scholarly journals Viable Disc Tissue Allograft Supplementation; One- and Two-level Treatment of Degenerated Intervertebral Discs in Patients with Chronic Discogenic Low Back Pain: One Year Results of the VAST Randomized Controlled Trial

2021 ◽  
Vol 24 (6) ◽  
pp. 465-477
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Lumbar Disc ◽  
Saline Group ◽  
Low Back ◽  
Disc Disease ◽  
Lumbar Disc Disease ◽  
Disc Tissue ◽  
Tissue Allograft ◽  
One Year

Background: A viable disc tissue allograft has been developed to supplement tissue loss associated with degenerative lumbar disc disease and the development of chronic discogenic lower back pain. Objectives: Viable disc allograft was injected into painful degenerated discs to evaluate safety and determine whether it can improve pain and function. Study Design: Patients received an active treatment of allograft or saline, or continued with nonsurgical management (NSM). Prior to entering the study, patients had back pain for a minimum of 6 months before treatment that was recalcitrant to nonoperative treatment modalities. Standardized outcome measures were used to evaluate the patient’s condition before and after treatment. Primary endpoints included improvement in Oswestry Disability Index (ODI) and Visual Analog Scale of Pain Intensity (VASPI). Conventional radiographs and magnetic resonance imaging scans were used to assess disc space height and spinal alignment, and to determine the degree of disc degeneration. Patients were followed for one year after enrollment. The NSM group could cross over to the allograft group after 3 months. Setting: This multicenter trial was completed in outpatient surgical centers and office injection suites. A total of 218 patients with chronic low back pain secondary to single-level or 2-level degenerative disc disease were enrolled. Inclusion criteria included pretreatment VASPI >= 40 mm, ODI score >= 40 and symptoms present longer than 6 months. Patients were blinded and randomized to receive intradiscal injections of either viable disc allograft or saline. Patients randomized to the NSM group continued existing treatment. Patients were assessed at 6 and 12 months. Adverse events (AEs) were continually assessed. Methods: The VAST trial is a prospective, multicenter, blind, randomized clinical trial (RCT) for patients with single-level or 2-level degenerative lumbar disc disease. Results: At 12 months, clinically meaningful improvements in mean VASPI and ODI scores were achieved in the investigational allograft and saline groups. A responder analysis demonstrated a clinically meaningful reduction in ODI of >= 15 points at 12 months that was statistically significant; 76.5% of patients randomized to allograft were responders (P = 0.03) compared to 56.7% in the saline group. A responder group characterized by a ? 20 point reduction in pain at 12 months achieved a statistically significant reduction in pain compared to the saline group (P = 0.022). In the allograft group, 11 safety adverse events occurred in 141 patients (3.5%) and there were no persistently symptomatic AEs. Limitations: Limitations of this study include a comparison to saline that has been shown to be more representative of an active comparator as opposed to a placebo. In addition, 36 patients were lost to follow-up; this loss resulted in the saline and NSM/crossover groups being smaller than the predetermined group size to have an appropriately powered analysis. Conclusions: This large, prospective blinded RCT demonstrated safety and efficacy results indicating that viable disc tissue allograft may be a beneficial nonsurgical treatment for patients who have chronically painful lumbar degenerative discs. Further studies would be optimal to confirm efficacy Key words: Viable disc tissue allograft, discogenic back pain, allograft supplementation, degenerative disc disease, low back pain, intervertebral disc, intradiscal injection

Non-surgical management of lumbar disc disease

1977 ◽  
Vol 15 (25) ◽  
pp. 98-99
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Metabolic Bone Disease ◽  
Lumbar Disc ◽  
Uterine Disease ◽  
Low Back ◽  
Disc Disease ◽  
Lumbar Disc Disease ◽  
Metabolic Bone ◽  
Objective Evidence

Persistent low back pain is often ascribed to lumbar disc disease. Frequently no objective evidence supports this and the management is designed solely to alleviate symptoms. Inflammatory arthritis, metabolic bone disease, ligamentous injuries, metastases, infections, uterine disease, retroperitoneal lesions involving the lumbo-sacral plexus, renal disease, intraspinal lesions and depression may also cause low back pain and should be considered in the management of the patient. Occasionally appropriate special investigations are necessary. Lumbar disc lesions may cause acute, sub-acute or chronic symptoms and the management differs accordingly.

Caudal epidural steroid injection for chronic low back pain: A prospective analysis of 107 patients

2021 ◽  
pp. 1-5
Author(s):  
Bahar Dernek ◽  
Suavi Aydoğmuş ◽  
İbrahim Ulusoy ◽  
Tahir Mutlu Duymuş ◽  
Sedef Ersoy ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Relief ◽  
Chronic Low Back Pain ◽  
Lumbar Disc ◽  
Lower Limbs ◽  
Low Back ◽  
Disc Disease ◽  
Lumbar Disc Disease ◽  
Caudal Epidural

BACKGROUND: Low back pain affects 80% of people worldwide at least once in a lifetime and reduces the quality of life and causes absence from work. OBJECTIVE: To evaluate the pain and functional status of patients with lumbar disc disease who received blind caudal epidural injections (CEI) for pain relief. METHODS: The records of 107 patients who had been given CEI between September 2017 and January 2018 were retrospectively analyzed. The inclusion criteria were age > 18 years, > 3-month history of low back pain, and diagnosis of lumbar disc disease by magnetic resonance imaging. The epidural injection solution consisted of 2 mL of betamethasone sodium and 8 mL saline. Follow-up examinations were conducted 3 and 6 months post-injection and the patients were evaluated using a visual analog scale (VAS) and the Oswestry Disability Index (ODI). RESULTS: The most common disc pathology was at the L4–L5 level. The VAS and ODI scores indicated significantly reduced pain at 3 and 6 months compared with the pre-injection baseline. Two patients experienced total anesthesia and paresis of the lower limbs, but recovered fully after 2 weeks. Blood was aspirated during the injection in two patients, but second-attempt injections were successful in both cases. No other complications were observed. CONCLUSION: Our results suggest that the blind method is safe for administering CEI to patients with chronic low back pain in the absence of radiological screening and results in significant pain relief with improved functional capacity.

scholarly journals A comparative study of conventional microlumbar discectomy and endoscopic lumbar discectomies

2021 ◽  
Vol 8 (10) ◽  
pp. 3024
Author(s):  
Vyabhav Raghu ◽  
Deepak Ranade ◽  
Anil Patil ◽  
Sarang Gotecha ◽  
Prashant Punia ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Lumbar Disc ◽  
Total Sample ◽  
Low Back ◽  
Tissue Destruction ◽  
Male Population ◽  
Disc Disease ◽  
Lumbar Disc Disease ◽  
Minimally Invasive Surgical

Background: Low back pain is fairly common in India and lumbar disc herniation is its most common specific cause. In the present study we compared three minimally invasive surgical modalities for treating lumbar disc herniation.Methods: This prospective observational study was conducted on patients who presented to our department with low back pain with radicular symptoms. Twenty-five patients who underwent either microlumbar disectomy (MLD), percutaneous endoscopic transforaminal lumbar discectomy (PELD) or microendoscopic lumbar discectomies (MED) were compared.Results: Of the total sample of 75 cases, it was found that male population was affected more and the degenerative disc process was more prevalent among those over 40 years of age. The MED had the shortest operative time while MLD had the longest mean duration. A comparison of the intraoperative blood loss was negligible in PELD group and 42.80 ml in MED and 63.20 ml in MLD which was strongly significant with a p<0.001. Pain scores were comparable between the patients in the three surgery groups. We observed significantly higher ODI score for patients in MLD group at in the immediate post-operative, 3 months and 6 months post-operative period.Conclusions: MLD is the gold standard for treatment for lumbar disc disease even today due to its familiarity among neurosurgeons; however, reduced tissue destruction and cosmetic demand with equally good results if not better, endoscopy could replace MLD as the first-line treatment for LDH until lesser invasive modality comes to light.

Total sitting time, leisure time physical activity and risk of hospitalization due to low back pain: The Danish Health Examination Survey cohort 2007–2008

2018 ◽  
Vol 47 (1) ◽  
pp. 45-52 ◽  
Author(s):  
Mie Balling ◽  
Teresa Holmberg ◽  
Christina B. Petersen ◽  
Mette Aadahl ◽  
Dan W. Meyrowitsch ◽  
...  
Keyword(s):  
Physical Activity ◽  
Low Back Pain ◽  
Back Pain ◽  
Lumbar Disc ◽  
Vigorous Physical Activity ◽  
Sitting Time ◽  
Low Back ◽  
Disc Disease ◽  
Lumbar Disc Disease ◽  
Herniated Lumbar Disc

Aims: This study aimed to test the hypotheses that a high total sitting time and vigorous physical activity in leisure time increase the risk of low back pain and herniated lumbar disc disease. Methods: A total of 76,438 adults answered questions regarding their total sitting time and physical activity during leisure time in the Danish Health Examination Survey 2007–2008. Information on low back pain diagnoses up to 10 September 2015 was obtained from The National Patient Register. The mean follow-up time was 7.4 years. Data were analysed using Cox regression analysis with adjustment for potential confounders. Multiple imputations were performed for missing values. Results: During the follow-up period, 1796 individuals were diagnosed with low back pain, of whom 479 were diagnosed with herniated lumbar disc disease. Total sitting time was not associated with low back pain or herniated lumbar disc disease. However, moderate or vigorous physical activity, as compared to light physical activity, was associated with increased risk of low back pain (HR = 1.16, 95% CI: 1.03–1.30 and HR = 1.45, 95% CI: 1.15–1.83). Moderate, but not vigorous physical activity was associated with increased risk of herniated lumbar disc disease. Conclusions: The results suggest that total sitting time is not associated with low back pain, but moderate and vigorous physical activity is associated with increased risk of low back pain compared with light physical activity.

scholarly journals Treatment of Degenerated Intervertebral Discs Using a Viable Disc Tissue Allograft for Chronic Discogenic Low Back Pain: A Randomized Controlled Trial Comparing Single-site Outcomes With Aggregate and Longer-Term Follow-Up Data

2021 ◽  
Author(s):  
Timothy Davis ◽  
Afrida Sara ◽  
Terry Nguyen ◽  
John Kenneth Burkus
Keyword(s):  
Randomized Controlled Trial ◽  
Back Pain ◽  
Controlled Trial ◽  
Single Site ◽  
Low Back ◽  
Disc Disease ◽  
Randomized Controlled ◽  
Disc Tissue ◽  
Tissue Allograft ◽  
Vas Scores

Abstract Background: Disruption of the internal structure of the nucleus pulposus commonly occurs with the development of painful degenerative lumbar disc disease. Supplementing disc tissue through autologous or allogeneic human cellular and tissue therapies has been tested in small sample clinical trials. A few investigators have reported substantial improvements in pain and function. A viable disc tissue allograft was developed to supplement tissue loss associated with intervertebral disc degeneration. Methods: We assessed results in a subgroup of patients from a large trial comparing this allograft with other treatments. A multicenter randomized controlled trial of 218 subjects with chronic low back pain secondary to degenerative disc disease was conducted. Patients were treated with the allograft, saline, or nonsurgical management and studied for 12 months. We assessed longer-term results in a single-site subgroup from this prospective trial.Results: At 12 months, subjects from the single-site subgroup who had been randomly assigned to the active allograft group (n=17) showed improvements in both mean Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) scores. There was an overall reduction of 28.69 points in the ODI and 33.06 points in the VAS. This was similar to the aggregate ODI and VAS scores of the active allograft group. At 24 months postprocedure, 9 of the 10 patients remaining in the active allograft group at the single study site had mean ODI and VAS score improvements of 28.23 and 36.13, respectively. A similar improvement in pain scores occurred in the 4 patients at 36 months with mean ODI and VAS score improvements from preoperative scores of 25.21 and 51.35, respectively.Conclusions: Clinically meaningful improvements demonstrated in this single-site analysis were comparable to the aggregate study population at 12 months. Longer-term results from this single site at 24 and 36 months suggested durability of viable disc tissue allograft supplementation for patients with discogenic back pain.Trial registration: The trial was retrospectively registered 17 October 2018 on www.clinicaltrials.gov (NCT03709901) and was approved by the Sterling Institutional Review Board, Atlanta, Georgia (IRB no. 5792).

scholarly journals Treatment of Degenerated Intervertebral Discs using a Viable Disc Tissue Allograft for Chronic Discogenic Low Back Pain: A Randomized Controlled Trial Comparing Single-Site Outcomes with Aggregate and Longer-term Follow-Up Data

2021 ◽  
Author(s):  
Timothy Davis ◽  
Afrida Sara ◽  
Terry Nguyen ◽  
John Kenneth Burkus
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Controlled Trial ◽  
Single Site ◽  
Low Back ◽  
Disc Disease ◽  
Randomized Controlled ◽  
Disc Tissue ◽  
Tissue Allograft ◽  
Vas Scores

Abstract BackgroundDisruption of the internal structure of the nucleus pulposus commonly occurs with the development of painful degenerative lumbar disc disease. Supplementing disc tissue through autologous or allogeneic human cellular and tissue therapies has been tested in small sample clinical trials. A few investigators have reported substantial improvements in pain and function. A viable disc tissue allograft was developed to supplement tissue loss associated with intervertebral disc degeneration. MethodsWe assessed results in a subgroup of patients from a large trial comparing this allograft with other treatments. A multicenter randomized controlled trial of 218 subjects with chronic low back pain secondary to degenerative disc disease was conducted. Patients were treated with the allograft, saline, or nonsurgical management and studied for 12 months. We assessed longer-term results in a single-site subgroup from this prospective trial.ResultsAt 12 months, subjects from the single-site subgroup who had been randomly assigned to the active allograft group (n=17) showed improvements in both mean Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) scores. There was an overall reduction of 28.69 points in the ODI and 33.06 points in the VAS. This was similar to the aggregate ODI and VAS scores of the active allograft group. At 24 months postprocedure, 9 of the 10 patients remaining in the active allograft group at the single study site had mean ODI and VAS score improvements of 28.23 and 36.13, respectively. A similar improvement in pain scores occurred in the 4 patients at 36 months with mean ODI and VAS score improvements from preoperative scores of 25.21 and 51.35, respectively.ConclusionsClinically meaningful improvements demonstrated in this single-site analysis were comparable to the aggregate study population at 12 months. Longer-term results from this single site at 24 and 36 months suggested durability of viable disc tissue allograft supplementation for patients with discogenic back pain.Trial registrationThe trial was retrospectively registered 17 October 2018 on www.clinicaltrials.gov (NCT03709901) and was approved by the Sterling Institutional Review Board, Atlanta, Georgia (IRB no. 5792).

scholarly journals Magnetic resonance imaging findings in patients with low backache

2017 ◽  
Vol 18 (2) ◽  
pp. 11-15 ◽  
Author(s):  
Narayan Bikram Thapa ◽  
Suraj Bajracharya
Keyword(s):  
Magnetic Resonance Imaging ◽  
Low Back Pain ◽  
Back Pain ◽  
Magnetic Resonance ◽  
Lumbar Disc ◽  
Low Back ◽  
Resonance Imaging ◽  
Lumbar Disc Degeneration ◽  
Disc Disease ◽  
Annular Tear

 Introduction: Low backache is commonly experienced by adults at some time during their lives. Though it is caused by degenerative changes, spinal stenosis, neoplasm, infection and trauma, lumbar disc degeneration is the most commonly diagnosed abnormalities associated. As Magnetic Resonance Imaging (MRI) is non invasive imaging technique with excellent spatial and contrast resolution, it has become the investigation of choice in evaluation of patients with low back pain. This study was designed to determine the patterns of degenerative disc disease on MRI in patients with low backache.Methods: A retrospective hospital based study was done by reviewing MRI report of 202 patients who underwent MRI of lumbar spine for complaint of chronic low back pain, radicular pain, neurogenic claudication or various other symptoms and signs suggestive of lumbar degenerative disc disease from January 2014 till June 2014. The patients having MRI findings of acute spinal infection, recent trauma, tumors, spinal dysraphism and metabolic conditions were excluded from the study.Results: Out of the 202 patients included in the study, 116 patients (57.4%) were male and 86 patients (42.6%) were female. The mean age of the study population was 44.26 ±15.61 (13-83) years. Multiple contiguous level disc disease was the most common type of involvement which was noted in 109 (54%) patients. Grade 4 lumbar disc degeneration (graded as per classification given by Pfirrmann et al) was noted in 65.3% (132) cases followed by Grade 2 in 25.2%(51) cases and Grade 1in 5.5% (11) cases. The most common involvement was observed at L4-L5 level (76.7%) and L5-S1 levels (55.9%) followed by L3-L4 (30.6%) in decreasing order of frequency. The most common category was disc bulge note in 46.5% (94) of cases. Nerve root compression was observed in 56% (114) of the total cases. Nerve root compromise was also noted most frequently compressing L5 nerve (28.23% of cases). Annular tear was observed in 14.4% (29) of cases and among them 20% (6) of cases had torn at two intervertebral discs. It is most frequently noted involving L4-L5 intervertebral disc (72.5% of cases), followed by L5-S1 (24.2% of cases).Conclusion: Disc generation is most common at L4-L5 level with multiple contiguous involvement of grade 4. Annular tear though not common can occur and is also common at L4-L5 level.Journal of Society of Surgeons of Nepal, 2015; 18 (2)                        

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