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In a single-center, randomized trial involving 128 patients with sciatica lasting 4 to 12 months and lumbar disk herniation, diskectomy was superior to conservative care in reducing leg-pain intensity at 6 months after enrollment. Among the patients assigned to conservative care, 34% crossed over to undergo surgery.

Background Although previous studies have illustrated improvements in surgical cohorts for patients with intervertebral disc herniation, there are limited data on predictors of long-term outcomes comparing surgical and nonsurgical outcomes. Questions/purposes We assessed outcomes of operative and nonoperative treatment for patients with intervertebral disc herniation and symptomatic radiculopathy at 8 years from the Spine Patient Outcomes Research Trial. We specifically examined subgroups to determine whether certain populations had a better long-term outcome with surgery or nonoperative treatment. Methods Patients with symptomatic lumbar radiculopathy for at least 6 weeks associated with nerve root irritation or neurologic deficit on examination and a confirmed disc herniation on cross-sectional imaging were enrolled at 13 different clinical sites. Patients consenting to participate in the randomized cohort were assigned to surgical or nonoperative treatment using variable permuted block randomization stratified by site. Those who declined randomization entered the observational cohort group based on treatment preference but were otherwise treated and followed identically to the randomized cohort. Of those in the randomized cohort, 309 of 501 (62%) provided 8-year data and in the observational group 469 of 743 (63%). Patients were treated with either surgical discectomy or usual nonoperative care. By 8 years, only 148 of 245 (60%) of those randomized to surgery had undergone surgery, whereas 122 of 256 (48%) of those randomized to nonoperative treatment had undergone surgery. The primary outcome measures were SF-36 bodily pain, SF-36 physical function, and Oswestry Disability Index collected at 6 weeks, 3 months, 6 months, 12 months, and then annually. Further analysis studied the following factors to determine if any were predictive of long-term outcomes: sex, herniation location, depression, smoking, work status, other joint problems, herniation level, herniation type, and duration of symptoms. Results The intent-to-treat analysis of the randomized cohort at 8 years showed no difference between surgical and nonoperative treatment for the primary outcome measures. Secondary outcome measures of sciatica bothersomeness, leg pain, satisfaction with symptoms, and self-rated improvement showed greater improvement in the group randomized to surgery despite high levels of crossover. The as-treated analysis of the combined randomized and observational cohorts, adjusted for potential confounders, showed advantages for surgery for all primary outcome measures; however, this has the potential for confounding from other unrecognized variables. Smokers and patients with depression or comorbid joint problems had worse functional outcomes overall (with surgery and nonoperative care) but similar surgical treatment effects. Patients with sequestered fragments, symptom duration greater than 6 months, those with higher levels of low back pain, or who were neither working nor disabled at baseline showed greater surgical treatment effects. Conclusions The intent-to-treat analysis, which is complicated by high rates of crossover, showed no difference over 8 years for primary outcomes of overall pain, physical function, and back-related disability but did show small advantages for secondary outcomes of sciatica bothersomeness, satisfaction with symptoms, and self-rated improvement. Subgroup analyses identified those groups with sequestered fragments on MRI, higher levels of baseline back pain accompanying radiculopathy, a longer duration of symptoms, and those who were neither working nor disabled at baseline with a greater relative advantage from surgery at 8 years. Level of Evidence Level II, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.

AbstractObjectiveTo assess the efficacy of three months of antibiotic treatment compared with placebo in patients with chronic low back pain, previous disc herniation, and vertebral endplate changes (Modic changes).DesignDouble blind, parallel group, placebo controlled, multicentre trial.SettingHospital outpatient clinics at six hospitals in Norway.Participants180 patients with chronic low back pain, previous disc herniation, and type 1 (n=118) or type 2 (n=62) Modic changes enrolled from June 2015 to September 2017.InterventionsPatients were randomised to three months of oral treatment with either 750 mg amoxicillin or placebo three times daily. The allocation sequence was concealed by using a computer generated number on the prescription.Main outcome measuresThe primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (range 0-24) at one year follow-up in the intention to treat population. The minimal clinically important between group difference in mean RMDQ score was predefined as 4.ResultsIn the primary analysis of the total cohort at one year, the difference in the mean RMDQ score between the amoxicillin group and the placebo group was −1.6 (95% confidence interval −3.1 to 0.0, P=0.04). In the secondary analysis, the difference in the mean RMDQ score between the groups was −2.3 (−4.2 to−0.4, P=0.02) for patients with type 1 Modic changes and −0.1 (−2.7 to 2.6, P=0.95) for patients with type 2 Modic changes. Fifty patients (56%) in the amoxicillin group experienced at least one drug related adverse event compared with 31 (34%) in the placebo group.ConclusionsIn this study on patients with chronic low back pain and Modic changes at the level of a previous disc herniation, three months of treatment with amoxicillin did not provide a clinically important benefit compared with placebo. Secondary analyses and sensitivity analyses supported this finding. Therefore, our results do not support the use of antibiotic treatment for chronic low back pain and Modic changes.Trial registrationClinicalTrials.gov NCT02323412.

Background Lumbar disc herniation is a prevalent condition that leads to pain, disability, and a reduction in quality of life. While conventional treatments are widely utilized, virtual reality-based exercise programs present a promising alternative. However, the effectiveness of these exercises in the rehabilitation of lumbar disc herniation remains unclear. The aim of this study was to evaluate the effects of virtual reality-based exercises on pain, daily activities, quality of life, and fall risk in individuals with lumbar disc herniation. Materials and methods This randomized controlled trial included 68 patients meeting the study criteria. Inclusion criteria: No other physical disabilities, no surgery in the last 6 months, no uncontrolled diseases, no vertigo, knee or joint issues, moderate/low balance impairment, and body mass ındex below 40. Exclusion criteria: Uncontrolled diseases, vertigo, knee/joint issues, cognitive impairments, pregnancy, inability to complete fall risk measurement, or attend follow-ups . Participants were divided into a virtual reality group ( n  = 34, Mean age ± Standard Deviation = 51.05 ± 13.39, 41.2% male, 58.8% female) and a control group ( n  = 34, Mean age ± Standard Deviation = 53.55 ± 12.25, 29.4% male, 70.6% female). The virtual reality group performed 28 sessions of virtual reality -based exercises, while the control group received routine hospital treatment. The study was conducted in a single hospital due to equipment limitations in the region. Data were collected using the Patient Information Form, Visual Analog Scale, Oswestry Disability Index, Short Form-36 Quality of Life Scale, and Fall Risk Device. Statistical analyses were performed using Statistical Package for the Social Sciences 20, including t-tests, chi-square tests, effect size analysis, and skewness/kurtosis assessments for homogeneity. Results The virtual reality group showed a significant reduction in pain (Visual Analog Scale: 3.38 ± 1.48, Cl: -2.49, -0.86, p  < 0.05) and disability (Oswestry Disability Index: 21.59 ± 6.00, Cl: -19.92, -7.38, p  < 0.05), along with significant improvements in all Short Form-36 Quality Of Life sub-dimensions ( p  < 0.05).Fall risk scores also decreased significantly in the virtual reality group (Cl: -26.57, -7.26, p  < 0.05). There were no significant baseline differences between the groups, confirming their comparability before the intervention. Conclusion Virtual reality -based exercises effectively reduced pain, improved daily activities and quality of life, and decreased fall risk in lumbar disc herniation patients, suggesting their potential as a complementary rehabilitation approach. Blinding was not applied due to the nature of the interventions, which may introduce a potential risk of bias. Trial registration This study was registered at ClinicalTrials.gov (Clinical trial number: NCT05463588; Registration date: 08/07/2022). The study was retrospectively registered.

Purpose The objective of this trial was to compare the safety and efficacy of TDA using the ProDisc-C implant to ACDF in patients with single-level SCDD between C3 and C7. Methods We report on the single-site results from a larger multicenter trial of 13 sites using an approved US Food and Drug Administration protocol (prospective, randomized controlled non-inferiority design). Patients were randomized one-to-one to either the ProDisc-C device or ACDF. All enrollees were evaluated pre- and post-operatively at regular intervals through month 84. Visual Analog Scale (VAS) for neck and arm pain/intensity, Neck Disability Index (NDI), Short-Form 36 (SF-36), and satisfaction were assessed. Results Twenty-two patients were randomized to each arm of the study. Nineteen additional patients received the ProDisc-C via continued access. NDI improved with the ProDisc-C more than with ACDF. Total range of motion was maintained with the ProDisc-C, but diminished with ACDF. Neck and arm pain improved more in the ProDisc-C than ACDF group. Patient satisfaction remained higher in the ProDisc-C group at 7 years. SF-36 scores were higher in the TDA group than ACDF group at 7 years; the difference was not clinically significant. Six additional operations (two at the same level; four at an adjacent level) were performed in the ACDF, but none in the ProDisc-C group. Conclusions The ProDisc-C implant appears to be safe and effective for the treatment of SCDD. Patients with the implant retained motion at the involved segment and had a lower reoperation rate than those with an ACDF.

Purpose Transforaminal endoscopic discectomy (TED) minimises paraspinal muscle damage. The aim of this trial was to compare clinical outcomes of TED to Microdiscectomy (Micro). Methods 143 patients, age 25–70 years and <115 kg, with single level lumbar prolapse and radiculopathy, were recruited and randomised. 70 received TED under conscious sedation and 70 Micro under general anaesthesia. Oswestry Disability Index (ODI), visual analogue scores (VAS) of back and leg pain, and Short Form Health Survey indices (SF-36) were measured preoperatively and at 3, 12 and 24 months. Results All outcome measures improved significantly in both groups ( p  < 0.001). Affected side leg pain was lower in the TED group at 2 years (1.9 ± 2.6 vs 3.5 ± 3.1, p  = 0.002). Hospital stay was shorter following TED (0.7 ± 0.7 vs 1.4 ± 1.3 days, p  < 0.001). Two Micro patients and five TED patients required revision giving a relative risk of revision for TED of 2.62 (95% CI 0.49–14.0). Conclusions Functional improvements were maintained at 2 years in both groups with less ongoing sciatica after TED. A greater revision rate after TED was offset by a more rapid recovery.

Background Lumbar herniated disc (HNP) is mainly treated by conservative management. Epidural steroid injection (ESI) has been an option to treat failed cases prior to surgery. Triamcinolone has been widely used due to its efficacy in bringing about pain reduction for up to three months. However, several reports have shown some severe adverse events. Platelet-rich plasma (PRP) is made from blood through centrifugation. Several studies supported the potential short to long-term effects, and safety of PRP injection in treating HNP. The study objective was to evaluate the efficacy of PRP in treatment of single-level lumbar HNP in comparison to triamcinolone. Methods Thirty patients were treated by transforaminal epidural injections. PRP was obtained from 24 ml venous blood through standardized double-spin protocol. Participants included fifteen patients each being in triamcinolone and PRP groups. The same postoperative protocols and medications were applied. The visual analogue scale of leg (LegVAS), collected at baseline, 2, 6, 12, and 24 weeks, was the primary outcome. The BackVAS, Oswestry Disability Index (ODI), adverse event, and treatment failure were the secondary endpoints. Results Platelet ratio of PRP in fifteen patients was 2.86 ± 0.85. Patients treated by PRP injections showed statistically and clinically significant reduction in LegVAS at 6, 12, and 24 weeks, and in ODI at 24 weeks. It demonstrated comparable results on other aspects. No adverse event occurred in either group. Conclusion Noncommercial epidural double-spin PRP yielded superior results to triamcinolone. Due to its efficacy and safety, the procedure is recommended in treating single level lumbar HNP. Trial registration NCT, NCT05234840. Registered 1 January 2019, https://clinicaltrials.gov/ct2/show/record/NCT05234840 .

Lumbar disc herniation (LDH) is a prevalent condition in spinal surgery, and Traditional Chinese Medicine (TCM) acupuncture has gained clinical attention as a potential treatment for LDH in recent years. This study aimed to assess the therapeutic efficacy of acupuncture combined with acupoint massage in LDH patients. We enrolled a total of 135 LDH patients treated at our hospital from May 2021 to February 2023. Among them, 63 patients received acupuncture treatment (control group), while the remaining 72 received acupuncture combined with acupoint massage (observation group). We compared treatment efficacy and the time it took for lumbar stiffness, lower back and leg pain, bending and flexing difficulties, and other symptoms to disappear between the two groups. The Visual Analogue Scale (VAS) and Japanese Orthopedic Association Scoring System (JOA) were used to evaluate patients' pain levels and lumbar vertebral function before and after treatment. Additionally, we assessed patients using the Generic Quality of Life Inventory-74 (GQOL-74) and recorded their treatment satisfaction. The observation group exhibited a slightly higher total effective rate compared to the control group, with a shorter time for the resolution of lumbar stiffness, lower back pain, leg pain, and other symptoms (P < .05). Furthermore, the observation group had lower VAS scores and higher JOA scores (P < .05). They also achieved higher GQOL-74 scores and reported greater treatment satisfaction (P < .05). Acupuncture combined with acupoint massage effectively alleviated clinical symptoms and pain in LDH patients, demonstrating significant clinical utility.

Purpose Modic type 1 changes/bone edema in the vertebrae are present in 6 % of the general population and 35–40 % of the low back pain population. It is strongly associated with low back pain. The aim was to test the efficacy of antibiotic treatment in patients with chronic low back pain (>6 months) and Modic type 1 changes (bone edema). Methods The study was a double-blind RCT with 162 patients whose only known illness was chronic LBP of greater than 6 months duration occurring after a previous disc herniation and who also had bone edema demonstrated as Modic type 1 changes in the vertebrae adjacent to the previous herniation. Patients were randomized to either 100 days of antibiotic treatment (Bioclavid) or placebo and were blindly evaluated at baseline, end of treatment and at 1-year follow-up. Outcome measures Primary outcome, disease-specific disability, lumbar pain. Secondary outcome leg pain, number of hours with pain last 4 weeks, global perceived health, EQ-5D thermometer, days with sick leave, bothersomeness, constant pain, magnetic resonance image (MRI). Results 144 of the 162 original patients were evaluated at 1-year follow-up. The two groups were similar at baseline. The antibiotic group improved highly statistically significantly on all outcome measures and improvement continued from 100 days follow-up until 1-year follow-up. At baseline, 100 days follow-up, 1-year follow-up the disease-specific disability-RMDQ changed: antibiotic 15, 11, 5.7; placebo 15, 14, 14. Leg pain: antibiotics 5.3, 3.0, 1.4; placebo 4.0, 4.3, 4.3. Lumbar pain: antibiotics 6.7, 5.0, 3.7; placebo 6.3, 6.3, 6.3. For the outcome measures, where a clinically important effect size was defined, improvements exceeded the thresholds, and a trend towards a dose–response relationship with double dose antibiotics being more efficacious. Conclusions The antibiotic protocol in this study was significantly more effective for this group of patients (CLBP associated with Modic I) than placebo in all the primary and secondary outcomes.

In patients with symptomatic lumbar disk herniation treated with surgery or conservative care, there was no significant association between findings on MRI and clinical outcome at 1 year. Disk herniation persisted in 35% with a favorable outcome and 33% with an unfavorable outcome. Sciatica is a relatively common condition, with a lifetime incidence of 13 to 40%. 1 The most common cause of sciatica is a herniated disk. The natural history of sciatica is favorable, with spontaneous resolution of leg pain within 8 weeks in the majority of patients. 2 Surgery should be offered only if symptoms persist after a period of conservative treatment. However, contrary to what one might expect, given the advancements in diagnostic imaging and surgical techniques, the results after lumbar-disk surgery do not seem to have improved during recent decades. Both classic studies and randomized, controlled trials have shown that during . . .