Improvement In Oswestry Disability Index Research Articles

Clinical Outcomes of Interlaminar Percutaneous Endoscopic Uniportal Pars Decompression for Lumbar Spondylolysis.

To evaluate the clinical and radiological outcomes of a novel full endoscopic procedure performed via an interlaminar approach to decompress entrapped nerve roots in patients with lumbar spondylolysis. Patients who underwent interlaminar percutaneous endoscopic pars decompression were included in this retrospective cohort study. Patients with back pain and dynamic lumbar instability were excluded from the study. Clinical parameters related to outcomes, including the Oswestry Disability Index (ODI) and visual analog scale (VAS) for leg pain, were assessed before and after surgery. The radiological outcomes, vertebral slippage percentage, and motion radiographs were evaluated preoperatively and postoperatively. Of the 11 patients included in the study, 5 had spondylolysis alone, 1 of whom had spondylolysis at L3-L4 and L4-L5, and 4 of whom had it at L5-S1; and 6 patients had spondylolysis in combination with spondylolisthesis, of whom 4 had involvement at L5-S1, 1 had involvement at L4-L5, and 1 had involvement at L3-L4. At a mean follow-up period of 22.64 months, 63.3% of patients achieved more than 50% improvement in ODI score and 90.91% of patients achieved more than 50% improvement in VAS score. Spondylolysis with vertebral slippage had inferior ODI improvement outcomes as compared with spondylolysis alone, but the VAS was not significantly different. No significant difference was observed on the slippage percentage observed between the pre- and postoperative periods. However, 1 patient experienced vertebral slippage after surgery, but fusion surgery was not required. Interlaminar percutaneous endoscopic pars decompression is a safe and successful treatment for patients with stable lumbar spondylolysis and nerve root compression. Even in situations in which vertebral slippage occurs, spinal fusion may not be the best option for all patients with lumbar spondylolysis. The interlaminar percutaneous endoscopic pars decompression is a safe and successful procedure for treatment of patients with stable lumbar spondylolysis and nerve root compression.

Systematic Review of Current Literature on Clinical Outcomes of Uniportal Interlaminar Contralateral Endoscopic Lumbar Foraminotomy for Foraminal Stenosis

Uniportal interlaminar contralateral endoscopic lumbar foraminotomy (ICELF) aims to achieve decompression of lumbar spinal stenosis in the contralateral lateral recess and foraminal and extraforaminal regions of the same segment. This technique is performed under normal saline irrigation using an endoscope with optical lens magnification close to the targeted stenotic segment and has the potential of lower incidence of exiting nerve root dorsal root ganglion irritation. A systematic review of the ICELF technique was conducted from March 2000 to March 2022. Articles were selected with Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Eligibility of studies was independently determined by 2 reviewers, and disagreements were resolved by a third author. Eight retrospective cohort studies comprising 194 patients with foraminal stenosis who underwent uniportal ICELF were selected for systematic review. Mean age range was 62-79 years, and surgical duration was 48-73.5 minutes. There was significant improvement in Oswestry Disability Index and visual analog scale leg pain score in the included studies. Four studies met the minimum clinically significant difference for leg pain, with visual analog scale improved >5 points and Oswestry Disability Index improved >8.2 points. Four studies reported a majority of the operated patients with good or excellent outcomes following surgery, with a low rate of complications in the studies selected. There is low-level evidence that ICELF when performed by an experienced spinal endoscopic surgeon is effective in providing pain relief and improved function with low rate of complications in select patients.

Mid-term efficacy and safety of Escherichia coli-derived rhBMP-2/hydroxyapatite carrier in lumbar posterolateral fusion: a randomized, multicenter study

PurposeThis study aimed to evaluate the mid-term efficacy and safety of Escherichia coli-derived bone morphogenetic protein-2 (E.BMP-2)/hydroxyapatite (HA) in lumbar posterolateral fusion (PLF).MethodsThis multicenter, evaluator-blinded, observational study utilized prospectively collected clinical data. We enrolled 74 patients who underwent lumbar PLF and had previously participated in the BA06-CP01 clinical study, which compared the short-term outcomes of E.BMP-2 with an auto-iliac bone graft (AIBG). Radiographs and CT scans were analyzed to evaluate fusion grade at 12, 24, and 36 months. Visual analog scale (VAS), Oswestry disability index (ODI), and Short Form-36 (SF-36) scores were measured preoperatively and at 36 months after surgery. All adverse events in this study were assessed for its relationship with E.BMP-2.ResultsThe fusion grade of the E.BMP-2 group (4.91 ± 0.41) was superior to that of the AIBG group (4.25 ± 1.26) in CT scans at 36 months after surgery (p = 0.007). Non-union cases were 4.3% in the E.BMP-2 and 16.7% in the AIBG. Both groups showed improvement in pain VAS, ODI, and SF-36 scores when compared to the baseline values, and there were no statistically significant differences between the two groups. No treatment-related serious adverse reactions were observed in either group. No neoplasm-related adverse events occurred in the E.BMP-2 group.ConclusionsThe fusion quality of E.BMP-2/HA was superior to that of AIBG. E.BMP-2/HA showed comparable mid-term outcomes to that of AIBG in terms of efficacy and safety in one-level lumbar PLF surgery.

Simultaneous Anterior Posterior Approach for Single-Position Lateral Lumbar Interbody Fusion with Robotic Assistance: Technical Guidelines and Early Outcomes

Lumbar lateral interbody fusion (LLIF) is traditionally performed in 2 stages: placing the interbody cage in the lateral decubitus position, then placing the percutaneous pedicle screw in the prone position. Performing interbody fusion and posterior fixation simultaneously could improve operative efficiency and clinical outcomes associated with longer operative times. We describe the operative steps and report clinical and radiographic outcomes associated with a simultaneous anterior and posterior approach (SAPA) for LLIF. Patients who underwent SAPA LLIF performed by a single surgeon over 1 year were retrospectively reviewed. Demographic, clinical, and radiographic data were analyzed, an operative guideline was created, and a learning curve was constructed using operative times. SAPA LLIF was performed in 11 patients. Three patients experienced transient postoperative femoral nerve plexopathy with symptoms of ipsilateral hip flexion weakness and/or anterior thigh numbness; there were no other complications in the cohort. Radiographically, patients achieved significant increases in disc height (8.3 mm vs. 13.5 mm, P= 0.002) and foraminal height (20.2 mm vs. 25.3 mm, P= 0.0001). Patients showed significant improvements in Oswestry Disability Index (52 vs. 27.8, P= 0.002) and Patient-Reported Outcome Measurement Information System Physical Function (32.6 vs. 39, P= 0.048) and Pain Interference (64.9 vs. 59.6, P= 0.001) at 3 months. A downward trend in operative time was observed for 1-level SAPA LLIF. SAPA LLIF is a safe approach for LLIF that results in favorable clinical outcomes. This technique can potentially improve operative efficiency further along the course of a surgeon's learning curve.

Pain Interference Influence on Postoperative Clinical Trajectory in Patients Undergoing Lumbar Decompression

Newer Patient-Reported Outcomes (PROs) may offer benefits over legacy PROs in ease of administration and interpretation. We aim to study the influence of preoperative pain interference (PI) using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PROMIS-PI) on postoperative clinical outcomes in patients undergoing lumbar decompression. Patients undergoing lumbar decompression without fusion were separated into 2 cohorts: PROMIS-PI < 64 (lesser PI) and PROMIS-PI ≥ 64 (greater PI). PROs included PROMIS physical function, PROMIS anxiety (PROMIS-A), PROMIS sleep disturbance (PROMIS-SD), PROMIS-PI, Patient Health Questionnaire-9, Visual Analog Scale (VAS) back, VAS leg, and Oswestry Disability Index (ODI) and were collected at preoperative and postoperative time points. Demographics, perioperative characteristics, PROs, and Minimum Clinically Important Difference (MCID) were compared among groups through non-parametric inferential statistics. One-hundred and seven patients were identified. Independent of preoperative PI, patients reported significant postoperative improvement in PROMIS physical function, PROMIS-A, PROMIS-PI, VAS back, VAS leg, and ODI. The greater PI cohort reported significant postoperative improvement in Patient Health Questionnaire-9 and PROMIS-SD. The lesser PI cohort reported superior preoperative PROs in all domains. Postoperatively, the lesser PI cohort reported superior 6-week PROMIS-A and PROMIS-SD. MCID achievement rates were higher in the greater PI cohort for PROMIS-PI, VAS back, VAS leg, and ODI. Patients with lower preoperative PI reported superior postoperative anxiety and sleep disturbance. Patients with greater preoperative PI had higher MCID achievement rates in PI, pain, and disability. Patients with greater preoperative PI undergoing lumbar decompression may demonstrate higher rates of clinically tangible improvement.

Comparative study of unilateral biportal endoscopy and coaxial large channel endoscopy for lumbar spinal stenosis

Objective: To compare the efficacy of unilateral biportal endoscopy (UBE) and coaxial large channel endoscopy for lumbar spinal stenosis. Methods: A total of 176 patients with lumbar spinal stenosis treated in Tianjin Hospital from March 2015 to October 2021 were included in this study. Of the patients, 110 cases were treated with UBE, including 52 males and 58 females, with a mean age of (75.1±10.4) years; while 66 cases were treated with coaxial large channel endoscopy, including 31 males and 35 females, with an average age of (77.2±13.1) years. The visual analogue scale (VAS) score of pain and Oswestry disability index (ODI) were compared before and after surgery between the two groups, with the improvement rate calculated. The operation time, intraoperative blood loss, perioperative conditions and complications were compared. The operation efficacy was evaluated according to MacNab scale and was compared between the two groups. Results: There was no significant differences in age, gender, disease course, VAS of pain, ODI and index levels between the two groups before operation (all P>0.05). The operation time and postoperative drainage in UBE group and coaxial large channel endoscopy group were comparable [(60.1±12.4)min, (62.5±13.2)min and (103.8±20.7)ml, (98.5±22.1)ml, respectively, both P>0.05]. After the operation, the VAS score of low back pain, VAS score of leg pain and ODI of the two groups were all lower than those before operation, and decreased continuously during follow-up; and under the repeated measures analysis of variance, significant differences were found between different time points (all P<0.05), no significant difference was found between the two groups (all P>0.05), nor interaction between groups and time points was detected (all P>0.05). The patients were followed-up for (18.0±4.2) months (6 to 30 months). There was no significant difference in VAS and ODI improvement rates and excellent rate of efficacy between the two groups at the last follow-up (all P>0.05). Conclusions: Both UBE and coaxial large channel endoscopy can provide excellent results for lumbar spinal stenosis. UBE has sufficient decompression and is convenient to explore and remove the herniated disc.

Modified Frailty Index Does Not Provide Additional Value in Predicting Outcomes in Patients Undergoing Elective Transforaminal Lumbar Interbody Fusion

To determine the predictive value of the modified Frailty Index (mFI) in evaluating sarcopenia and clinical outcomes in patients undergoing 1-level or 2-level transforaminal lumbar interbody fusion (TLIF). Patients who underwent a 1-level or 2-level TLIF between 2012 and 2020 were retrospectively identified. Frailty was compared among groups using mFI, and sarcopenia was classified by the psoas muscle cross-sectional area. Bivariate statistics compared demographics, comorbidities, and clinical outcomes. A linear regression model was developed using the Charlson Comorbidity Index (CCI) or mFI as independent variables to determine potential predictors for improvement in 1-year patient-reported outcomes. Of 488 included patients, 60 were severely frail and 60 patients had sarcopenia, but sarcopenia was not associated with patient frailty (P= 0.469). Severely frail patients had worse baseline Oswestry Disability Index (ODI) (P < 0.001), Mental Component Score-12 (P= 0.001), and Physical Component Score-12 (P < 0.001), and worse improvement in ODI (P= 0.037), Physical Component Score-12 (P < 0.001), and visual analog scale (VAS) back (P= 0.007). mFI was an independent predictor of poorer improvement in VAS back and ODI, whereas age+ CCI in addition predicted poorer improvement in VAS leg. Patients with higher mFI experienced longer length of stay, less frequent home discharge, and higher rates of complications, but similar readmission and reoperation rates. Frailer patients experience poorer improvement in back pain, physical functioning, and disability after TLIF. mFI and the combination of age and CCI comparably predict patient-reported outcomes but do not correlate to baseline sarcopenia. Frailty increased the risk of complications, length of hospital stay, and risk of nonhome discharge.

Global realignment after posterior vertebral column resection in severe thoracolumbar post-tubercular kyphosis: correlation with patient-reported outcomes.

To investigate spinal realignment in patients with severe post-tubercular kyphosis (PTK) who underwent posterior vertebral column resection (PVCR) and its correlation with patient-reported outcomes (PROs). Eighty-two patients were included in this study. Spinopelvic parameters (focal scoliosis (FS), coronal balance (CB), sagittal vertical axis (SVA), focal kyphosis (FK), C2-7 lordosis (CL), thoracic kyphosis (TK), lumbar lordosis (LL), sacral slope (SS), pelvic tilt (PT), pelvic incidence (PI), and pelvic incidence minus lumbar lordosis (PI-LL)) and PROs (Visual Analog Scale (VAS) and Oswestry Disability Index (ODI)) were analyzed. The correlation between spinopelvic parameters and PROs was evaluated. FK, FS, CL, TK, LL, and PI-LL significantly changed after surgery. FK decreased from pre-operative 108.5 ± 16.4° to 31.8 ± 4.5° at threemonths after surgery and increased to 38.7 ± 6.6° at final follow-up (P < 0.001). FS decreased from pre-operative 20.9 ± 2.2° to 5.1 ± 2.2° at final follow-up (P < 0.001). CL decreased from pre-operative 7.2 ± 7.3° to 3.3 ± 8.3° at final follow-up (P = 0.002). TK improved from pre-operative - 5.6 ± 7.1° to 12.9 ± 8.2° at final follow-up (P < 0.001). LL decreased from pre-operative 75.5 ± 12.6° to 45.5 ± 7.9° at final follow-up (P < 0.001). PI-LL improved from pre-operative - 24.8 ± 13.4° to 4.8 ± 9.9° at final follow-up (P < 0.001). The improvement of PROs was found to be significantly correlated with the variations of FK, CL, TK, LL, and PI-LL. The multiple regression analysis revealed that FK was an independent predictor for the improvement of VAS and ODI. PVCR is effective in treating severe PTK, which can significantly improve patients' clinical and radiographic outcomes. Spine surgeons should pay more attention to reducing the residual kyphosis.

Increased Surgical Experience in Microendoscopic Spinal Surgery Can Reduce Development of Postoperative Spinal Epidural Hematoma and Improve the Clinical Outcomes.

No reports have previously evaluated the association between surgical technique and the incidence of postoperative spinal epidural hematoma (PSEH) following microendoscopic decompression surgery (MED). This study aimed to evaluate the association between the development of radiographic PSEH (rPSEH) following MED and microendoscopic surgical experience and postoperative clinical outcomes related to the quality of life (QoL). This retrospective cohort study included 3922 patients who had undergone MED performed by a single surgeon. rPSEH was defined as a hematoma that was identified via routine magnetic resonance images performed 3-4 days postoperatively. Patients were divided into rPSEH and control groups to identify the risk factor of rPSEH and assess clinical outcomes. In the multivariate analysis, age (p = 0.002), surgical experience (p = 0.003), surgical time (p = 0.038), multilevel decompression (p &lt; 0.001), and diagnosis (p = 0.004) were identified as independent variables associated with rPSEH. Moreover, in mixed-effect models, the rPSEH group showed less improvement in Oswestry Disability Index (p = 0.014) than the control group. In conclusion, the surgical experience was identified as a risk factor for rPSEH that could lead to poor QoL. The sharing of microendoscopic surgical techniques among surgeons may reduce rPSEH incidence and improve patients' QoL.

Sinuvertebral nerve block treats discogenic low back pain: a retrospective cohort study.

Discogenic low back pain (DLBP) is considered the most common type of chronic low back pain (CLBP). Sinuvertebral nerve block (SVNB) is a rapid and precise intervention performed under local anesthesia to treat DLBP induced CLBP. Thus, in this study, we aimed to explore the clinical efficacy of SVNB for DLBP. We retrospectively included 32 DLBP patients from July 2020 and April 2021. Inclusion criteria: The patients had chronic pain, diagnosed as single-segment disc degeneration induced DLBP, and suffered from one-year ineffective conservative treatment. SVNB was performed and the patients were followed up at 3 and 7 days, and at 1 and 3 months after SVNB. The basic clinical characteristics, including age and gender, were collected. The measurements of Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI) were assessed. The average age was 49.31±14.37 years, and females vs. males was 20 (62.50%) vs. 12 (37.50%). The preoperative VAS and ODI score were 5.75±1.41 and 32.59±21.56, respectively. The VAS score was reduced to 2.50±1.46, 2.63±1.60, 3.53±2.17, and 3.78±2.18 at 3 and 7 days, and 1 and 3 months after SVNB, respectively (P<0.05). The improvement rates in the VAS score were 56.52%, 54.34%, 38.61%, and 34.26% at 3 and 7 days, and 1 and 3 months after SVNB, respectively. 18 patients (56.25%) experienced varying degrees of pain recurrence within 3 months. The ODI score was reduced by 17.28±13.06, 16.84±13.51, 19.63±17.12, and 21.44±19.03 points at 3, 7 days and 1, 3 months after SVNB, respectively (P<0.05). At 3 day and 3 month after SVNB, the ODI scores of 22 patients (68.75%) and 20 patients (62.50%) decreased to ≤20, respectively. The ODI improvement rates were 46.98%, 48.33%, 39.80%, and 34.24% at 3, 7 days and 1, 3 months after SVNB, respectively. We conducted a retrospective study of the clinical efficacy of SVNB for DLBP. As a rapid and cost-effective minimally invasive treatment, SVNB provided some assistance for the short-term pain relief and physical functional improvement of DLBP. SVNB could be a good choice for the treatment of DLBP.

Twelve-Month Results from a Prospective Clinical Study Evaluating the Efficacy and Safety of Cellular Bone Allograft in Subjects Undergoing Lumbar Spinal Fusion.

While autologous bone grafts remain the gold standard for spinal fusion procedures, harvesting autologous bone is associated with significant complications, including donor site infection, hematomas, increased operative time, and prolonged pain. Cellular bone allograft (CBA) presents an alternative to autologous bone harvesting, with a favorable efficacy and safety profile. The current study further investigates CBA as an adjunct to lumbar spinal fusion procedures. A prospective, multicenter, open-label clinical study was conducted in subjects undergoing lumbar spinal fusion with CBA (NCT02969616). Radiographic fusion status was assessed by an independent review of dynamic radiographs and CT scans. Clinical outcome measures included the Oswestry Disability Index (ODI) and visual analogue scale (VAS) for back and leg pain. Adverse-event reporting was conducted throughout 12 months of follow-up. Available subject data at 12 months were analyzed. A total of 274 subjects were enrolled into the study, with available data from 201 subjects (73.3%) who completed 12 months of postoperative radiographic and clinical evaluation at the time of analysis. Subjects had a mean age of 60.2 ± 11.5 years. A higher number of women (n = 124, 61.7%) than men (n = 77, 38.3%) were enrolled, with a collective mean BMI of 30.6 + 6.5 kg/m² (range 18.0-51.4). At month 12, successful fusion was achieved in 90.5% of subjects. A significant (<i>p</i> &amp;lt; 0.001) improvement in ODI, VAS-back, and VAS-leg clinical outcomes was also observed compared to baseline scores. One adverse event related to CBA (postoperative radiculopathy) was reported, with surgical exploration demonstrating interbody extrusion of graft material. This subject reported successful fusion at month 12. CBA represents a viable substitute for harvesting of autograft alone with a high rate of successful fusion and significant improvements in subject-reported outcomes, such as pain and disability. Positive benefit was observed in subjects reporting single and multiple risk factors for pseudoarthrosis.

Usefulness of preoperative Short Form-36 Mental Component Score as a prognostic factor in patients who underwent decompression surgery for degenerative lumbar spinal stenosis.

Physical factors such as frequency of low back pain, sensory abnormalities in the lower extremities, smoking history before surgery, and preoperative mental health status as predictors of operative outcomes have been growing as areas of interest in the field of degenerative lumbar spinal stenosis (DLSS). This study aimed to investigate the correlation between the preoperative Short Form-36 Mental Component Score (SF-36 MCS) and long-term prognosis after decompression surgery for DLSS. In total, 198 patients were enrolled in this study. The Oswestry Disability Index (ODI) and Rolland Morris Disability Questionnaire (RMDQ) were used to evaluate spinal functional outcomes. The SF-36 questionnaire was used and analyzed by classifying it into physical component score (PCS) and mental component score (MCS). The SF-36 MCS was divided into role limitations caused by emotional problems, social functioning, vitality, and emotional well-being. In the correlation between preoperative MCS and ODI improvement, the r value was −0.595 (P < .05) at 12 months postoperatively. ODI improvement at 12 months after decompression surgery showed a statistically significant and strong negative correlation with preoperative MCS. In the correlation between preoperative MCS and RMDQ improvement, the r value was −0.544 (P < .05) at 12 months postoperatively. Therefore, RMDQ improvement 12 months after decompression surgery showed a strong negative correlation with preoperative MCS. Regarding the correlation between preoperative MCS and SF-36 PCS improvement, the r values were 0.321 (P < .05) at 6 months postoperatively and 0.343 (P < .05) at 12 months postoperatively. Therefore, SF-36 PCS improvement at 6 and 12 months after decompression surgery showed a strong positive correlation with preoperative SF-36 MCS scores. Preoperative SF-36 MCS is a factor that can predict the prognosis of patients who underwent decompression surgery for lumbar spinal stenosis for at least 1 year postoperatively.

Indirect Decompression Using Oblique Lumbar Interbody Fusion Revision Surgery Following Previous Posterior Decompression: Comparison of Clinical and Radiologic Outcomes Between Direct and Indirect Decompression Revision Surgery.

ObjectiveThis study compared the radiological and clinical outcomes with transforaminal lumbar interbody fusion (TLIF) to evaluate the effect of indirect decompression through oblique lumbar interbody fusion (OLIF) as revision surgery. MethodsWe enrolled patients who underwent single-level fusion with revision surgery at the same level as the previous decompression level. We retrospectively reviewed 25 patients who underwent OLIF from 2017 to 2018 and 25 who received TLIF from 2014 to 2018. Radiologic and clinical outcomes were evaluated by cross-sectional area (CSA) of the spinal canal, thickness and area of ligamentum flavum (LF), subsidence, disc height, fusion rate, Oswestry Disability Index (ODI), and visual analogue scale (VAS). ResultsCompared with OLIF, the thickness and area of the LF after surgery were significantly less in TLIF, and the resulting CSA extension was also significantly higher. However, both groups showed improvement in ODI and VAS after surgery, and there was no difference between the groups. Complications related to the posterior approach in TLIF were 4 cases, and in OLIF, there were 2 cases that underwent additional posterior decompression surgery and 6 cases of transient paresthesia. ConclusionSince complications associated with the posterior approach can be avoided, OLIF is a safer and useful minimally invasive surgery. Therefore, appropriate indications are applied, OLIF is a good alternative to TLIF when revision surgery is considered.

Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction

BackgroundRestorative neurostimulation is a rehabilitative treatment for patients with refractory chronic low back pain (CLBP) associated with dysfunction of the lumbar multifidus muscle resulting in impaired neuromuscular control. The ReActiv8-B randomized, sham-controlled trial provided evidence of the effectiveness and safety of an implanted, restorative neurostimulator. The two-year analysis previously published in this journal demonstrated accrual of clinical benefits and long-term durability. ObjectiveEvaluation of three-year effectiveness and safety in patients with refractory, disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery. Materials and MethodsProspective, observational follow-up of the 204 implanted trial participants. Low back pain visual analog scale (VAS), Oswestry Disability Index (ODI), EuroQol quality of life survey, and opioid intake were assessed at baseline, six months, and one, two, and three years after activation. The mixed-effects model repeated measures approach was used to provide implicit imputations of missing data for continuous outcomes and multiple imputation for proportion estimates. ResultsData were collected from 133 participants, and 16 patients missed their three-year follow-up because of coronavirus disease restrictions but remain available for future follow-up. A total of 62% of participants had a ≥ 70% VAS reduction, and 67% reported CLBP resolution (VAS ≤ 2.5cm); 63% had a reduction in ODI of ≥ 20 points; 83% had improvements of ≥ 50% in VAS and/or ≥ 20 points in ODI, and 56% had these substantial improvements in both VAS and ODI. A total of 71% (36/51) participants on opioids at baseline had voluntarily discontinued (49%) or reduced (22%) opioid intake. The attenuation of effectiveness in the imputed (N = 204) analyses was relatively small and did not affect the statistical significance and clinical relevance of these results. The safety profile remains favorable, and no lead migrations have been observed to date. ConclusionAt three years, 83% of participants experienced clinically substantial improvements in pain, disability, or both. The results confirm the long-term effectiveness, durability, and safety of restorative neurostimulation in patients with disabling CLBP associated with multifidus muscle dysfunction. Clinical Trial RegistrationThe Clinicaltrials.gov registration number for the study is NCT02577354.

Epidural Steroid Injection Versus Conservative Measures in Treatment of Chronic Axial Low Back Pain, A Prospective Randomized Controlled Study

Chronic low back pain (CLBP) is a very common disorder with various management strategies. There is still debate regarding treatment alternatives for axial CLBP. This study aimed to compare the effect of epidural steroid injection (ESI), interferential current (IFC) therapy and core strengthening exercises in a prospective randomized controlled manner. Hence, sixty patients complaining of axial CLBP were included and randomly assigned into either a group of ESI and exercises (group A) or IFC and exercises (group B) or exercises only (group C); each group was of 20 patients. Outcomes were visual analogue scale (VAS) for pain, Oswestry disability index (ODI) for function and Beck's depression inventory (BDI) for depression, assessed at baseline and 3-, 6- and 12-week follow-ups. At the start of the study, there were no significant differences between the three groups in age, gender, cause and duration of CLBP, body mass index, abdominal muscle power, muscle spasm or tenderness (p &gt; 0.05). Significant improvement in VAS and ODI at 3-, 6- and 12-weeks was observed compared to baseline assessment in the three studied groups. The improvement was higher for group A compared to B and C. BDI was significantly improved in group A and C at 3 weeks, and in all groups at 6- and 12-weeks compared to baseline. However, at the end of the study, there was no significant difference in the BDI between the three groups. From this study and over a period of 3 months, all studied groups showed improvement in pain, function, and depression but the group who received epidural steroid injection with core strengthening exercises was statistically better than the other two groups, with significant improvement in pain and function, but not in depression. Early effective assessment and dealing with depression, even prophylactic treatment and cognitive behavioral therapy should be addressed. Trial registration: The Pan African Clinical Trial Registry (www.pactr.org) identification number is PACTR201901523042787 on 16 January 2019.

Treatment of Lumbosacral Radiculopathy with Acupuncture and Medical Herbs: Four Case Reports

Lumbosacral radiculopathy (LR) is a musculoskeletal disorder or pain syndrome that is generally linked to the compression or irritation of the nerve root. There is a growing interest in the development of efficient acupuncture-based treatments for LR comparable to western medicine. Structured traditional Korean medical treatments including intensified acupuncture stimulus on the EX-B2 point using the G-shaped posture modified from the sitting posture were applied to four LR patients, and the outcomes were evaluated based on objective clinical endpoints including a numeric rating scale (NRS), the Oswestry disability index (ODI), the manual muscle test (MMT), neurological symptoms, and plantar photography. Patients showed improvements in NRS, ODI, MMT, and neurological symptoms without adverse effects during hospitalization and follow-up visits. Moreover, we observed substantial dissolvement of hyperkeratinization and parchedness of the soles of the feet, which was not reported previously. These four cases demonstrate the clinical usefulness of traditional medicine and the diagnostic applicability of plantar photography. However, further randomized controlled trials are required to confirm our findings.

Increased Surgeon-specific Experience and Volume is Correlated With Improved Clinical Outcomes in Lumbar Fusion Patients.

The present study design was that of a single center, retrospective cohort study to evaluate the influence of surgeon-specific factors on patient functional outcomes at 6 months following lumbar fusion. Retrospective review of a prospectively maintained database of patients who underwent neurosurgical lumbar instrumented arthrodesis identified the present study population. This study seeks to evaluate surgeon-specific variable effects on patient-reported outcomes such as Oswestry Disability Index (ODI) and the effect of North American Spine Society (NASS) concordance on outcomes in the setting of variable surgeon characteristics. Lumbar fusion is one of the fastest growing procedures performed in the United States. Although the impact of surgeon-specific factors on patient-reported outcomes has been contested, studies examining these effects are limited. This is a single center, retrospective cohort study analyzing a prospectively maintained database of patients who underwent neurosurgical lumbar instrumented arthrodesis by 1 of 5 neurosurgery fellowship trained spine surgeons. The primary outcome was improvement of ODI at 6 months postoperative follow-up compared with preoperative ODI. A total of 307 patients were identified for analysis. Overall, 62% of the study population achieved minimum clinically important difference (MCID) in ODI score at 6 months. Years in practice and volume of lumbar fusions were statistically significant independent predictors of MCID ODI on multivariable logistic regression ( P =0.0340 and P =0.0343, respectively). Concordance with evidence-based criteria conferred a 3.16 (95% CI: 1.03, 9.65) times greater odds of achieving MCID. This study demonstrates that traditional surgeon-specific variables predicting surgical morbidity such as experience and procedural volume are also predictors of achieving MCID 6 months postoperatively from lumbar fusion. Independent of surgeon factors, however, adhering to evidence-based guidelines can lead to improved outcomes.

Transforaminal Versus Interlaminar Endoscopic Lumbar Discectomy for Lumbar Disc Herniation: A Systematic Review and Meta-Analysis.

Meta-analysis and systematic review. This study aims to investigate and compare patient-reported outcomes, perioperative data, and complications between 2 common endoscopic approaches for lumbar disc herniation: transforaminal and interlaminar endoscopic lumbar discectomy, by published high-quality evidence. Electronic databases were searched for reported outcomes following TELD and IELD. Oswestry Disability Index (ODI), visual analog scale of back (VASB) and leg pain (VASL), and MacNab criteria were evaluated. Operative time, hospital stays, blood loss, radiation exposure, and complications were investigated. Odds ratio (OR) and mean differences (MD) with 95% confidence intervals (CI) were calculated using random and fixed-effect models. Total of 1948 patients from 18 studies were included, consisting of 1006 patients (51.6%) in TELD group and 942 (48.4%) patients in IELD group. TELD had better improvement of postoperative ODI (MD = 1.26; 95% CI: .07-2.16; P = .04), postoperative VASB (MD = -.23; 95% CI: -.40 to -.05; P = .01) and last follow-up VASB (MD = -.25; 95% CI: -.41 to -.09; P = .002), but with longer operative time (MD = 10.1min; 95% CI: 1.925-18.77; P < .00001) and more fluoroscopic time (SMD = 4.12; 95% CI: 3.22-5.03; P < .00001), especially in L5-S1 operation. Bed rest time was significantly longer following IELD, with no difference in VASL, hospital stays, or complication. We found comparable clinical outcomes in terms of ODI, VAS, patient satisfaction, hospital stays, and complication between both techniques. TELD required more radiation exposure and longer operative time at L5-S1 level than IELD. Our study provided results to help consider appropriate approaches for selected patients and informed consent of benefits from each approach.

107. Intraosseous basivertebral nerve ablation randomized control trial 24-month results

BACKGROUND CONTEXT Vertebral endplates, innervated by the basivertebral nerve, can be a source of vertebrogenic low back pain when damaged with inflammation visible as types 1 or 2 Modic changes. PURPOSE A randomized controlled trial (RCT) compared basivertebral nerve ablation (BVNA) to standard care (SC) showing significant differences between arms at 3 and 6-months. At 12 months, significant improvements were sustained for BVNA. We report results of the BVNA arm at 24 months. METHODS Prospective, open label, single-arm follow-up of the BVNA treatment arm of an RCT in 20 US sites with visits at 6 weeks, and 3, 6, 9, 12 and 24 months. Paired comparisons to baseline were made at each time point for Oswestry Disability Index (ODI), Visual Analog Scale (VAS), Short Form Health Survey (SF-36), EQ-5D-5L, and responder rates. RESULTS A total of 140 patients were randomized, 66 to BVNA. In the 58 BVNA patients completing a 24-month visit, 67% had back pain for >5 years, 36% were actively taking opioids at baseline, 50% had prior epidural steroid injections, and 12% had prior low back surgery. Improvements in ODI, VAS, SF-36 PCS, and EQ-5D-5L were statistically significant at all time points through 2 years. At 24 months, ODI and VAS improved 28.5±16.2 points (from baseline 44.5; p <0.001) and 4.1±2.7 cm (from baseline 6.6; p <0.001), respectively. A combined responder rate of ODI=15 and VAS=2 was 73.7%. A 50% reduction in pain was reported in 72.4% of patients and 31.0% were pain-free at 2 years. At 24 months, only 3 (5%) of patients had BVNA-level steroid injections, and 62% fewer patients were actively taking opioids. There were no serious device or device-procedure related adverse events reported through 24 months. CONCLUSIONS Intraosseous BVNA demonstrates an excellent safety profile and significant improvements in pain, function, and quality of life that are sustained through 24 months in patients with chronic vertebrogenic low back pain. FDA DEVICE/DRUG STATUS Basivertebral nerve ablation (Approved for this indication) Vertebral endplates, innervated by the basivertebral nerve, can be a source of vertebrogenic low back pain when damaged with inflammation visible as types 1 or 2 Modic changes. A randomized controlled trial (RCT) compared basivertebral nerve ablation (BVNA) to standard care (SC) showing significant differences between arms at 3 and 6-months. At 12 months, significant improvements were sustained for BVNA. We report results of the BVNA arm at 24 months. Prospective, open label, single-arm follow-up of the BVNA treatment arm of an RCT in 20 US sites with visits at 6 weeks, and 3, 6, 9, 12 and 24 months. Paired comparisons to baseline were made at each time point for Oswestry Disability Index (ODI), Visual Analog Scale (VAS), Short Form Health Survey (SF-36), EQ-5D-5L, and responder rates. A total of 140 patients were randomized, 66 to BVNA. In the 58 BVNA patients completing a 24-month visit, 67% had back pain for >5 years, 36% were actively taking opioids at baseline, 50% had prior epidural steroid injections, and 12% had prior low back surgery. Improvements in ODI, VAS, SF-36 PCS, and EQ-5D-5L were statistically significant at all time points through 2 years. At 24 months, ODI and VAS improved 28.5±16.2 points (from baseline 44.5; p <0.001) and 4.1±2.7 cm (from baseline 6.6; p <0.001), respectively. A combined responder rate of ODI=15 and VAS=2 was 73.7%. A 50% reduction in pain was reported in 72.4% of patients and 31.0% were pain-free at 2 years. At 24 months, only 3 (5%) of patients had BVNA-level steroid injections, and 62% fewer patients were actively taking opioids. There were no serious device or device-procedure related adverse events reported through 24 months. Intraosseous BVNA demonstrates an excellent safety profile and significant improvements in pain, function, and quality of life that are sustained through 24 months in patients with chronic vertebrogenic low back pain.

40. Disc progenitor cell therapy improves pain, disability, and quality of life for patients with lumbar disc degeneration: results of an FDA-approved clinical trial

BACKGROUND CONTEXT Allogeneic disc progenitor cells derived from adult intervertebral disc tissue have demonstrated both immunomodulatory and regenerative properties in preclinical animal studies. This includes the ability to increase aggrecan and collagen production and restore disc histology. These cells have the potential to impact the pathophysiology of degenerative disc disease (DDD) and lead to lasting pain relief and improved quality of life for patients with symptomatic DDD. PURPOSE To report the results of an FDA-approved clinical trial of injectable allogeneic disc progenitor cells and a viscous carrier for the treatment of DDD vs carrier and saline controls. STUDY DESIGN/SETTING A randomized, double-blind, placebo-controlled study at 13 clinical sites. PATIENT SAMPLE Sixty subjects (mean age 38, 60% male) were enrolled. OUTCOME MEASURES Subjects were assessed using validated safety and efficacy parameters including low-back pain visual analog scale (VAS), Oswestry Disability Index (ODI) and EQ-5D. METHODS Subjects with early to moderate, symptomatic lumbar DDD were randomized to one of four treatment groups and received single intradiscal injections of either low-dose cells (3,000,000cells/mL; N=20), high-dose cells (9,000,000cells/mL; N=20), vehicle alone (N=10) or placebo (N=10). Subject outcomes were assessed over 52 weeks. RESULTS VAS scores in the high-dose cell group were statistically significantly improved over baseline at weeks 12 (-54.53% [-69.46, -39.60], p=0.0056), 26 (-50.94% [-66.10, -35.78], p=0.0140), and 52 (-62.79% [90% CI -77.13, -48.46], p=0.0005). The vehicle group achieved statistical significance in VAS at week 52 only (-52.83% [90%CI -74.73, -30.92], p=0.0443). Mean pain VAS improved from baseline after treatment but only achieved statistical significance at week 26 with low-dose cells (-48.49% [90% CI -61.03, -35.94], p=0.0101) and saline (-50.13% [-65.24, -35.02], p=0.0206); neither demonstrated statistical significance at week 52. Further analysis showed that only the high-dose cell group showed reduction from baseline in back pain VAS that was statistically significantly greater than a minimum clinically important difference (MCID) of -20mm at week 52 (-39.8 [-50.0, -29.6], p=0.0001). Only the high-dose cell group exhibited an improvement from baseline in ODI score at week 52 that was statistically significantly greater than a MCID of -10 points (-24.3[-31.2, -17.5], p <0.0001) and an EQ-5D index score that was statistically significantly greater than a MCID of 0.08 (0.194 [0.139, 0.250], p <0.0001). CONCLUSIONS High-dose allogeneic disc progenitor cells produced meaningful, statistically significant improvements in back pain VAS, ODI and EQ-5D at one-year post-intradiscal injection. FDA DEVICE/DRUG STATUS IDCT - Injectable Discogenic Cell Therapy (Investigational/Not Approved) Allogeneic disc progenitor cells derived from adult intervertebral disc tissue have demonstrated both immunomodulatory and regenerative properties in preclinical animal studies. This includes the ability to increase aggrecan and collagen production and restore disc histology. These cells have the potential to impact the pathophysiology of degenerative disc disease (DDD) and lead to lasting pain relief and improved quality of life for patients with symptomatic DDD. To report the results of an FDA-approved clinical trial of injectable allogeneic disc progenitor cells and a viscous carrier for the treatment of DDD vs carrier and saline controls. A randomized, double-blind, placebo-controlled study at 13 clinical sites. Sixty subjects (mean age 38, 60% male) were enrolled. Subjects were assessed using validated safety and efficacy parameters including low-back pain visual analog scale (VAS), Oswestry Disability Index (ODI) and EQ-5D. Subjects with early to moderate, symptomatic lumbar DDD were randomized to one of four treatment groups and received single intradiscal injections of either low-dose cells (3,000,000cells/mL; N=20), high-dose cells (9,000,000cells/mL; N=20), vehicle alone (N=10) or placebo (N=10). Subject outcomes were assessed over 52 weeks. VAS scores in the high-dose cell group were statistically significantly improved over baseline at weeks 12 (-54.53% [-69.46, -39.60], p=0.0056), 26 (-50.94% [-66.10, -35.78], p=0.0140), and 52 (-62.79% [90% CI -77.13, -48.46], p=0.0005). The vehicle group achieved statistical significance in VAS at week 52 only (-52.83% [90%CI -74.73, -30.92], p=0.0443). Mean pain VAS improved from baseline after treatment but only achieved statistical significance at week 26 with low-dose cells (-48.49% [90% CI -61.03, -35.94], p=0.0101) and saline (-50.13% [-65.24, -35.02], p=0.0206); neither demonstrated statistical significance at week 52. Further analysis showed that only the high-dose cell group showed reduction from baseline in back pain VAS that was statistically significantly greater than a minimum clinically important difference (MCID) of -20mm at week 52 (-39.8 [-50.0, -29.6], p=0.0001). Only the high-dose cell group exhibited an improvement from baseline in ODI score at week 52 that was statistically significantly greater than a MCID of -10 points (-24.3[-31.2, -17.5], p <0.0001) and an EQ-5D index score that was statistically significantly greater than a MCID of 0.08 (0.194 [0.139, 0.250], p <0.0001). High-dose allogeneic disc progenitor cells produced meaningful, statistically significant improvements in back pain VAS, ODI and EQ-5D at one-year post-intradiscal injection.