were measured in one-leg stance. The numerical rating scale was used to evaluate immediate pain-reducing effects.Pelvic morphometry was largely unaltered in SIJ patients and also by pelvic belt application. The angle of lumbar lateral flexion was significantly larger in SIJ patients without belt application. Muscle activity and center of pressure were unaffected by SIJ pain or by belt application in one-leg stance. Nine of 17 patients reported decreased pain intensities under moderate belt application, four reported no change and four reported increased pain intensity. For the entire population investigated here, this qualitative description was not confirmed on a statistical significant level.Minute changes were observed in the alignment of the lumbar spine in the frontal plane in SIJ patients. The potential pain-decreasing effects of pelvic belts could not be attributed to altered muscle activity, pelvic morphometry or body balance in a static short-term application. Long-term belt effects will therefore be of prospective interest. The sacroiliac joint (SIJ) is frequently involved in painful conditions of the pelvis and the lower extremity –9. The aform and force closure [According to the recommendations of the international association for the study of pain (IASP), SIJ pain should primarily be managed conservatively . Overall closure . However closure ,32,34. TThis study compares pelvic morphometry of patients with SIJ pain to healthy controls in a static position. Muscle activation patterns of pelvis and lower limb muscles and center of pressure data (COP) of the foot in one-leg stance were also subject of this investigation. Additionally, in both groups, the effects of pelvic belts were investigated on pelvic morphometry, muscle activation and on COP. It was hypothesized that pelvic morphometry, muscle activation and COP are different in SIJ patients, as compared to healthy controls. It was furthermore hypothesized that pelvic belts are capable of normalizing altered pelvic morphometry, muscle activation patterns and/or COP.ClinicalTrials.gov (NCT02027038). The ethics committee approved the clinical trial protocol shown in This study was approved by the ethics committee of the University of Leipzig (number 063-11-07032011) and registered at The study population consisted of 24 patients suffering from chronic pain arising from the SIJ joint, enrolled between August 2011 and December 2012. The patients were sent from orthopedic outpatients’ clinics. SIJ patients were selected according to the following criteria: pain duration of at least twelve weeks, at least three positive SIJ pain provocation tests  and if iThe effects of pelvic belts  were determined in three levels of application intensity: no pelvic belt application, moderate pelvic belt tension and the maximal tolerable pelvic belt tension. The magnitude of moderate tension was adapted by the participants as being suitable for everyday situations, according to the manufacturer. The maximum tolerable tension was defined as the highest applicable belt tautness without perceiving pelvic belt-related pain or discomfort in the standing position. Each pelvic belt was exclusively used for one participant. Four different clothing sizes were available, being adapted depending on the pelvic circumference of each participant. Magnetic resonance imaging (MRI), electromyography (EMG) and stance analyses were performed in each step and in all participants, as shown in All patients were surveyed regarding their pain intensity with the 11-point NRS. They were surveyed without applying the pelvic belt and with the pelvic belt under moderate and under maximum tension. The survey was performed immediately after the participants underwent each trial including the respective MRI scan, EMG and stance analyses of the respective level of application, averaging one hour each.Three Tesla MRI data  of the lumbar spine and pelvis were recorded in all participants to investigate pelvic belt-related effects on the morphometry of the pelvic ring and the SIJ. With the exception of the lumbar spine scanned only without pelvic belt application, all scans were recorded without a pelvic belt and with a pelvic belt under moderate and maximum tension. Additionally, MRI scans were obtained from all participants to rule out inflammatory causes of SIJ pain or extra-articular pathologies that potentially cause comparable symptoms. The lumbar spine, the pelvic ring and both SIJ were investigated in T1-weighted, T2-weighted, Turbo-Inversion Recovery-Magnitude and Double Echo Steady State sequences in the lying position ,40,41.Center of the respective anatomical structure,within the plane of the patient- or control-specific coordinate system that was (most) perpendicular to the landmark,in the MRI section that included the anatomical landmark to maximum extent, and (if this applied to more than one section)within the MRI section most distally from the region of interest.Two investigators  performed the morphometric evaluation with the Voxim software . Prior to the measurements, the MRI data of all participants were rendered anonymous and blinded to which group the participants were in. Additionally, both investigators were blinded to their previous measurements. Anatomical landmarks were defined at the lumbar spine, the pelvic ring and the SIJ in a patient- or control-specific coordinate system. The placement points of the anatomical landmarks were defined as follows:Based on these data, distances and angles between the anatomical landmarks were computed as shown below. Every anatomical landmark was determined twice in each dataset in a random order.Each angle was determined in the respective anatomical plane, as done in standard X-rays of the lumbar spine . The lumThe following anatomical landmarks were defined bilaterally at the pelvic ring: the anterior superior iliac spine (ASIS), posterior superior iliac spine (PSIS) and the center of the inferior ramus (symphysis) of the pubic bone ; S4 Fig.The distances between the cartilage of the ilium and the sacrum were measured bilaterally at the S1-S2 and S2-S3 disk level to depict compression effects at the auricular surface of the SIJ ; S5 Fig.Surface EMG were recorded simultaneously with COP measurements in one-leg stance for all pelvic belt conditions  Figs.. TBody balance analyses were performed with an AFDM 1.5 measuring plate  at a frequency of 100 Hz. All participants were asked to stand upright, look straightforward for the duration of data recording, lasting ten seconds. Data from the side (more) affected by SIJ pain regarding the patient group and the dominant leg regarding the controls were recorded . COP excP-values of 5% or less were considered being statistically significant.Statistical computations were performed using R software , Excel 2010  and SPSS version 20.0 . Normal distribution was determined with the Kolmogorow-Smirnow test. The Student’s t test for independent samples and the Mann-Whitney-U test were applied to evaluate differences in the baseline characteristics of the participants including age, gender, body height and weight, the pain-reducing effect (Δ NRS) and the angle of lumbar lateral flexion. Within-group comparison on the different tension conditions of the pelvic belt was performed using Levene’s test to assess the equality of variances, proceeded by a repeated measures univariate ANOVA for more than two paired samples and post-hoc analyses with the Bonferroni, Fisher's Least Significant Difference and Tukey's range test if applicable. Between-group comparison of patients and controls was performed with the Friedman’s tests with posthoc analyses with the Wilcoxon signed-rank test if applicable. Bland-Altman plots were used to determine the reliability of the measurements in the MRI scans ,46. P-va2. Controls had a mean age of 43.7 ± 19.9 years and a mean BMI of 24.2 ± 3.9 kg/m2. Mean age, body height, weight and BMI did not vary significantly between patients and controls. All patients suffered from moderate or severe SIJ pain  and healthy controls  were included in this prospective study. Seven patients and one control were excluded for the following reasons: claustrophobia in MRI (5 patients) and conflicting pathology after physical examination . One patient was excluded after the interpretation of the MRI records due to a gynecological pathology. Patient mean age was 45.1 ± 11.0 years (mean ± standard deviation) and mean body mass index (BMI) was 24.9 ± 3.4 kg/male ≥ 3; ). Furthep = 0.23, Friedman test). Pelvic belt application under maximum tension was related to a pain intensity of 4.0 ± 1.9 . Nine of 17 patients reported decreased pain intensity under moderate tension, whereas four patients reported no change and four patients reported increased pain intensity , applying pelvic belt under moderate tension tended to non-significantly decrease SIJ-related pain intensity to more extent than maximum tension with -0.6 ± 1.7 (median = -0.5) vs. 0.0 ± 1.6 . The mean values and standard deviations of the data from the lumbar spine, the pelvis and the SIJ are given in Without wearing the pelvic belt, the angle of lateral flexion at the lumbar spine displayed slight but significantly higher values in SIJ patients (4.73 ± 2.72°), as compared to the healthy controls  symptomatic side was investigated in the SIJ patients. Though the side of the affected SIJ in the patient group was the dominant one in the majority of the cases , this simplification impacted the results of the EMG data. Measuring the muscles on both sides would have solved this issue. However, we wanted to keep the data comparable between patients and controls and only had a limited amount of EMG equipment available for this study. Furthermore, most clinical tests in the context of SIJ pain may be regarded as “static”, e.g. the active straight leg raise test ,18–20,22The EMG data was subject to the following restrictions: Skin preparation and repetitive electrode positioning might have caused different conditions in the participants . Also, nform and force closure might have optimized the force transition to the foot, being reflected by similar COP as a compensatory mechanism [form and force closure, resulting in minute changes of pelvic and lower extremity biomechanics in SIJ patients.Based on the assumption of differences in muscle activity, we further hypothesized that the body balance might differ in patients and in controls and that pelvic belts affect the center of foot pressure or weight distribution when standing. Joseph and coworkers  and by Mechanism . A smallechanism . The lacPatients with pain arising from the SIJ were shown to have a minutely increased angle of lateral flexion at the lumbar spine. There was a lack of evidence that compressive forces were exerted on the SIJ or pelvis via pelvic belts. Muscle activity was largely unaltered in patients with SIJ dysfunction in one-leg stance. A majority of SIJ patients reported decreased pain intensity with a pelvic belt applied under moderate tension. However, the mean pain-altering effects averaged over all patients were minute in a short-term setting and on a non-significant level. Muscle activity was largely unaltered in patients with SIJ dysfunction in one-leg stance, as compared to healthy controls. There were no significant differences in the COP excursions between SIJ patients and controls. The given study focused on morphometric und functional differences between SIJ patients and controls as well as immediate effects of pelvic belts in a static setting. Being well aware of the multi-facet pathogenesis of SIJ dysfunction that well incorporates bio-psychosocial dimensions, this study focused on the biomedical point of view exclusively. However, this simplification helped determine somatic effects of SIJ dysfunction, which was also strengthened by the strict exclusion criteria of the SIJ patients in our study. In the static one-leg stance setting presented here, neither 3 Tesla MRI, nor surface electromyography of the given muscles or COP analyses served as a tool to differentiate patients with SIJ-related pain from control participants. Further research is necessary to establish differences between SIJ patients and controls in a long-term and dynamic setting, and to elucidate the dynamic effects of pelvic belts, addressing their potential in improving the health-related quality of life in SIJ patients.S1 Data(PDF)Click here for additional data file.S1 FigEach of the landmarks was checked in all standard anatomical planes. The lumbar lordotic angle was defined by the intersection of two lines in the median sagittal plane. One line represented the lower twelfth thoracic vertebra surface (baseplate) and the other line represented the upper first sacral vertebra surface (endplate). Each line consisted of a landmark at the ventral and the dorsal edge at the respective vertebra.(TIF)Click here for additional data file.S2 FigEach of the landmarks was checked in all standard anatomical planes. The angle of lumbar rotation was defined by the intersection of two lines from the baseplate of the twelfth thoracic vertebra and the endplate of the first sacral vertebra in the horizontal plane. Each line consisted of a landmark at the ventral edge and the spinous process of the respective vertebra.(TIF)Click here for additional data file.S3 FigEach of the landmarks was checked in all standard anatomical planes. The angle of lateral flexion was defined by the intersection of a line at the twelfth thoracic vertebra baseplate with a line at the first sacral vertebra endplate in the frontal plane. Both lines consisted of two points set at the lateral edges of each respective vertebral body.(TIF)Click here for additional data file.S4 FigEach of the landmarks was checked in all standard anatomical planes. The anterior and superior iliac spine and the pubic symphysis are marked at the pelvis.(TIF)Click here for additional data file.S5 FigEach of the landmarks was checked in all standard anatomical planes. A reference plane was created with three landmarks: the ventral edge of the first sacral vertebra endplate (promontory), the first sacral vertebra spinous process and the caudal tip of the fifth sacral vertebra. Two lines indicated in green perpendicular to this plane were set at the S1-S2 and S2-S3 disk level. At this line, landmarks were set on the sacral and the iliac side of the sacroiliac joint, measuring the cartilage and joint cavity to full extent.(TIF)Click here for additional data file.S6 FigThe electrodes were positioned on the adductor magnus, the rectus femoris, the medial vastus, the tibialis anterior.(TIF)Click here for additional data file.S7 FigThe electrodes were positioned on the gluteus maximus, the tensor fasciae latae, the biceps femoris and the  gastrocnemius.(TIF)Click here for additional data file.S1 TableA: Between-group comparison of SIJ patients and healthy controls. B: Within-group comparison of the SIJ patient group and the control group measurements from two ratersMeans and bias of the Bland-Altman analyses are given. ASIS = anterior superior iliac spine, PSIS = posterior superior iliac spine, S1  = first  sacral vertebral body. (DOCX)Click here for additional data file.S2 Tablep-values refer to the data given in The (DOCX)Click here for additional data file.


Identification of subgroups and appropriate treatment regimen was proposed as a key priority by the Cochrane Back Review Group. We developed a multimodal treatment (MMT) for patients with moderate to severe disability and medium risk of poor outcome. MMT includes A pilot study was conducted to investigate the feasibility of MMT, prior to a larger RCT, with focus on patients’ adherence and the evaluation of short-term effects on pain and disability of MMT when compared to usual physiotherapy.We conducted a randomised controlled trial (RCT) in a primary care physiotherapy centre in Switzerland. Outcome assessment was 12 weeks after baseline. Patients with NSCLBP, considerable disability (five or more points on the Roland and Morris Disability Questionnaire (RMDQ) and medium or high risk of poor outcome on the Keele Start Back Tool (KSBT) were randomly allocated to either MMT or usual physiotherapy treatment (UPT) by an independent research assistant. Treatment included up to 16 sessions over 8 to 12 weeks. Both groups were given additional home training of 10 to 30 minutes to be performed five times per week. Adherence to treatment was evaluated in order to assess the feasibility of the treatment. Assessments were conducted by an independent blinded person. The primary outcome was pain (NRS 0-10) and the secondary outcome was disability (RMDQ). Between-group effects with Student’s t-test or the Mann-Whitney U test and the standardized mean difference of the primary outcome were calculated.Twenty-eight patients ) were randomized to MMT (n = 14) or UPT (n = 14). Patients’ adherence to treatment was >80% in both groups. Pain reduction  was 2.14 [1.0 to 3.5] in the MMT and 0.69 [-2.0 to 2.5.] in the UPT. The between-group difference was 1.45 [0.0 to 4.0] (p = 0.03), representing a moderate effect size of 0.66 [-0.1 to 1.5]. Reduction in disability on the RMDQ was 6.71 [4.2 to 9.3] in MMT and 4.69 [1.9 to 7.4] in UPT, with a non-significant between-group difference of 2.02 [-1.5 to 5.6] (p = 0.25). The required sample size for a RCT with six months follow-up was estimated at 170 patients.MMT was found to be feasible and to significantly reduce pain in the short term when compared with UPT. A future RCT with a six-month follow-up would require approximately 170 patients.ISRCTN66262199. Registered 8 January 2014.Current Controlled Trials The online version of this article (doi:10.1186/s12891-015-0533-2) contains supplementary material, which is available to authorized users. Low back pain (LBP) is a major international health problem with a lifetime prevalence of 80–85% . In Switcognitive, sensory and motor disturbances.Various research groups have demonstrated the potential value of focusing on abnormal cortical processing of the central nervous system (CNS) in patients with non-specific chronic low back pain (NSCLBP) -14: abnocognitive approach may play an important role in the treatment of NSCLBP and explains why our multimodal treatment (MMT) includes education on the neurophysiology of pain.One trial, in which neurophysiological education was applied to patients with NSCLBP, showed a significant change (p < 0.05) in catastrophizing beliefs about pain or injury and in inappropriate coping strategies, measured with the pain catastrophizing scale (PCS) . This incentral sensory changes play a role in NSCLBP and that TPD training may reverse it. This is the reason the decision was made to integrate TPD training into MMT.Flor et al. applied two-point-discrimination (TPD), or graphaesthesia-training, on patients with phantom limb pain (amputees). This led to a significant reversal in abnormal cortical processing, shown by functional magnetic resonance imaging (fMRI), and a reduction in phantom limb pain (p = 0.002), positively associated with improved sensory discrimination ability . This efmotor cortex was extensively exceeded in patients with phantom limb pain, shown on fMRI. It was reversed  after six sessions of imagined movement and showed significant pain reduction (p = 0.0005) [motor cortex. MMT therefore includes exercises on imagined movement, selective activation of deep trunk muscles and recognition training using pictures of the trunk at different angles.Processing in the  0.0005) . Moseley 0.0005) , plus de 0.0005) . Delayed 0.0005) ,17 and p 0.0005) ,19 are oTo our knowledge, a multimodal approach including patient education and sensorimotor retraining has been described only in a small exploratory study (n = 3) . RandomiThis pilot study was designed to investigate the short-term effects of multimodal treatment on pain and disability in a clinical subgroup of patients with NSCLBP. Adherence to treatment was evaluated to provide an assessment of the treatment feasibility. Results were used to estimate the required sample size for a larger RCT to evaluate longer term effects.medbase centre for health care in Saint Gallen, Switzerland. Assessments were performed at baseline before first treatment and 12 weeks after baseline. Following inclusion, written informed consent and baseline assessment, patients with NSCLBP were randomly allocated to either the multimodal treatment group (MMT) or usual physiotherapy treatment group (UPT). Randomization of the pre-defined number of 28 patients was concealed, using a randomization list with a block size of four, which was generated electronically before start of the trial. Patients were treated by two independent physiotherapists, one in the MMT group and the other in the UPT group. The follow up assessments were conducted by an independent physiotherapist blinded to the group assignment. Treatment was free of charge for all patients participating in the study. The trial was approved by the local ethics committee .This was a single-centre, assessor-blinded RCT carried out at the Telephone contact was made with referring general practitioners (GP), chiropractors and rheumatologists. Fifteen received a 20-minute power point presentation on the background of the trial and were supplied with flyers outlining the study. In addition, human resources managers of local companies were contacted and requested to distribute information to their employees. Patient recruitment was also achieved through advertisements in a local newspaper. Interested participants were referred to an online questionnaire for a first eligibility check. Suitable candidates were then contacted and invited for a final eligibility check, informed consent and baseline assessment.The inclusion criteria were designed to recruit patients with moderate to severe disability and pain and were in accordance with the definition in the European guidelines for the management of NSCLBP . EligiblPhysiotherapy treatment dosage in both groups was one or two sessions per week during the 8 week programme, with a maximum of 16 sessions. Patients were given home assignments to be performed for 30 minutes five days per week. An extension to a maximum of twelve weeks was allowed to account for discontinuity, such as holiday or other time issues.Patients from both groups had personalized access to a web-based home training interface (HTI) to guide the home assignments. The HTI recorded adherence to assignments and allowed evaluation of performance (further details outlined in the treatment paragraphs below).Patient education on the neurophysiology of pain was aimed at the reduction of patients’ perception of pain and disability, a reconsideration of protective behaviour and self-limitation resulting from fear of movement, assistance in regaining a confident and positive perspective of their abilities and acknowledgment of the beneficial value of activity. The content of this section was based on a RCT by Moseley et al. that demonstrated a beneficial effect of intensive neurophysiological education in patients with NSCLBP [h NSCLBP . Our eduh NSCLBP . During sensory retraining section was to restore discriminate sensory acuity of the lower back and, potentially, to restore normal cortical processing in the sensory cortex, as Flor et al. have shown in patients with phantom limb pain [The aim of the imb pain . Dependiimb pain . A similimb pain .Figure 1motor retraining was to improve movement control of the lower back [The goal of the wer back . Patientwer back  linked tMMT included: 1. Education on the neurophysiology of pain; 2. Sensory retraining; and 3. Motor retraining. Treatment was aimed at reducing pain and disability and, potentially, addressing associated abnormal cortical processing in NSCLBP. Additional file At the initial visit, patients were given basic patient education on adequate behaviour when having an exacerbation of LBP: a short period of protection followed, as soon as possible, by a return to normal movement, work and leisure activities. Further sessions addressed signs and symptoms. Two-thirds (i.e. 20 minutes) of each session consisted of active treatment, such as exercises for strengthening muscles, neuro-meningeal mobilisation and stretching muscles. A maximum of ten minutes of passive applications per session was allowed . These activities are in accordance with the European guidelines for the management of active rehabilitation . Each paFeasibility-related outcomes were: suitability of recruitment; patients’ ability to complete each part of the home training programme; suitability of the time frame set; treatment attendance; and adherence to home assignments.The primary outcome was mean pain intensity over the prior 7 days (NRS 0-10). Secondary outcomes were disability, measured with the Roland and Morris Disability Questionnaire (RMDQ), and patient-specific disability, measured with the patient-specific functional scale (PSFS), an outcome measure found to be reliable and responsive in patients with NSCLBP . Fear avTreatment feasibility was defined as 80% patient participation over the complete programme (i.e. 8 to 12 weeks) and completion of at least 80% of each part of the home training assignments. For MMT, we aimed at ≥ 80% correct answers to the questions related to the lessons in the book “Explain Pain”; ≥ 80% of the required quota of 10 × 60 images on recognition training using the Recognise® software; ≥ 80% completion of the required quota of 55 sets of sensory training with the SRT. Time and frequency spent on the movement control retraining exercises were recorded. For UPT, we aimed at ≥ 80% compliance with the 40 home training assignments. Satisfaction with treatment was evaluated in both groups. Patients were asked to rate whether the contents of each section were helpful using a five point Likert scale, ranging from “strongly agree” to “strongly disagree”.Outcome analysis was by “intention to treat”. The results of patients fulfilling the before-mentioned requirements for treatment adherence were analysed in the per protocol analysis.We compared changes within and between groups for the primary and secondary outcomes. We used a two-tailed Student’s t-test for data showing normal distribution, which was tested with the SHAPIRO-Wilks test, and a two-tailed Mann Whitney U test where data were not normally distributed. Results were analysed with SPSS 20. Confidence intervals for the median difference (e.g. for the Mann Whitney U test) were calculated with the software r, version 3.1.1 using the Hodges-Lehman test.Figure The time span required to recruit the 28 patients was seven months (October 2012 to May 2013). Inclusion criteria excluded 90% of all persons interested in study participation. Thirty-six of the 372 interested persons met the inclusion criteria. Twenty-eight gave written informed consent and were assigned either to the MMT (n = 14) or UPT (n = 14). Additional files Six patients (three each from the MMT and UPT groups) stopped programme attendance before completion of the eight weeks of participation for cogent individual reasons Table . All patA per protocol analysis  was conducted because inclusion of the six drop-out patients’ data would have confounded the outcomes. Treatment was found to be feasible. The pre-defined level of treatment adherence was reached: in each group more than 80% adhered to the minimum performance of ≥80% of each section of the assigned home programme Table . TreatmePatients’ satisfaction with treatment was sufficient and comparable in both groups, although the time spent on sensory retraining in the MMT group was experienced as too long by some patients  and disability (10 points on the RMDQ) could be recruited. The stringent admission criteria may have contributed to the good patient compliance rate and positive short-term outcome.Programme adherence was similarly satisfying in both groups. Cogent individual reasons led to two withdrawals of participants in the MMT: in one case, the patient’s aid person withdrew; in the other case, the patient was irritated by the fact that the HTI had difficulty in running on his Samsung tablet . Both patients attended post-therapy assessment. Inappropriate and misleading use of the home training on the HTI was observed in one patient in the multimodal treatment group, leading to termination of treatment. This person also attended post-therapy assessment. The time spent on the home programme was recorded by the HTI, which was considered more accurate and valid than self-reporting.Cogent individual reasons also led to two withdrawals from the UPT: one person was forced to stop because of pain exacerbation and another person could not afford the time required for home training. We found no exact data indicating how many NSCLBP patients showed exacerbation of pain during usual physiotherapy care treatment. Only one participant had no time to exercise, indicating high adherence to our home programme compared with the 70% of non-engagement in given home exercises prescribed by physiotherapists to patients with CLBP, as reported in a systematic review . ProgramThe mean number of 8.5 treatment sessions was below the assumed average of 12 sessions, and therefore well in line with usual prescriptions in NSCLBP. Unfortunately, statistical data on the number of physiotherapy sessions for patients with NSCLBP are not available for comparison. It was feasible to perform the treatment programme within 12 weeks, comparable with 10 weeks in the study by Wand et al. ).The 1.45 point between-group difference in pain was smaller than the minimally clinical important difference of 1.7, as stated in the IMMPACT recommendations by Dworkin et al. In the same publication, the IMMPACT recommendations suggest that the minimally clinical important difference between groups is smaller than that in an individual patient. Between-group changes on a 1 to 10 scale ranged from 0.9 to 1.5 in nine drug studies concerning pain relief in patients with knee osteoarthritis, reviewed by Dworkin et al. .The negative outcome regarding pain catastrophizing (PCS) was unexpected; the more so since pain was significantly reduced in the MMT group. Moseley et al. showed a significant decrease in catastrophizing beliefs on the PCS after intensive neurophysiology education on pain in patients with NSCLBP . Pain caTPD threshold in our patients was 70 mm (SD14), which is slightly higher than in a previous study in a population with NSCLBP that reported 61 mm (SD 13) . SensoryMovement control decreased slightly in both groups, but more clearly in the UPT group. This might be explained by the fact that, due to restricted resources, baseline assessment and post-treatment assessment were performed by different assessors, with the post-treatment assessor rating more conservatively. In future research, baseline and post-treatment tests for MCI should be rated by an independent blinded assessor using video recordings.The study showed that this particular population of NSCLBP patients was able to participate in a multimodal treatment (intervention group) or a usual physiotherapy treatment (UPT group) and report their performed home training on a personal web interface. Our study shows that ≥ 80% of patients engaged in at least 80% of the requested home exercises, apart from those with cogent individual reasons for withdrawal from programme participation. This RCT including 28 patients demonstrates the pain reduction potential of the MMT.The outcomes of this study have to be interpreted with caution because of the small sample size, as there is evidence that the risk of a type 1 error is larger in small sample sizes ,41. We uDifferences between groups for disability on the RMDQ, as well as on the PSFS, were not significant. The small between-group difference in change on fear avoidance beliefs (FABQ) may be explained by low responsiveness of the FABQ identified in a review . We chosOur assumptions on changes to the central nervous system were based on studies with comparable, but not identical, diagnoses. Based on these assumptions, we designed a treatment targeting three topics: education, sensory system and motor system. The question of causative relationship between NSCLBP and changes in the central nervous system would require functional imaging to evaluate changes in the central nervous system.To our knowledge, this is the first study in a NSCLBP population to use the internet for treatment and require an aid person for home exercises. These requirements reduce its general applicability in physiotherapy. Within the next ten years, a rapid increase in the use of technology is expected and technical solutions may be developed to enable independent exercise.Our results allow cautious sample size estimation for a study with a six-month follow-up. In the present study, the true mean between-group difference was 1.45 and the pooled standard deviation 2.11. Based on the assumption of a smaller true mean between-group difference in favour of MMT of 1.0 NRS point and a SD of 2.2. at six months, a power of 0.8 and a Type I error probability of 0.05 and accounting for 10% drop-outs, a total of 170 patients would be needed (g power software version 3.1.7 ).Both treatment programmes were feasible. Patients in both treatment groups showed good adherence both to treatment sessions and home assignments. Although the size of the effect was moderate, multimodal treatment reduced pain compared with usual physiotherapy. The results must be interpreted with caution because of the small sample size. MMT focussed on cognitive aspects concerning pain, sensory acuity of the lower back, movement control and body-awareness in daily living.The multimodal treatment approach seems to be a potential alternative to conventional physiotherapy treatment. Based on our results, we estimate that 170 patients are needed to evaluate the six months’ effects. To increase the recruitment rate from approximately 50 to 200 eligible participants per year the study will be conducted in four centres.


Roux-en-Y gastric bypass surgery (RYGBP) is one of the most common bariatric surgeries, which is being performed using various techniques like gastrojejunostomy by hand swen, linear or circular stapler. Abdominal pain is a common complaint following laparoscopic gastric bypass procedure (LGBP), which has different aetiologies, such as overeating, adhesion, internal herniation, bile reflux and many more. In this study LGBP was performed in an ante-colic ante-gastric pattern in a double loop manner and the prevalence and distribution of pain in morbidly obese patients undergoing LGBP was assessed.The aim of this study was to analyze the distribution and frequency of post LGBP pain in morbidly obese patients.This study was performed on 190 morbidly obese patients referred to Hazrat Rasoul Hospital in Tehran. After LGBP, pain was measured in the following intervals: 24 hours, one week and one month after the operation. Before the operation onset, 2 mg Keflin and 5000 IU subcutaneous heparin were administered as prophylaxis. LGBP was performed using five ports including: one 11 mm port was placed 15-20 cm far from the xiphoid, one 12-mm port in mid-clavicular line at the level of camera port, one 5-mm port in subcostal area in ante-axillary region in the left, another 5-mm port in the right mid-clavicular area and a 5-mm port in sub-xyphoid. All operations were done by the same team. Staple was used for all anastomoses and hand sewn technique to close the staple insertion site. The mesenteric defect was left open and no effort was made to repair it.The results of this study showed that 99.94 % of the patients had complains of pain in the first 24 hours of post operation, about 60% after one week and 29.5 % still had pain after one month. In addition, left upper quadrant (LUQ) was found to be the most prevalent site for the pain in 53.7% of the patients in the first 24 hours, 59.6% after one week and 16.8% after one month (except for obscure pain) with a significance of < 0.05.In this study, the authors analyzed the location and disturbance level of pain after LGBP, which could serve as a cornerstone for further researches. The authors suggest that long-term follow-up (for more than a year after operation) should be considered in future studies and also the relationship between the drainage site and pain should be investigated. There are increasing numbers of requests for gastric bypass surgery due to the global obesity growth. The annual bariatric surgeries in USA are about 20000 . Roux-enObesity causes changes in bowel habit and these changes are more obvious after surgery. Most patients go through functional changes in the gastro intestinal tract after surgery, most common being constipated and lower abdominal pain , 8. TherTo the best of our knowledge, no previous studies have been done to analyze the distribution and frequency of post LGBP pain in patients.The aim of this study was to analyze the distribution and frequency of post LGBP pain in morbidly obese patients.In this study, 190 morbidly obese patients with BMI > 35 were selected. They all had concomitant diseases, such as hyper metabolic conditions, DM, HTN and HLP, pulmonary diseases like asthma, non-alcoholic steatosis, stress incontinency, venous stasis, hyper ventilation syndrome and GERD. All patients’ surgeries were in Hazrat Rasoul Hospital from May 2012 to June 2013. Classic RYGBP with a double technique was performed in an ante-colic anti-gastric pattern. Before the onset of the operation 2 mg Keflin and 5000 IU subcutaneous heparin were administered as prophylaxis. LGBP was performed using five ports including: one 11-mm port, 15-20 cm far from the xiphoid, one 12-mm port in mid-clavicular line at the level of camera port, one 5-mm port in subcostal area in ante-axillary region in the left and another 5-mm port in the right mid-clavicular area and a 5-mm port placed in sub-xiphoid. All operations were performed by the same team. Staple was used for all anastomoses and hand sewn technique to close the staple insertion site. The mesenteric defect was left open and no effort was made to repair it. At the end of operation leak test was performed for all cases. Penrose drains were placed for each patient. The day after the operation, gastrografin upper GI series was performed. The case was excluded from the study if the surgeon was encountered with any case of positive leak test or had to convert the operation into open surgery. A questionnaire was edited and filled for each patient in first 24 hours, one week, and one month after the surgery. The questionnaire contained pain scoring according to the visual analogue pain scale, the quality and quantity of pain, its distribution, association with the drained site and other port entry sites, and also how the patient could manage to reduce the pain. Pain scoring system in this study was based on VAS method with the scales 1 to 10. Scores of 1-3 were considered as mild, 4-6 were categorized as moderate and 7-10 scores were considered as high or severe pain. Finally all data were analyzed by SPSS software (version 11.5). The quantitative data were expressed as the mean standard deviation (SD), and the frequency was used for the qualitative data. For comparing the qualitative data, chi-square or Fisher’s exact test was used. A p-value less than 0.05 was considered as statistically significant.This trial was registered at http://www.irct.ir. The registration number of this trial was IRCT201202198588N3.A total number of 190 patients underwent laparoscopic RYGBP. The mean age of patients was 37.93  years, 145 patients (76.3%) were female and 45 patients (23.7%) were male. The mean BMI of patients was 41.84 ± 6.17. At the first week, 188 (98.9%) of patients had abdominal pain, by the next week 114 (60%) and by 5th week, 56 (29.5%) had abdominal pain . At weekThere are different aetiologies for pain following visceral surgeries , althougMorbid obesity is one of the major problems in the world, as in the US more than 30% of the population have this problem  and the


The management of patients suffering from opioid-refractory cancer pain with a neuropathic component remains an important challenge for healthcare workers. Only one retrospective study specifically reported the use of intravenous (IV) lidocaine amongst the palliative care unit population, the study found that there was a positive response to this therapy. These preliminary uncontrolled results need to be confirmed by randomized controlled trials. The primary objective of this study is to assess the analgesic efficacy of IV lidocaine in patients in palliative care suffering from opioid-refractory cancer pain with a neuropathic component. The secondary objectives are to assess the tolerance of, symptomatology, and patient satisfaction with the therapeutic approach.This will be a multicenter, prospective, randomized, placebo-controlled, double-blind, two-parallel group study. It will take place in eight adult palliative care units across France. The main inclusion criteria are as follows: adult patients suffering from opioid-refractory cancer pain with a neuropathic component, and those receiving palliative care as defined by French Society of Palliative and Support Care. Participants will be randomized  to one of two treatment groups: a) lidocaine-experimental group (intravenous lidocaine), or b) placebo-control group . Evaluation assessments will be taken at baseline (T0 randomization), 40 minutes (T1), 120 minutes (T2), 12 hours (T3), 24 hours (T4), 48 hours (T5), and 14 days (T6) after baseline. The primary endpoint is change in the pain level between T0 and T1. The secondary endpoints are: changes in the pain level between T0 and other times, intensity of the neuropathic pain component, daily opioid consumption, symptoms (as classified by the MD Anderson Symptom Inventory), adverse events, and patient’s satisfaction . A sample size of 200 individuals will be needed to obtain 90% power to detect a 25% difference in pain success at T1 between the two groups; pain success is classified as a 30% decrease in the pain level between T0 and T1 (10% of patients lost to follow-up expected).The randomized, double-blind, placebo-controlled design is the most appropriate design to demonstrate the efficacy of a new experimental intervention (Evidence-Based Medicine Working Group classification). National and international recommendations could be updated based on the findings of this study.NCT02137954 (registration date: 7 May 2014).Current controlled trials  The management of patients suffering from pain that is refractory to opioids remains an important challenge for healthcare workers. Patients experiencing pain with a neuropathic component, those experiencing an isolated neuropathic component, and those experiencing mixed pain including neuropathic and nociceptive components, are of particular concern. Some therapies such as tricyclic antidepressants, anticonvulsants, or antiarrhythmics, have already demonstrated efficacy but may require a few weeks to be fully effective. Analgesic interventions with more rapid action would be valuable.The analgesic effect of intravenous (IV) sodium channel blockers, such as lidocaine, could be a viable alternative as they suppress the ectopic discharges recorded in a neuroma . HoweverPrevious randomized controlled trials (RCTs) have already assessed the efficacy of IV lidocaine on non-cancer neuropathic pain such as diabetic neuropathy , 4, postOnly one retrospective study specifically evaluated the needs of the palliative care unit population . The stuSince 2010, despite a limited amount of evidence, the French drug and device regulation agency  has recommended local anesthetics given parenterally for palliative care. Lidocaine can be used to treat cancer pain that is refractory to standard opiates in the hospital at the medical staff’s discretion. The maximum dose is 8 mg/kg per day. Monitoring for toxicity should be implemented, specifically for the occurrence of a metallic taste in the mouth, numbness of the lips and tongue, hot and/or cold feelings, and headache leading to lidocaine discontinuation.These observations prompted us to establish a multicenter, prospective, two-group, placebo-controlled, double-blind, randomized study with the primary objective of assessing the analgesic efficacy of IV lidocaine in patients in palliative care suffering from opioid-refractory cancer pain with a neuropathic component. The secondary objectives are to assess the tolerance of, symptomatology, and patient satisfaction with this therapeutic approach.This multicenter, prospective, randomized, placebo-controlled, double-blind, two-parallel group study is performed to compare the efficacy of the use of lidocaine  with the use of a placebo (control group). The study protocol was designed using the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) statement.The sponsor of the study is the Assistance Publique-Hôpitaux de Marseille . The recruiting will be performed in eight adult palliative care units across France. The methodological support will be provided by the Clinical Research Unit of Palliative Care , the Clinical Investigation Unit , and the Self-perceived Health Assessment Research Unit . The central pharmacy of AP-HM is in charge of the assignment, allocation, and delivery of the treatments. This work is supported by institutional grants from the French 2012 National Program of Clinical Research . All details are provided in Table The details of the inclusion and exclusion criteria are provided in Table The administration of the treatment (lidocaine or placebo) will be blinded and neither the patient nor the nurse responsible for the administration will be informed of the nature of the treatment. The treatment (lidocaine or placebo) will be administered during 48 hours.The protocol for administration of first-line level 3 opiates (morphine hydrochloride or oxycodone) will be given to all the included patients. This protocol will be conducted according to the recommendations of the World Health Organization (WHO), the ’Standard Options and Recommendations (SOR) on cancer nociceptive pain treatments for adult patients’ published by the French Union of Comprehensive Cancer Centers , and the European Association for Palliative Care (EAPC) recommendations on morphine and alternative opioids in cancer pain . AlthougLidocaine will be administered to participants randomized to the experimental group. The lidocaine will be administered by continuous IV infusion. The initial dose will be 5 mg/kg per day for the first 24 hours and then 8 mg/kg per day after 24 hours if the pain level does not decrease by at least 30% between the time of administration and the following 24 hours.An IV saline solution (placebo) will be administered to participants randomized to the control group. The protocol for administration of the placebo will be strictly similar to the lidocaine protocol and the protocol for administration of morphine hydrochloride or oxycodone will be the same as in the experimental group. The placebo will be administered by continuous IV infusion throughout the treatment period.No other opioids will be added during the study period. Tricyclic antidepressants, anticonvulsants, and antiarrhythmics may be given. Support care and symptomatic treatments will be delivered in accordance with the French SOR .Any adverse effects of the lidocaine treatment such as a metallic taste, perioral numbness and tingling, feeling hot and cold, headache, and tremors, will be cautiously evaluated to determine whether the IV lidocaine should be interrupted. The patients will be carefully monitored by electrocardiograph for 24 hours after the initiation of the treatment.The participating centers will be used to recruit the patients. Eligible patients satisfying the screening inclusion and exclusion criteria will be randomized into one of the two treatment groups after completing the consent form.Computer-generated randomized lists will be drawn up before the beginning of the study, using a permuted block design, under the responsibility of the clinical research unit (AP-HM). The randomization will be stratified by center and the nature of the opioid (morphine hydrochloride or oxycodone). The patients will be randomized to one of the two treatment groups using a computer-generated randomization schedule with a 1:1 allocation ratio. The randomization will be to either the experimental group (IV morphine hydrochloride or oxycodone in addition to lidocaine) or the control group (IV morphine hydrochloride or oxycodone in addition to placebo). Only the pharmacist will know the allocation. Prior to and during the treatment period, the participant, treating medical staff, and the investigators will all be unaware of the allocation.The evaluation will be performed at seven different time points: baseline (T0 after randomization and before starting lidocaine or placebo introduction) and 40 minutes (T1), 120 minutes (T2), 12 hours T3), 24 hours (T4), 48 hours (T5), and 14 days (T6) after baseline. The study procedure and data collection are detailed in Table , 24 hourAnalgesic efficacy will be assessed by several endpoints. The primary endpoint will be defined as the change in the pain level between baseline (T0) and 40 minutes (T1) after baseline. Pain level will be assessed using a self-administered numeric pain intensity scale (NPIS), ranging from 0 (no pain) to 10 (worst pain possible). A minimum 30% decrease in the pain level between the baseline and T1 will define the success of the treatment, and all other cases will be classed as failure of the treatment.Analgesic efficacy will be assessed by the following endpoints: the changes in the pain level (as measured by the NPIS) between T0 and T2, T3, T4, T5, and T6; the intensity of the neuropathic pain component as measured by the Neuropathic Pain Symptom Inventory (NPSI) at T4, T5, and T6 ; the NPSSymptoms will be assessed using the French version of the MD Anderson Symptom Inventory (MDASI). The MDASI is a 19-item self-reported symptom scale largely used in palliative care patients .The tolerance to the treatments (morphine-oxycodone and lidocaine) will be assessed during the first 48 hours following the treatment administration. Adverse events will be cautiously observed (intensity and discomfort). For morphine and oxycodone, the following symptoms will be monitored: nausea and/or vomiting, constipation, sleepiness, psychodysleptic effects, and signs of opioid overdose. For lidocaine, the following symptoms will be monitored: arrhythmia, blurred vision, headache, malaise, tremors, metallic taste, nausea and/or vomiting, perioral numbness and tingling, sedation, and tinnitus.Patient satisfaction will be assessed using the Pain Treatment Satisfaction Scale (PTSS) , 22, whiAll study drugs will be packaged in blinded trial packs by a clinical trial pharmacist who will be blinded to the interventions and outcomes. Lidocaine, oxycodone, and morphine are controlled drugs.Standard operating procedures (SOPs) have been developed for every stage of a controlled drug’s journey from procurement  to safe storage, supply, administration, destruction, and for dealing with an adverse event. The SOPs will be accessible to the staff at all times.P value of 0.05 , these calculations show that 170 patients are needed (85 per group). Assuming that a potential 10% of patients will be lost to follow-up, a total of 200 individuals need to be included.The sample size was determined to obtain 90% power to detect a 25% difference in pain success at 40 minutes between the two groups, as this difference is considered to be clinically significant. Pain success was defined as a 30% decrease in the pain level between baseline and 40 minutes. In accordance with a previous study , we hypo2 test or Fisher’s exact test for categorical variables and Student’s t-test for continuous variables.The data will be analyzed using SPSS Statistics for Windows, Version 17.0. Chicago, USA. The patients found to be eligible but not included in the study will be described and compared with the included patients. The patients who present at least one of the following conditions will be not in the final analysis: patients inappropriately included despite not providing consent and patients who withdraw their consent. The full analysis population  will be used in the primary analysis, and the per protocol population  will be used in the secondary analysis to assess the robustness of the results. No interim analysis is planned. The normality of these parameters will be estimated using frequency histograms and the Shapiro test. The baseline parameters will be compared between the two groups  using the chi2 test or Fisher’s exact test for categorical variables. Changes in the pain level between each baseline score and the score at T2, T3, and T4 will be compared between the two groups, and the analysis of variance for repeated measurements will be performed to compare the changes in the pain scores over time between the two groups. The NPSI, MDASI, and PTSS scores will be compared between the two groups using Student’s t-test for continuous variables if applicable (or using nonparametric tests and the Mann–Whitney test). Multivariate analysis using logistic regression models will be performed to determine variables potentially linked to pain success. Variables relevant to the models will be selected based on their clinical significance  and/or a threshold of P ≤0.2 in the univariate analysis. The final models will estimate the odd ratios and 95% confidence intervals. All of the tests will be two-tailed with a 5% significance level.The analysis of the primary endpoint will consider the proportion of pain success  calculated for each group. These proportions will be compared using the chiThe study will be conducted in accordance with the Helsinki declaration and the French laws and regulations  and the International Conference on Harmonization (ICH) E6 Guideline for Good Clinical Practice. Regulatory monitoring will be performed by the sponsor. The sponsor obtained the approval of the French authorities, including the French ethics committee  and the French drug and device regulation agency , before beginning the study. The ClinicalTrials.gov identifier is NCT02137954. Informed consent will be obtained from all subjects.To date, no randomized study has determined the analgesic efficacy and tolerance of lidocaine in patients receiving palliative care with opioid-refractory cancer pain with a neuropathic component.We will use a randomized, double-blind, placebo-controlled design, which is the most appropriate design to demonstrate the efficacy of a new experimental intervention in accordance with the Levels of Evidence classification of the Evidence-Based Medicine Working Group. In the future, national and international recommendations could be updated based on our findings.However, some issues related to the content of the protocol study should be discussed. A parallel design has been adopted, although an intra-individual crossover design is generally considered to be the most appropriate to assess the efficacy of a new analgesic strategy because of the well-known patient variation in the subjective perception of pain. In the crossover study, each subject acts as his or her own control. Several limitations of crossover trials have led us to avoid this design . The croThe treatment procedure has been established in accordance with common recommendations. The administration modalities and doses for level III opioids (morphine and oxycodone) are described in the WHO’s pain ladder and in the French recommendations . Lidocaiet al. [In clinical trials, pain level is usually assessed using the self-administered NPIS , 25 and et al.  designatThe selection criteria included cancer patients receiving palliative care with opioid-refractory pain with a neuropathic component to ensure a homogeneous population, but it can be assumed that patients with opioid-refractory non-cancer pain could also benefit from this therapy.The randomization could have been stratified by other factors , analgesic dose equivalents, or co-administration of non-opioid agents, and so on), but this was not done due to the large number of other available factors.At the time of manuscript submission , the status of the trial is ‘not yet recruiting’.


To explore the hypothesis that burning mouth syndrome (BMS) probably is a neuropathic pain condition, thermal and mechanical sensory and pain thresholds were tested and compared with age- and gender-matched control participants using a standardized battery of psychophysical techniques.Twenty-five BMS patients  and 19 age- and gender-matched healthy control participants were included. The cold detection threshold (CDT), warm detection threshold (WDT), cold pain threshold (CPT), heat pain threshold (HPT), mechanical detection threshold (MDT) and mechanical pain threshold (MPT), in accordance with the German Network of Neuropathic Pain guidelines, were measured at the following four sites: the dorsum of the left hand (hand), the skin at the mental foramen (chin), on the tip of the tongue (tongue), and the mucosa of the lower lip (lip). Statistical analysis was performed using ANOVA with repeated measures to compare the means within and between groups. Furthermore, Z-score profiles were generated, and exploratory correlation analyses between QST and clinical variables were performed. Two-tailed tests with a significance level of 5 % were used throughout.P < 0.02) were significantly lower (less sensitivity) and HPTs (P < 0.001) were significantly higher (less sensitivity) at the tongue and lip in BMS patients compared to control participants. WDT (P = 0.007) was also significantly higher at the tongue in BMS patients compared to control subjects . There were no significant differences in MDT and MPT between the BMS patients and healthy subjects at any of the four test sites. Z-scores showed that significant loss of function can be identified for CDT (Z-scores = −0.9±1.1) and HPT (Z-scores = 1.5±0.4). There were no significant correlations between QST and clinical variables .CDTs (BMS patients had a significant loss of thermal function but not mechanical function, supporting the hypothesis that BMS may be a probable neuropathic pain condition. Further studies including e.g. electrophysiological or imaging techniques are needed to clarify the underlying mechanisms of BMS. Burning mouth syndrome (BMS) is characterized by the presence of a persistent burning sensation of the oral mucosa in the absence of clinical or laboratory data to explain these symptoms , 2. ThusThe pathophysiology of BMS remains an enigma. Various factors are related to its mechanisms, and overall this syndrome has been divided into local, systemic and psychological types , 6. SeveAs a reliable, non-invasive psychophysical tool for evaluating the conscious perception of different standardized stimuli, quantitative sensory testing (QST) has been used to investigate small and large nerve fiber function , 11. HowThe primary aim of our study was to compare thermal and mechanical sensory and pain thresholds in BMS patients and their age- and gender-matched controls to investigate a probable neuropathic basis of BMS. The secondary aim was to perform explorative correlation analyses between QST variables and clinical characteristics.Twenty-five BMS patients  and 19 age- and gender-matched healthy control participants were included in the study. None of the participants had prior experience with QST methods.The inclusion criteria of BMS patients were according to the ICHD-3 classification as follows: 1. superficial intraoral pain for more than 3 months; 2. a persistent (more than 2 h/day) and burning quality of the pain; age from 30 to 68 years; 3. no visible clinical changes of the oral mucosa . The inclusion criterion of the control participants was self-reported health without a history of any type of orofacial pain problems. The exclusion criteria for all participants were as follows: systemic factors known to be related to BMS/orofacial pain, a history of systemic diseases or mental disorders, the presence of any acute or chronic pain conditions in the head, neck, face and upper limb region, ongoing dental treatment, taking pain medication, antidepressants or non-steroidal anti-inflammatory drugs (NSAIDs) in the last month, and the current use of caffeine within 24 h of the day of testing. Specifically, BMS patients were ruled out for candida infections by candida culture, vitamin B12 deficiency, folic acid deficiency, diabetes by blood tests and hyposalivation by the spit method for 5 min.The protocol was approved by the local ethical committee of Nanjing Medical University. P.C. with approval number (No:PJ2013-013-04). Informed consent in accordance with the Helsinki II declaration was obtained from all participants prior to inclusion.Thermal and mechanical sensory testing was performed at the following four sites for all participants: tip of the tongue (tongue), mucosa of the lower lip (lip), skin of the mental foramen (V3), and dorsum of the left hand . All participants were tested at the four sites in a randomized manner by one examiner (Xueyin Mo) who had been trained extensively in the use of QST by Wang K and Svensson P.The thermal tests were performed using a computerized thermal stimulator . Two different thermodes were used for the assessments. The contact area of the extra-oral thermode was 30 × 30 mm and that of the intra-oral thermode was 6 × 6 mm.°C for the extra-oral site and 37 °C for the intra-oral sites and heated-up or cooled-down at a rate of 1 °C/s to the lower limits of 0 °C or upper limits of 50 °C. The participants were instructed to press a button on the computer mouse as soon as they perceived the respective thermal sensation of cold, warm, cold pain, or heat pain following the instructions developed by the German Research Network on Neuropathic Pain (DFNS). The procedure then ended, and the temperature returned to baseline at a rate of 1 °C/s. The participants were instructed not to look at the computer screen at any time during the testing procedures.Cold and warm detection thresholds  were measured first, followed by cold and heat pain thresholds . The mean thresholds of three consecutive measurements were calculated. The temperature of the thermode started from a baseline of 32 Mechanical detection thresholds (MDT) were measured using standardized Semmes-Weinstein monofilaments with 20 different diameters . The number of each filament (1.65 to 6.65) corresponds to a logarithmic function of the equivalent forces of 0.008 to 300 g. The filament was applied vertically on the test sites, and pressure was applied slowly until the filament bowed with a total contact time of approximately 1 s. To prevent filament slippage, intra-oral examination sites were dried with gauze before testing , 15.To detect the mechanical pain threshold (MPT), weighted pinprick stimuli delivered with a custom-made set of seven pinprick stimulators  were used . Each stThe present pain intensity was rated on a numerical rating scale (NRS) from 0 = no pain to 10 = worst pain imaginable; the duration of BMS pain (months) and the location of BMS (questionnaires) were also determined. Furthermore, all participants were screened for signs of major depression with the Zung Self-Rating Depression Scale, which includes 20 items . The ZunDescriptive statistics were used to summarize all measurements. Thermal and pain thresholds were expressed as the means ± SD. The necessary logarithmic transformation was performed to secure normal distribution of the data set. The data was first analyzed using a 2-way ANOVA with repeated analysis of variance, with the group as between-subject factors and the test site as within-subject factor. A Bonferroni test was employed for post-hoc comparisons.patients–value controls)/SD controls.Second, to demonstrate the degree of the differences between the BMS patients and controls groups independently of the different units of the QST parameters, a Z-score transformation was performed for all QST variables to provide a somatosensory profile . A Z-scoFinally, explorative correlations analyses were performed between the QST variables and clinical characteristics, such as pain intensity, pain duration and depression scores, using Spearman tests. All statistical calculations were performed using the Statistical Package for Social Sciences, version 20 . The significance level was set at 0.05.All participants were able to understand the instructions and cooperate during the QST. The healthy control participants were age- and gender-matched with the BMS patients (see Table P = 0.02), there were no significant differences between the two groups at the hand and V3 sites  than in the healthy subjects (P <0.001). Furthermore, at the tongue, the WDTs in the BMS patients were also significantly higher (less sensitive) compared to control subjects (P = 0.007), as shown in Table At the tongue and lip, the HPTs in the BMS patients were higher (less sensitivity) than in the healthy subjects  (data not shown).The explorative correlation analyses did not demonstrate any significant associations amongst any of the QST variables or the clinical characteristics  and higher warm detection and pain thresholds (less sensitivity) at the tongue and lip than healthy participants. In addition, there were no significant differences in mechanical detection and pain thresholds between the BMS patients and healthy participants at any test site. These findings with a localized loss of thermal function in the BMS patients further support the hypothesis that BMS could be a neuropathic pain condition with involvement of peripheral and/or central pain mechanisms.An increasing number of investigations suggest pathophysiological alterations at different levels of the neuroaxis, either alone or simultaneously within the peripheral or central nervous system, in the etiopathogenesis of primary BMS. However, some studies using QST to assess this phenomenon have produced conflicting results. Grushka et al.  performeAs a measure of Aδ-fiber function, CDT, CPT, HPT and MPT were assessed. C-fiber function was tested by assessing the thresholds for WDT. The present study found that BMS patients had hypoesthesia at the tongue and lip. However, the present study did not find any localized loss of mechanical function in BMS patients, indicating that the small-fiber neuropathy may only, or predominately, involve the small C and A-δ nerve fibers in BMS patients. Neurophysiological testing and biopsies of the tongue have indicated that there are peripheral nerve changes with abnormal perception of temperature but central nervous system changes have also been noted using fMRI testing . Lauria Although several neurophysiological studies have suggested that the central and/or peripheral nervous systems are implicated in the pain of BMS , 27, 28,It should be noted that the ICHD-3 criteria specifically mention a lack of clinical sensory abnormalities in BMS patients. However, the present study clearly demonstrates a loss of thermal function in a group of BMS patients who otherwise adhered strictly to the ICHD-3 criteria. Furthermore, several other studies , 22, 24,The main limitation of this study is that the sample size is relatively small, and due to time constraints, we only chose the one most likely to demonstrate a difference in QST parameters rather than the entire DFNS QST battery. The strengths of the present study include the fact that compared to other studies; we examined four test sites, adding the lower lip site which often is associated with burning pain in BMS patients. Furthermore, we included an extraoral control site, in strict accordance with the standardized QST guidelines  and the The present study in Chinese patients with BMS pain convincingly demonstrated a loss of thermal function but not mechanical function when compared to age- and gender matched control participants. No correlations were found between QST variables and clinical characteristics. It can be proposed that BMS appears to fulfill the criteria for a probable neuropathic pain condition. Further studies combining QST, electrophysiology, biopsies and imaging tests will be needed to substantiate this hypothesis.All experiments were performed in accordance with the guidelines of the Nanjing Medical University ethics committee (No: PJ2013-013-04).


We read the review by Petitpal et al on intra-osseous access (IOA) in adults with great interest . The revn = 26) which does not state if lidocaine was given and at what dose [The authors state that: “Despite a lack of evidence-based medicine, administration of lidocaine … has been proposed in conscious patients”. Two studies are cited to support that IOA is painful, and that it is unclear if lidocaine decreases pain associated with IOA. The first study is a case series n = 6 which dhat dose .n = 10), open-label and manufacturer-sponsored, and compared different doses of lidocaine and insertion sites with regards to pain. Based on those findings the review concluded that injecting lidocaine both before and after flushing an IO needle is an effective method of reducing the pain of fluid infusion.A short-cut review from 2013 assessed the evidence for the use of local anaesthetics in IOA . The revIn clinical practice, using lidocaine for IO insertion in conscious patients takes little time and is unlikely to cause harm. We agree with the authors that there is a paucity of evidence, but the little research that does exist supports administering lidocaine in order to prevent pain.IO, intra-osseous; IOA, intra-osseous access


The primary study endpoints were pain relief and functional improvement (muscle strength) one week after therapy. The secondary endpoint consisted of the results of the follow-up observation . Successive measurements showed that the amount of pain patients felt decreased in both groups. At the same time grip strength as well as strength of wrist extensors and flexors of the affected extremity improved significantly. Both focused and radial shock wave therapies can comparably and gradually reduce pain in subjects with tennis elbow. This process is accompanied by steadily improved strength of the affected extremity.The purpose of this article was to evaluate and compare the efficacy of radial and focused shock wave therapies applied to treat tennis elbow. Patients with tennis elbow were randomized into two comparative groups: focused shock wave therapy  and radial shock wave therapy . Subjects in the FSWT and RSWT groups were applied with a focused shock wave (3 sessions, 2000 shocks, 4 Hz, 0.2 mJ/mm Tennis elbow is a painful condition affecting the outside part of the elbow, which is associated with observable tenderness of the lateral epicondylus of the humeral bone. Resistant extension of the wrist and fingers and supination of the forearm clearly increase the amount of pain that frequently radiates peripherally. The tennis elbow syndrome seriously disturbs the function of the upper extremity .The condition is frequently difficult to treat. The two approaches that are employed to this end are conservative treatment and surgery . The firPhysiotherapeutic treatment modalities include eccentric resistance and stretching exercises , Mills’ Focused Shock Wave Therapy (FSWT) has been used for conservative treatment of tennis elbow for over 20 years now . The numA prospective randomised study was designed to assess and compare the efficacy of focused and radial extracorporeal shock wave therapies applied to treat tennis elbow. The primary study endpoints were pain relief and functional (muscle strength) improvement one week after therapy. The secondary endpoint consisted of the results of the follow-up observation .Ethical approval for the study was granted by the Local Research Ethics Committee (reference No KNW/0022/KB1/158/10). All participants gave their written informed consent to participate.The patient inclusion criteria were as follows: (1) painful tennis elbow during at least 3 previous months; (2) painful palpation of the lateral epicondyle; (3) painful resisted middle finger and wrist extension (Thomson test).Patients meeting the following criteria were excluded from the experiment: (1) younger than 18 years; (2) local infection; (3) malignancy; (4) bilateral tennis elbow; (5) carpal tunnel syndrome; (6) medial epicondylitis; (7) elbow arthritis or instability; (8) generalised polyarthritis; (9) ipsilateral shoulder dysfunction; (10) neurological abnormalities; (11) radial-nerve entrapment; (12) cardiac arrhythmia or a pacemaker; (13) cancer; (14) diabetes; (15) physical therapy and/or a corticosteroid injection administered within the previous six weeks; (17) pregnancy.Patients who consented to participate in the study were randomly allocated in a one-to-one ratio to either the FSWT group or the RSWT group. Before the study commenced, its coordinator, who was not involved in patient selection and inclusion, delivered non-transparent and sealed envelopes containing patient’s treatment allocation. Using a computerised number generator, the study statistician gave random numbers to the envelopes. After final enrolment and baseline assessment, the study researcher allocated sequential numbers to participants and handed them the envelope with the corresponding number. The envelopes were opened when individual participants met with the treating clinician. The study researcher in charge of the follow-up measurements was blinded to treatment allocation for the length of the trial.The FSWT group consisted of 25 patients (13 men and 12 women) with a mean age of 47.64 ±7.62 years, a mean body mass of 76.40 ±17.15 kg and a mean height of 171.0 ±7.69 cm. The right upper extremity was affected in 21 patients and the left upper extremity in 4. The dominant and non-dominant extremities represented 22 and 3 cases, respectively. The average duration of the condition was 8.44 ±7.52 months. All patients in this group were treated with a focused shock wave.The RSWT group included 25 patients (11 men and 14 women) with a mean age of 45.76 ±7.52 years, a mean body mass of 75.24 ±16.36 kg and a mean height of 170.36 ±6.86 cm). The right upper extremity was affected in 19 patients and the left upper extremity in 6. The dominant and non-dominant extremities represented 19 and 6 cases, respectively. The average duration of the condition was 7.16 ±6.28 months. All subjects included in this group were treated with a radial shock wave.2). Each subject participated in 3 treatment sessions held at weekly intervals.Focused shock wave therapy was administered without anaesthesia using the Wolf Piezowave device. The most sensitive point on patient’s lateral epicondyle received a total of 2000 shocks per session  were applied to the most sensitive point of the lateral epicondyle and then 2000 shocks to the dorsal part of the forearm using the same frequency and pressure variables. Each patient participated in 3 treatment sessions held at weekly intervals.Before treatment and 1, 3, 6 and 12 weeks after its cessation, all patients in the FSWT and RSWT groups were assessed for the amount of pain they felt . Strength of wrist flexors and extensors and grip strength of the affected and unaffected extremity were also established.To measure the amount of pain the VAS scale was employed, where 0 indicates “no pain” and 10 indicates “most severe pain”.Grip strength was measured using the Saehan dynamometer, model SH5001, in a subject sitting with the elbow joint flexed at 90°. Strength of wrist extensors was measured in the same position and using the same dynamometer, which was stabilised on the table. The moving arm of the dynamometer was always set in the lowest position. To measure strength of wrist extensors and flexors, subjects were asked to press the dynamometer with respectively the dorsal and palmar, distal part of the metacarpus . All subjects performed 3 maximum-effort trials separated by rest periods of 30 seconds. For statistical analysis average values from three measurements were used.The variables that were analysed for each group of patients were the following:Average strength of wrist extensors and flexors in the affected and unaffected extremity, respectively;The ratio between average wrist extensor strength calculated for the affected and unaffected extremity;The ratio between average wrist flexor strength calculated for the affected and unaffected extremity;Average grip strength of the affected and unaffected extremity;The grip strength ratio between the affected and unaffected extremity.Percentage change in muscle strength was derived from the following formula:where:X – percentage change,Xp – average strength before treatment,Xk – average strength 12 weeks after treatment,To calculate percentage change in the amount of pain felt by patients the following formula was used:where:X – percentage change in the amount of pain,Xp – average amount of pain before treatment,Xk – average amount of pain 12 weeks after treatment.According to the results of the Mann-Whitney U test conducted before the experiment, the comparative groups were homogenous in terms of all investigated variables.p≤0.05.The statistical analysis of changes recorded in the groups was performed using the post-hoc Tukey’s t-test. An assumption was made that differences were statistically significant at p≤0.05.To make inter-group comparisons of changes, the Mann-Whitney U-test was adopted. The level of significance was set at Successive measurements showed that the amount of pain felt by patients in both comparative groups gradually decreased .Grip strength and strength of wrist extensors and flexors of the affected and unaffected extremity improved in both groups, the improvement being greater in the affected extremity .The ratios between wrist flexors, wrist extensors and grip strength of the affected and unaffected extremity steadily improved (with one exception) in both groups over the period of observation .Apart from strength of wrist flexors of the unaffected extremity, percentage changes in all analysed parameters were comparable between the groups .Apart from strength of wrist flexors of the unaffected extremity, percentage changes in all analysed parameters were comparable between the groups .According to the results of the study, extracorporeal shock wave therapy (ESWT) is a promising physical agent in tennis elbow treatment. Both early and long-term results show good tissue response. A significant relief in pain and significant improvement in function were noted, particularly during the follow-up observation.A radial shock wave stimulates a much larger area of tissue than a focused shock wave. The effective focal zone of the latter is very small , thus, tIn our experiment, all three types of pain decreased gradually and comparably between groups over the observation period. The reduction in pain did not differentiate the groups significantly.In some experiments where researchers repeated the observation of subjects with tennis elbow, a shock wave  was also found to reduce pain intensity over time . An exceSince patients with tennis elbow suffer from pain and decreased strength of the affected extremity, researchers argue that grip strength assessment can be a reliable indication of how efficacious the applied therapy has been . Even soIn our experiment, grip strength of the affected and unaffected extremity improved in both groups over the observation period, but steady progress was only noted for the affected extremity. It was observed that in both groups the grip strength ratio between the affected and unaffected extremity changed in favour of the affected side. This confirmed that grip strength of the affected extremity was coming back to normal in both groups.Greater muscle strength after treatment was observed by other researchers as well , excludiOnly few researchers measured strength of wrist extensors and wrist flexors in their patients . The meaIn the FSWT group, the ratios between strength of extensors and flexors of the affected and unaffected extremity were greater 12 weeks after treatment by 43.46% and 35.64%, respectively. In the RSWT group the increases were 58.86% and 23.03%. The improvements indicate that the affected extremity was recovering to its normal strength.The reason for both extensors and flexors to increase in strength may have been weaker pain after treatment, allowing increased physical activity of the affected extremity. The fact that the flexor/extensor strength ratio did not improve significantly in the affected extremities although their strength in absolute terms was steadily improving can be attributed to physiological muscular balance between extremities before treatment. Although incorrect muscle balance is widely covered in research reports, there are no studies explaining the phenomenon with regard to forearm muscles in subjects with tennis elbow .In the There are no reports where focused and radial shock wave therapies applied to patients with tennis elbow are compared. We had found only two original studies that compared their effect on patients with other conditions.2 (FSWT) and 8 Hz, 2.4 bar (RSWT), respectively). Moreover, the patients participated in an eccentric exercise programme that started 2 weeks after the last shock wave treatment. Follow-up measurements that were performed 1, 4, 7 and 14 weeks after treatment showed that FSWT and RSWT were not significantly different from each other regarding their efficacy. In both groups decreasing amounts of pain were observed and VISA-P questionnaires pointed to significant improvements in the subjects’ condition.2 (focused). The efficacy of the modalities was determined from a multivariate analysis of changes in the Foot Functional Index (FFI), neuromuscular performance  and a composite score from baseline to the 12 weeks’ follow up. The study provided some evidence that FSWT was more effective than RSWT in the treatment of recalcitrant plantar fasciitis.In our opinion, FSWT may not always outperform RSWT. According to the results of our experiment, both shock wave therapies are worth considering in the treatment of tennis elbow (the conclusion is consistent with that formulated by Tennis elbow is a condition caused by strenuous overuse of the muscles. Some patients are unable to perform their duties at work and affected athletes are frequently incapable of participating in training and/or competitions. Sport activities carry much greater risk of some structures of the motor system (e.g. muscle attachments or tendons) being overused, which provides a valid argument for shock wave treatment being used in sport more often than it is now.Neither of the therapies was observed in the course of treatment to have serious adverse effects. Only 19 patients in the FSWT group and 23 patients in the RSWT group reported feeling pain during procedures, which was gone after the session was over. In 3 patients in the FSWT group and 4 patients in the RSWT group, petechiae and minor edema appeared near the lateral epicondyle while the shock wave was being applied, but they receded before the next session.The greatest limitation of the study seems to be the absence of two placebo groups receiving a sham focused shock wave and a sham radial shock wave, respectively. In this case, however, creating placebo groups is difficult, as people generally know that shock wave therapy elicits strong physical sensations. Another limitation is that for the lack of a control group the results of treatment with both types of shock waves we obtained cannot be compared with the results of other conservative therapy, one of those that are usually employed to treat tennis elbow, e.g. ultrasound therapy. The number of patients is also relatively small and the long-term effects of the therapies are not presented, however, it is worth noting that the individuals enrolled in our study were generally healthy and did not have any other conditions but tennis elbow. Many of them, particularly those who did not feel pain after the period of treatment or in whom its intensity was considerably reduced, did not show up for follow-up examination 6 and 12 months afterwards. For this reason, representative groups could not be formed.Focused and radial shock waves comparably and gradually reduce pain in tennis elbow patients. With subsiding pain, strength of the affected extremity improves.Neither focused nor radial shock waves improve the function of affected tissues quickly, but they apparently initiate a chain reaction restoring physiological function to affected structures.