Dexketoprofen Trometamol and Tramadol Hydrochloride Fixed-Dose Combination in Moderate to Severe Acute Low Back Pain: A Phase IV, Randomized, Parallel Group, Placebo, Active-Controlled Study (DANTE).

INTRODUCTION: Dexketoprofen/tramadol 25/75 mg (DKP/TRAM) is a fixed-dose combination of a cyclooxygenase inhibitor and opioid receptor agonist. To better understand the efficacy and safety of DKP/TRAM in the treatment of moderate to severe acute lower back pain (LBP) with or without radiculopathy, we carried out a large explorative phase IV international, multicenter, prospective, randomized, double-blind, parallel group, placebo-controlled study (DANTE). METHODS: A total of 538 patients with or without a history of LBP and experiencing acute LPB of moderate to severe intensity [Numerical Rating Scale-Pain Intensity (NRS-PI) score > 5] were randomized 4:4:1:1 to DKP/TRAM 25/75 mg every 8 h (n = 211), tramadol (TRAM) 100 mg (n = 207), placebo-matched DKP/TRAM (n = 59), or placebo-matched TRAM (n = 61). RESULTS: The proportion of patients achieving the primary endpoint, defined as the time to first achieve NRS-PI score < 4 or pain intensity reduction ≥ 30% from drug intake up to 8 h after the first dose, was higher in the DKP/TRAM arm than in the placebo group, but the difference was not statistically significant (46.1% vs. 42.6%, respectively; hazard ratio 1.11; 95% confidence interval 0.775, 1.595; p = 0.566). DKP/TRAM achieved superiority over TRAM in total pain relief at 4, 6, and 8 h (p < 0.05). Conversely, in relation to the secondary endpoints, a significantly greater reduction in NRS-PI score was seen with DKP/TRAM versus placebo starting from 1 h, and this reduction remained numerically lower throughout 8 h. Summed pain intensity difference values were also significantly lower at 4, 6, and 8 h with DKP/TRAM compared to TRAM (p < 0.05). Overall, DKP/TRAM was well tolerated. CONCLUSION: Although the primary endpoint was not met, secondary efficacy analyses suggest the superiority of DKP/TRAM over placebo and TRAM alone in terms of total pain relief. DKP/TRAM can be considered to be an effective and safe option for the treatment of moderate to severe acute LBP. DANTE STUDY REGISTRATION: EudraCT number: 2019-003656-37; ClinicalTrials.gov Identifier: NCT05170841.

Acute back pain: The role of medication, physical medicine and rehabilitation: WFNS spine committee recommendations.

Objectives: To formulate the most current, evidence-based recommendations for the role of medication, physical medicine, and rehabilitation in the management of acute low back pain lasting <4 weeks. Methods: A systematic literature search in PubMed and Google Scholar databases was performed from 2012 to 2022 using the search terms "acute low back pain," "drugs," "bed rest," "physical medicine," rehabilitation." Standardized screening criteria resulted in a total of 39 articles that were analyzed, including 16 RCTs, 8 prospective studies, 6 retrospective studies, and 9 systematic reviews. This up-to-date information was reviewed and presented at two separate meetings of the World Federation of Neurosurgical Societies (WFNS) Spine Committee. Two rounds of the Delphi method were utilized to vote on the statements and arrive at a positive or negative consensus. Results and conclusion: The WFNS Spine Committee finalized twelve recommendation guidelines on the role of medication, physical medicine and rehabilitation in the management of acute LBP. We advocate for a uniform approach to the treatment of these patients, including proper patient education and utilizing drugs with proven efficacy and minimal side effects. First-line pharmacologic agents are acetaminophen and NSAIDs; muscle relaxants can be used for spasms and pain reduction, and opioids should be minimized. Continued activity, rather than bed rest, is recommended, and lumbar spine orthotics may be used to reduce pain and augment functional status. Thermotherapy, cryotherapy, TENs, spinal manipulative therapy, and acupuncture may all be used as adjuncts to improve acute LBP.

Comparison of diclofenac with tramadol, tizanidine or placebo in the treatment of acute low back pain and sciatica: multi-center randomized controlled trial.

BACKGROUND: Low back pain (LBP) is a leading cause of disability worldwide and has posed numerous health and socioeconomic challenges. This study compared whether nonsteroidal anti-inflammatory drugs (NSAIDs) in combination with tramadol, tizanidine or placebo would be the best treatment regime to improve the Roland Morris Disability Questionnaire (RMDQ) scores at 1 week. METHODS: This was a multi-center, double-blind, randomized, and placebo-controlled trial including adult patients with acute LBP and sciatica in three emergency departments in Hong Kong. Patients were randomized to the receive tramadol 50 mg, tizanidine 2 mg, or placebo every 6 hours for 2 weeks in a 1:1:1 ratio. The RMDQ and other secondary outcomes were measured at baseline, Day 2, 7, 14, 21, and 28. Data were analyzed on an intention to treat basis. Crude and adjusted mean differences in the changes of RMDQ and NRS scores from baseline to Day 7 between tizanidine/tramadol and placebo were determined with 95% confidence intervals. RESULTS: Two hundred and ninety-one patients were analyzed with the mean age of 47.4 years and 57.7% were male. The primary outcome of mean difference in RMDQs on Day 7 (compared with baseline) was non-significant for tizanidine compared with placebo (adjusted mean difference - 0.56, 95% CI -2.48 to 1.37) and tramadol compared with placebo (adjusted mean difference - 0.85, 95% CI -2.80 to 1.10). Only 23.7% were fully compliant to the treatment allocated. Complier Average Causal Effect analysis also showed no difference in the primary outcome for the tizanidine and tramadol versus placebo. CONCLUSION: Among patients with acute LBP and sciatica presenting to the ED, adding tramadol or tizanidine to diclofenac did not improve functional recovery.

Emergency Department Management of Low Back Pain: A Comparative Review of Guidelines and Practices.

This narrative review examines the current best practices and guidelines for integrating pharmacologic interventions, imaging, and physiotherapy in the management of low back pain. The review also explores how patient factors such as age, sex, comorbidities, and prevalent pathologies/diagnoses influence the choice and effectiveness of these treatment approaches.

Sensory profiles and their role in the persistence of central sensitization symptoms in low back pain. A prospective cohort study.

INTRODUCTION: Acute lower back pain can lead to neuroplastic changes in the central nervous system, and symptoms of central sensitization after 12 weeks. While sensory sensitivity has been shown to predict symptoms of central sensitization, trait sensory profiles may be prognostic in the persistence of central sensitization symptoms in low back pain over time. OBJECTIVE: To examine sensory profiles as prognostic symptoms of central sensitization in people with acute low back pain. METHODS: A longitudinal type 2 prognostic factor research study was performed according to the PROGRESS framework. Baseline and 12-week follow-up measures were taken using the Adolescent/Adult Sensory Profile and the Central Sensitization Inventory measures. Study participants were consecutively included from primary care physiotherapy practices. Univariable, and multivariable regression analyses were performed to adjust sensory profiles based on previous history of low back pain, baseline Central Sensitization Inventory scores, level of pain, disability, age, and duration of low back pain. RESULTS: After adjustment, the sensory profiles of Low Registration B = 0.44, 95%CI (0.18, 0.70), Sensation Seeking B = 0.38, 95%CI (0.19, 0.57), Sensory Sensitive B = 0.49, 95%CI (0.25, 0.74), Sensation Avoiding B = 0.40, 95% CI (0.15, 0.65) was significantly associated with the persistence of central sensitization symptoms (N = 103). CONCLUSION: Sensory profiles may predict symptoms of central sensitization after 12 weeks in people with acute low back pain.

Multidimensional risk factor analysis of acute low back pain progressing to chronicity: a longitudinal cohort study protocol.

Introduction: Approximately 40% of patients with acute low back pain (LBP) develop chronic low back pain, which significantly increases the risk of poor prognosis. To reduce the risk of acute LBP becoming chronic, effective preventive strategies are needed. Early identification of risk factors for the development of chronic LBP can help clinicians choose appropriate treatment options and improve patient outcomes. However, previous screening tools have not considered medical imaging findings. The aim of this study is to identify factors that can predict the risk of acute LBP becoming chronic based on clinical information, pain and disability assessment, and MRI imaging findings. This protocol describes the methodology and plan for investigating multidimensional risk factors for acute LBP becoming chronic, in order to better understand the development of acute LBP and prevent chronic LBP. Methods: This is a prospective multicenter study. We plan to recruit 1,000 adult patients with acute low back pain from four centers. In order to select four representative centers, we find the larger hospitals from different regions in Yunnan Province. The study will use a longitudinal cohort design. Patients will undergo baseline assessments upon admission and will be followed up for 5 years to collect the time of chronicity and associated risk factors. Upon admission, patients will be collected detailed demographic information, subjective and objective pain scores, disability scale, and lumbar spine MRI scanning. In addition, patient's medical history, lifestyle, psychological factors will be collected. Patients will be followed up at 3 months, 6 months, 1 year, 2 years and up for 5 years after admission to collect the time of chronicity and associated factors. Multivariate analysis will be used to explore the multidimensional risk factors affecting the chronicity of acute LBP patients (such as age, gender, BMI, degree of intervertebral disc degeneration, etc.), and survival analysis will be performed to explore the impact of each factor on the time of chronicity. Ethics and dissemination: The study has been approved by the institutional research ethics committee of each study center (main center number: 2022-L-305). Results will be disseminated through scientific conferences and peer-reviewed publications, as well as meetings with stakeholders.

Thoracolumbar fascia deformation during deadlifting and trunk extension in individuals with and without back pain.

Background: Alterations in posture, lumbopelvic kinematics, and movement patterns are commonly seen in patients with low back pain. Therefore, strengthening the posterior muscle chain has been shown to result in significant improvement in pain and disability status. Recent studies suggest that thoracolumbar fascia (TLF) has a major impact on the maintenance of spinal stability and paraspinal muscle activity, and thus is likely to have an equal impact on deadlift performance. Objective: Aim of the study was to evaluate the role of thoracolumbar fascia deformation (TFLD) during spinal movement in track and field athletes (TF) as well as individuals with and without acute low back pain (aLBP). Methods: A case-control study was performed with n = 16 aLBP patients (cases) and two control groups: untrained healthy individuals (UH, n = 16) and TF (n = 16). Participants performed a trunk extension task (TET) and a deadlift, being assessed for erector spinae muscle thickness (EST) and TLFD using high-resolution ultrasound imaging. Mean deadlift velocity (VEL) and deviation of barbell path (DEV) were measured by means of a three-axis gyroscope. Group differences for TLFD during the TET were examined using ANOVA. Partial Spearman rank correlations were calculated between TLFD and VEL adjusting for baseline covariates, EST, and DEV. TLFD during deadlifting was compared between groups using ANCOVA adjusting for EST, DEV, and VEL. Results: TLFD during the TET differed significantly between groups. TF had the largest TLFD (-37.6%), followed by UH (-26.4%), while aLBP patients had almost no TLFD (-2.7%). There was a strong negative correlation between TLFD and deadlift VEL in all groups (r = -0.65 to -0.89) which was highest for TF (r = -0.89). TLFD during deadlift, corrected for VEL, also differed significantly between groups. TF exhibited the smallest TLFD (-11.9%), followed by aLBP patients (-21.4%), and UH (-31.9%). Conclusion: TFLD maybe a suitable parameter to distinguish LBP patients and healthy individuals during lifting tasks. The cause-effect triangle between spinal movement, TFLD and movement velocity needs to be further clarified. Clinical trial registration: https://drks.de/register/de/trial/DRKS00027074/, German Clinical Trials Register DRKS00027074.

A randomized controlled trial evaluating the short-term efficacy of a single-administration intramuscular injection with the fixed combination of thiocolchicoside-diclofenac versus diclofenac monotherapy in patients with acute moderate-to-severe low back pain.

BACKGROUND: Non-specific acute low back pain (LBP) is a common health problem that may be accompanied by muscle spasm and decreased mobility. The combination of non-steroidal anti-inflammatory drugs and muscle relaxants represents an advantageous therapeutic option, however, available data on their combined use are conflicting. This prospective, randomized, single-blind, two-parallel-group trial assessed the efficacy of a single intramuscular (IM) injection of the fixed-dose combination (FDC) diclofenac (75 mg)-thiocolchicoside (4 mg/4 ml) product (test treatment) compared to diclofenac (75 mg/3 ml) alone (reference treatment) for the symptomatic relief of acute LBP. Tolerability and safety were also assessed as secondary variables. METHODS: One hundred thirty-four patients were enrolled (safety population) and randomly allocated to the combination or single-agent regimen. Pain intensity and muscle spasm, assessed respectively by the patient-reported visual analogue scale and investigator-performed finger-to-floor distance test, were determined prior to the injection as well as 1 and 3 h post-injection in 123 patients (per-protocol population). The patients were blinded to treatment. Safety was assessed up to 24 h post-injection. RESULTS: The test treatment was superior in both alleviating the pain intensity and reducing the finger-to-floor distance at both 1 (p < 0.01 and p = 0.023 respectively) and 3 h post-injection (p < 0.01). A higher percentage of patients experienced > 30% reduction in pain intensity at 1 and 3 h with the test treatment (p = 0.037 and p < 0.01 respectively). The corresponding VAS (SD) scores for the test treatment group were at baseline, 1 and 3 h post-injection 72.03 (± 11.72), 45.37 (± 16.28) and 31.56 (± 15.08) respectively and for the reference treatment group 65.20 (± 12.16), 48.98 (± 18.76) and 44.52 (± 17.33) respectively. No adverse effects were reported with the combination treatment, whereas two patients treated with diclofenac reported dizziness. CONCLUSIONS: The FDC treatment is an effective and well-tolerated option for the symptomatic treatment of LBP. Clinical and patient-reported assessments confirmed that a single IM injection of FDC diclofenac-thiocolchicoside was more effective than diclofenac alone in conferring rapid and sustained improvement in mobility and pain intensity. TRIAL REGISTRATION: EudraCT No: 2017-004530-29 Available at https://eudract.ema.europa.eu/ Registered 04 Dec 2017.

Effectiveness of Integrative Korean Medicine Treatment in Patients with Traffic-Accident-Induced Acute Low Back Pain and Mild Adult Scoliosis.

We investigated the effectiveness of integrative Korean medicine treatment in patients with pre-existing scoliosis who received inpatient care for traffic-accident-induced acute LBP. We selected 674 patients diagnosed with scoliosis between 1 January 2015, and 30 June 2021, using lumbar spine (L-spine) imaging, across four Korean medicine hospitals in Korea for a retrospective chart review and sent them a questionnaire-based follow-up survey. The primary outcome was a numeric rating scale (NRS) score of LBP. The secondary outcomes were the Oswestry Disability Index (ODI), 5-level EuroQol 5-dimension (EQ-5D-5L), and patient global impression of change (PGIC) scores. In total, 101 patients responded to the follow-up survey. NRS scores decreased from 4.86 (4.71-5.02) to 3.53 (3.17-3.90) from admission to discharge, subsequently decreasing to 3.01 (2.64-3.38) (p < 0.001) at the last follow-up. Similarly, ODI scores decreased from 35.96 (33.08-38.85) to 22.73 (20.23-25.24) and 14.21 (11.74-16.67) (p < 0.001), respectively. Approximately 87.1% of patients were satisfied with their inpatient care. There were no significant differences in the degree of improvement according to the severity of scoliosis. Integrative Korean medicine treatment can improve pain, lumbar dysfunction, and quality of life in patients with traffic-accident-induced acute low back pain and pre-existing mild scoliosis.

The association of biomarkers with pain and function in acute and subacute low back pain: a secondary analysis of an RCT.

BACKGROUND: Low back pain (LBP) is a common musculoskeletal condition and a major cause of disability worldwide. Previous studies have found associations of biomarkers with pain and pain-related disability in LBP patients. This study aimed to explore the association between serum biomarkers and pain and disability in patients with acute or subacute axial LBP. METHODS: This study was ancillary to a parent randomized controlled trial. Enrolled participants were randomized into three intervention groups: one of two types of spinal manipulation or medical care. In the parent study, 107 adults who experienced a new episode of LBP within 3 months prior to enrollment were recruited. For this study, 90 of these 107 participants consented to have blood samples obtained, which were drawn immediately before the beginning of treatment. Seven biomarkers were chosen based on previous literature and analyzed. Clinical outcomes were pain and Oswestry Disability Index (ODI) evaluated at baseline and 4 weeks. Spearman's |r| was used to study the association of initial levels of each biomarker with pain and ODI scores at baseline and with changes in outcome scores from baseline to 4 weeks (end of treatment) within each intervention group. RESULTS: At baseline, 4 of 7 biomarkers had an association with pain that was |r| ≥ .20: neuropeptide Y (NPY) (r = 0.23, p = .028), E-Selectin (r = 0.22, p = .043), vitamin D ((r = - 0.32, p = .002), and c-reactive protein (CRP) (r = 0.37, p = .001). No baseline biomarker had an association with disability that was |r| ≥ 0.20. For the correlations of baseline biomarkers with 4-week change in outcomes, vitamin D showed a correlation with change in disability and/or pain (|r| ≥ 0.20, p > .05) in manipulation-related groups, while CRP, NPY, and E-selectin along with TNFα, Substance P and RANTES showed at least one correlation with change in pain or disability (|r| ≥ 0.20, p > .05) in at least one of the treatment groups. CONCLUSIONS: In 90 LBP patients, the analyzed biomarkers, especially vitamin D, represent a small set of potential candidates for further research aimed at individualizing patient care. Overall, the associations investigated in the current study are an initial step in identifying the direct mechanisms of LBP and predicting outcomes of manipulation-related treatments or medical care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01211613, Date of Registration: September 29, 2010, https://clinicaltrials.gov/ct2/show/NCT01211613?term=schneider&cond=Low+Back+Pain&cntry=US&state=US%3APA&draw=2&rank=1.

Low back pain definitions: effect on patient inclusion and clinical profiles.

Introduction: Numerous definitions of acute low back pain (aLBP) exist. The use of different definitions results in variability in reported prevalence or incidence, conflicting data regarding factors associated with the transition to chronic LBP (cLBP), and hampers comparability among studies. Objective: Here, we compare the impact of 3 aLBP definitions on the number of aLBP cases and participants' characteristics and explore the distribution of participants across definitions. Methods: A sample of 1264 participants from the Quebec Low Back Pain Study was included. Three definitions of aLBP were used: (1) not meeting the National Institutes of Health (NIH) cLBP definition ("nonchronic"), (2) pain beginning <3 months ago ("acute"), and (3) pain beginning <3 months with a preceding LBP-free period ("new episode"). Results: There were 847, 842, and 489 aLBP cases meeting the criteria for the 3 definitions, respectively. Participants included in the "nonchronic" had lower pain interference, greater physical function scores, and fewer participants reporting >5 years of pain than in the other definitions. Half the participants meeting the "acute" definition and one-third of participants meeting the "new episode" definition were also classified as cLBP based on the NIH definition. Conclusions: Our results highlight the importance of the definition used for aLBP. Different definitions influence the sample size and clinical profiles (group's characteristics). We recommended that cohort studies examining the transition from aLBP to cLBP ensure that the definitions selected are mutually exclusive (ie, participants included [aLBP] differ from the expected outcome [cLBP]).

Self-Treatment of Chronic Low Back Pain Based on a Rapid and Objective Sacroiliac Asymmetry Test: A Pilot Study.

BACKGROUND: Low back pain (LBP) is common, costly, and disabling. This study assesses a novel and simple LBP evaluation method and its merit in guiding the direction of a self-treatment exercise. METHODS: Randomized open-label intention is used to treat the study. Consecutive patients with LBP ≥ three months and pain ≥ 5/10 were evaluated in a Vancouver clinic with the sacroiliac forward flexion test (SIFFT) by comparing the height of posterior superior iliac spines using a level. Those with asymmetry ≥ 5 mm were offered participation. The assistant, who generated and encrypted the randomization, assigned participants: group 1 learned a two-minute, SIFFT-derived, sacroiliac-leveling exercise (SIFFT-E) as needed for LBP relief; group 2 used a pelvic stabilization belt as needed to prevent LBP, and group 3 continued the usual care. After one month, all participants used SIFFT-E and belt as needed for one month. The identifier number of this article in Clinicaltrials.gov is #NCT03888235. The trial is closed. Our primary outcome measure was the Oswestry disability index (ODI) (decrease) from baseline to one and two months. We also followed SIFFT improvement (decrease). FINDINGS: Of 72 LBP patients, 62 (86%) had ≥ 5 mm asymmetry. From zero to one month, the 21 (one dropout) SIFFT-E participants outperformed the 20 usual care participants for ODI improvement (12.5 ± 14.8 vs. -3.4 ± 14.9 points; mean difference 15.9 [CI 6.7-25.0]; P = 0.002 with number needed to treat (NNT) of 3.0 for ODI improvement ≥ 11). Belt use results were intermediate. At two months, after all the 62 participants used the exercise and belt as needed, combined ODI improvements were clinically significant (12.0 ± 18.4 points), and SIFFT asymmetry was reduced by 8.6 ± 8.6 mm. Five (8%) exercise and 12 (19%) belt wearers experienced mild side effects. INTERPRETATION: Sacroiliac asymmetry appears to be frequent. SIFFT may be clinically useful as an evaluation tool for prescribing a simple self-directed corrective exercise as seen by clinically significant improvements in function and asymmetry.

Utility of Physical Examination Findings for Predicting Low-Back Pain in Adolescent Patients with Early-Stage Spondylolysis: A Retrospective Comparative Cohort Study.

INTRODUCTION: This study aimed to elucidate low-back pain (LBP) characteristics, i.e., its qualities, extent, and location, in patients with early-stage spondylolysis (ESS). METHODS: We recruited patients (≤18 years old) who presented with acute LBP lasting up to 1 month. Patients were divided into ESS and nonspecific LBP (NS-LBP) groups based on their magnetic resonance imaging findings; patients showing no pathological findings that might explain the cause of LBP were classified as NS-LBP. All patients were evaluated using the following tests: hyperextension and hyperflexion (pain provocation tests in a standing position), pain quality (sharp/dull), pain extent (fingertip-sized area/palm-sized area), and pain location (left and/or right pain in side [side]/central pain [center]). We have also compared outcomes between the ESS and NS-LBP groups in terms of gender and physical symptoms. RESULTS: Of 101 patients, 53 were determined to have ESS (ESS group: mean age: 14.3 years old; 43 males/10 females), whereas 48 had no pathological findings explaining the LBP origin [NS-LBP group (mean age, 14.4 years old; 31 males/17 females)]. Chi-squared test has identified gender (male), a negative result on hyperflexion test, pain extent (fingertip-sized area), and pain location (side) to be significantly associated with ESS. Among these, regression analysis revealed that male gender and LBP located on the side were significantly associated with ESS (p<0.05). CONCLUSIONS: Although the hyperextension test is generally considered useful for ESS, we demonstrated that its association is not deemed significant. Our results indicate that male gender, a negative result of the hyperflexion test, fingertip-sized pain area, and LBP on the side may be specific characteristics of ESS. Of these physical signs, male gender and LBP located on the side are characteristic factors suggesting ESS presence.

Saddle Aortic Embolism Following Recovery From Severe COVID-19 Pneumonia.

Coronavirus disease 2019 (COVID-19) is a multi-organ disease with a wide range of manifestations. Coagulopathy is one of the well-recognized complications of COVID-19. We report the case of a 42-year-old man who presented with progressively worsening low back pain of two days in duration. The pain was burning in character, non-radiating, and was not related to movement. The patient had a recent history of severe COVID-19 pneumonia requiring mechanical ventilation and has stayed in the intensive care unit for eight days. He was discharged three days before the acute onset of his back pain. Examination of the lumbar spine was unremarkable. However, lower limb examination revealed coldness and absent pulses bilaterally. The patient underwent computed tomography angiography which revealed complete occlusion of the lower abdominal aorta at its bifurcation. Emergency endovascular treatment was performed to aspirate the clot. The symptoms resolved following the procedure and the patient was discharged on the third post-intervention day. Saddle aortic embolism is a rare life-threatening condition that may present solely with low back pain. The case demonstrated a possible complication of COVID-19 that occurred after the recovery from the acute phase of the disease.

Efficacy of the Combination of Indomethacin and Methocarbamol versus Indomethacin Alone in Patients with Acute Low Back Pain: A Double-Blind, Randomized Placebo-Controlled Clinical Trial.

OBJECTIVE: Acute low back pain is a common ailment and causes pain and disability. Physicians often prescribe nonsteroidal anti-inflammatory drugs (NSAIDs) to treat acute low back pain; however, due attention has recently been drawn to muscle relaxants to reduce the severity of patients' daily physical dysfunction. Therefore, this study aimed to evaluate the therapeutic effect of the administration of indomethacin alone compared with methocarbamolas a muscle relaxant and indomethacin as an NSAID on the treatment of acute low back pain. METHODS: The present double-blind clinical trial was performed on 64 patients with acute low back pain. The patients were categorized into two groups and received the treatments as follows. Indomethacin capsules of 25 mg every 8 h and placebo tablets every 8 h were administered in the first group (Group I). Indomethacin capsules of 25 mg every 8 h and methocarbamol tablets of 500 mg every 8 h were administered in the second group (Group I + M). Patient pain intensity and physical function based on Back Pain Function Scale (BPFS) were recorded before and 1 week after the intervention. FINDINGS: The present study results revealed that the mean pain reduction of patients in Group I + M was significantly higher than that of Group I (3.66 ± 3.17 vs. 1.84 ± 1.53; P < 0.001). Moreover, the mean BPFS increase in Group I + M was significantly higher than that of Group I (19.44 ± 8.66 vs. 4.75 ± 4.35; P < 0.001). CONCLUSION: According to the results of the present study, concomitant administration of indomethacin and methocarbamol can be more effective in reducing pain intensity and improving the patient's physical function (or performance).

Comparative study of combination therapy with non-steroidal anti inflammatory drugs and different doses of low level laser therapy in acute low back pain.

According to various side effects of medication in low back pain, respecting conservative therapy, owing to the widespread use of laser therapy in recent decades, related therapeutic outcomes were different and contradictory. The current study aimed at comparing the effect of non-steroidal drugs and laser therapy with different doses in patients with acute low back pain. METHODS: The current randomized, placebo-controlled study was conducted on 65 patients randomly assigned to four groups. In group 1(N = 20), only drug therapy and in group 2(N = 15), laser therapy (3 J/cm 2) in addition to medication was administrated to the patients. For group 3(N = 15), a therapeutic plan similar to that of group 2 was given; however, the laser dose was 6 J/cm 2. Finally, drug therapy plus placebo laser therapy was applied to group 4(N = 15). Pain was compared among the groups using visual analogue scale and Oswestry low back pain disability questionnaire. RESULTS: Significant difference between baseline pain scores and those of the weeks 1, 2, 3, and 4 of laser therapy in all intervention groups. Also, the results of the intergroup analyses showed a significant difference between group 1 compared with groups 2 and 3. There was a significant ODI difference between the groups after laser therapy. CONCLUSION: Findings showed that laser therapy plus drug therapy in comparison with drug therapy alone was a more effective method to relieve pain and disability in patient with acute low back pain; however, evidence to support this finding is still inadequate.

Efficacy and safety of acupuncture in treating acute low back pain: a systematic review and bayesian network meta-analysis.

BACKGROUND: Acute low back pain (ALBP) is common and acupuncture therapy is a treatment option. The comparative efficacy and safety of different acupuncture therapies are still unclear. The aim of this network meta-analysis (NMA) was to evaluate and compare the efficacy and safety of different acupuncture therapies for ALBP. METHODS: We performed a systematic search in PubMed, Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure (CNKI), VIP Database, Wanfang Database, and Chinese Biomedical Database (CBM). The outcome indicators measured were visual analog scale (VAS) score, lumbar range of motion (ROM) score, and adverse events. The risk of bias among included studies was assessed with the Cochrane risk-of-bias tool. WinBUGS 1.4 was used for the NMA. RESULTS: In total, nineteen randomized controlled trials (RCTs) comprising 1,427 participants were included. Results of NMA showed the following: (I) compared with placebo, motion style acupuncture (MSA) (SMD: -2.21; 95% CI, -3.33 to -1.08), manual acupuncture (MA) (SMD: -1.14; 95% CI, -2.01 to -0.27), and electroacupuncture (EA) (SMD: -1.57; 95% CI, -2.98 to -0.15) were found to be more effective for decreasing VAS score; (II) compared with pharmacotherapy, MSA (SMD: -1.00; 95% CI, -1.47 to -0.54) and MA (SMD: -0.60; 95% CI, -1.15 to -0.05) were found to be more effective in reducing ROM score. Results of the surface under the cumulative ranking curve indicated that all acupuncture types were superior to placebo or pharmacotherapy in lowering VAS and ROM score. It was noted that MSA was the most effective treatment. CONCLUSIONS: This study indicated that acupuncture therapy achieved good therapeutic effects in the treatment of ALBP, especially MSA therapy. Nevertheless, due to the low quality of the included trials, the credibility of our conclusions is low. Further well-designed RCTs with high quality and large samples are still needed to evaluate the efficacy and safety of acupuncture therapy for ALBP.

Erector spinae plane block: a new option for managing acute axial low back pain in the emergency department.

Aim: To evaluate pain and length of stay outcomes in six patients who received an erector spinae plane block (ESPB) in the emergency department (ED) for low back pain. Materials & methods: A case series of six patients who received unilateral or bilateral ESPB after presenting to the ED for acute atraumatic axial low back pain. Results: The average visual analog scale pain score reduction was 81.8%, and length of stay after ESPB was 73.5 min. No postprocedure opiates in the ED or after discharge were required. Conclusion: The ESPB is a rapid, safe and opiate-sparing option for the treatment of acute low back pain.

Lay abstract Acute low back pain is one of the most common reasons patients present to the emergency department (ED), and it is often difficult to treat. The erector spinae plane block (ESPB) is a nerve block used to treat thoracic, rib, spine and abdominal wall pain. There is currently limited evidence to support its use in treating low back pain in the ED. This case series looks at outcomes of six patients who presented to the ED with low back pain who were treated with an ESPB that targets the low back muscles. Visual Analog Scale pain score reduction after the procedure ranged between 71 and 100%, with an average of 81.8%. The average length of stay (LOS) prior to the nerve block was 225 min, with a range of 107­480 min. Average LOS after the block was 73.5 min, with a range of 26­180 min. Five of six patients did not have any return ED visits for back pain. All six patients required no opiates after the procedure in the ED or after discharge. These cases show the ESPB is a promising technique that gives emergency physicians a rapid, safe and opiate-sparing option for the treatment of low back pain. ESPBs can result in decreased pain, decreased LOS, decreased opiate requirements and decreased admission for refractory pain.

Acupuncture for acute low back pain: a systematic review and meta-analysis.

BACKGROUND: Acupuncture has been widely used for acute low back pain (LBP), yet there remains continued controversy regarding its efficacy. Therefore, we aimed to critically evaluate the evidence for acupuncture as an effective treatment for acute LBP. METHODS: English and Chinese databases were searched for randomized controlled trials (RCTs) that involved acupuncture for acute LBP published up to May 2020. Data on the outcomes of pain intensity, functional status, and analgesic use were extracted. The meta-analysis was performed using the Cochrane Collaboration's RevMan 5.3, and pooled data were expressed as mean differences (MD) with 95% confidence intervals (CIs). RESULTS: Of the 13 eligible RCTs identified, 11 RCTs (involving 707 patients) provided moderate-quality evidence that acupuncture has a statistically significant association with improvements in VAS (visual analog scale) score [MD: -1.75 (95% CI: -2.39, -1.12)]. Two studies indicated that acupuncture did not influence the RMDQ (Roland-Morris Disability Questionnaire) scores more than the control treatment [MD: -2.34 (95% CI: -5.34, 0.67)]. Three studies suggested that acupuncture influenced the ODI (Oswestry Disability Index) scores more than the control treatment [MD: -12.84 (95% CI: -23.94, -1.74)]. Two studies suggested that acupuncture influenced the number of pills more than the control treatment [MD: -3.19 (95% CI: -3.45, -2.92)]. CONCLUSIONS: Acupuncture treatment of acute LBP was associated with modest improvements in the VAS score, ODI score, and the number of pills, but not the RMDQ score. Our findings should be considered with caution due to the low power original studies. High-quality trials are needed to assess further the role of acupuncture in the treatment of acute LBP.

The effect of oral magnesium supplementation on acute non-specific low back pain: Prospective randomized clinical trial.

OBJECTIVE: We aimed to investigate the effect of oral magnesium supplementation for acute low back pain. METHODS: This is a three-arm, prospective randomized open label clinical trial, which included two hundred and forty patients. We based our sample size calculation assumptions on a recently published clinical trial, thus we enrolled 80 patients for each group. NSAID alone group included (400 mg etodolac twice a day), NSAID + mg group included NSAID - magnesium combination treatment (400 mg etodolac twice a day with 365 mg oral magnesium supplementation) and NSAID + paracetamol group included NSAID - paracetamol combination treatment (400 mg etodolac twice a day with 500 mg paracetamol twice a day). Follow-up visits after initiation of relevant treatment were performed at 4th and 10th days and outcome measures included pain (Visual analogue scale - VAS), mobility of lumbar spine and functional outcome (RMDQ). RESULTS: Thirty-one patients were considered lost to follow-up or excluded due to use of other medications and final analysis was performed with 209 participants in three groups (71 patients in NSAID alone group, 68 patients in NSAID + mg group and 70 patients in NSAID + paracetamol group). NSAID + mg showed a significantly higher improvement in RMDQ and VAS scores at acute stage (at 4th day visit) compared to two other study groups However, there was no significant difference between three groups in terms of mean improvement of RMDQ, VAS scores and lumbar mobility between initial visit and 10-day. CONCLUSION: Results of this study suggest that addition of magnesium to acute low-back pain treatment does not significantly improve final clinical outcomes. LEVEL OF EVIDENCE: Level I, prospective randomized controlled study.