scholarly journals Vertebroplasty Augmentation Procedures: Examining the Controversy

2013 ◽  
Vol 5;16 (5;9) ◽  
pp. E483-E490
Author(s):  
Arif Hussain
Keyword(s):  
Pain Relief ◽  
Randomized Controlled Trials ◽  
Medical Community ◽  
Vertebral Compression Fractures ◽  
Controlled Trials ◽  
Vertebral Augmentation ◽  
Compression Fractures ◽  
Randomized Controlled ◽  
Starting Point

Background: Vertebral compression fractures are a common pathology affecting primarily the elderly, postmenopausal women, and those with metastatic vertebral disease. Vertebral augmentation procedures are popular treatment options for stability and pain relief. Preliminary studies have suggested that such procedures are adequately efficacious. However, the first randomized controlled trials (RCTs) published in the New England Journal of Medicine in 2009 showed that these procedures were not significantly different than placebo with regards to pain relief and quality of life. These studies were met with considerable criticism. The matter was further complicated when The Lancet published an RCT of its own that demonstrated the superiority of vertebroplasty over conservative management. The conflicting evidence has sparked ongoing debate in the medical community. All sides have provided arguments supported by evidence of varying strength and validity. Objective: To provide a concise and comprehensive presentation of the controversy surrounding vertebral augmentation procedures and the evidence cited by proponents on both sides of the debate. Methods: We began by researching the major randomized controlled trials both for and against vertebroplasty. These articles were already known to us, and were used as a starting point. We then performed a literature search in PubMed for articles dated from 2000 through 2012. The bibliographies of major articles and reviews were also cross-referenced for additional sources. Results: A number of articles that included comprehensive and systematic reviews, metaanalyses, and commentaries about noted studies were found. These provided a broad, detailed overview of the subject. Many of the common themes of these articles included limitations in the design, methods, and patient selection with regard to the RCTs and other available studies. Limitations: This review does not analyze the quality of evidence available nor does it provide an opinion in this regard. The conclusions of the present article are, therefore, general and descriptive in nature. Conclusions: The arguments presented by proponents of both sides of the debate appear to have validity. All of the major studies cited as evidence for or against vertebral augmentation procedures have limitations in their quality. Consequently, the debate cannot be concluded, convincingly, until more elaborate studies are conducted involving larger numbers of patients with clear procedure methods agreed upon by the major authorities in the field. Key words: Vertebroplasty, kyphoplasty, vertebral augmentation procedures, controversy of vertebroplasty, vertebral cancer, vertebral pain, compression fractures, back pain, vertebral fractures.

scholarly journals Comparing Pain Reduction Following Vertebroplasty and Conservative Treatment for Osteoporotic Vertebral Compression Fractures: A Meta-Analysis of Randomized Controlled Trials

2013 ◽  
Vol 5;16 (5;9) ◽  
pp. 455-464
Author(s):  
Hong Jiang
Keyword(s):  
Pain Relief ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Osteoporotic Fractures ◽  
Pain Reduction ◽  
Vertebral Compression Fractures ◽  
Controlled Trials ◽  
Osteoporotic Vertebral Compression Fractures ◽  
Compression Fractures ◽  
Randomized Controlled

Background: Osteoporotic vertebral compression fractures (OVCFs) are the most common osteoporotic fractures. Pain is the main symptom. Percutaneous vertebroplasty (PVP) is a therapeutic procedure performed to reduce pain in vertebral compression fractures. Numerous case series and several small, non-blinded, non-randomized controlled studies have suggested that vertebroplasty is an effective means of relieving pain from osteoporotic fractures. However, a recent pooled analysis from 2 multicenter randomized controlled trials concluded that the improvement in pain afforded by PVP was similar to placebo. Objective: To compare the amount of pain reduction measured using the visual analog scale when OVCF is treated with vertebroplasty or conservatively, and assess the clinical utility of PVP. Design: A meta-analysis and systematic review of randomized controlled trials was performed comparing pain reduction following vertebroplasty and conservative treatment. Limitations: There were few data sources from which to extract abstracted data or published studies. There were only 5 randomized controlled trials that met our criteria. The conservative treatments used as comparators in these trials were different. Methods: A search of MEDLINE from January 1980 to July 2012 using PubMed, the Cochrane Database of Systematic Reviews and Controlled Trials, CINAHL, and EMBASE. Relevant reports were examined by 2 independent reviewers and the references from these reports were searched for additional trials, using the criteria established in the QUOROM statement. Results: Pooled results from 5 randomized controlled trials are shown. There was no difference in pain relief in the PVP group at 2 weeks and one month when compared with the conservatively managed group. Pain relief in the PVP group was greater than that of the conservative group at 3 months, 6 months, and 12 months. However, after subgroup analysis, pain scores were similar between the PVP group and the sham injection group from 2 weeks to 6 months. Compared with non-operative therapy, PVP reduced pain at all times studied. Conclusion: PVP has some value for relieving pain; however, the possibility of a placebo effect should be considered. PVP has gained acceptance as a complementary treatment when conservative management has failed before its benefits have been fully understood. More large scale, double blinded, controlled trials are necessary in order to quantify the pain relief afforded by PVP more precisely. Key words: Vertebroplasty, osteoporosis, vertebral compression fracture, randomized controlled trials, systemic review, meta-analysis

Electric Stimulation for Pain Relief in Patients with Fibromyalgia: A Systematic Review and Meta-analysis of Randomized Controlled Trials

2017 ◽  
Vol 2 (20;2) ◽  
pp. 15-25 ◽  
Author(s):  
Ana Paula da Silva Salazar
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Pain Relief ◽  
Randomized Controlled Trials ◽  
Electric Stimulation ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Quality Evidence

Background: Fibromyalgia (FM) is a syndrome whose primary symptoms include chronic widespread muscle pain and fatigue. The treatment of patients with FM aims to provide symptomatic relief and improvement in physical capacities to perform daily tasks and quality of life. Invasive or non-invasive electric stimulation (ES) is used for pain relief in patients with FM. Objective: This systematic review aimed to assess the effects of treatment with ES, combined or not combined with other types of therapy, for pain relief in patients with FM. Study Design: Systematic review and meta-analysis. Setting: Electronic search was conducted on databases (from the inception to April 2016): MEDLINE (accessed by PubMed), EMBASE, Cochrane Central Register of Controlled Trials (Cochrane CENTRAL), and Physiotherapy Evidence Database (PEDro). Methods: Two independent reviewers assessed the eligibility of studies based on the inclusion criteria: randomized controlled trials (RCTs) examining the effects of ES combined or not with other types of treatment for pain relief in patients with FM (according to the American College of Rheumatology), regardless of the ES dosages. The primary outcome was pain, assessed by the visual analogue scale (VAS). The secondary outcomes extracted were quality of life, assessed by short form-36 health survey (SF- 36), and fatigue, assessed by VAS. Results: Nine studies were included, with 301 patients. The meta-analysis for pain showed positive effect of ES treatment versus control [-1.24 (95% CI: -2.39 to -0.08; I2 : 87%, P = 0.04) n = 8 RCTs]. The sensitivity analysis for pain showed significant results for invasive ES, combined or not with other types of therapy [-0.94 (95% CI, -1.50 to -0.38; I2 0%, P = 0.001) n = 3 RCTs]. No significant improvement was found regarding quality of life [-3.48 (95% CI: -12.58 to 5.62; I2 : 0%, P = 0.45), n = 2 RCTs] or fatigue [-0.57 (95% CI, -1.25 to 0.11; I2 34%, P = 0.100; n = 4 RCTs]. Limitations: This systematic review included a small number of studies and reduced number of participants in each study. Furthermore, most of the studies showed some biases and lack of methodological quality. Conclusion: This meta-analysis indicates that there is low-quality evidence for the effectiveness of ES for pain relief in patients with FM. However, moderate-quality evidence for the effectiveness of electroacupuncture (EA), combined or not combined with other types of treatment, was found for pain relief. Clinical Trial Registration Information: PROSPERO under the identification CRD42015025323 Key words: Electric stimulation, electroacupuncture, transcutaneous electric nerve stimulation, pain, fibromyalgia, review, physical therapy, rehabilitation

scholarly journals A Systematic Review and Meta-analysis of Randomized Controlled Trials of Unilateral Versus Bilateral Kyphoplasty for Osteoporotic Vertebral Compression Fractures

2013 ◽  
Vol 4;16 (4;7) ◽  
pp. 277-290
Author(s):  
Qin Fu
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Vertebral Compression Fractures ◽  
Controlled Trials ◽  
Osteoporotic Vertebral Compression Fractures ◽  
Compression Fractures ◽  
Randomized Controlled ◽  
Long Term Follow Up

Background: Kyphoplasty reduces the pain caused by osteoporotic vertebral compression fracture (OVCF). Although the procedure is typically carried out using a bilateral approach, it is now increasingly performed using a unilateral approach because of the concern for longterm adverse effects. However, little evidence is available to demonstrate superior safety of the unilateral approach. Objective: The purpose of this study was to compare the short- and long-term safety and efficacy of unilateral vs. bilateral kyphoplasty. Study Design: A systematic review and meta-analysis of randomized controlled trials. Settings: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and abstracts published in the related orthopedic journals were systematically searched up to September 2012, using “unilateral kyphoplasty” and “osteoporotic vertebral compression fractures” as key words. Methods: Two investigators independently searched and identified relevant reports and abstracts using the PRISMA statement criteria. Relevant studies cited by the identified papers were also included. The level of evidence was classified as good, fair, and limited (or poor) based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Results: Four randomized controlled trials (RCTs) of 159 cases were enrolled. The methodological quality of the articles was determined as moderate. We did not find any significant difference between unilateral and bilateral kyphoplasty on pain relief, in either short-term or long-term follow-up (P = 0.65 and P = 0.69, respectively). The rate of adjacent vertebral fracture was not statistically different with a P value of 0.88 and 95% CI (confidence intervals) of 0.25-3.26. Cement leakage was comparable between unilateral and bilateral kyphoplasty (P = 0.56, 95% CI = 0.46-4.26). The loss of vertebral height in long-term follow-up was not different (P = 0.10, 95% CI = -0.39-4.54). Operation time and cement dosage were considerably less for unilateral kyphoplasty (P < 0.01 and P < 0.05, respectively). Limitations: Only 4 RCTs and 159 patients were included in this systematic review. Publication bias also existed among the studies included. Conclusions: Both unilateral and bilateral kyphoplasty are effective in alleviating the back pain caused by OVCF. Two approaches have the same degree of safety. More RCTs are needed to examine the efficacy and adverse reactions of the 2 approaches. Key words: Unilateral kyphoplasty, bilateral kyphoplasty, osteoporotic vertebral compression fractures, systematic review, meta-analysis, randomized controlled trials

scholarly journals The Role of Unilateral Balloon Kyphoplasty for the Treatment of Patients with OVCFS: A Systematic Review and Meta-Analysis

2018 ◽  
Vol 1 (21;1) ◽  
pp. 209-218
Author(s):  
Chen Rong Ke
Keyword(s):  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Balloon Kyphoplasty ◽  
Vertebral Compression Fractures ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Osteoporotic Vertebral Compression Fractures ◽  
Compression Fractures ◽  
Randomized Controlled

Background: An increasing number of studies have been conducted to apply unilateral balloon kyphoplasty in the treatment of ostroporotic vertebral compression fractures (OVCFs). However, the efficacy and safety of unilateral kyphoplasty and whether a unilateral or a bilateral approach is superior is controversial. Objectives: The purpose of this study was to evaluate the role of unilateral balloon kyphoplasty and use meta-analysis to compare the efficacy and safety of unilateral and bilateral kyphoplasty in patients with OVCFs. Study Design: A systematic literature search was conducted from 1970 to April 2017 using Medline database and the Cochrane Central Register of Controlled Trials. Articles were limited to those published in English. Randomized controlled trials and nonrandomized comparative studies were also included. Setting: The following search terms were used: “osteoporotic vertebral compression fractures,” or “OVCF,” and “unilateral kyphoplasty,” or “unipedicular approach,” or “single balloon kyphoplasty,” or “one balloon kyphoplasty.” A comprehensive search of reference lists of retrieved articles and previous published reviews was also performed to ensure inclusion of all possible studies. Methods: All potential articles were independently reviewed by 2 investigators for inclusion into the final analysis. MINORS score was used for nonrandomized studies, and Detsky quality index was applied for prospective randomized controlled trials. Systematic review and meta-analysis was performed for the included studies. Results: After unilateral balloon kyphoplasty the mean postoperative visual analog score (VAS) was from 1.74 to 4.77, mean postoperative kyphotic angle was from 5.9º to 11.22º, and complications involving cement leaks was from 6.8 to 21.9% or adjacent level fractures was from 0 to 5.6%). Unilateral kyphoplasty had significantly lower operative time, and less bone cement volume; however, the postoperative VAS, Oswestry Disability Index (ODI), vertebral height restoration rate, and cement leakage and adjacent vertebral fracture rate, were similar to bilateral kyphoplasty. Limitations: Only 6 randomized controlled trials and 3 retrospective comparative studies were selected for analysis. Heterogeneity was detected among the studies when we pooled the outcomes. Conclusions: Based on the available evidence, the clinical and radiological results of unilateral balloon kyphoplasty were as good as those of bilateral balloon kyphoplasty for the treatment of OVCFs. And unilateral kyphoplasty had advantages in terms of operation time, radiation exposure, and cost. Key words: Unilateral balloon kyphoplasty, bilateral balloon kyphoplasty, osteoporotic vertebral compression fractures, complications of balloon kyphoplasty, meta-analysis

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