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Background Although glucocorticoid therapy has been used in patients with lumbar radiculopathy for many years, the results of studies in literature are inconsistent. The aim of the study was to evaluate the effects of intramuscular betamethasone injection on pain, disability, quality of life and electroneuromyography (ENMG) findings in patients with lumbar radicular pain (LRP). Methods Patients with LRP ( n  = 98) were evaluated between July 2022 and June 2023. Sixty patients who met the inclusion criteria were randomized into two groups. Glucocorticoid group (GC) received intramuscular injection of betamethasone and Placebo group (PB) received isotonic sodium chloride. Visual analog scale (VAS), Oswestry disability index (ODI), Nottingham health profile (NHP) and ENMG were applied to both groups. Patients were evaluated before treatment and after first week, first month and third month of treatment. Results Significant improvements were seen in all clinical parameters in GC group. At the end of third month, VAS and NHP-Pain subscale scores improved significantly in both groups ( p  < 0.001) but the change of these values over time was statistically significant in favor of GC group ( p  = 0.03 and p  = 0.044, respectively). The significant improvements observed in ODI, Energy and Physical Mobility subscales and Total scores of NHP in both groups ( p  < 0.05) revealed no significant difference between the groups over time. The ENMG data revealed no significant difference within the groups except the fibrillation potentials, which disappeared in both groups. Conclusion Intramuscular glucocorticoid administration provided improvements on pain, disability and quality of life of patients with LRP. Especially the effects on pain scores were superior to placebo. No superiority over placebo on ENMG findings has been demonstrated and further studies are needed in this regard. Clinical trial registration The study protocol was registered to Clinicaltrials.gov with the number NCT05571046 (retrospectively registered on 30/09/2022).

Cervical spondylotic radiculopathy (CSR) is the most commonly encountered cervical spine disorder. Cervical manipulation has been demonstrated as an effective therapy for patients. However, the mechanisms of manipulations have not been elucidated. A total of 120 cervical spondylotic radiculopathy patients were divided into the “three-dimensional balanced manipulation” treatment group (TBM group) and control group randomly. The control group was treated with traditional massage; the TBM treatment group was treated with “three-dimensional balanced manipulation” based on traditional massage. The symptoms and clinical efficacy of the patients were compared before and after treatment for one month. A three-dimensional finite element model was established. The mechanical parameters were imported to simulate TBM, and finite element analysis was performed. The results showed that the total effective rate was significantly higher in the TBM group compared with the control group. The biomechanical analysis showed the vertebral body stress was mainly distributed in the C3/4 spinous processes; the deformation mainly concentrated in the anterior processes of the C3 vertebral body. The intervertebral disc stress in the C3~C7 segment was mainly distributed in the anterior part of the C3/4 intervertebral disc, and the deformation extends to the posterior part of the C3/4 nucleus pulposus. In summary, these data are suggesting that TBM was effective in CSR treatment. The results of the finite element model and biomechanical analysis provide an important foundation for effectively avoiding iatrogenic injuries and improving the effect of TBM in the treatment of CSR patients.

Background: Chronic radicular pain can occur after disc pathology and failed back surgery. An evidence-based effective therapeutic option is not available nor does a gold standard exist. Objectives: A randomized controlled trial to analyze the clinical efficacy of percutaneous epidural lysis of adhesions in chronic radicular pain. Study Design: Prospective randomized placebo controlled interventional trial. Power calculation based on a feasibility trial. Setting: Medical university centers. Methods: Within 4 years a total of 381 patients with chronic radicular pain lasting longer than 4 months which failed to respond to conservative treatments were screened and 90 patients were enrolled. They were randomly assigned to receive either percutaneous neurolysis or placebo with concealed allocation in permuted blocks of 4 to 8, stratified by treatment center. The primary outcome measure was the differences in percent change of Oswestry Disability Index (ODI) scores 3 months after intervention. Secondary outcome measures were difference in percent change of ODI scores and Visual Analog Scale (VAS) 6 and 12 months after intervention and success rates defined as at least 50% reduction in ODI scores and VAS scores (mean change from baseline) at 3, 6, and 12 months after treatment. Explorative, 2-sided group comparisons for baseline characteristics between active treatment and controls were done using the t-test for 2 independent samples for quantitative data and Fisher’s exact test for binary data. Results: The ODI and VAS scores as well as the success rates for ODI vs VAS were significantly better 3, 6, and 12 months in the lysis group vs the control group. The ODI in the lysis group improved from 55.3 ± 11.6 to 26.4 ± 10.8 after 3 months. The placebo group improved from 55.4 ± 11.5 to 41.8 ± 14.6 (P < 0.01). VAS improved from 6.7 ± 1.1 to 2.9 ± 1.9 in the active group and from 6.7 ± 1.1 to 4.8 ± 2.2 (P < 0.01) after placebo. Twelve month follow-up shows further improvement, the differences remain significant. In multiple linear regression, forward and backward variable selection methods resulted in the same covariate model confirming the univariate result for group comparison in the primary analysis. No severe side effects occurred but minor transient neurological effects such as partial sensomotoric deficits did. One dura puncture and one catheter displacement were found. Limitations: Specific effects of single treatment components cannot be specified because there was no imaging examination after treatment. Conclusion: Based on the findings of our study as well as other studies, we believe the minimally invasive percutaneous adhesiolysis procedure should be the first choice treatment option for patients with chronic lumbosacral radicular pain who present with clinical history and findings similar to those of the patients enrolled in our study. Key words: Lysis, low back pain, randomized controlled trial (RCT), placebo, epidural, radiculopathy, outcome, evidence-based medicine

Background: Lumbar disc herniation and radiculitis are common elements of low back and lower extremity pain. Among minimally invasive treatments, epidural injections are one of the most commonly performed interventions. However, the literature is mixed about their effectiveness in managing low back and lower extremity pain. In general, individual studies and systematic reviews of epidural steroid injections have been hampered by their study design, baseline differences between treatment groups, inadequate sample sizes, highly controlled settings, lack of validated outcome measures, and the inability to confirm the injectate location because fluoroscopy was not used. Study Design: A randomized, controlled, double blind, active control trial. Setting: A private, interventional pain management practice, specialty referral center in the United States. Objectives: To assess the effectiveness of fluoroscopically directed caudal epidural injections with local anesthetic with or without steroids in managing chronic low back and lower extremity pain in patients with disc herniation and radiculitis. Methods: One hundred twenty patients were randomized to two groups: Group I received 10 mL caudal epidural injections of local anesthetic, lidocaine 0.5%; Group II patients received caudal epidural injections of 0.5% lidocaine, 9 mL, mixed with 1 mL of steroid. Outcome Assessment: Multiple outcome measures were utilized. The primary outcome measures were Numeric Rating Scale (NRS) and the Oswestry Disability Index 2.0 (ODI). Secondary outcome measures were employment status and opioid intake. Significant pain relief improvement was defined as 50% or more improvement in NRS and ODI scores. Results: In the successful category, 77% of Group I had significant pain relief of ≥ 50% and functional status improvement of ≥ 50% reduction in ODI scores; in Group II it was 76%, whereas overall it was 60% and 65% in Groups I and II. Over the two years, Group I had an average number of procedures of 5.5 ± 2.8; Group II was 5.3 ± 2.4. Even though there was no significant difference in overall relief between the two groups, the average relief for each procedure was superior for steroids. Limitations: Presumed limitations of this evaluation include lack of a placebo group. Conclusion: Caudal epidural injections of local anesthetic with or without steroids might be an effective therapy for patients with disc herniation or radiculitis. The present evidence illustrates the potential superiority of steroids compared with local anesthetic at two year follow up based on average relief per procedure. Key words: Chronic low back pain, caudal epidural injections, disc herniation, radiculitis, lower extremity pain, local anesthetic, steroids

Background: The pathophysiology of lumbar radicular pain is the subject of ongoing research, with a reported prevalence of sciatica or radiculitis ranging from 1.2% to 43%. Among the numerous nonsurgical interventions available, epidural injections are the most commonly performed interventions in the United States in managing chronic low back and lower extremity pain. Study Design: A randomized, double-blind, controlled trial. Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. Objective: To evaluate the effectiveness of lumbar interlaminar epidural injections with local anesthetic, with or without steroids, in managing chronic low back and lower extremity pain secondary to disc herniation or radiculitis in providing effective and long-lasting pain relief. Methods: Patients were assigned to one of 2 groups with local anesthetic only or with local anesthetic mixed with non-particulate betamethasone. Randomization was performed by computer-generated random allocations sequence by simple randomization. Seventy patients were included in this analysis. Outcomes Assessment: Patient outcomes were measured at baseline, 3, 6, and 12 months post-treatment with the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake. Decrease of ≥ 50% of NRS scores and Oswestry scores were considered significant. Results: Significant pain relief (≥ 50%) was seen at 12 months in 74% of patients in Group I and 86% in Group II, and 69% and 83% in ODI scores respectively. Significant differences were noted in pain relief characteristics at 6 months between Group I and Group II (P = 0.001) and functional status improvement was significantly better in Group II at 6 months and 12 months (P = 0.019 and 0.045). The overall average procedures per year were 4.3 in Group I and 4.2 in Group II with an average total relief per year of 42.2 ± 10.5 weeks in Group I and 41.4 ± 11.0 weeks in Group II over a period of 52 weeks in the successful group. Limitations: The study limitations include the lack of a placebo group and the fact that this is a preliminary report of 35 patients in each group. Conclusion: Overall, 74% of patients in Group I without steroids and 86% in Group II with steroids with lumbar disc herniation or radiculitis might benefit from lumbar interlaminar epidural injections. Key words: Chronic low back pain, lower extremity pain, disc herniation, radiculitis, lumbar interlaminar epidural injections, epidural steroids, local anesthetic

Purpose Adjacent segment degeneration (ASD) is known to occur after anterior cervical arthrodesis. However, it is not known whether cervical canal stenosis enhances the risk of ASD. The purpose of this study was to explore whether congenital stenosis could be used as a predictor of ASD after anterior cervical decompression and fusion (ACDF). Methods We enrolled 141 patients who had undergone ACDF for cervical myelopathy and/or radiculopathy, and had at least 6 years of follow-up. In standard radiographs of cervical spine in lateral view, bony congenital stenosis was evaluated and all patients were divided into two groups: stenosis ( n  = 63) and non-stenosis ( n  = 78). Radiographic ASD was assessed according to the criteria of Kellgren and Lawrence and correlated with symptomatic ASD. Clinical and radiological parameters were compared between the groups. The primary outcome was the rate of radiographic ASD after initial ACDF. The incidence of symptomatic ASD was assessed by Kaplan–Meier method. Results Radiographic ASD and symptomatic ASD developed in 46.8 % and 18.4 % of all patients, respectively. There was a significant association between congenital stenosis and radiographic ASD. The area under the receiver operating characteristic curve of preoperative anteroposterior (AP) diameter of cervical canal for predicting radiographic ASD was 0.756. 13.0 mm was the cutoff value of preoperative AP diameter of cervical canal predicting radiographic ASD. Kaplan–Meier analysis predicted a disease-free survival rate of symptomatic ASD in 97.2 % of patients at 5 years and 78.0 % at 10 years after ACDF. There was no significant difference in survival rates of the adjacent segment between the two groups via log-rank analysis ( P  = 0.102). Conclusion Congenital stenosis can increase the rate of radiographic ASD after initial ACDF. The cutoff value of 13.0 mm for preoperative AP diameter of cervical canal had the highest validity for predicting radiographic ASD.

Background: The pathophysiology of lumbar radicular pain is a subject of ongoing research. The prevalence of sciatica or radiculitis ranges from 1.2% to 43%. Epidural injections are one of the most commonly performed interventions in the United States in managing chronic low back and lower extremity pain secondary to disc herniation and radiculitis. There is a paucity of evidence with contemporary methodology used in performing epidural injections under fluoroscopy and based on pain relief and functional status improvement. Study Design: A randomized, double-blind, equivalence trial. Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. Objective: To evaluate the effectiveness of caudal epidural injections with or without steroids in managing chronic low back and lower extremity pain secondary to disc herniation or radiculitis in providing effective and long-lasting pain relief and evaluate the differences between local anesthetic with or without steroids. Methods: Patients were assigned to one of 2 groups; Group I patients received caudal epidural injections with an injection of local anesthetic (lidocaine 0.5%), whereas, Group II patients received caudal epidural injections with 0.5% lidocaine 9 mL mixed with 1 mL of steroid. Randomization was performed by computer-generated random allocations sequence by simple randomization. Outcomes Assessment: Multiple outcome measures were utilized which included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3 months, 6 months, and 12 months post-treatment. Significant pain relief was defined as 50% or more, whereas significant improvement in disability score was defined as a reduction of 40% or more. Results: The percentage of patients with significant pain relief of 50% or greater at 12 months was 79% in Group I and 81% in Group II. Reduction of Oswestry scores of at least 40% was seen in 83% of the patients in Group I and 91% in Group II. The overall average procedures per year were 3.9 ± 1.26 in Group I and 3.6 ± 1.08 in Group II with an average total relief per year of 35.2 ± 17.18 weeks in Group I and 35.9 ± 15.34 weeks in Group II over a period of 52 weeks. Limitations: The results of this study are limited by lack of a placebo group and a preliminary report of 42 patients in each group. Conclusion: Caudal epidural injections with or without steroids may be effective in patients with disc herniation or radiculitis with between 79% to 91% of patients showing significant pain relief and improvement in functional status. Key words: Chronic low back pain, disc herniation, radiculitis, lower extremity pain, caudal epidural injections, epidural steroids, local anesthetic

Purpose Heterotopic ossification is a phenomenon in cervical arthroplasty. Previous reports have mainly focused on various semiconstrained devices and only a few publications have focused on ossification around devices that are nonconstrained. The purpose of this study was to assess the occurrence of heterotopic ossification around a nonconstrained cervical device and how it affects clinical outcome 2 years after surgery. Methods Thirty-seven patients were included from a larger cohort of a randomized controlled trial (NORCAT) which compared single-level cervical arthroplasty with fusion. The occurrence of heterotopic ossification was assessed with a CT scan and two neuroradiologists determined its degree. For grading, we used the Mehren/Suchomel classification system (grade 0–4). The patients were divided by level of ossification, low grade (0–2) or high grade (3–4), and clinical outcomes were compared. Self-rated disability for neck and arm pain (Neck Disability Index), health-related quality of life (the Short Form-36 and EuroQol-5D), and pain (the Numeric Rating Scale 11) were used as clinical outcome measures. Results Heterotopic ossification was encountered in all patients 2 years after surgery. Complete fusion (grade 4) was found in 16 % of participants, and high-grade ossification (grade 3–4) occurred in 62 %. The remaining patients were classified as having low-grade ossification (grade 2). There were no differences in the clinical outcomes of patients with low- and high-grade ossification. Conclusion High-grade heterotopic ossification and spontaneous fusion 2 years after surgery were seen in a significant number of patients. However, the degree of ossification did not influence the clinical outcome.

Background Many studies on low back pain (LBP) have identified prognostic factors, but prediction models for use in secondary health care are not available. The purpose of this cohort study, based on a randomised clinical study, was to identify risk factors for unsuccessful return to work (U-RTW) in sick-listed LBP patients with or without radiculopathy and to validate a prediction model for U-RTW. Methods 325 sick-listed LBP patients with or without radiculopathy were included in an intervention study and followed for one year. Afterwards, 117 other LBP patients were recruited similarly, included in a validation study and also followed for one year. All patients were subjected to identical procedures and interventions and received a brief intervention by the same rehabilitation doctor and physiotherapist. Half of them received case manager guidance within a multidisciplinary setting. At baseline, they completed a questionnaire and went through a clinical low-back examination. Sciatica was investigated by magnetic resonance imaging (MRI). U-RTW was registered in a national database both initially and at 1-year. Results Neither initial U-RTW (24.0%) nor one-year U-RTW (38.2%) were statistically significantly different in the two intervention groups nor in patients with and without radiculopathy. Multivariate logistic regression analysis identified two clinical and five psychosocial baseline predictors for one-year U-RTW (primary outcome). The clinical predictors included pain score (back+leg pain) and side-flexion. The five psychosocial predictors included ‘bodily distress’ ‘low expectations of RTW’, ‘blaming the work for pain’, ‘no home ownership’ and ‘drinking alcohol less than once/month’. These predictors were not statistically significantly different in patients with and without radiculopathy, and they also predicted initial U-RTW (secondary outcome). Obesity and older age were only supplementary predictors in patients with radiculopathy. A prediction model was established and tested in the validation study group. The model predicted one-year U-RWT in patients with intermediate and high risk, but only partially in patients with low risk. The model predicted all three risk categories in initial U-RTW. Conclusions A prediction model combining baseline clinical and psychosocial risk factors predicted patients with low, intermediate and high risk for unsuccessful return to work, both initially and at 1-year.

Background A research gap exists for optimal management of cervical radiculopathy in the first 12 weeks and short term natural history of the condition is somewhat unclear, although thought to be favourable. The primary aim of this assessor blinded, superiority, 2 parallel group randomised controlled trial is to investigate the effects of a 4 week physiotherapy programme (6–8 sessions) of manual therapy, exercise and upper limb neural unloading tape, compared to a control of weekly phone advice; on disability, pain and selected biopsychosocial measures, in acute and sub-acute cervical radiculopathy patients. A secondary aim is to identify whether any baseline variables, symptom duration or group allocation can predict outcome. Methods Participants are recruited from GP referrals in an urban setting, from a neurosurgery non-urgent waiting list and from self-referral through Facebook advertising. Eligible participants ( n  = 64) are diagnosed with radiculopathy based on a clinical prediction rule and must have symptoms of unilateral, single level, radiculopathy for between 2 and 12 weeks, without having yet received physiotherapy. Random 1:1 group allocation (using variable block sizes), allocation concealment, blinded assessment and intention to treat analysis are being employed. Treatment is provided by clinical specialist physiotherapists in primary and secondary care settings. Outcomes are measured at baseline, 4 (primary endpoint) and 12 weeks. Participants’ report of pain, disability and their rating of recovery is also recorded by telephone interview at 6 months. Statistical analysis of between group differences will be performed with ANOVAs and MANOVAs, and multivariable regression analysis will be undertaken to explore predictor variables. Ethical approval for this study has been received from the Beaumont Hospital and Irish College of General Practitioners Research Ethics Committees. The trial is registered at ClinicalTrials.gov (NCT02449200). Discussion An internal pilot study to test retention and recruitment strategies led to trial expansion and this is now a multi centre trial involving 5 clinical sites. Trial registration NCT02449200 . Registered 20/05/15.