One of the treatments to reduce pain consists of using plantar orthoses to address specific imbalances during foot placement or gait. The aim of the present study was to determine if reduction of pain with a treatment based on plantar orthoses is related to changes in reflexes and muscle activity of the muscles of the lower limbs. Ten patients  with plantar fasciitis for less than 1 year were followed up during nine weeks. Soleus M, H, and V waves recorded at rest and during voluntary contraction and Root Mean Square-Electromyogram from four leg muscles recorded during walking and static position were analyzed in patients before and 3, 6, and 9 weeks after wearing orthoses. Pain level and gait and posture parameters were also analyzed. Results were compared to five healthy participants exhibiting no pain . Results indicated that pain was significantly reduced after 3 weeks. Hmax/Mmax and Hsup/Msup ratios were significantly higher and MHmax/Mmax and MHsup/Msup were significantly lower in healthy participants compared to patients with plantar fasciitis. No difference in the V/Msup ratio was found between groups. Furthermore, all other measured locomotor, stabilometric, and electromyographic parameters remained unchanged throughout the entire protocol. The reduction of pain is not related to change in neural activity suggesting that, after 9 weeks of wearing plantar orthoses, patients are not yet cured and return to physical activity should be delayed.Plantar Planreaction , 4. Durireaction –7. fasciitis, foot orthoses, that reduce tissue stress during standing and ambulation, and the ability to raise the medial longitudinal arch of the foot immediately relieve patients of pain [ fasciitis results in an excessive foot pronation and suggest that subtalar joint pronation everts the calcaneus and lengthens the plantar aponeurosis, thereby increasing the intrafascial tension [ fasciitis. Indeed, pain is reduced, gait is improved, and walking distance is increased in individuals with plantar fasciitis wearing flat insoles [The initial treatments are to reduce activity and standing and possible inflammation by use of anti-inflammatory drugs in addition to using arch supports in the shoes. If pain continues and if all the conservative methods  do not work or when symptoms worsen surgery may be considered , 9. Surg of pain , 13. A l tension . Cadaver tension . Thus, i insoles –20. fasciitis than custom-made orthotic insert and that benefit can last up to 12 weeks [Despite a variety of orthosis types available, it was shown that prefabricated heel pad was better or identical to customized orthoses for reducing symptom of plantar12 weeks . Theoret12 weeks , 22, the12 weeks , the Phy12 weeks , the Max12 weeks , or the 12 weeks . Althoug12 weeks . The sec12 weeks . In this12 weeks . Althoug12 weeks . soleus (SOL) muscle at rest and during voluntary contraction and Root Mean Square (RMS)-EMG from vastus medialis (VM), tibialis anterior (TA), soleus, and biceps femoris (BF) muscles in patients before and 3, 6, and 9 weeks after wearing orthoses. We hypothesized that plantar orthoses lead to spinal adaptations at the origin of the suppression of the pain. Furthermore, because we also hypothesized that potential changes in neural strategy could affect muscle activities of the lower limbs, gait (3 main steps of the stance phase) and posture  were analyzed as a secondary measure. Results were compared to healthy participants exhibiting no pain. Analysis was performed over a period of nine weeks in order to characterize the middle term effects of the foot orthoses.Because most studies were limited to evaluate Foot Function Index with a questionnaire and pain with a Visual Analogue Scale (VAS), the aim of the present study was to determine if reduction of pain with a treatment based on plantar orthoses known to correct postural deviations and muscle deficiencies and to address specific imbalances during foot placement or gait is related to changes in reflexes and muscle activity of the muscles of the lower limbs. Thus, neural strategy was accessed by firstly analyzing M(muscle)-, H(reflex)-, and V-waves from fasciitis with valgus foot profile. They had to present pain at rest leading to impairment during their daily activities and increasing when the level of activity increases. No claudication was to be observed.This study was conducted in a podiatry office. Patients were included in the protocol from September 2014 to April 2016. For inclusion in this study, people had to suffer from chronic plantar pain for at least 6 months. Furthermore, no patients had had previous treatment of the injury. Only patients with a pain perception equal to or above 60% when active were included in the protocol. They had to be physically active, i.e., they had not been sedentary and they had regularly engaged, once a week, between 2 and 4 hours, in moderate levels of sport or physical or recreational activities. The diagnostic was an ultrasonography-verified chronic unilateral plantar fasciitis, etc.) that may have influenced the condition. Undiagnosed plantar fasciitis or nonambulatory and noncommunicative patients were also excluded. Finally, obesity patients with a Body Mass Index (BMI) greater than 30 kg.m−2 were excluded.Exclusion criteria were infiltration and pharmacological treatments with anti-inflammatory drugs or corticosteroids, surgery, or any other treatments . Furthermore, they were excluded if they had history of a major orthopedic or medical condition . For ethical considerations and because the French law does not allow, no eligible patient with plantar pain was enrolled in the study without treatment to constitute a SHAM group. Furthermore, sham devices like sham insoles previously used [Eighteen patients were eligible. Four of them did not meet inclusion criteria and four declined to participate to the 9 weeks of follow-up. The remaining 10 patients (3 women and 7 men) suffering from plantarsly used  could no flowchart of the 2 groups of subjects through each stage of the trial, respectively.Each subject was assessed using a standardized assessment by an experienced podiatrist. During the nine weeks of the study, custom-made plantar biomechanical podiatric orthoses, according to the instructions of the podiatrist, were bilaterally placed inside the shoes of patients suffering from plantar pain. During initial assessment, patients were positioned barefoot with a distance of 7 cm between feet. According to the Jean E. Smekens's vade-mecum, the foot was carefully measured by plantagraphy using a computer assisted optical podoscope and by making a mold of the foot using platform equipped with two silicone air bags. The aim was to respond to the specific needs of patients with pain, i.e., to reduce pain. The in-shoe orthoses are designed to reduce rearfoot misalignment and to hold the foot close to its subtalar neutral position  in the goal to restore normal alignment of the entire lower limb. Orthoses were fabricated in ethylene-vinyl acetate (EVA), an elastomeric copolymer with characteristic properties such as low-temperature toughness, stress-crack resistance, hot-melt adhesive waterproof properties, and resistance to UV radiation. The imprint of the sole was in EVA 50 Shore hardness while the corrective elements were in EVA 80 Shore hardness. Resin (1.2 mm thickness) was used to reinforce the heel and the inner arch of the sole. Finally, an absorbing material (3.2 mm thickness) was stuck under the sole at the level of the heel to absorb shock during locomotion. This relatively rigid device was designed to provide significant support for the foot and influence the position of the foot relative to the leg. The patients wore the custom-fit orthotics for activities of daily living at home and were instructed not to drastically alter the time they wore their shoes from a normal day. This device represents those that are commonly prescribed. Healthy participants did not wear foot orthoses.Eligible patients were informed about the study and the study design. They were also well informed about the advantages and disadvantages of participation. The experiments were conducted in accordance with the Declaration of Helsinki and were approved by the Regional Council of the College of podiatrists . All the subjects provided their written informed consent to participate in this study. Local ethics committee approved this consent procedure (IRB00005048). soleus (SOL) muscle of the painful leg were recorded.The day of the first appointment, an examination was performed for the specific design of orthoses. Then, the experiment was divided into 4 sessions: at W0, two weeks later after the first appointment, orthoses were delivered and preorthotic scores were recorded and after three (W3), six (W6), and nine (W9) weeks wearing plantar orthoses. At each session, pain intensity, gait analysis coupled to EMG recordings, postural oscillations coupled to EMG recordings, and spinal reflexes and supraspinal influences at rest and during voluntary contraction of thePain. As previously described [ fasciitis studies [escribed , to analescribed  and has  studies .Locomotion. Gait analysis was carried out on dynamic platform  according to a protocol previously described [escribed . Quantitescribed .Stabilometry. Postural oscillations were recorded on a stabilometric platform  and analyzed with the software  coupled to the platform. The posturographic platform measured 530 mm × 460 mm × 35 mm and was equipped with three pressure gauges (hysteresis <0.2%). In accordance with recommendations from the French Posturology Association and the International Society for Posture and Gait Research (ISPGR), patients were positioned standing on the platform, lowered arms, barefoot, with heels 2 cm apart and feet away at 30° so that the centroid of sustentation polygon was located on the sagittal axis of the platform at a known distance back from the electrical center of the platform. As previously described [escribed , with th soleus (SOL), the tibialis anterior (TA), the biceps femoris (BF), and the vastus medialis (VM) muscles of the two lower limbs. The interelectrode distance was set at 25 mm center to center. For SOL, the electrodes were positioned along the midline of the leg, about 50 mm below gastrocnemii insertion of Achilles tendon. For TA, the electrodes were placed on the line of the fibula to the distance of 1/3 from the end of the medial malleolus. For BF, the electrodes were placed at 50% of the line formed between the ischial tuberosity and the lateral epicondyle of the tibia. For the VM, the electrodes were fixed to the distance of 2/3 from the line originating at the anterior superior iliac and up to the medial face of the patella. The four reference electrodes were positioned on the patella or on the ankle. Each electrode was attached firmly to the skin using adhesive strips. The position of each electrode was carefully measured, recorded in a notebook, and photographed to ensure identical positioning of the electrodes during the following sessions. The electromyogram (EMG) activities of these muscles were recorded on dynamic (locomotion over a distance of 10 meters) condition and on static (standing) condition either with eyes opened or with eyes closed. The signals were amplified (x10000), filtered (bandwidth 10-500 Hz), sent to a computer via an analog-digital converter interface (Biopac® MP100), and analyzed with AcqKnowledge® 3.7.3 software (Biopac System Inc.). Root Mean Square (RMS)-EMG (expressed in μV) of each muscle was calculated for each burst and averaged during walking for each limb (pain and control limb) or calculated within 5 periods of 10 s for static condition.In accordance with the SENIAM international recommendations  and in order to maintain the interelectrode impedance below 5 kΩ, the skin was carefully shaved, slightly roughed, degreased, and disinfected by using alcohol wipes. If the interelectrode impedance was higher than 5 kΩ, the skin preparation steps were repeated. Surface bipolar electrodes  were placed on the fasciitis, the pain limb was blocked with a knee and ankle angle set at 90°. In healthy participants, the dominant limb was blocked in the same position. This position minimized gastrocnemii muscle contribution to the force production [ soleus muscle [ soleus muscle contraction. To reduce movement of the upper body during contractions and therefore to reduce the contribution of the thigh extensor muscles and hip flexor muscles, a belt was fixed to the hip of the subject. The contralateral limb was kept the most relaxed. Particular attention was focused on the head position in order to prevent its rotation during the recordings because any movements lead to vestibular influences on motor reflexes [ soleus muscle contraction. The signal obtained from the strain gauge was sent to a computer via an analog-digital converter  interface  and analyzed with AcqKnowledge® 3.7.3 software (Biopac System Inc.). All neuromuscular tests were therefore carried out under isometric conditions with the same position on the chair for each subject.Then, the subject was comfortably seated on a home-made ergonomic chair in order to record muscle reflexes. Recording electrodes were left on the 4 muscles. In patients with plantaroduction  ensurings muscle . The limreflexes . The foo tibial nerve was stimulated using a nerve stimulator  via a self-adhesive electrode  placed in the popliteal fossa. The anode  was positioned on the anterior surface of the knee. Single and biphasic pulses with 1 ms duration and variable intensity (20 mA to 160 mA) for a maximum voltage of 400 V were delivered. Before any prior recordings, the optimal stimulation site was localized with a tungsten electrode (5 mm diameter). It corresponded to the skin position where the largest H-wave amplitude was obtained for a current set at 20 mA intensity. In order to minimize intraindividual variability, the stimulation site was localized in the same way for the following recording sessions . Indeed, it was essential to standardize. The electrode position was determined in the standing position. Once the site was found, the stimulating electrode was placed and firmly secured by a strap.In order to record the M(muscle)-, H(reflex)-, and V-waves on the SOL muscle, the tibial nerve produced two EMG responses (sup and V-wave). H-reflex recording allows evaluation of the proportion of motoneurons activated [sup and V-wave, when a muscle is relaxed (at rest), supramaximal stimulation of the motor fibers provides a maximal M-wave  that abolishes the H-wave. However, when the same stimulation is evoked during a voluntary contraction, the M-wave is followed by a wave appearing with a delay similar to the H-wave delay. Indeed, during a voluntary contraction, electrical stimulation of a mixed peripheral nerve depolarized afferent and efferent axons. On the efferent side, evoked nerve influxes are propagated orthodromically to the muscle where they generated with the motor descending voluntary influxes a M-wave (Msup) and antidromically to the spinal cord. Descending influxes by the corticospinal and extrapyramidal pathways collide with the antidromic evoked influxes [sup when voluntary contraction reaches 60% of the maximal voluntary contraction and V-wave  when the contraction is maximal. Hsup and V waves allow evaluating the modulation of the spinal loop and reflect the efficiency of the transmission between Ia afferent and α-motoneuron during voluntary contraction, i.e., the presynaptic inhibition [Transcutaneous stimulation of theesponses . The earctivated  and the ctivated . It is activated . Regardiinfluxes . The proinfluxes . Under thibition  and the hibition .max) was reached. Hmax was detected when the H-reflex began to decrease significantly while the M-wave increased. For a better reproducibility, many precautions have been taken during recording. Stimulations were separated by an interval of at least 10 seconds [Hmax) was also noted. The peak to peak amplitudes of Hmax and MHmax were measured. The results of previous sessions were viewed to ensure the consistency of measures. Once Hmax value was obtained, the stimulation intensity was increased until the disappearance of the H-reflex and M-wave stabilization (maximum intensity). Then, 3 to 5 pulses were delivered at supramaximal intensity (125% of the maximum intensity) to obtain the maximal M-wave (Mmax).Measurements started by determining the H and M recruitment curves. To achieve that, the intensity of stimulation (starting at 20 mA) was gradually increased every two stimulations until the maximal H-reflex (H seconds  and perfmax was delivered during a stable period of contraction. The superimposed H-reflex (Hsup) and the corresponding M-wave (MHsup) were recorded on 3-5 trials. Then, the patient performed 3 MVC stabilized for 3 seconds during which a pulse of supramaximal intensity was delivered. The wave with a similar delay (between 30 and 45 ms) to the H-wave corresponded to the V-wave [sup).Afterwards, the subject was encouraged to lift the heel by contracting solely the SOL without other muscles contribution. Surface electrodes from the TA, BF, and VM muscles were used to ensure that their participation in the force production was negligible. The subject was asked to keep his arms crossed over the chest during contractions. During training, the subject visualized the EMG of the 3 muscles and the force developed on the strain gauge platform. Then, the feedback was removed and he was asked to perform 3 maximum voluntary isometric contractions (MVC) using only the SOL. During each MVC, the subject was verbally encouraged and the maximal forces developed were noted. Because it was previously shown that the H-reflex increased linearly with force production until reaching a plateau at 40-60% of the maximal voluntary force , the sube V-wave . The cormax, MHmax, and Mmax were measured at rest. Hmax/Mmax and MHmax/Mmax ratios were thus determined. During voluntary contractions, amplitudes of Hsup and MHsup (measured at intensity used to evoke Hmax) and V as Msup (during a maximum voluntary isometric contraction) were recorded. Thus, Hsup/Msup, V/Msup, and MHsup/Msup ratios were determined.Measurements were randomized. All wave or force amplitudes were measured peak to peak. Inconsistent results were systematically excluded from the study. Amplitudes of SOL Hmax/Mmax, Hsup/Msup, and V/Msup ratios were calculated to ensure that any changes in the evoked Hmax, Hsup and V amplitudes were not due to changes at the muscle fiber membrane or neuromuscular junction [α-motoneurones was activated by the electrical stimuli, the MHmax/Mmax ratio was compared to the MHsup/Msup ratio [Hjunction . To ensuup ratio .max, Mmax, Hsup, Msup, MHmax, MHsup, and V waves. Secondary dependent variables were pain level, parts of the stance phase and stabilometric parameters . A power analysis was used to determine the number of patients to include in the protocol. The calculation of the sample size was performed in a pilot study involving 6 subjects , in which there was a Hmax/Mmax ratio lower than 0.167 in the suffering patients compared to the healthy participants. Using a standard deviation of 0.08, α = 0.05 and 90% power, the sample was estimated as 10 subjects (5 in each group).Primary dependent variables were RMS, H post hoc test. Data processing was performed using commercially available statistical software . Data were expressed as mean±SEM. Results were considered statistically significant if the p-value fell below 0.05.Normality of the data was checked and subsequently confirmed using the Kolmogorov-Smirnov test. Other assumptions  were also checked. Differences were tested by analysis of variance  completed by a Tukey vs. postintervention scores) by the pooled standard deviation.Finally, in order to facilitate the interpretation of the results and to evaluate the clinical relevance, according to Cohen (1988), for paiAnalyses were focused on 5 healthy participants and only on the 10 patients presenting plantar pain who participated to the nine weeks of study. No participant reported adverse effects from wearing foot orthotic devices.In the Control group, no plantar pain was reported by all the participants throughout the experimental sessions. At rest, the mean pain score was significantly reduced from the third week after the beginning of the treatment  when compared to W0. During activity, reported mean pain score was also significantly reduced from the third week  when compared to W0. Furthermore, statistical analysis indicated a significant (p<0.01) decrease from W3 to W9. However, although at rest the pain almost disappeared (1.87±1.31%), low persistent pain (16.87±6.19%) was reported during the activity after 9 weeks of treatment . r=0.804 (Cohen's d=2.70) and r=0.841 (Cohen's d=3.11) for rest and during exercise, respectively.Considering the mean values obtained at preintervention and postintervention, the effect sizes wereThe dynamic analysis of the locomotion was assessed by measuring the percentage of the 3 steps of the stance phase of the gait cycle. Although the first and the third steps seemed to increase and the second step seemed to decrease from W1 to W9, repeated ANOVA analysis does not reveal significant changes in the 3 steps of the stance phase over time. However, when compared to healthy participants, data indicated that (1) the first step  of the stance phase was significantly (p<0.001) lower during the nine weeks of experiment , (2) the second step  was significantly higher (p<0.01) only during the third week (from W1 to W3) and then returned to normal values (45% of the stance phase), and (3) the last step  was significantly higher (p<0.05) from W6 to W9 than normal value (30% of the stance phase). fasciitis. Stance surface, Xm, Ym, LFS, and VFY parameters analysis indicated that our suffering patients exhibited values within the lower and upper limits when eyes were opened or closed and no difference was found when compared to Control group. Furthermore, there was no significant change in the parameter from W0 to W9 .In all subjects , RMS-EMG remained fairly stable during the nine weeks of the protocol either during walking or in standing position. During walking, no RMS-EMG change was found between the control and the painful limb in patients suffering from plantarprotocol . Finallymax/Mmax, Hsup/Msup, and V/Msup ratios remained stable during the nine weeks of the protocol. Furthermore, MHmax/Mmax and MHsup/Msup ratios did not change between each experimental session indicating that the measurement conditions of motor reflexes were stable and reproducible. Finally, our results revealed that the Hmax/Mmax and Hsup/Msup ratios were significantly higher (p<0.01) and that MHmax/Mmax and MHsup/Msup were significantly lower (p<0.01) in healthy participants compared to patients with plantar fasciitis. Our results also indicated no difference in the V/Msup ratio between groups , Hn groups . fasciitis with a conservative treatment based on plantar orthoses known to correct postural deviations and muscle deficiencies and to address specific imbalances during foot placement or gait was related to changes in reflexes and muscle activity of the muscles of the lower limbs.Our study aimed to determine if reduction of pain in patients with plantarmax/Mmax, Hsup/Msup, and V/Msup ratios remained stable during the 9 weeks of the protocol indicating that pain decrease at rest and during activity reported by patients wearing orthoses is not related to change in neural strategy. We also noted that Hmax/Mmax ratio was higher and MHmax/Mmax ratio was lower in healthy participants compared to patients with plantar fasciitis indicating that in this last group the number of α-motoneurons directly activated was greater and the number of α-motoneurons reflexively activated was lower which makes it possible to assume with caution that (1) presynaptic inhibition was greater and/or (2) Ia afferents were more difficult to activate and/or (3) threshold of excitation was lower in α-motoneurons. We also noted the same results during voluntary contraction, i.e., Hsup/Msup ratio was higher and MHsup/Msup was lower in healthy patients. We also observed no change in RMS-EMG from vastus medialis (VM), tibialis anterior (TA), soleus, and biceps femoris (BF) muscles during walking and static position between the two limbs of patients suffering from plantar fasciitis and when compared to healthy participants. Furthermore, although values of the 3 steps of the stance phase of the gait cycle were significantly different from values of healthy participants, no significant change in the stance phase was observed during the 9 weeks of the protocol. Finally, stabilometric parameters indicated no change in the postural tone after wearing the plantar orthoses.Our results indicated that the HIn our study, plantar orthoses allowed a significant pain regression throughout our protocol at rest and during activity. Although pain did not completely disappear during activity as already observed in other studies , the qua fasciitis remained different from the Control group and unchanged from W0 to W9. This pathological gait pattern persisted despite correction of the biomechanical function of the foot and support of the arch of the foot. Thus, due to its implication and solicitation in the different phases of the stance phase of the gait cycle, any plantar fascia alterations  may alter the gait cycle. Furthermore, because the sole of the foot plays a major role in regulating balance and posture control during standing and walking [Despite pain decrease during the 9 weeks of the protocol, the dynamic analysis of the locomotion assessed by measuring the percentage of the 3 steps of the stance phase of the gait cycle indicated that the locomotion in the group of patients suffering from plantar walking , plantar fasciitis and poor information on the effect of foot orthoses on the gait cycle. Previous studies indicated that plantar pain induced changes in foot roll-over patterns, thus causing load reductions in the rearfoot and load increases in other plantar regions, such as the midfoot, possibly owing to the protective mechanisms of pain [ fasciitis during gait [ fasciitis associated with less flexibility of the triceps surae muscular group and decreases in extension of the toes are described [ fasciitis.The literature indicates that there is little consensus regarding the effect of plantar of pain . Kelly eing gait . It was ing gait . Liddle ing gait  contrarying gait . Wearinging gait . Furthering gait . A decreescribed , 52. Finescribed . The aut fasciitis despite a decrease of pain, we can assume that the plantar aponeurosis had not recovered 9 weeks after wearing biomechanical/functional orthotics and that the reduction of pain may be a result either of change in the distribution of plantar loads or of other processes such as neural adaptations implemented to block the transmission of painful influxes.In our study, because we did not observe a return to a normal locomotion in patients with plantar fasciitis, statokinesigram surface, Xm, Ym, LFS, and VFY parameters remained, as in healthy participants, within the lower and upper limits before (W0) and after (W1 to W9) wearing foot orthoses. These results indicate that the postural control is not compromised despite pain. A change in postural control could have been expected over time to explain the reduction of pain. However, despite wearing biomechanical/functional orthoses capable of controlling functional pathology of the foot by maintaining the foot in its neutral position or close to it, or to change plantar sensitivity as suggested by Vie et al. [ fasciitis and reported if foot orthoses change the postural control over time. However, the literature reported that patients with plantar fasciitis presented a slight limitation of dorsiflexion of the hallux that was not present in healthy participants and that hallux dorsiflexion and the Foot Posture Index were inversely correlated [ fasciitis did not differ in rearfoot valgus misalignments but showed increases in the longitudinal plantar arch during bipedal static stance, regardless of the presence of pain symptoms [ fasciitis when compared to runners without the disease.In our patients with plantare et al. , we do nrrelated . Anothersymptoms . The samMolded foot orthoses are known to increase stability of the foot, to reduce plantar fascia strain, and to change frontal plane and rearfoot alignment. Wearing foot orthotics improves, by mechanical effect, the postural control by optimizing positioning of the foot –59. FurtIn light of our findings, we can conclude that the reduction of pain results from a temporary reduction in stresses on plantar fascia and not from a long-term modification of the postural control, i.e., protection of the plantar fascia occurs only when the patient wore his orthoses and this effect may last several hours, days, or weeks after removing the orthoses. It is likely that if the subjects stop wearing their foot orthoses, the pain will reappear after a few hours, days, or weeks. fasciitis. Cheung et al. described that intense muscle contraction of the plantar flexor muscles increases the risk of developing symptom of pain related to the disease [ posterior tibialis muscle that provided the most significant dynamic arch support during the stance phase of the gait can be easily fatigued because of its lengthened position necessary to control excess motion [ fasciitis present less flexibility of the triceps surae (gastrocnemius and SOL) muscular groups [ fasciitis, elevation of the heel increases flexibility of the Achille tendon and consequently decreases the tension of the gastrocnemius muscle. This result can be obtained with orthotic devices elevating the heel. Finally, other distal muscles such as flexor digitorum longus, flexor hallucis brevis, and peroneus longus and proximal muscles such as gluteus medius, gluteus minimus, tensor fasciae latae, and quadriceps were described to be involved in windlass mechanism and plantar fascia abnormalities, respectively [If the literature reports that foot orthoses affect frequency components of muscle activity in the lower extremity during running or walking in subjects without the disease , 61 or w disease . It was  disease  or by fa disease  influencs motion . Kibler r groups . Thus, iectively –70. fasciitis. We also did not observe any differences between patients suffering from plantar fasciitis and healthy subjects. These results indicate that plantar fasciitis does not affect these muscles. In the leg, the SOL muscle mainly acts to flex the foot and to support the knee while the TA is responsible for dorsiflexing and inverting the foot. In the thigh, the BF performs knee flexion while VM is involved in the knee extension. Our results are in accordance with the absence of changes in postural regulation and suggest that these muscles are not involved in the altered locomotion in patients with plantar fasciitis.In our study, we did not observe any EMG changes in the SOL, TA, BF, and VM muscles of the two lower limbs during locomotion and static conditions in patients with plantarHmax/Mmax ratio was stable regardless of the session indicating that the same proportion of α-motoneurons was activated from W0 to W9. Thus, we did not observe any changes in spinal reflexes over time despite pain reduction suggesting that no neural strategy was involved in reduction of pain. It was already shown that stretching or counter resistance movement in patients with plantar fasciitis did not modify H-reflex as well as stretch reflex despite a short term decrease in pain sensation [Our study showed that, in healthy participants as in suffering patients, the value of the Mensation .max/Mmax ratio was higher than that of patients with plantar fasciitis indicating that a greater pool of α-motoneurons was activated by the Ia afferents and/or a greater motoneuron excitability. However, MHmax/Mmax ratios were always lower in healthy participants compared to patients with plantar fasciitis indicating that the fraction of α-motoneurons directly activated when Hmax is obtained is lower in healthy participants compared to patients with plantar fasciitis. Because Mmax was identical in both Hmax/Mmax and MHmax/Mmax ratios, we can conclude that mean amplitude of Hmax was always greater than that of MHmax. This means that, at the intensity of stimulation to obtain Hmax, the number of α-motoneurons (mainly slow motoneurons) transynaptically activated was higher than the fraction of α-motoneurons (both slow and fast) directly activated.Furthermore, in healthy participants the Hmax/Mmax ratio was higher and MHmax/Mmax ratio was lower in healthy participants compared to patients with plantar fasciitis, we could conclude that in this last group the number of α-motoneurons directly activated was greater and the number of α-motoneurons reflexively activated was lower suggesting that (1) presynaptic inhibition was greater and/or (2) Ia afferents were more difficult to activate and/or (3) threshold of excitation was lower in α-motoneurons. However, it is difficult to compare Hmax/Mmax and MHmax/Mmax ratios together and to propose a reliable explanation because the different categories of α-motoneurons are not activated similarly by the two ways .Because Hmax/Mmax, Hsup/Msup, and V/Msup ratios during the nine weeks of the protocol, we can conclude that reduction of pain in patients wearing plantar orthoses was not associated with change in reflexes or consequently with the reduction of inflammation, i.e., the spinal motoneuron responsiveness was not affected and voluntary motor output (motoneuron recruitment and/or firing frequency) was not increased despite wearing plantar orthoses. Thus, our results suggest that either the level of inflammation remained constant during the nine weeks of the protocol despite wearing orthoses or no inflammation was present in patients with plantar fasciitis during the experimental session. However, comparison between the Control group and patients with plantar fasciitis revealed that the Hmax/Mmax and Hsup/Msup ratios were significantly higher in healthy participants indicating that spinal reflexivity was different in the two groups. Our results also indicate no difference in the V/Msup ratio between groups. The Hmax/Mmax is related to the type of physical training (endurance vs. resistance) and to the level of training [ fasciitis may be the consequence of the decrease activity in patients with plantar pain. As for Hmax/Mmax ratio, the Hsup/Msup ratio, obtained during MVC, is considered as a global index of the spinal modulation produced by presynaptic inhibition, motoneuron excitability, collision in antidromically activated axons, and Renshaw cell inhibition. Thus, our results may suggest that, during MVC, motoneuron pool excitability was affected in group of patients with plantar fasciitis. Reduction of activity in patients with plantar fasciitis may have affected the recruitment and/or rate coding of the motoneurons activated by the H-reflex afferent volley. Thus, as previously suggested [sup ratios were similar between groups, we can conclude that the descending drive from higher centers was similar [Hsup/Msup ratios were higher in patients with plantar fasciitis compared to healthy participants indicating that the proportion of α-motoneurons directly activated by the electrical stimuli was different in the two groups, the group of patients with plantar fasciitis presenting a higher proportion of motor unit directly activated [Pain may have several origins including inflammation of the plantar fascia , 72. Indtraining . Becausetraining , the lowuggested , change  similar . Finallyctivated . fasciitis during the nine weeks of the protocol despite wearing orthoses and that the reduction of pain was not due to neural changes or healing but probably due to an unloading effect on painful plantar zone.Whatever the origin of pain (inflammation or collagen degeneration without inflammation) , our res fasciitis would further reduce this heterogeneity, but to our knowledge this model does not exist. Finally, despite a pain reduction with the use of orthotics, it is difficult to distinguish between patients who recover spontaneously and those who respond to such conservative intervention. For this later parameter , because statistical significance is based on hypothesis testing that gives enough evidence against the null hypothesis  or not and because it was possible to have statistical significance without having clinical relevance, we calculated the effect size which simplifies the transfer of knowledge from research to practice [ vs. postintervention) at W9 confirming the effectiveness of biomechanical orthoses.As for the majority of experiments involving humans, despite the drastic criteria of inclusion and exclusion of subjects, some limitations in this study can be pointed. First of all, there is some intragroup variability between subjects in terms of age, weight, anthropometric parameters, level of daily activity, and perception of pain. Some intergroup differences were also present, the suffering patients (51.0±3.5 years) being older than healthy participants (30.6±2.1 years). Secondly, because enrolled patients presented chronic plantar pain for at least 6 months, some differences may exist between a patient suffering for 6 months and another suffering for a year or more; with time, neural and morphological adaptations can take place. Third, the origin of plantar pain may have different origins (inflammation or tissue degeneration followed by an inflammation). It is important to keep in mind that there is heterogeneity between patients despite all our efforts in patient selection and that these differences can diminish the power of our results. Furthermore, because muscle recordings were performed extracellularly, some heterogeneity can also be introduced despite the fact that we had taken care to replace the electrodes always in the same place during the different experimental sessions and took the necessary precautions so that the conditions of recording of the signals were always the same. Only an animal model of plantarpractice . Thus, i fasciitis. However, during the 9 weeks of the protocol, patient relief is not associated with restoration of locomotion and spinal reflexes. No neural changes seem to occur despite pain decrease. It is possible that the study duration was not long enough to observe the expected changes. If the reduction of pain is simply due to the change in pressures on the painful plantar areas that induce a decrease of stretch and tear on the plantar fascia ligaments, it is likely that a return to physical activity too early will lead to a return of pain. Our results suggest that, after 9 weeks of wearing plantar orthoses based on sound biomedical principles, patients are not yet cured and return to physical activity should be delayed. It could be interesting to compare our results with those obtained with orthoses mainly based on proprioceptive stimulations in order to determine which type of orthotic devices is most effective.Wearing plantar orthoses based on sound biomechanical principles is an efficient conservative strategy to reduce pain in patients with plantar


In vitro” studies seek to simulate actual biological conditions in the laboratory and providing principles to be studied later, to facilitate the development of new techniques of root instrumentation in primary teeth and to ensure the integrity and function of the element.“This study aimed to demonstrate the technological advances in endodontics by endodontic treatment performed on artificial primary teeth using a rotary instrumentation system and reciprocation.Instrumentation of the root canal was performed via a manual, rotatory and Reciproc system.The rotatory systems can facilitate endodontic treatment in one session.These procedures become increasingly easy and rapid with the help of technological advances in dentistry.Hecksher F, Vidigal B, Coelho P, Otoni D, Alvarenga C, Nunes E. Endodontic Treatment in Artificial Deciduous Teeth by Manual and Mechanical Instrumentation: A Pilot Study. Int J Clin Pediatr Dent, 2018;11(6):510-512 In addition, exposure of the pulp can also occur much more often during cavity preparation due to the thickness of the enamel and dentin, which are very often thinner in deciduous teeth. It is also noteworthy that traumatic injuries, especially in anterior teeth, occur frequently, contributing to a public health problem.3 The instrumentation of the root canal may be performed with manual or mechanical tools.4The main goal of dentistry is to maintain the integrity and function of the primary dentition to its physiological exfoliation. When the deciduous pulp is compromised, endodontic treatment should be performed to preserve the integrity and function of the tooth and its supporting tissues.5The instruments that incorporate reciprocating movements were introduced in the market to model the dental channel using only a file. These file instruments have a different mechanism compared with other previously developed files. The system is designed to be used with a reciprocating.6 This study aims to demonstrate the potential applications of technological advances in endodontics in pediatric dentistry.Endodontic treatment with rotary systems can contribute significantly to reduce the duration of clinical care for pediatric patients. However, it is essential to evaluate the dentin wear created by both hands and by rotary instruments to analyze the safety of this procedure in the different root thirds and the presence of resorption.The sample comprised artificial deciduous teeth with coronary and root pulp  divided into three groups: group one was instrumented with a manual technique (G1), group 2 used a roundabout technique (G2) and group 3 used a reciprocating instrumented technique (G3).The manual instrumentation group used instrumentation techniques such as the Scheduling Crown-Down Manual, which were performed with Kerr type files 1st series 21 mm . The instrumentation system used RECIPROC file Reciproc 25/0.08 , while the instrumentation group's rotary system utilized Mtwo files of sizes 10/0.4, 15/0.5, 20/0.6, 25/0.6–21 mm, adapted to the VDW engine .The procedure to gain access to the root canal was performed by an endodontist experienced in crown-opening with a round burn° 1011, exploitation of channels C file–Pilot # 10 0.2, 21 mm, to the working length (CT) without resistance, and widening the entrance of the conduits with Gates Glidden drills using #2–4. It was then performed at timed instrumentation conduits. We used a stopwatch to measure the instrumentation time in each root canal.The comparisons between the manual instrumentation group and the rotary and reciprocating systems showed that all the three groups were able to perform the instrumentation of the conduits. The average time required for the manual technique was 4.4 minutes, while with the rotary and reciprocating systems required 3.4 minutes .If we consider these procedures implemented in professional clinical practice for 4 weeks, from the 2nd to the 6th week, and with two patients per day, the rotary and reciprocating systems will have saved approximately 24% of time spent relative to the manual procedure  and 3.Considering the practice over the course of one year, at a rate of two patients per day, the time saving is still approximately 24%. Thus, this economical approach could result in 18 more patients being seen per month, as indicated by the formula below.1.8 hours = 3648 seconds, until 3648/204 = 17.9~18 patients month7Pediatric dentistry's main objective in pulp treatment is maintaining the integrity and health of dental tissues. This is accomplished through the use of techniques and/or medications that allow the continuation of normal development until exfoliation and respect the particular characteristics of the life cycle of these elements.3Comprehensive endodontic therapy for primary teeth can be challenging due to the peculiar anatomy of these teeth, as well as the child's behavior. For this reason, the length of the root must be correctly determined to minimize the apical periodontitis and possible damage to the permanent successor.Procedures applied in this study demonstrated that modern endodontic techniques had identical effects in reducing treatment time. In addition, this can limit the risk of clinical stress as much as possible.8 This is consistent with observations from other researchers who have noted that the optimization of endodontic treatment in primary teeth is important because it improves treatment quality and decreases clinical time.13 The principles of rotary instrumentation for deciduous teeth are the same as for permanent teeth.The rotary technique required significantly less time compared to manual instruments.11The rotary instruments offer several advantages over traditional stainless steel instruments. They are flexible, have more cutting power, provide better maintenance of the original canal shape, considerably reduce deviation tendency or movement of the foramen, and reduce operative time.16 Results are consistent with the study showing that preparation time with rotary instruments was significantly less than with manual instrumentation, which is a clinically relevant factor for endodontic treatment.Several studies have been conducted comparing the Ni-Ti instruments’ reciprocating and rotational movement. In evaluating the cyclic fatigue and bending of these instruments, there was a greater resistance observed for files applied in a reciprocal motion relative to the conventional rotational method, longer life-spans for these instruments, and a greater ability to maintain the centralized channel. In addition, the instrument's reciprocating movement caused less movement of apical foramen and less extrusion of dentin debris to the periapex.Technological advances have simplified endodontic procedures with regard to the roundabout technique and reciprocation, even in the context of primary dentition, confirming other findings in the literature. However, good treatment also depends on the reduction or elimination of the infectious agent, appropriate instrumentation, efficient irrigation, and shutter-compatible antibacterial materials, as well as knowledge of the case study. However, well-designed follow-up studies for further statistical investigation are necessary for performing endodontic treatment of primary teeth.


IntroductionPainful diabetic peripheral neuropathy (PDPN) complicates 25% of type II diabetes mellitus. It has a profound impact on diabetes-related morbidity and worsens the quality of life. Both pregabalin and duloxetine may be indicated for PDPN. In this study, the efficacy of duloxetine and pregabalin was compared in patients with PDPN.MethodsIt was a single-centre open-label study conducted with patients of diabetes mellitus type II diagnosed with PDPN. Patients were randomized to receive 60 mg/daily duloxetine or 300 mg/daily pregabalin. Pain scores were recorded using visual analogue scale (VAS) on day 0, week 4, and week 12. Data was entered and analysed using SPSS version 22.0 .ResultsIn the duloxetine group, the mean VAS score decreased from 6.81 ± 0.91 to 4.01 ± 1.12 with 12 weeks of therapy (p <0.0001). In the pregabalin group, the mean VAS score decreased from 6.99 ± 1.12 to 4.91 ± 0.82 with 12 weeks of therapy (p <0.0001). At 12 weeks, duloxetine showed lower VAS scores than pregabalin (p <0.0001). In the duloxetine group, the mean change in VAS score over time was - 2.80 and in the pregabalin group, the mean change was - 2.80. Adverse events were reported in 17.9% of the participants. Lethargy/somnolence (8.1%) and peripheral edema (3.4%) were commonly reported in the pregabalin group and constipation (6.9%) and orthostatic hypotension (4.6%) were commonly reported in the duloxetine group.ConclusionsDuloxetine at a daily fixed dose of 60 mg is efficacious in the relief of neuropathic pain. Pregabalin also showed a comparable outcome. Both duloxetine and pregabalin have a promising safety profile and are well-tolerated. Chronic painful diabetic peripheral neuropathy (PDPN) is a common, debilitating, and distressing complication of type II diabetes mellitus . DiabetiOnce the diagnosis of PDPN is established, one of the two therapeutic approaches may be ensued: pathogenic treatments targeting the underlying pathophysiological processes to prevent nerve fibre loss; and symptomatic treatments aiming to alleviate the painful symptoms which helps in improving physical and psychological functioning . The symDuloxetine is a serotonin and norepinephrine reuptake inhibitor. Its mechanism of action is related to the potentiation of serotonergic and noradrenergic activity in the descending inhibitory pain pathways of the central nervous system . PregabaIt was an open-label prospective trial conducted in a public tertiary care hospital in Karachi. The study duration was from January to March 2019. The study was conducted in the outpatient diabetes clinic after approval from the Institutional Review Board. Informed consent was attained from all participants.During the study period, all patients of diabetes mellitus type II, diagnosed with PDPN were included after informed consent. The diagnosis of PDPN is primarily clinical, based on a history of neuropathic pain and confirmatory examination findings, establishing deficits associated with neuropathy. All patients were diabetic, with history of pain and numbness in hands and feet in "gloves and stocking" pattern. Biothesiometry was done for all patients. Biothesiometer score of 16 volts or above was diagnostic for PDPN. Participants were randomized into two groups. Group A included patients who received duloxetine 60 mg/daily and Group B included patients who received pregabalin 300 mg/day. All patients were naïve to their respective drug. Patients with diabetes-related foot injuries, ulcers, and/or any other painful wound/lesion were excluded as they would’ve created a bias in pain scores. Patients with any other diabetes-related complication such as nephropathy, retinopathy and/or cardiopathy were also excluded. Patients who couldn’t understand and/or communicate in English were also excluded.Neuropathic pain was evaluated using the visual analogue scale (VAS). Scores were based on self-reported measures of pain intensity ranging from 0: no pain to 10: worst pain. A higher score indicates greater pain intensity . PatientAt the beginning of the study, 193 participants were invited. Twenty of these were not included either due to lack of consent or language barrier. The remaining 173 were randomized to Group A (n=87) and Group B (n=86). On week four, no patient was lost to follow up in group A and two were lost in group B. By week 12 follow up, two patients had stopped taking the medication in group B due to adverse events. Another three patients were lost to follow up in group B by week 12 follow up and five in group A. Hence, 12-week study was completed by 161 patients - 82 in group A and 79 in group B. Data was processed through and analysed using SPSS for Windows, version 22.0 . Mean and standard deviation (SD) was calculated for continuous variables and frequencies and percentages were calculated for categorical variables. For analysis of mean scores of VAS only patients who completed the study (n=161) were included, and for adverse events, all 173 patients were included.Among the 161 patients, there were 93 (%) men and 68 (%) women. Their mean age was 63 ± 7 years (range: 54-70 years). The mean duration of diabetes was 9.4 ± 3.5 years (range: 6-14 years). The duloxetine group had a longer mean duration of diabetes than the pregabalin group (10.3 ± 1.4 vs. 7.5 ± 1.9 years).Mean pain intensity recorded on VAS for duloxetine and pregabalin group on day 0, week 4, and week 12 are shown in Table Adverse events were reported in 31/173 (17.9%) participants. Two participants of the pregalabin group discontinued treatment due to adverse events. Both were males and both complained of sexual dysfunction. No patient in the duloxetine group discontinued therapy. The most common adverse events reported in the pregabalin group were lethargy/somnolence, peripheral edema, and constipation. The commonly reported adverse events in the duloxetine group were orthostatic hypotension and constipation. The frequency of adverse events reported in both groups is shown in Table Both duloxetine and pregabalin have shown a significant reduction in neuropathic pain over a period of 12 weeks. Duloxetine showed a higher reduction in pain as compared to pregabalin and the differences were statistically significant.While this study, to the best of our knowledge, is the first local study to compare pregabalin and duloxetine for pain reduction in diabetic peripheral neuropathy, it has its limitations. First, since it was an open-label trial, it may have introduced bias from both the patients as well as the doctors. The results cannot be projected for a longer duration as it was only a 12-week-long study. Furthermore, being a single centre study, its results cannot be extrapolated for the general population. This study has rolled out preliminary results and generates the need to conduct a large scale study with a robust methodology.In this study, duloxetine showed better pain reduction as compared to pregabalin. From day 0 to week 12, duloxetine showed -2.8 point mean reduction in VAS score. This result was comparable to Tanenberg et al.  where paIn a double-blind randomized trial, both the duloxetine and pregabalin treatment groups showed improvement in neuropathic pain from baseline; there were no significant differences between the two groups. Both drugs were well tolerated . SimilarBoth duloxetine and pregabalin produce clinically meaningful pain relief. The efficacy of both drugs is comparable. Both the drugs are well tolerated. The choice of drug may be determined by clinical as well as patient factors.Duloxetine at a daily fixed dose of 60 mg is efficacious in the relief of neuropathic pain. Pregabalin also showed a comparable outcome. Both duloxetine and pregabalin have a promising safety profile and are well-tolerated. Multi-centre, longitudinal, double-blind trials must be ensued to establish robust evidence on the superiority of either drug in the management of PDPN.


M = 5.10 (SD = 1.07) vs. control group: M = 5.41 (SD = 1.15). At 12-week follow-up the Kaia App group reported significantly lower pain intensity (M = 2.70 (SD = 1.51)) compared to the control group (M = 3.40 (SD = 1.63)). Our results indicate that the Kaia App as a multidisciplinary back pain app is an effective treatment in LBP patients and is superior to physiotherapy in combination with online education.Non-specific low back pain (LBP) is one of the leading causes of global disability. Multidisciplinary pain treatment (MPT) programs comprising educational, physical, and psychological interventions have shown positive treatment effects on LBP. Nonetheless, such programs are costly and treatment opportunities are often limited to specialized medical centers. mHealth and other digital interventions may be a promising method to successfully support patient self-management in LBP. To address these issues, we investigated the clinical effects of a multidisciplinary mHealth back pain App (Kaia App) in a randomized controlled trial . One-hundred one adult patients with non-specific LBP from 6 weeks to 1 year were randomly assigned to an intervention group or a control group. In the intervention group, the Kaia App was provided for 3 months. Control treatment consisted of six individual physiotherapy sessions over 6 weeks and high-quality online education. The primary outcome, pain intensity, was assessed at 12-week follow-up on an 11-point numeric rating scale (NRS). Our per-protocol analysis showed no significant differences between the groups at baseline (Kaia App group:  Multidisciplinary pain treatment (MPT) programs focusing on physical, psychological, and educational interventions have proved effective in the treatment of subacute and chronic LBP with positive effects on pain intensity and disability.8 However, MPT programs are expensive and usually limited to specialized medical centers with waiting lists for admission.9Non-specific low back pain (LBP), i.e., LBP without a known specific pathoanatomical cause, is a leading contributor to disease burden and disability worldwide, affecting people of all ages.11 They have been proposed as a promising mode of delivery for self-management support programs and have been shown to effectively improve chronic pain.13 Nonetheless, systematic reviews found only weak evidence for beneficial effects of digital interventions in LBP management.15 However, the analyzed data seemed quite heterogeneous across the included trials. This may have been the reason for the overall inconclusive results, prompting the need for further trials in this field.18Digital interventions and the practice of medical and public health through the use of mobile devices  has introduced new opportunities in health care.22 The objective of the present randomized controlled trial was to compare treatment effects of Kaia App to a control group of patients who received a therapy program consisting of physiotherapy guided by a certified therapist plus online patient education on various issues of back pain. We hypothesized that the patients who were treated with Kaia App would report lower pain intensity after a follow-up period of 12 weeks.The Kaia App is an mHealth app adopting a comprehensive evidence-based MPT program for non-specific LBP in accordance with current international disease management guidelines.Recruitment was started on 1st August 2017. Last follow-up data were received on 30th October 2018. Four-hundred ninety-eight patients were screened. A total of 101 patients met the inclusion criteria and were enrolled . With regard to attrition rate, six and one patients were lost to follow-up in the Kaia App and control group, respectively, providing no data at both follow-ups. One patient in the control group provided only 12-week follow-up data. Thus, follow-up rate at 6 weeks was 87.5 and 93.5%, and at 12 weeks 87.5% and 95.7% in the intervention and control group, respectively. Owing to administrative errors and patient withdrawal of consent during the study a total of 48 patients in the intervention group and 46 in the control group were included. There were no significant group differences regarding patient baseline characteristics  = 31.38, p < 0.001, η = 0.492. Both groups reported a significant decrease in pain symptoms over time (baseline vs. 6 weeks and 6 weeks vs. 12 weeks) . Furthermore, a significant interaction of group and measure point, F = 5.44, p = 0.031, η = 0.043, was found, which was driven by a significant lower pain intensity only after 12 weeks in the Kaia App group compared to the physiotherapy group, t(84) = 2.061, p = 0.021, while the between-group difference was not significant at baseline nor after 6 weeks . The main effect of group was not significant, F = 1.54, p = 0.218, η = 0.018).Figure X2(3) = 3.33, p = 0.344; yet, descriptively, the Kaia App group is clearly overrepresented in the >50% group, whereas the control group has a peak in the 30–49% but also in the <15% group . Additionally, there were no substantial between-group differences in the Graded Chronic Pain Scale (GCPS) although there was a tendency of higher reduction in impairment in the Kaia App group. For physical and mental wellbeing (VR-12) there were significant main effects of measure point  = 6.12, p = 0.003, η = 0.067; physical: F = 48.54, p < 0.001, η = 0.363), indicating that both groups improved over time. Neither the main effect of group nor the interaction of group was significant . Table No main effects  were observed with regard to functional ability and wellbeing measured by the Hannover Functional Ability Questionnaire (HFAQ) and VR-12 . In order to examine, if frequency of Kaia App use is positively related to symptom improvement, bivariate correlations were computed between the pain index at baseline and after 12 weeks, as well as the Δ pain index. Interestingly, there was no significant correlation between Kaia App activity and Δ pain index . Additionally, the correlations between Kaia App activity and pain index at baseline and after 12 weeks were non-significant, although, there were positive tendencies for pain index at baseline  and after 12 weeks . In consequence, even though there was no relationship between Kaia App activity and symptom improvement, patients who reported a higher pain severity at baseline tended to use the app more frequently.Figure M = 2.4 (SD = 3.31) vs. M = 2.8 (SD = 3.59), p = 0.56, M = 1.0 (SD = 2.07) vs. M = 1.7 (SD = 3.07), p = 0.22 and M = 0.9 (SD = 2.40) vs. M = 1.9 (SD = 3.01), p = 0.11, respectively.Concerning concomitant pain medication there was no significant group difference at baseline nor at 6- or 12-week follow-ups, although a trend towards less intake of pain medication could be demonstrated in favor of the intervention group. Medication Quantification Scale (MQS) in the intervention and control group at baseline, 6- and 12-week follow-up There was a high degree of adherence to the physical interventions. Of the possible 6 sessions, participants in the control group attended 89.8% sessions  sessions. In addition, no correlation between outcome measures and completed therapy sessions was observed. In terms of online education, after 6 weeks 62% and after 12 weeks 41% of the participants reported to have used the links. Sixty-two percent after 6 weeks and 41% after 12 weeks stated they considered the content useful.One patient in the intervention group was diagnosed with a lumbar disc herniation in the course of the running investigation, after his general practitioner (GP) had referred him for a routine lumbar magnetic resonance imaging (MRI) scan during the study. We believe that this was an incidental finding. Since the patient did not report new symptoms nor showed new signs in clinical investigations, a causal relation to exercising with the Kaia App seemed very unlikely. Apart from this case no other adverse events were observed.To the best of our knowledge, this is the first randomized controlled trial to investigate treatment efficacy of an mHealth app digitalizing an MPT program in patients with subacute or chronic non-specific LBP in comparison to a control group receiving individual physiotherapy plus online education.25 Of note, most of the enrolled patients in this trial fulfilled the criteria for chronic LBP with 81.3% and 80.4% in terms of LBP that had been lasting for >3 months in the intervention and control group, respectively.The enrolled population showed comparable clinical characteristics to other larger samples of LBP patients but in this trial there was a slightly more pronounced female preponderance and patients tended to be somewhat younger.15 we chose a control treatment taking into account existing clinical guidelines.22 In our opinion this is the remarkable strength in our study.After 12 weeks the therapy program provided by Kaia App was superior with regard to the primary outcome: reported pain levels were significantly lower as compared to the control group , providing education, behavioral strategies and instructional videos on specific physical exercises, with a waiting group  and a group receiving online education only. Interestingly, after 4 months the FitBack group reported lower pain levels only compared to the waiting group, whereas FitBack was not superior to the online-education group. In contrast, in the present study, the Kaia App group showed superiority in spite of a guideline-oriented (physiotherapy + online education) intervention as control condition, which underlines the value of our app-based multidisciplinary approach.In line with results of two retrospective analyses of Kaia App data15Analysis of the number of completed active days with Kaia App at group level revealed a weak to moderate positive association between patient adherence and pain severity at baseline. This observation might suggest that a higher level of suffering consequently precipitates greater patient engagement. Otherwise, against our expectations no correlation between adherence and reduction of pain intensity was found. Nonetheless, to draw more reliable inferences about the determinants of app adherence the currently available evidence is insufficient. In particular, the two recent systematic reviews on digital interventions for LBP did not report any relevant data on adherence to the intervention.31Remarkably, after evaluating the response rate of patients who reported at least 50% pain improvement compared to baseline, a distinct, though statistically not significant advantage was seen in the intervention group, suggesting that our results with respect to the primary outcome were also relevant from a clinical point of view Fig. . Althoug34 However, the investigated patient populations were distinct from this study in terms of duration of back pain and other parameters.With respect to functional ability, baseline scores revealed high functional ability in both groups. The missing over-time differences in functional ability may be due to this ceiling effect. In previous LBP trials, that included a functional assessment using the HFAQ, comparably lower mean scores, ranging from about 46 to 70, were reported, indicative of greater back-pain-related disability.At this stage, we cannot ascertain which of the treatment modules contained in the Kaia App account for the treatment effect. All modules may stand-alone or synergistically interact thus improving treatment outcome. Furthermore, by implementing reengagement emails and push notifications, treatment adherence may have been improved. However, our study design did not allow us to specifically assess the impact of these notifications and other relevant motivational factors.35 Thus, we believe that this did not diminish the significance of our results.Compared to “real-world” LBP patients, our study population was slightly younger and better educated, which may impact prevalence and adherence. However, the influence of educational level at least on prevalence is controversial. While some studies found an association of low educational status with an increased prevalence of LPB, other studies showed an inverse relationship between social status and the risk of LBP.M = 2.53 on the TA-EG scale, which ranges from 1 to 536). Upcoming results from another randomized controlled trial with the Kaia App (registration number: DRKS00015048) provide evidence for a substantial treatment success of Kaia in a large cohort of patients of older age, lower educational background and an exclusive inclusion process via GP-based recruitment .The introduction of a selection bias by the recruitment via online advertising may be considered to weaken the significance of the results. Yet, this issue seems to be rather unproblematic since the Kaia App group did not show a substantially high affinity to technology . Yet, an a posteriori power analysis for the between-group comparison of the pain reduction  revealed an optimal sample size of >200 patients in each group. Since our a priori power analysis was based on our primary outcome, i.e., the pain level at 12-week follow-up, our study was clearly underpowered for this other analysis.Another limitation of our study is that although we found a substantially lower pain intensity after 12 weeks (predefined primary outcome) in the Kaia App group, the between-group difference in pain reduction was not significant. There was only a descriptive tendency in favor of the Kaia App group . This is due to the small sample size and the multiple potential combinations. However, we could observe that all three therapy modules were used by the participants to a comparable extent . Addressing this important point more thoroughly would require a larger sample size, as well as analyses of a large retrospective data set. This is currently under investigation.We opted not to include an additional waiting group in our trial due to ethical considerations . Moreover, investigators were not blinded to subject group assignment for simplifying study design. Since we assessed patient-reported outcomes with standardized questionnaires, we think this is less relevant in terms of a potential bias.Furthermore, as previously discussed, we did not systematically assess adherence to home exercises in the control group. Similarly, no process was implemented to verify if control group patients actually opened the provided education links.In conclusion, in this randomized controlled trial, both groups experienced a significant pain reduction with a non-significant between-group difference. Despite that, we still argue that Kaia App is superior to physiotherapy plus education, as the Kaia App group reports significantly lower pain intensity than the control group, is safe and less expensive than the control intervention.37 It is accepted that there is a lack of sufficient LBP management in regular medical practice, potentially leading to sustained ongoing pain and potentially harmful non-evidenced based invasive procedures.39 Nevertheless, more studies will be needed to specifically investigate these issues and further our understanding of the applicability and full therapeutic potential of Kaia App and mHealth in general.As a perspective, being rapidly available and easily accessible, the Kaia App might be especially useful early in the disease course for patients at high risk for developing chronic LBP. It would allow GPs to start effective low-cost treatment without delay. Thus, while waiting to be admitted to a specialized day clinic or hospital, patients could in the meantime be treated with Kaia App. Patients could also benefit from Kaia App to continue their pain self-management after completion and discharge from treatment, because a significant proportion develop recurrent pain and seek additional health care.We conducted a randomized controlled trial with two treatment groups while investigators were not blinded. Eligible patients were assigned to Kaia App or control group 1:1.Patients were assigned to Kaia App or control group in an alternating fashion without allocation concealment, starting with the intervention group, i.e., the first enrolled patient was assigned to Kaia App group and the next patient to control group. Then, the sequence was continually iterated.Adult patients (aged 18–65 years) were eligible to participate in the study if they complained of non-specific low back pain  with a mean pain intensity of ≥ 4 on NRS over the preceding 2 weeks. Pain had to be ongoing for the last 6 weeks up to 12 months prior to inclusion. Participants were required to be fluent in German language. Only patients without experience with the Kaia App were included. Participants were excluded if they had a past medical history of a malignancy, spinal surgery or any other known serious medical condition, pregnancy, or if they exhibited any clinical signs of a specific underlying cause (“red flags”). A list of inclusion and exclusion criteria is available as supplementary methods.https://www.mri.tum.de/schmerztherapie). After a short telephone interview to screen for inclusion and exclusion criteria, individuals were invited to a visit (t0) at our study-center for a personal assessment, including a physical examination by a medical doctor. Before enrollment, most of the patients had been seen by a GP because of their back pain.Interested patients were submitted by GPs that had been recruited by the Center of Interdisciplinary Pain Medicine within the area of Munich, Germany, or via Facebook advertisements and announcement on the official website of the Center for Interdisciplinary Pain Medicine at the Klinikum rechts der Isar, Technische Universität München  is a multiplatform mHealth app for iOS, Android, and native Web solutions. Kaia came to market September 2016 and is classified as a medical product class I. Patients were involved in the very first steps of development of Kaia App. In this context, patients  were invited for interviews and briefings to discuss feasibility. Moreover, semistructured interviews were conducted to assess adherence-related questions. Moreever, with the help of the checklist “ Mobile App Rating Scale” (MARS)40 patients needs and expectations were targeted. MARS is a brief and reliable tool to assess the quality of mHealth apps. In addition, criteria proposed by the German Federal Ministry of Education and Research  were incorporated in this process. Scenarios and potential strategies were further discussed in focus groups, including potential users.Patients in the intervention group were provided access to Kaia App and encouraged by the clinical investigator to use the app on their smartphone or tablet at least four times a week throughout the study duration of 3 months. The Kaia App has been described in detail previously.42 Educational content was authored by board-certified physicians with relevant expertize in the field of back pain  and clinical psychologists with experience in pain psychotherapy. The single physiotherapeutic exercises and the individual composition of exercises for every user per day (up to five exercises) were designed by physiotherapists of the Center for Interdisciplinary Pain Medicine at the Klinikum rechts der Isar, Technische Universität München according to guidelines and curricula of the European Pain Federation (EFIC) and German Pain Society.43 Exercises are ranked depending on exercise difficulty and strain. Depending on user feedback, exercises are constantly adopted to the user’s fitness level. Mindfulness and relaxation techniques are recommended as an important part of multidisciplinary LBP treatment according to most guidelines.22 The Kaia App contains units of breathing techniques, body scan, visualization, and progressive muscle relaxation. The value of the various techniques is explained in the education module of the Kaia App. Mindfulness content is generally broadcasted as audio content only.The Kaia App involves three therapy modules: (1) back pain-specific education, (2) physiotherapy/physical exercise, and (3) mindfulness and relaxation techniques Fig. . Daily cThe content for an individual patient is compiled and updated from day to day (or upon each login) from a large background of exercises and skills archived in the Kaia App. Depending on the patient´s status of knowledge, practice, and progress this is adapted continually. Thus, exercise regimen and content are tailored to the individual patient. Each section is comprehensive as a stand-alone—there is no obligation to perform all 3 therapy modules in a single session. Pain levels are recorded using a 11-point numeric ratings scale  at the end of each day of therapy in a pain diary.22 recommend physiotherapy for subacute and chronic back pain. Therefore, in the control group patients received six individual face-to-face sessions of standard physiotherapy once a week comprising physical exercises tailored to the individual symptoms and fitness level, as well as manual therapy. Minimal duration of the physiotherapy sessions was 20 min. The physiotherapy sessions were carried out by a certified physiotherapist at a local affiliated center for physiotherapy (therapiePUNKT GmbH). Furthermore, patients were encouraged to an active lifestyle and also to perform the physiotherapeutic exercises at home. In addition, links to a selection of medically oriented websites providing online resources for patient education about pathophysiology, diagnoses, treatment and self-management in LBP were sent to control group patients by the clinical investigators via email weekly, along with a brief motivating message . In total each control group patient received six emails during the trial.National guidelinesPre-specified measures for primary- and secondary outcomes were assessed by self-administered standardized questionnaires to be completed by the patients. At baseline, questionnaires were handed out by the clinical investigators  and completed via paper-pencil at our medical center on the day of inclusion. For 6- and 12-week follow-ups, questionnaires were sent to patients 1 week in advance via postal service. The completed questionnaires were resubmitted via postal service as well. Subsequently, data were entered electronically (DUF). Data sheets were double-checked by JAP.We attempted to remind patients to complete the assessments via email requests and phone calls and to verify if they properly received our surveys when submission was overdue. Patients were not contacted further.45 NRS is a reliable and valid method of rating pain intensity.46 In addition, a pain index was calculated as the mean of current, maximum and average pain intensity. The primary outcome was defined as the pain index at the 12-week follow-up.Pain intensity was assessed on a 11-points numeric ratings scale  for current pain, as well as for maximum and average pain over the last 4 weeks. Pain intensity is a recommended core outcome domain for clinical trials in non-specific LBP and chronic pain.48 The questionnaire contains 12 questions about the ability to perform daily activities, rated on a Likert-scale. A functional ability score is calculated. Scores below 80% are considered as impairment, whereby scores around 70% equal a moderately, scores below 60% a severely limited function.Functional and behavioral measures were assessed at the 12-week follow-up as secondary outcomes. Functional ability was measured using the pain-specific German version of The HFAQ (FFbH-r “Funktionsfragebogen Hannover Rücken”). The HFAQ has been acknowledged to be well suited for measuring functional ability in patients with back pain.49 Thus, our analysis of GCPS was carried out in the subgroup of chronic LBP patients. A translated German version was tested in primary care back pain patients and found to be valid and reliable.50 Pain severity is graded into four hierarchical classes, according to simple scoring rules: Grade I, low disability-low intensity; Grade II, low disability-high intensity; Grade III, high disability-moderately limiting; and Grade IV, high disability-severely limiting.The GCPS has been widely used to collect data on both mental and physical aspects of chronic pain disorders, including chronic LBP.51 The VR-12 was derived from the Veterans RAND 36 Item Health Survey (VR-36) and contains 12 items relating to quality of life, including physical and mental health. Physical and Mental Health Component Scores are calculated.52 Both scores are t-transformed . The VR-12 has been validated and is widely applied as a metric for tracking health-related quality of lifeImpairment of health-related quality of life was assessed using the German version of the Veterans RAND 12-Item Health Survey (VR-12).Data entered by Kaia App users as part of their self-test or app diaries stored on company servers in Frankfurt, Germany, were analyzed. Only pseudonymized data were extracted from the user database via reporting criteria and no personal data were submitted for scientific evaluation.53As part of the questionnaires, concomitant pain medication was assessed and quantified by the MQS.The number of completed physiotherapy sessions was assessed as part of the questionnaires at follow-up (“How many physiotherapy sessions did you attend?”). Regarding online education, patients were also asked at follow-up if they used the provided links meanwhile and if they found the content useful.N = 82 is recommended. In order to compensate for drop-outs in the follow-up measurements with an estimated drop-out rate of 20–25%, and with respect to an unknown exact value of the effect size, >100 patients were considered as suitable. At the end, 101 patients were included.In order to determine the sample size, an a-priori power analysis was performed. For a two-way split-plot ANOVA with the between-factor group (Kaia App vs. control group) and the within-factor measure point (baseline—6 weeks follow-up—12 weeks follow-up), alpha-level of 5%, power of 80% and an expected medium effect size, a sample size of t-tests were run. Our main analysis referred to the patients who completed the questionnaires at each of the three measure points . Furthermore, an exploratory responder analysis was performed. We analyzed the frequency of patients in specific subgroups defined by response rate. Response rate was calculated as percentage reduction of pain index at 12-week follow-up in relation to the baseline: 0–14%, 15–29%, 30–49%, 50–100%. These cutoffs have been used previously.54 The 30 and 50% cutoffs have been used to define moderate and substantial benefits.31The primary outcome (pain index) as well as the secondary outcomes were subjected to separate two-way split-plot ANOVAs with the between-factor group (Kaia App vs. control group) and the within-factor measure point (baseline vs. 6 weeks vs. 12 weeks). In case of significant ANOVA-effects, Bonferroni-corrected post-hoc X2–tests for each measure point. For comparing sample characteristics between groups, two-sided t-tests (metric variables) and X2–tests  were used. Next, the relationship between Kaia App activity and pain relief was analyzed in the Kaia App group. For this purpose, a difference score was calculated by subtracting the baseline pain index values from the values after 12 weeks (Δ) for each patient in the Kaia App group. Additionally, the number of days the Kaia app was used within the first 6 weeks and 12 weeks was calculated (“Kaia App activity”). Then, in order to quantify the relationship between Kaia App activity and pain relief bivariate correlations between the Δ-values and Kaia App activity were performed.GCPS data was analyzed by 3 separate The pre-specified study protocol was approved and registered by the Institutional Ethic Committee of the Medical Faculty of the Technische Universität München (registration number 170/17s) and in agreement with current data protection regulations. The trial is registered at DRKS  with No. DRKS00016329. Patients had to give written informed consent prior to enrollment.Supplementary MethodsRepSum


This study was established to compare single-dose lornoxicam 8 mg (NSAID) in addition to 0.15 mg.kg−1 ketamine and Group P received pethidine 50 mg IV. Parameters were noticed at baseline and after 0, 15, 30, and 45 minutes and 1 hour after drug administration. The efficiency of the drug was determined by observing: patient rated pain, time to pain relief, rate of pain recurrence, the need for rescue analgesia, adverse events, and functional status. One hundred and twenty patients with acute renal colic pain received in emergency room were included in this prospective, randomized, and double blind clinical study. They were aimlessly designated into one of two groups using a computer-generated table. Group L received lornoxicam 8 mg IV plus 0.15 mg.kg The visual analogue scale was significantly lower in Group L after 30 minutes in comparison to Group P. In addition, there was statistically significant increase in Group P regarding their need for rescue analgesia after 30 min in comparison to Group L. Group P showed nonsignificantly increased sedation score compared to Group L. Patients receiving lornoxicam-ketamine attained greater reduction in pain scores and less side effects with better functional state and also are less likely to require further analgesia than those administered pethidine to control acute renal colic pain. Renal colic is represented by an abrupt attack of severe agonizing pain transmitted from the flank to the groin. Movement of renal calculi over the urinary tract is considered the most prevalent reason for this colic .Impediment of urinary flow takes place with consequent rise in the wall tension provocating prostaglandin (PGs) synthesis in renal pelvis; the latter induces vasodilatation which further raises dieresis and ensuing increase in intrarenal pressure. Also prostaglandins deed precisely on the ureter creating spasm in smooth muscles .Both opioids and nonsteroidal anti-inflammatory drugs deliberated the gold standard for pain relief in acute renal colic , 4.Although opioids are cheap and potent and can be easily titrated but they have various adverse effects as constipation, drowsiness, nausea, and vomiting, larger doses lead to depression of respiration, hypotension, and drug seeking behavior presenting as renal colic .Numerous studies have proved that NSAIDs are competent in managing renal colic , 7. TheyLornoxicam-oxicam derivative is as efficient as opioid in alleviating postoperative pain. It has an encouraging sustainability profile and tolerable gastrointestinal and renal adverse effects .Ketamine is a hydrosoluble aryl-cyclo-alkyl amine which exerts its action by acting mainly on N-Methyl-D-Aspartate receptors (NMDA), non-NMDA receptors, and glutamate binding sites. Ketamine opposes NMDA receptor inducing amnesia, analgesia, psych sensory effects, and neuroprotection .It was reported that low-dose ketamine has tremendous affinity for the NMDA receptor generating suppression of nociception , 12.The present study was conducted to compare the relative advantages and hazards of lornoxicam plus ketamine and pethidine to decide which type of drug is most pertinent for pain control in acute renal colic.NCT03780556.This study was conducted in Ain Shams Specialized Hospital in the period between January 2016 and July 2017 on 120 patients having acute pain of renal origin based on classic clinical history and consistent radiological investigations. The study protocol was approved by institution's ethical committee. This study is registered in ClinicalTrials.com ID Patients of either sex aged 20–60 years, who did not administer any analgesics at least within the last two hours, were contained in the study. Exclusion criteria involved patients with liver and renal failure, previous renal surgery, hypersensitivity to lornoxicam, ketamine and pethidine, history of peptic ulcer, gastrointestinal bleeding and perforation, hypertension and history of cardiac diseases, pregnancy and lactation, and urine analysis displaying more than 5 leukocytes suggestive of pyuria.The proposed study is a prospective, randomized, and double blind. Drug solution was given intravenously to all patients by a nurse who had no idea about the study protocol. Observation of different parameters was done by a doctor who also has no information about the drugs administered.R) 8 mg IV in addition to ketamine  0.15 mg.kg−1 infused in 50 ml normal saline over 10 minutes and Group P received pethidine  50 mg IV infusion in 50 mL normal saline and infused over 10 minutes.Patients were randomly assigned into two groups 60 patients each. Group L received lornoxicam , onset and duration of action of the drug administered, the need for rescue medications, rate of pain recurrence, physiologic parameters, adverse effects, and functional status.Respiratory rate, blood pressure, heart rate, oxygen saturation, and sedation score were registered. VAS was used to measure pain intensity. The patients marked their pain severity on a nondemarcated 100 mm horizontal line. This line had “most severe pain” written to the right and “no pain” to the left.Adverse reactions were listed on datasheet including major and minor adverse effects. Major adverse effects are respiratory depression, renal failure, hypotension, and gastrointestinal bleeding. Minor adverse effects are pain and gastrointestinal disturbance without bleeding as vomiting and diarrhea in addition to dizziness and sleepiness.Rescue analgesia was given at 30 minutes if on the verbal pain score “no pain” or “pain much better” is not achieved. The rescue drug was pethidine 25 mg slowly IV to be repeated as needed every 15 minutes in an open fashion.Functional status was calculated as follows, patient's ability to regain regular activities was assessed on 3-point scale: not impaired (capable of coming again to work and driving a car), mildly impaired (able to practice activities of daily living at home), or severely impaired (restricted to bed).α = 0.05 and β = 0.80, so, the number of patients required in each group will be at least 58 patients. That was the main reason to enroll 120 patients in this study.By assuming that pethidine would diminish renal colic pain by 60%, a power calculation with  t-test. Data not normally distributed were compared using Mann-Whitney U test and are presented as median (IQR). P < 0.05 is considered statistically significant.The statistical analysis was executed using a standard SPSS 20 . Normally distributed numerical data are conferred as mean ± SD and differences between groups were compared using the independent Student's−1. Group P consisted of 60 patients who received pethidine 50 mg IV. Parameters were checked at baseline and after 15, 30…..and 4 hours of drug treatment. The efficiency of the drug was assessed by observing patient rated pain, time to pain relief, rate of pain recurrence, the need for rescue analgesia, adverse events, and functional status. There was no statistical difference between the 2 groups regarding sex, age, and body weight  is a NSAID with strong analgesic and anti-inflammatory effect in addition to equal cyclooxygenase (COX-1/COX-2) inhibition and better gastrointestinal and tolerability profile. This is as a result of its short half-life (~4 hs) in comparison to more than 24 h for the other NSAIDs , 23. LorIlias et al. reported that lornoxicam 8 mg IV was higher than placebo and equal to tramadol 50 mg IV in controlling moderate to severe posthysterectomy pain . Işik etLornoxicam 16 mg was found to be equal to fentanyl as intraoperative IV analgesia and was combined with fewer incidences of adverse events ; howeverμ, κ, and σ opioid receptors) [Low-dose ketamine has great tendency for the NMDA receptor resulting in suppression of nociception , 12. It ceptors) , 30.−1 ketamine when compared to control group which used morphine [Many studies showed that combination of morphine with low-dose ketamine in patients with moderate to severe acute pain diminish morphine demands by about 26%–60% –35. Johamorphine .−1 was found in many studies to cause extensive neuropsychiatric adverse reactions. To avoid such undesirable event, a very low-concentration intermittent intravenous bolus or a 2–3 mcg.kg−1.min−1 continuous infusion might be appreciated [−1 IV) has been exhibited to be opioid sparing. Some of the main effects with IV push low-dose ketamine consist of its adverse reactions such as dizziness, nausea, vomiting, and feelings of unreality [Ketamine administration at doses of only 0.15–0.3 mg.kgreciated , 34. Alsnreality .We preferred to administer ketamine by infusion over 10 minutes to avoid unwanted side effects like nausea, vomiting, and feeling of unreality. Mild sedation occurring with this low-dose ketamine is wanted effect in patients with acute renal colic.Ketamine is metabolized mainly to norketamine (80%) which is an effective metabolite. Norketamine commences to appear in blood 2–3 min after a ketamine IV bolus injection and approaches a peak about 30 min later. Norketamine is known to have an analgesic effect, whose potency is about 20–30% in comparison to ketamine . Norketaμ-opioid receptor [Pethidine is a synthetic opioid pain medication of the phenylpiperidine class, synthesized in 1939 as a potential anticholinergic agent –42. It aIt was thought that pethidine has many advantages over morphine especially in controlling pain due to biliary spasm and renal colic as a consequence to its anticholinergic effect, but later researches denied this and considered it as more toxic than other opioids due to its metabolite norpethidine chiefly with long term application. Pethidine could lead to serotonin syndrome due to serotonergic effects of its norpethidine metabolite , 44. NowWe performed our study to compare the analgesic effect of pethidine 50 mg, as it is still the most common pain killer used in our country as a single dose of 50 mg administered to all adult patients to control renal colic in emergency room, with lornoxicam which is a short acting NSAID stated to be efficient in controlling acute pain.It was more reasonable if we administered pethidine according to the body weight or with titration according to the patient's pain feeling but we concentrated to mimic what happens really in emergency room for management of acute renal colic pain.Low-dose ketamine added to lornoxicam to potentiate the analgesic effect and at the same time may help in mild sedation which is obtained from pethidine and deficient with lornoxicam and desired in such patients.Many researches nowadays try to contribute low-dose ketamine to control acute pain control in emergency room to get benefit from its analgesic effect and at the same time to spare narcotics as much as possible –47.In our study we decided also to add pethidine to 50 ml normal saline and infuse over 10 minutes to reduce side effects from direct bolus injection like nausea, vomiting, and histamine release especially at site of injection, in addition to, similarity in the way of administration to ketamine.We failed to find studies which compare IV lornoxicam to IV pethidine. We showed that IV lornoxicam in addition to low-dose ketamine contributed to slightly better analgesia with fewer disadvantages than IV pethidine in spite of the finding of enhanced analgesia in patients with renal colic may be related to local synthesis and production of prostaglandins particular to this situation.In a previous study  Cordell Our study had some limitations; as there were no placebo control group and this was for ethical reasons, so comparison was done using an active control only. Adverse effects of drugs were measured for short time because the study duration was 4 hours only. As many emergency department (ED) studies, we used a convenience sample and this may have introduced a selection bias. Finally, the included trials used fixed dose of pethidine rather than titration to an appropriate level of pain relief. The standard practice in the majority of emergency department is titration rather than fixed dose and this limits the applicability of our results to everyday practice .−1 is as effective as pethidine (50 mg IV) for the ED relief of acute renal colic. In addition, IV lornoxicam causes greater reduction in pain scores, less side effects with better functional state, and also are less likely to require further analgesia than IV pethidine.In the doses studied, single-dose lornoxicam (8mg IV) in addition to ketamine 0.15 mg.kg