scholarly journals Effectiveness of Parasagittal Interlaminar Epidural Local Anesthetic with or without Steroid in Chronic Lumbosacral Pain: A Randomized, Double-Blind Clinical Trial

2015 ◽  
Vol 3;18 (3;5) ◽  
pp. 237-248 ◽  
Author(s):  
Dr. Babita Ghai
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Relief ◽  
Local Anesthetic ◽  
Chronic Low Back Pain ◽  
Low Back ◽  
Double Blind ◽  
Time Points ◽  
One Year

Background: Epidural injections (EI) are the most commonly performed minimally invasive intervention to manage chronic low back pain (CLBP) with lumbosacral radicular pain (LRP). Local anesthetic (LA) and/ or steroids are frequently used injectates for EI and are reported with variable effectiveness. The majority of earlier studies have used either caudal, transforaminal (TF), or undefined interlaminar approaches for EI. The parasaggital interlaminar (PIL) approach route is reported to have good ventral epidural spread and comparable effectiveness to the TF route. However, there is a lack of head-to-head comparative effectiveness research of LA with or without steroid for managing CLBP with LRP using a PIL approach. Objective: To compare the effectiveness of EI of LA alone and LA with steroid using a PIL approach for managing CLBP with LRP. Study Design: Randomized, double blind, active control one year follow-up study. Setting: Interventional pain management clinic in a tertiary care center in India. Methods: Sixty-nine patients were randomized to receive fluoroscopic guided EI of either 8 mL of 0.5% lidocaine (group L, n = 34) or 6 mL of 0.5% lidocaine mixed with 80 mg (2 mL) of methylprednisolone acetate (group LS, n = 35). Patients were evaluated for pain intensity using 0 – 10 numerical rating scale (NRS) and functional disability using Modified Oswestry Disability Questionnaire (MODQ) at baseline; and 2 weeks, one, 2, 3, 6, 9, and 12 months after injection. Patients with inefficacy with the initial injection or response deterioration received an additional injection of the same injectate and dose. Patients were evaluated for achieving effective pain relief (EPR, i.e., ≥ 50% from baseline), overall NRS and MODQ, number of injections, and presence of ventral and perineural spread over one year follow-up. Primary outcome was proportion of patients achieving EPR at 3 months. Results: A significantly higher proportion of patients achieved EPR at 3 months in group LS [30 (86%, 90% CI 73% – 93%)] as compared to group L [17 (50%, 90% CI 36% – 64%)] (P = 0.02). Similar results were obtained at 6, 9, and 12 months, respectively. The probability of achieving EPR was significantly higher in group LS at various time-points during the one year follow-up as compared to group L (P = 0.01) A significant reduction in NRS and improvement in MODQ were observed at all time-points post-intervention compared to baseline (P < 0.001) in both groups. NRS and MODQ scores were significantly lower in group LS as compared to group L at all time intervals post baseline. On average patients in group L received 2.0 (0.85) and group LS received 1.7 (0.71) injections annually (P = 0.07). Ventral epidural spread was comparable in both groups (97%). No major complications were encountered in either group; however, intravascular spread of contrast was noted during 2 injections (one in each group) requiring relocation. Limitations: A single center study, lack of documentation of adjuvant therapies like individual analgesic medication, and lack of placebo group. Conclusions: Using a PIL approach and the addition of steroid to LA for EI may provide superior effectiveness in terms of extent and duration of pain relief for managing CLBP with unilateral LRP, even though, local anesthetic alone also was effective. Trial registration: CTRI/2014/04/004572 Key words: Epidural injection, epidural steroid, chronic low back pain, chronic lumbosacral pain, parasagittal interlaminar

scholarly journals Lumbar Facet Joint Nerve Blocks in Managing Chronic Facet Joint Pain: One-Year Follow-up of a Randomized, Double-Blind Controlled Trial: Clinical Trial NCT00355914

2008 ◽  
Vol 2;11 (3;2) ◽  
pp. 121-132
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Relief ◽  
Local Anesthetic ◽  
Chronic Low Back Pain ◽  
Facet Joint ◽  
Low Back ◽  
Lumbar Facet Joint ◽  
Nerve Blocks ◽  
Lumbar Facet

Background: Lumbar facet joints have been implicated as the source of chronic pain in 15% to 45% of patients with chronic low back pain. Various therapeutic techniques including intraarticular injections, medial branch blocks, and radiofrequency neurotomy of lumbar facet joint nerves have been described in the alleviation of chronic low back pain of facet joint origin. Objective: The study was conducted to determine the clinical effectiveness of therapeutic local anesthetic lumbar facet joint nerve blocks with or without steroid in managing chronic function-limiting low back pain of facet joint origin. Design: A randomized, double-blind, controlled trial. Setting: An interventional pain management setting in the United States. Methods: This study included 60 patients in Group I with local anesthetic and 60 patients in Group II with local anesthetic and steroid. The inclusion criteria was based on the positive response to the diagnostic controlled comparative local anesthetic lumbar facet joint blocks. Outcome measures: Numeric pain scores, Oswestry Disability Index, opioid intake, and work status. All outcome assessments were performed at baseline, 3 months, 6 months, and 12 months. Results: Significant improvement with significant pain relief (> 50%) and functional improvement (> 40%) were observed in 82% and 85% in Group I, with significant pain relief in over 82% of the patients and improvement in functional status in 78% of the patients. Based on the results of the present study, it appears that patients may experience significant pain relief 44 to 45 weeks of 1 year, requiring approximately 3 to 4 treatments with an average relief of 15 weeks per episode of treatment. Conclusion: Therapeutic lumbar facet joint nerve blocks, with or without steroid, may provide a management option for chronic function-limiting low back pain of facet joint origin. Key words: Chronic low back pain, lumbar facet or zygapophysial joint pain, facet joint nerve or medial branch blocks, comparative controlled local anesthetic blocks, therapeutic lumbar facet joint nerve blocks

Spinal manipulation compared with back school and with individually delivered physiotherapy for the treatment of chronic low back pain: a randomized trial with one-year follow-up

2010 ◽  
Vol 24 (1) ◽  
pp. 26-36 ◽  
Author(s):  
Francesca Cecchi ◽  
Raffaello Molino-Lova ◽  
Massimiliano Chiti ◽  
Guido Pasquini ◽  
Anita Paperini ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Randomized Trial ◽  
Chronic Low Back Pain ◽  
Spinal Manipulation ◽  
Low Back ◽  
Back School ◽  
One Year

One-Year Follow-Up of a Randomized Clinical Trial Comparing Flexion Distraction with an Exercise Program for Chronic Low-Back Pain

2006 ◽  
Vol 12 (7) ◽  
pp. 659-668 ◽  
Author(s):  
Jerrilyn A. Cambron ◽  
M. Ram Gudavalli ◽  
Donald Hedeker ◽  
Marion McGregor ◽  
James Jedlicka ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Randomized Clinical Trial ◽  
Chronic Low Back Pain ◽  
Exercise Program ◽  
Low Back ◽  
One Year

scholarly journals Management of Pain of Post Lumbar Surgery Syndrome: One-Year Results of a Randomized, Double-Blind, Active Controlled Trial of Fluoroscopic Caudal Epidural Injections

2010 ◽  
Vol 6;13 (6;12) ◽  
pp. 519-521
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Relief ◽  
Local Anesthetic ◽  
Low Back ◽  
Lumbar Surgery ◽  
Epidural Injections ◽  
Group I ◽  
One Year ◽  
Caudal Epidural

Background: Post lumbar surgery syndrome represents a cluster of nomenclature and syndromes following spine surgery wherein the expectations of the patient and spine surgeon are not met, with persistent pain following lumbar surgery. Multiple causes have been speculated to cause pain after lumbar surgery. Epidural steroid injections are most commonly used in managing post surgical pain in the lumbar spine. However, there is a paucity of evidence of epidural injections in managing chronic low back pain with or without lower extremity pain in post surgery syndrome. Study Design: A randomized, double-blind, active controlled trial. Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. Objectives: To evaluate the effectiveness of caudal epidural injections in patients with chronic low back and lower extremity pain after surgical intervention with post lumbar surgery syndrome. Methods: One-hundred forty patients were randomly assigned to one of 2 groups; Group I patients received caudal epidural injections with local anesthetic (lidocaine 0.5%), whereas Group II patients received caudal epidural injections with 0.5% lidocaine 9 mL mixed with 1 mL of 6 mg non-particulate Celestone. Randomization was performed by computer-generated random allocation 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 and disability reduction were described as 50% or more reduction in scores from baseline. Results: Combined pain relief (≥50%) and disability reduction was recorded in 53% of the patients in the local anesthetic group, and 59% of patients in the local anesthetic and steroid group with no significant differences noted with or without steroid over a period of one-year. However, the data from the successful group showed improvement in 70% of patients in Group I and 75% of patients in Group II. The average procedures per year were 4 with an average total relief per year of 38.1 ± 14.5 weeks in Group I and 38.4 ± 13.2 weeks in Group II over a period of 52 weeks in the successful group. Limitations: The results of this study are limited by the lack of a placebo group and one-year outcomes. Conclusion: Caudal epidural injections in chronic function-limiting low back pain in post surgery syndrome without facet joint pain may be effective in a significant proportion of patients with improvement in functional status and significant pain relief. Key words: Post lumbar surgery syndrome, post lumbar laminectomy syndrome, chronic low back pain, epidural adhesions, epidural steroid injections, epidural fibrosis, recurrent disc herniation, spinal stenosis

scholarly journals Efficacy of 12 Hourly Controlled-Release Condeine Compared with as Required Dosing of Acetaminophen Plus Codeine in Patients with Chronic Low Back Pain

1997 ◽  
Vol 2 (1) ◽  
pp. 33-38 ◽  
Author(s):  
Martin E Hale ◽  
Kevin L Speight ◽  
Zoltan Harsanyi ◽  
Tad Iwan ◽  
N Susan Slagle ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Controlled Release ◽  
Pain Relief ◽  
Pain Intensity ◽  
Chronic Low Back Pain ◽  
Fixed Combination ◽  
Combination Group ◽  
Low Back ◽  
Double Blind

OBJECTIVE: To compare pain relief and stability of pain control in patients with chronic low back pain treated with scheduled 12 hourly doses of controlled-release codeine or as required doses of a fixed combination of acetaminophen and codeine.PATIENTS AND METHODS: Patients were assigned to five days of treatment with controlled-release codeine (Codeine Contin; Purdue Frederick) 100 mg q12h or placebo q12h in a randomized, double-blind, parallel group study. Acetaminophen 325 mg q4h prn was available as rescue to the codeine group and acetaminophen 325 mg plus codeine 30 mg q4h prn was available to the placebo group. Pain intensity was assessed pretreatment and four times daily using a four-point categorical scale. Acceptability of therapy was assessed twice daily on a five-point scale.RESULTS: Of 104 patients enrolled, 82 were able to be evaluated for safety and efficacy. Sum of pain intensity differences scores were significantly lower on controlled-release codeine than on as required acetaminophen plus codeine at all assessments. The number of changes in pain intensity throughout the day was higher with acetaminophen plus codeine than with codeine alone (8.6±0.7 versus 6.1±0.6, respectively, P=0.011). Mean total daily codeine dose was 200 mg in the codeine group and 71.1±6.6 mg in the acetaminophen plus codeine group (P=0.0001). Mean total daily prn acetaminophen consumption was 542.2±86.5 mg in the codeine group and 770.8±71.5 mg in the fixed combination group (P=0.0452).CONCLUSION: Twelve hourly dosing of controlled-release codeine provides greater and more stable pain relief in patients with chronic low back pain than as required dosing of an acetaminophen plus codeine combination.

scholarly journals Preliminary Results of a Randomized, DoubleBlind, Controlled Trial of Fluoroscopic Lumbar Interlaminar Epidural Injections in Managing Chronic Lumbar Discogenic Pain Without Disc Herniation or Radiculitis

2010 ◽  
Vol 4;13 (4;7) ◽  
pp. E279-E292
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Relief ◽  
Disc Herniation ◽  
Local Anesthetic ◽  
Chronic Low Back Pain ◽  
Low Back ◽  
Epidural Injections ◽  
Group I ◽  
Group Ii

Background: Low back pain without disc herniation is the most common problem among chronic pain disorders. Epidural injections are commonly used interventions in managing chronic low back pain without disc herniation. However, little evidence exists regarding the effectiveness, indications, and medical necessity of lumbar epidural injections in managing axial low back pain without disc herniation or radiculitis. 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. Objectives: To evaluate the ability to provide effective and long-lasting pain relief with lumbar interlaminar epidural injections with local anesthetic with or without steroids in managing chronic low back pain not caused by disc herniation or radiculitis. Methods: Patients were randomly assigned to one of 2 groups with Group I patients receiving local anesthetic only, whereas Group II patients received local anesthetic mixed with non-particulate betamethasone. Seventy patients were included in this analysis. Randomization was performed by computer-generated random allocation sequence by simple randomization. Outcomes Assessment: Outcome measures included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake. The assessments were done at baseline, 3 months, 6 months, and 12 months post-treatment. Significant pain relief and/or improvement in disability were defined as at least 50% improvement. Results: Significant pain relief (≥ 50%) was demonstrated in 74% of patients in Group I and 63% in Group II. Functional status improvement (reduction of ≥ 50%) in the ODI scores was seen in 71% of patients in Group I and 60% of patients in Group II. The overall average procedures per year were approximately 4. Limitations: The results of this study are limited by the lack of a placebo group and that it is a preliminary report of 35 patients in each group with a total of 70 patients. Conclusion: Lumbar interlaminar epidural injections of local anesthetic with or without steroids was effective in 63% and 74% of patients with chronic function-limiting low back pain without facet joint pain, disc herniation, and/or radiculitis. Key words: Chronic low back pain, lumbar interlaminar epidural injections, discogenic pain, disc herniation, radiculitis, local anesthetic, steroids, controlled comparative local anesthetic blocks

scholarly journals Efficacy of antibiotic treatment in patients with chronic low back pain and Modic changes (the AIM study): double blind, randomised, placebo controlled, multicentre trial

BMJ ◽  
2019 ◽  
pp. l5654 ◽  
Author(s):  
Lars Christian Haugli Bråten ◽  
Mads Peder Rolfsen ◽  
Ansgar Espeland ◽  
Monica Wigemyr ◽  
Jörg Aßmus ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Antibiotic Treatment ◽  
Disc Herniation ◽  
Chronic Low Back Pain ◽  
Modic Changes ◽  
Low Back ◽  
Double Blind ◽  
The Difference ◽  
One Year

Abstract Objective To 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). Design Double blind, parallel group, placebo controlled, multicentre trial. Setting Hospital outpatient clinics at six hospitals in Norway. Participants 180 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. Interventions Patients 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 measures The 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. Results In 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. Conclusions In 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 registration ClinicalTrials.gov NCT02323412 .

Percutaneous pulsed radiofrequency applied to the L-2 dorsal root ganglion for treatment of chronic low-back pain: 3-year experience

2010 ◽  
Vol 12 (2) ◽  
pp. 190-196 ◽  
Author(s):  
Hsi-Kai Tsou ◽  
Shao-Ching Chao ◽  
Chao-Jan Wang ◽  
Hsien-Te Chen ◽  
Chiung-Chyi Shen ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Relief ◽  
Chronic Low Back Pain ◽  
Lower Limb ◽  
Low Back ◽  
Pulsed Radiofrequency ◽  
Limb Pain ◽  
Lower Limb Pain

Object The authors assessed the effectiveness of percutaneous pulsed radiofrequency treatment for providing pain relief in patients with chronic low-back pain with or without lower-limb pain. Methods Data were obtained in 127 patients who had chronic low-back pain with or without lower-limb pain due to a herniated intervertebral disc or previous failed back surgery and who underwent pulsed radiofrequency treatment. Their conditions were proven by clinical features, physical examination, and imaging studies. Low-back pain was treated with pulsed radiofrequency applied to the L-2 dorsal root ganglion (DRG) and lower-limb pain was treated with pulsed radiofrequency applied to the L3–S1 DRG. Patients underwent uni- or bilateral treatment depending on whether their low-back pain was unilateral or bilateral. A visual analog scale was used to assess pain. The patients were followed up for 3 years postoperatively. Results In patients without lower-limb pain (Group A), 27 (55.10%) of 49 patients had initial improvement ≥ 50% at 3-month follow-up. At 1-year follow-up, 20 (44.44%) of 45 patients in Group A had pain relief ≥ 50%. An analysis of patients with pain relief ≥ 50% for at least 1 month showed that the greatest effect was at 3 months after treatment. In patients with low-back pain and lower-limb pain (Group B), 37 (47.44%) of 78 patients had initial improvement ≥ 50% at 3-month follow-up. At 1-year follow-up, 34 (45.95%) of 74 patients had pain relief effect ≥ 50%. An analysis of patients in Group B with pain relief ≥ 50% for at least 1 month showed that the greatest effect was at 1 month after treatment. Conclusions The results of this prospective analysis showed that treatment with pulsed radiofrequency applied at the L-2 DRG is safe and effective for treating for chronic low-back pain. Satisfactory pain relief was obtained in the majority of patients in Group A with the effect persisting for at least 3 months. The results indicate that pulsed radiofrequency provided intermediate-term relief of low-back pain. Further studies with long-term follow-up are necessary.

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