scholarly journals Two-Year Follow-Up Results of Fluoroscopic Cervical Epidural Injections in Chronic Axial or Discogenic Neck Pain: A Randomized, Double-Blind, Controlled Trial

2014 ◽  
Vol 11 (4) ◽  
pp. 309-320 ◽  
Author(s):  
Laxmaiah Manchikanti ◽  
Kimberly A. Cash ◽  
Vidyasagar Pampati ◽  
Yogesh Malla
Keyword(s):  
Neck Pain ◽  
Controlled Trial ◽  
Double Blind ◽  
Epidural Injections

scholarly journals A Randomized, Double-Blind, Active-Control Trial of the Effectiveness of Lumbar Interlaminar Epidural Injections in Disc Herniation

2014 ◽  
Vol 17;1 (1;17) ◽  
pp. E61-E74 ◽  
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Functional Status ◽  
Disc Herniation ◽  
Local Anesthetic ◽  
Controlled Trial ◽  
Low Back ◽  
Double Blind ◽  
Epidural Injections ◽  
Group I ◽  
Interventional Pain Management

Background: Among the multiple nonsurgical modalities, epidural injections are one of the most commonly utilized treatment modalities in managing chronic low back and lower extremity pain due to disc herniation and radiculitis. There is a paucity of randomized trials from contemporary interventional pain management settings utilizing fluoroscopy with long-term follow-up. Study Design: Randomized, double-blind, active-controlled trial with 2-year follow-up. Setting: An interventional pain management practice in the United States. Objective: The objective was to assess the effectiveness of lumbar interlaminar epidural injections of local anesthetic with or without steroids for managing chronic low back pain of disc herniation or radiculitis. Methods: Two groups of patients were studied, with 60 patients in each group receiving either local anesthetic only or local anesthetic mixed with betamethasone. Outcome Measures: The primary outcome measure was defined as pain relief and functional status improvement of 50%. The outcomes were assessed by numeric rating scale (NRS) of pain and functional status with Oswestry Disability Index (ODI). Secondary outcome measures included employment status and opioid intake. Results: Results showed significant improvement in 60% of patients in Group I and 70% of patients in Group II at the end of 2 years. In addition, in the successful groups, those with at least 3 weeks of relief (with the first 2 procedures), the improvement was 72% in Group I and 71% in Group II. Results were somewhat superior for pain relief at 6 months and functional status at 12 months in the steroid group. Thus, the results indicate that a patient’s failure to respond to local anesthetic alone, may be treated with addition of steroids. Limitations: The results of the study are limited by the lack of a placebo group. Conclusion: Lumbar interlaminar epidural injections of local anesthetic with or without steroids is an effective modality, in patients with chronic function limiting low back and lower extremity pain secondary to disc herniation after failure of conservative modalities. Key words: Lumbar disc herniation, lumbar radiculitis, lumbar interlaminar epidural injections, local anesthetic, steroids, randomized controlled trial, active-controlled trial

Double-Blind, Placebo-Controlled Trial of Oral Immunotherapy (OIT) in Peanut (PN) Allergic Children: A Follow-up

2010 ◽  
Vol 125 (2) ◽  
pp. AB58 ◽  
Author(s):  
S.M. Jones ◽  
A.M. Scurlock ◽  
L. Pons ◽  
T.T. Perry ◽  
A.R. Morgan ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Oral Immunotherapy ◽  
Double Blind ◽  
Double Blind Placebo

The SNAP Trial: 2-Year Results of a Double-Blind Multicenter Randomized Controlled Trial of a Silicon Nitride Versus a PEEK Cage in Patients After Lumbar Fusion Surgery

2021 ◽  
pp. 219256822098547
Author(s):  
R. F. M. R. Kersten ◽  
F. C. Öner ◽  
M. P. Arts ◽  
M. Mitroiu ◽  
K. C. B. Roes ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Silicon Nitride ◽  
Interbody Fusion ◽  
Controlled Trial ◽  
Segmental Motion ◽  
Lumbar Interbody Fusion ◽  
Double Blind ◽  
Randomized Controlled ◽  
Disability Questionnaire

Study Design: Randomized controlled trial. Objectives: Lumbar interbody fusion with cages is performed to provide vertebral stability, restore alignment, and maintain disc and foraminal height. Polyetheretherketone (PEEK) is commonly used. Silicon nitride (Si3N4) is an alternative material with good osteointegrative properties. This study was designed to assess if Si3N4 cages perform similar to PEEK. Methods: A non-inferiority double-blind multicenter RCT was designed. Patients presenting with chronic low-back pain with or without leg pain were included. Single- or double-level instrumented transforaminal lumbar interbody fusion (TLIF) using an oblique PEEK or Si3N4 cage was performed. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ). The non-inferiority margin for the RMDQ was 2.6 points on a scale of 24. Secondary outcomes included the Oswestry Disability Questionnaire (ODI), Visual Analogue Scales (VAS), SF-36 Physical Function, patient and surgeon Likert scores, radiographic evaluations for subsidence, segmental motion, and fusion. Follow-up was planned at 3, 6, 12, and 24-months. Results: Ninety-two patients were randomized ( i.e. 48 to PEEK and 44 to Si3N4). Both groups showed good clinical improvements on the RMDQ scores of up to 5-8 points during follow-up. No statistically significant differences were observed in clinical and radiographic outcomes. Mean operative time and blood loss were statistically significantly higher for the Si3N4 cohort. Although not statistically significant, there was a higher incidence of complications and revisions associated with the Si3N4 cage. Conclusions: There was insufficient evidence to conclude that Si3N4 was non-inferior to PEEK.

scholarly journals Effect of Metformin on Cigarette Withdrawal Syndrome and Abstinence in Lung Cancer Patients; A Double-blind Placebo-controlled Trial

2021 ◽  
Vol 14 (5) ◽  
Author(s):  
Bijan Pirnia ◽  
Raheleh Masoudi ◽  
Melika Sefidrood ◽  
Elham Zarghami ◽  
Kambiz Pirnia ◽  
...  
Keyword(s):  
Withdrawal Syndrome ◽  
Controlled Trial ◽  
Nicotine Withdrawal ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Urinary Cotinine ◽  
Metformin Group ◽  
Secondary Outcomes ◽  
Cigarette Withdrawal

Background: Lung cancer (LC) is a leading cause of cancer morbidity and mortality worldwide. One of the predisposing factors for LC is smoking. Metformin is the first line for diabetes treatment and is shown that it can be used for nicotine withdrawal syndrome reduction. Objectives: This study was conducted to evaluate the effects of metformin on reducing the nicotine withdrawal syndrome and increasing nicotine abstinence in patients with LC. Methods: In a randomized double-blind placebo-controlled trial from February 2018 to May 2019, 53 patients with LC were selected by respondent-driven sampling (RDS), and were assigned into two experimental and wait-list control (WLC) group through block randomization (BR). After 3 weeks of baseline assessment, metformin or placebo was prescribed in the form of escalating doses. Cigarette Withdrawal Scale (CWS-21), urinary cotinine levels, and exhaled carbon monoxide (eCO) levels were evaluated in 16 steps by the repeated measures. The primary outcomes include metformin efficacy on cigarette withdrawal syndrome and secondary outcomes include urinary cotinine levels and eCO level. The data were analyzed by generalized estimation equation (GEE), chi-square, and Atlas-Ti5. Results: The primary outcomes showed that the metformin group had significant effects on the improvement of depression, anxiety, craving, irritability, and appetite, difficulty in concentrating, appetite-weight, and insomnia during the 12-weeks treatment period (all P's < 0.05). In addition, only cravings scores remained constant until the 6-month follow-up (P < 0.05). Secondary outcomes demonstrated that urinary cotinine levels and eCO level significantly decreased in the metformin group (all P's < 0.05). However, this decrease did not remain constant at both levels until the 6-month follow-up (P > 0.05). Conclusions: Metformin had a clinical potential for reducing nicotine withdrawal. However, more studies are needed.

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