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Extracorporeal Shockwave Therapy for Treating Chronic Low Back Pain: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

ABSTRACT:

Objective

To assess the effectiveness and safety of extracorporeal shockwave therapy (ESWT) for the treatment of chronic low back pain (CLBP).

Methods

This was a systematic review and meta-analysis of randomized controlled trials (RCTs) designed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement standard. We identified relevant studies by searching multiple electronic databases, trial registries, and websites up to April 30, 2021, and examining reference lists. We selected RCTs that compared ESWT, in unimodal or multimodal therapeutic approaches, with sham ESWT or other active therapies. Two investigators independently extracted data and assessed the risk of bias and quality of the evidence. The main outcomes were pain intensity and disability status, examined as standardized mean differences (SMD) with 95% confidence intervals (CI). The risk of bias was assessed by using Cochrane Back and Neck (CBN) Group risk of bias tool and Jadad score, and GRADE was applied to determine the confidence in effect estimates. Heterogeneity was explored using sensitivity analysis and meta-regression.

Results

Ten RCTs, including a total of 455 young to middle-aged individuals (29.2-55.8 years), were identified. Compared with control, the ESWT group showed lower pain intensity at month 1 (SMD = -0.81, 95% CI -1.21 to -0.42), as well as lower disability score at month 1 (SMD = -1.45, 95% CI -2.68 to -0.22) and at month 3 (SMD = -0.69, 95% CI -1.08 to -0.31). No serious shockwave-related adverse events were reported.

Conclusion

The use of ESWT in CLBP patients results in significant and quantifiable reductions in pain and disability in the short term. However, further well-conducted RCTs are necessary for building high-quality evidence and promoting the application of ESWT in clinical practice.

SUBMITTER: Yue L

PROVIDER: S-EPMC8617566 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundExtracorporeal shock wave therapy (ESWT) has been widely used for pain control in musculoskeletal disorders. Whether ESWT can relieve chronic low back pain (CLBP) and improve lumbar function is still unclear. Therefore, we conducted a meta-analysis of relevant studies to comprehensively analyse and determine the efficacy and safety of ESWT for chronic low back pain.MethodsFour databases were systematically searched for randomized controlled trials (RCTs) on ESWT for CLBP. The quality of the included studies was evaluated according to Cochrane systematic review criteria, relevant data were extracted, and meta-analysis was performed using RevMan 5.4 software. The primary outcomes were pain intensity, disability status, and mental health. The data were expressed as standardized mean differences (SMD) or weighted mean difference (WMD) and 95% confidence intervals (CI). Heterogeneity was assessed using the I2 statistic. If I2 ≥ 50%, a random effects model was applied; otherwise, a fixed effects model was used.ResultsTwelve RCTs involving 632 patients were included in this meta-analysis. The ESWT group reported significantly more pain relief than the control group at 4 weeks (WMD = - 1.04; 95% CI = - 1.44 to - 0.65; P < 0.001) and 12 weeks (WMD = - 0.85; 95% CI = - 1.30 to - 0.41; P < 0.001). Regarding the dysfunction index, ESWT led to significant improvement in lumbar dysfunction compared with the control group at 4 weeks (WMD = - 4.22; 95% CI = - 7.55 to - 0.89; P < 0.001) and 12 weeks (WMD = - 4.51; 95% CI = - 8.58 to - 0.44; P = 0.03). For mental health, there was no significant difference between the ESWT group and the control group after 4 weeks of intervention (SMD = 1.17; 95% CI = - 0.10 to 2.45; P = 0.07).ConclusionThis systematic review and meta-analysis found that ESWT provided better pain relief and improved lumbar dysfunction compared with the other interventions included, and no serious adverse effects were found. There was no significant effect of ESWT on the mental health of patients, but we hope to obtain more RCTs for further analysis in the future. Based on the pooled results, we suggest that ESWT is effective and safe for treating chronic low back pain.

Project description:BACKGROUND CONTEXT:Mobilization and manipulation therapies are widely used to benefit patients with chronic low back pain. However, questions remain about their efficacy, dosing, safety, and how these approaches compare with other therapies. PURPOSE:The present study aims to determine the efficacy, effectiveness, and safety of various mobilization and manipulation therapies for treatment of chronic low back pain. STUDY DESIGN/SETTING:This is a systematic literature review and meta-analysis. OUTCOME MEASURES:The present study measures self-reported pain, function, health-related quality of life, and adverse events. METHODS:We identified studies by searching multiple electronic databases from January 2000 to March 2017, examining reference lists, and communicating with experts. We selected randomized controlled trials comparing manipulation or mobilization therapies with sham, no treatment, other active therapies, and multimodal therapeutic approaches. We assessed risk of bias using Scottish Intercollegiate Guidelines Network criteria. Where possible, we pooled data using random-effects meta-analysis. Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) was applied to determine the confidence in effect estimates. This project is funded by the National Center for Complementary and Integrative Health under Award Number U19AT007912. RESULTS:Fifty-one trials were included in the systematic review. Nine trials (1,176 patients) provided sufficient data and were judged similar enough to be pooled for meta-analysis. The standardized mean difference for a reduction of pain was SMD=-0.28, 95% confidence interval (CI) -0.47 to -0.09, p=.004; I2=57% after treatment; within seven trials (923 patients), the reduction in disability was SMD=-0.33, 95% CI -0.63 to -0.03, p=.03; I2=78% for manipulation or mobilization compared with other active therapies. Subgroup analyses showed that manipulation significantly reduced pain and disability, compared with other active comparators including exercise and physical therapy (SMD=-0.43, 95% CI -0.86 to 0.00; p=.05, I2=79%; SMD=-0.86, 95% CI -1.27 to -0.45; p<.0001, I2=46%). Mobilization interventions, compared with other active comparators including exercise regimens, significantly reduced pain (SMD=-0.20, 95% CI -0.35 to -0.04; p=.01; I2=0%) but not disability (SMD=-0.10, 95% CI -0.28 to 0.07; p=.25; I2=21%). Studies comparing manipulation or mobilization with sham or no treatment were too few or too heterogeneous to allow for pooling as were studies examining relationships between dose and outcomes. Few studies assessed health-related quality of life. Twenty-six of 51 trials were multimodal studies and narratively described. CONCLUSION:There is moderate-quality evidence that manipulation and mobilization are likely to reduce pain and improve function for patients with chronic low back pain; manipulation appears to produce a larger effect than mobilization. Both therapies appear safe. Multimodal programs may be a promising option.

Project description:Background and objectiveChronic Low Back Pain (CLBP) is very common, with a lifetime prevalence between 51% and 80%. In majority, it is nonspecific in nature and multifactorial in etiology. Pregabalin (PG) and Gabapentin (GB) are gabapentinoids that have demonstrated benefit in neuropathic pain conditions. Despite no clear rationale, they are increasingly used for nonspecific CLBP. They necessitate prolonged use and are associated with adverse effects and increased cost. Recent guidelines from the National Health Service (NHS), England, expressed concerns on their off-label use, in addition to the risk of misuse. We aimed to assess the effectiveness and safety of gabapentinoids in adult CLBP patients.MethodsElectronic databases of MEDLINE, EMBASE, and Cochrane were searched from their inception until December 20th, 2016. We included randomized control trials reporting the use of gabapentinoids for the treatment of CLBP of >3 months duration, in adult patients. Study selection and data extraction was performed independently by paired reviewers. Outcomes were guided by Initiative on Methods, Measurement and Pain Assessment in Clinical Trials guidelines, with pain relief and safety as the primary outcomes. Meta-analyses were performed for outcomes reported in 3 or more studies. Outcomes were reported as mean differences (MDs) or risk ratios (RRs) with their corresponding 95% confidence intervals (CIs), and I2 in percentage representing the percentage variability in effect estimates that could be explained by heterogeneity. GRADE (Grading of Recommendations Assessment, Development, and Evaluation) was used to assess the quality of evidence.ResultsOut of 1,385 citations, eight studies were included. Based on the interventions and comparators, studies were analyzed in 3 different groups. GB compared with placebo (3 studies, n = 185) showed minimal improvement of pain (MD = 0.22 units, 95% CI [-0.5 to 0.07] I2 = 0%; GRADE: very low). Three studies compared PG with other types of analgesic medication (n = 332) and showed greater improvement in the other analgesic group (MD = 0.42 units, 95% CI [0.20 to 0.64] I2 = 0; GRADE: very low). Studies using PG as an adjuvant (n = 423) were not pooled due to heterogeneity, but the largest of them showed no benefit of adding PG to tapentadol. There were no deaths or hospitalizations reported. Compared with placebo, the following adverse events were more commonly reported with GB: dizziness-(RR = 1.99, 95% CI [1.17 to 3.37], I2 = 49); fatigue (RR = 1.85, 95% CI [1.12 to 3.05], I2 = 0); difficulties with mentation (RR = 3.34, 95% CI [1.54 to 7.25], I2 = 0); and visual disturbances (RR = 5.72, 95% CI [1.94 to 16.91], I2 = 0). The number needed to harm with 95% CI for dizziness, fatigue, difficulties with mentation, and visual disturbances were 7 (4 to 30), 8 (4 to 44), 6 (4 to 15), and 6 (4 to 13) respectively. The GRADE evidence quality was noted to be very low for dizziness and fatigue, low for difficulties with mentation, and moderate for visual disturbances. Functional and emotional improvements were reported by few studies and showed no significant improvements.Conclusions and relevanceExisting evidence on the use of gabapentinoids in CLBP is limited and demonstrates significant risk of adverse effects without any demonstrated benefit. Given the lack of efficacy, risks, and costs associated, the use of gabapentinoids for CLBP merits caution. There is need for large high-quality trials to more definitively inform this issue.Trial registrationPROSPERO CRD42016034040.

Project description:Osteopathic manipulative treatment (OMT) is a distinctive modality commonly used by osteopathic physicians to complement their conventional treatment of musculoskeletal disorders. Previous reviews and meta-analyses of spinal manipulation for low back pain have not specifically addressed OMT and generally have focused on spinal manipulation as an alternative to conventional treatment. The purpose of this study was to assess the efficacy of OMT as a complementary treatment for low back pain.Computerized bibliographic searches of MEDLINE, EMBASE, MANTIS, OSTMED, and the Cochrane Central Register of Controlled Trials were supplemented with additional database and manual searches of the literature. Six trials, involving eight OMT vs control treatment comparisons, were included because they were randomized controlled trials of OMT that involved blinded assessment of low back pain in ambulatory settings. Data on trial methodology, OMT and control treatments, and low back pain outcomes were abstracted by two independent reviewers. Effect sizes were computed using Cohen's d statistic and meta-analysis results were weighted by the inverse variance of individual comparisons. In addition to the overall meta-analysis, stratified meta-analyses were performed according to control treatment, country where the trial was conducted, and duration of follow-up. Sensitivity analyses were performed for both the overall and stratified meta-analyses.Overall, OMT significantly reduced low back pain (effect size, -0.30; 95% confidence interval, -0.47 - -0.13; P = .001). Stratified analyses demonstrated significant pain reductions in trials of OMT vs active treatment or placebo control and OMT vs no treatment control. There were significant pain reductions with OMT regardless of whether trials were performed in the United Kingdom or the United States. Significant pain reductions were also observed during short-, intermediate-, and long-term follow-up.OMT significantly reduces low back pain. The level of pain reduction is greater than expected from placebo effects alone and persists for at least three months. Additional research is warranted to elucidate mechanistically how OMT exerts its effects, to determine if OMT benefits are long lasting, and to assess the cost-effectiveness of OMT as a complementary treatment for low back pain.

Project description:ObjectiveTo determine the proportion of chronic low back pain patients who achieve a clinically meaningful response from different pharmacologic and nonpharmacologic treatments.Data sourcesMEDLINE, EMBASE, Cochrane Library, and gray literature search.Study selectionPublished randomized controlled trials (RCTs) that reported a responder analysis of adults with chronic low back pain treated with any of the following 15 interventions: oral or topical nonsteroidal anti-inflammatory drugs (NSAIDs), exercise, acupuncture, spinal manipulation therapy, corticosteroid injections, acetaminophen, oral opioids, anticonvulsants, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors, cannabinoids, oral muscle relaxants, or topical rubefacients.SynthesisA total of 63 RCTs were included. There was moderate certainty that exercise (risk ratio [RR] of 1.71; 95% CI 1.37 to 2.15; number needed to treat [NNT] of 7), oral NSAIDs (RR = 1.44; 95% CI 1.17 to 1.78; NNT = 6), and SNRIs (duloxetine; RR = 1.25; 95% CI 1.13 to 1.38; NNT = 10) provide clinically meaningful benefits to patients with chronic low back pain. Exercise was the only intervention with sustained benefit (up to 48 weeks). There was low certainty that spinal manipulation therapy and topical rubefacients benefit patients. The benefit of acupuncture disappeared in higher-quality, longer (> 4 weeks) trials. Very low-quality evidence demonstrated that corticosteroid injections are ineffective. Patients treated with opioids had a greater likelihood of discontinuing treatment owing to an adverse event (number needed to harm of 5) than continuing treatment to derive any clinically meaningful benefit (NNT = 16), while those treated with SNRIs (duloxetine) had a similar likelihood of continuing treatment to attain benefit (NNT = 10) as those discontinuing the medication owing to an adverse event (number need to harm of 11). One trial each of anticonvulsants and topical NSAIDs found similar benefit to that of placebo. No RCTs of acetaminophen, cannabinoids, muscle relaxants, selective serotonin reuptake inhibitors, or tricyclic antidepressants met the inclusion criteria.ConclusionExercise, oral NSAIDs, and SNRIs (duloxetine) provide a clinically meaningful reduction in pain, with exercise being the only intervention that demonstrated sustained benefit after the intervention ended. Future high-quality trials that report responder analyses are required to provide a better understanding of the benefits and harms of interventions for patients with chronic low back pain.

Project description:Epidural injections of anesthetic with or without steroids are widely used for treating lumbar spinal stenosis, a common cause of chronic low back pain, but there is a lack of rigorous data comparing the effectiveness of epidural injections of anesthetic with and without steroids. This meta-analysis presents a current, comprehensive picture of how epidural injections of anesthetic with steroids compare with those using local anesthetic alone.PubMed, Embase, Web of Science, and Cochrane Library databases were searched from their inception through February 5, 2015. Weight mean difference, risk ratio, and 95% confidence intervals were calculated. A random effects model or fixed effects model was used to pool the estimates, according to the heterogeneity between the included studies.We included 13 randomized controlled trials, involving 1,465 patients. Significant pain relief (?50%) was demonstrated in 53.7% of patients administered with epidural injections of anesthetic with steroids (group 1) and in 56.4% of those administered with local anesthetic alone (group 2). Patients showed a reduction in numeric rating scale pain score of 3.7 and 3.6 in the two groups, respectively. Significant functional improvement was achieved in 65.2% of patients in group 1 and 63.1% of patients in group 2, with Oswestry Disability Index reductions of 13.8 and 14.5 points, respectively. The overall number of injections per year was 3.2±1.3 and 3.4±1.2 with average total relief per year of 29.3±19.7 and 33.8±19.3 weeks, respectively. The opioid intakes decreased from baseline by 12.4 and 7.8 mg, respectively. Among the outcomes listed, only total relief time differed significantly between the two groups.Both epidural injections with steroids or with local anesthetic alone provide significant pain relief and functional improvement in managing chronic low back pain secondary to lumbar spinal stenosis, and the inclusion of steroids confers no advantage compared to local anesthetic alone.