Spinal cord stimulation for low back pain.

BACKGROUND: Spinal cord stimulation (SCS) is a surgical intervention used to treat persistent low back pain. SCS is thought to modulate pain by sending electrical signals via implanted electrodes into the spinal cord. The long term benefits and harms of SCS for people with low back pain are uncertain. OBJECTIVES: To assess the effects, including benefits and harms, of SCS for people with low back pain. SEARCH METHODS: On 10 June 2022, we searched CENTRAL, MEDLINE, Embase, and one other database for published trials. We also searched three clinical trials registers for ongoing trials. SELECTION CRITERIA: We included all randomised controlled trials and cross-over trials comparing SCS with placebo or no treatment for low back pain. The primary comparison was SCS versus placebo, at the longest time point measured in the trials. Major outcomes were mean low back pain intensity, function, health-related quality of life, global assessment of efficacy, withdrawals due to adverse events, adverse events, and serious adverse events. Our primary time point was long-term follow-up (≥ 12 months). DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included 13 studies with 699 participants: 55% of participants were female; mean age ranged from 47 to 59 years; and all participants had chronic low back pain with mean duration of symptoms ranging from five to 12 years. Ten cross-over trials compared SCS with placebo. Three parallel-group trials assessed the addition of SCS to medical management. Most studies were at risk of performance and detection bias from inadequate blinding and selective reporting bias. The placebo-controlled trials had other important biases, including lack of accounting for period and carryover effects. Two of the three parallel trials assessing SCS as an addition to medical management were at risk of attrition bias, and all three had substantial cross-over to the SCS group for time points beyond six months. In the parallel-group trials, we considered the lack of placebo control to be an important source of bias. None of our included studies evaluated the impact of SCS on mean low back pain intensity in the long term (≥ 12 months). The studies most often assessed outcomes in the immediate term (less than one month). At six months, the only available evidence was from a single cross-over trial (50 participants). There was moderate-certainty evidence that SCS probably does not improve back or leg pain, function, or quality of life compared with placebo. Pain was 61 points (on a 0- to 100-point scale, 0 = no pain) at six months with placebo, and 4 points better (8.2 points better to 0.2 points worse) with SCS. Function was 35.4 points (on a 0- to 100-point scale, 0 = no disability or best function) at six months with placebo, and 1.3 points better (3.9 points better to 1.3 points worse) with SCS. Health-related quality of life was 0.44 points out of 1 (0 to 1 index, 0 = worst quality of life) at six months with placebo, and 0.04 points better (0.16 points better to 0.08 points worse) with SCS. In that same study, nine participants (18%) experienced adverse events and four (8%) required revision surgery. Serious adverse events with SCS included infections, neurological damage, and lead migration requiring repeated surgery. We could not provide effect estimates of the relative risks as events were not reported for the placebo period. In parallel trials assessing SCS as an addition to medical management, it is uncertain whether, in the medium or long term, SCS can reduce low back pain, leg pain, or health-related quality of life, or if it increases the number of people reporting a 50% improvement or better, because the certainty of the evidence was very low. Low-certainty evidence suggests that adding SCS to medical management may slightly improve function and slightly reduce opioid use. In the medium term, mean function (0- to 100-point scale; lower is better) was 16.2 points better with the addition of SCS to medical management compared with medical management alone (95% confidence interval (CI) 19.4 points better to 13.0 points better; I2 = 95%; 3 studies, 430 participants; low-certainty evidence). The number of participants reporting opioid medicine use was 15% lower with the addition of SCS to medical management (95% CI 27% lower to 0% lower; I2 = 0%; 2 studies, 290 participants; low-certainty evidence). Adverse events with SCS were poorly reported but included infection and lead migration. One study found that, at 24 months, 13 of 42 people (31%) receiving SCS required revision surgery. It is uncertain to what extent the addition of SCS to medical management increases the risk of withdrawals due to adverse events, adverse events, or serious adverse events, because the certainty of the evidence was very low. AUTHORS' CONCLUSIONS: Data in this review do not support the use of SCS to manage low back pain outside a clinical trial. Current evidence suggests SCS probably does not have sustained clinical benefits that would outweigh the costs and risks of this surgical intervention.

Efficacy, safety, and dose-dependence of the analgesic effects of opioid therapy for people with osteoarthritis: systematic review and meta-analysis.

OBJECTIVE: To evaluate the efficacy and safety of opioids for analgesic therapy for people with osteoarthritis. STUDY DESIGN: Systematic review and meta-analysis of randomised, placebo-controlled trials of opioid therapies for treating the pain of osteoarthritis. The primary outcome was medium term pain relief (six weeks to less than 12 months). Quality of evidence was assessed with GRADE criteria. DATA SOURCES: MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews and Central Register of Controlled Trials, CINAHL, PsycINFO, AMED, and the WHO International Clinical Trials Registry; trials published to 31 October 2020. DATA SYNTHESIS: We extracted pain, disability, health-related quality of life, and adverse events data for 36 eligible trials (overall dose range: 10-210 oral morphine milligram equivalents [MME] per day). Continuous pain and disability outcomes were converted to common 0-100-point scales; changes of less than ten points were deemed to be very small effects. Differences in dichotomous outcomes were expressed as risk ratios. Data were pooled for meta-analysis in random effects models. The evidence from 19 trials (8965 participants; dose range, 10-126 MME/day) for very small medium term pain relief (mean difference [MD], -4.59 points; 95% CI, -7.17 to -2.02 points) was low quality, as was that from 16 trials (6882 participants; dose range, 10-126 MME/day) for a very small effect on disability (MD, -4.15 points; 95% CI, -6.94 to -1.35 points). Opioid dose was not statistically significantly associated with either degree of pain relief or incidence of adverse events in a meta-regression analysis. Evidence that opioid therapy increased the risk of adverse events (risk ratio, 1.43; 95% CI, 1.29-1.59) was of very low quality. CONCLUSIONS: Opioid medications may provide very small pain and disability benefits for people with osteoarthritis, but may also increase the risk of adverse events. PROSPERO REGISTRATION: CRD42019142813 (prospective).

Recall, perceptions and determinants of receiving physical activity advice amongst cancer survivors: a mixed-methods survey.

PURPOSE: This study explored cancer survivors' views and experiences of receiving physical activity advice post-diagnosis. We also determined the influence of sociodemographic characteristics on the recall of physical activity advice and whether receiving advice was associated with meeting physical activity guidelines. METHODS: An anonymised, mixed-methods, 27-item survey was distributed to cancer survivors via online cancer communities in the UK. RESULTS: Of the 242 respondents, 52% recalled receiving physical activity advice. Of those who recalled receiving advice, only 30% received guidance on type of physical activity and 14% were referred to another source of information or exercise specialist. Advice was most often given after treatment cessation, with only 19% of respondents receiving advice during active treatment. Most respondents (56%) expressed a need for further information. There was no evidence of associations between sociodemographic characteristics and recall of physical activity advice. However, cancer survivors who perceived the physical activity advice they received as being appropriate (odds ratio [OR] 3.8, 95% confidence interval [95% CI]: 1.4-10.7) and those with a higher level of education (OR 3.2, 95% CI: 1.8-5.8) were more likely to meet aerobic exercise guidelines. Females were less likely to meet resistance exercise guidelines than males (OR 0.44, 95% CI: 0.21-0.90). CONCLUSION: There is scope to improve the provision of physical activity advice in cancer care by providing advice in a timely manner after diagnosis, referring patients to a suitable exercise or rehabilitation specialist when indicated, and using a tailored approach to ensure the advice is appropriate for specific sociodemographic groups.

Effects of short-term, medium-term and long-term resistance exercise training on cardiometabolic health outcomes in adults: systematic review with meta-analysis.

OBJECTIVE: To examine the effects of short-term, medium-term and long-term resistance exercise training (RET) on measures of cardiometabolic health in adults. DESIGN: Intervention systematic review. DATA SOURCES: MEDLINE and Cochrane Library databases were searched from inception to February 2018. The search strategy included the following keywords: resistance exercise, strength training and randomised controlled trial. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials published in English comparing RET≥2 weeks in duration with a non-exercising control or usual care group. Participants were non-athletic and aged ≥18 years. RESULTS: A total of 173 trials were included. Medium-term and long-term RET reduced systolic blood pressure (-4.02 (95% CI -5.92 to -2.11) mm Hg, p<0.0001 and -5.08 (-10.04 to -0.13) mm Hg, p=0.04, respectively) and diastolic blood pressure (-1.73 (-2.88 to -0.57) mm Hg, p=0.003 and -4.93 (-8.58 to -1.28) mm Hg, p=0.008, respectively) versus control. Medium-term RET elicited reductions in fasted insulin and insulin resistance (-0.59 (-0.97 to -0.21) µU/mL, p=0.002 and -1.22 (-2.29 to -0.15) µU/mL, p=0.02, respectively). The effects were greater in those with elevated cardiometabolic risk or disease compared with younger healthy adults. The quality of evidence was low or very low for all outcomes. There was limited evidence of adverse events. CONCLUSIONS: RET may be effective for inducing improvements in cardio metabolic health outcomes in healthy adults and those with an adverse cardio metabolic risk profile. PROSPERO REGISTRATION NUMBER: CRD42016037946.

Effects of a lifestyle intervention on endothelial function in men on long-term androgen deprivation therapy for prostate cancer.

BACKGROUND: Treatment of prostate cancer with androgen deprivation therapy (ADT) is associated with metabolic changes that have been linked to an increase in cardiovascular risk. METHODS: This randomised controlled trial investigated the effects of a 12-week lifestyle intervention that included supervised exercise training and dietary advice on markers of cardiovascular risk in 50 men on long-term ADT recruited to an on-going study investigating the effects of such a lifestyle intervention on quality of life. Participants were randomly allocated to receive the intervention or usual care. Cardiovascular outcomes included endothelial function (flow-mediated dilatation (FMD) of the brachial artery), blood pressure, body composition and serum lipids. Additional outcomes included treadmill walk time and exercise and dietary behaviours. Outcomes were assessed before randomisation (baseline), and 6, 12 and 24 weeks after randomisation. RESULTS: At 12 weeks, the difference in mean relative FMD was 2.2% (95% confidence interval (CI) 0.1-4.3, P=0.04) with an effect size of 0.60 (95% CI <0.01-1.18) favouring the intervention group. Improvements in skeletal muscle mass, treadmill walk time and exercise behaviour also occurred in the intervention group over that duration (P<0.05). At 24 weeks, only the difference in treadmill walk time was maintained. CONCLUSIONS: This study demonstrates that lifestyle changes can improve endothelial function in men on long-term ADT for prostate cancer. The implications for cardiovascular health need further investigation in larger studies over longer duration.

A content analysis of the interventions for low back pain promoted on the websites of Australian pain clinics.

BACKGROUND: The Internet is a widely used source of health information, yet the accuracy of online information can be low. This is the case for low back pain (LBP), where much of the information about LBP treatment is poor. METHODS: This research conducted a content analysis to explore what pain treatments for LBP are presented to the public on websites of Australian pain clinics listed in the PainAustralia National Pain Services Directory. Websites providing information relevant to the treatment of LBP were included. Details of the treatments for LBP offered by each pain service were extracted. RESULTS: In total, 173 pain services were included, with these services linking to 100 unique websites. Services were predominantly under private ownership and located in urban areas, with limited services in non-urban locations. Websites provided detail on a median of six (IQR 3-8) treatments, with detail on a higher number of treatments provided by services in the private sector. Physical, psychological and educational treatments were offered by the majority of pain services, whereas surgical and workplace-focused treatments were offered by relatively few services. Most services provided details on multidisciplinary care; however, interdisciplinary, coordinated care characterised by case-conferencing was infrequently mentioned. CONCLUSIONS: Most websites provided details on treatments that were largely in-line with recommended care for LBP, but some were not, especially in private clinics. However, whether the information provided online is a true reflection of the services offered in clinics remains to be investigated.

Assessment of endothelial dysfunction by flow-mediated dilatation in men on long-term androgen deprivation therapy for prostate cancer.

NEW FINDINGS: What is the central question of this study? Androgen deprivation therapy (ADT) for prostate cancer has been linked with increased cardiovascular risk, but the mechanisms are unclear. Is there evidence that endothelial dysfunction, as evidenced by reduced flow-mediated dilatation (FMD), is associated with ADT? What is the main finding and its importance? Reduction in FMD with preservation of glyceryl trinitrate-mediated dilatation indicates endothelial dysfunction in men with prostate cancer on long-term ADT compared with well-matched control subjects. Vascular endothelial dysfunction associated with long-term ADT for prostate cancer might explain the observed epidemiological increases in adverse cardiovascular events. Assessment of FMD may be useful in the monitoring of cardiovascular risk in men with prostate cancer on ADT. Androgen deprivation therapy (ADT) in men with prostate cancer has been linked to an increased incidence of cardiovascular events and mortality, but the underpinning mechanisms are unclear. Endothelial dysfunction is considered a precursor for cardiovascular disease. Previous studies have reported variably on the association between ADT and endothelial function. This blinded case-control study examined endothelial function, using high-resolution ultrasound to measure flow-mediated dilatation (FMD) and glyceryl trinitrate (GTN)-mediated-dilatation in the brachial artery, in 20 men with prostate cancer (69 ± 7 years old) treated by ADT (median duration 22 months, range 6-133 months) and 20 men without prostate cancer (69 ± 5 years old) matched for age, physical activity, coexistent cardiovascular disease and body mass index. The magnitude of dilatation was calculated traditionally and allometrically scaled, adjusting for baseline diameter. There were no differences between groups for resting vascular measures (means ± SD). Flow-mediated dilatation was lower in men on ADT than in control subjects (3.9 ± 2.1 versus 5.9 ± 3.8% for traditional, P = 0.047; 3.7 ± 2.7 versus 6.0 ± 2.7% for allometrically scaled, P = 0.023). Response to GTN was similar in both groups (12.2 ± 4.2 versus 14.8 ± 5.7% for traditional, P = 0.113; 12.3 ± 4.6 versus 14.4 ± 4.6% for allometrically scaled, P = 0.163). The magnitude of difference in mean FMD between groups was marginally altered to 2.4% (95% confidence interval 0.3-4.5) after adjustment for the difference in body fat mass and concomitant cardiovascular medication, with the difference in FMD remaining significant (P = 0.029). There is evidence of endothelial dysfunction in men with prostate cancer on long-term ADT. Although a causal relationship is unproven, the findings are consistent with observational reports of adverse cardiovascular outcomes associated with long-term ADT for prostate cancer.