132 research outputs found
Process evaluation protocol for the I-WOTCH study: an opioid tapering support programme for people with chronic non-malignant pain
No full text58.<Nichols VP, Abraham C, Eldabe S, Sandhu HK, Underwood M, Seers K onbehalf of the I-WOTCH Team (Iglesias CP is member of the I-WOTCH team).. BMJ Open 2019; 9(10):e028998. Published online 2019 Oct 10. DOI: 10.1136/bmjopen-2019-028998PMID: 3160158
Rethinking clinical trials of transcranial direct current stimulation: Participant and assessor blinding is inadequate at intensities of 2mA
No full textCopyright @ 2012 The Authors. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and 85 reproduction in any medium, provided the original author and source are credited. The article was made available through the Brunel University Open Access Publishing Fund.Background: Many double-blind clinical trials of transcranial direct current stimulation (tDCS) use stimulus intensities of 2 mA despite the fact that blinding has not been formally validated under these conditions. The aim of this study was to test the assumption that sham 2 mA tDCS achieves effective blinding. Methods:
A randomised double blind crossover trial. 100 tDCS-naïve healthy volunteers were incorrectly advised that they there were taking part in a trial of tDCS on word memory. Participants attended for two separate sessions. In each session, they completed a word memory task, then received active or sham tDCS (order randomised) at 2 mA stimulation intensity for 20 minutes and then repeated the word memory task. They then judged whether they believed they had received active stimulation and rated their confidence in that judgement. The blinded assessor noted when red marks were observed at the electrode sites post-stimulation. Results: tDCS at 2 mA was not effectively blinded. That is, participants correctly judged the stimulation condition greater than would be expected to by chance at both the first session (kappa level of agreement (κ) 0.28, 95% confidence interval (CI) 0.09 to 0.47 p = 0.005) and the second session (κ = 0.77, 95%CI 0.64 to 0.90), p = <0.001) indicating inadequate participant blinding. Redness at the reference electrode site was noticeable following active stimulation more than sham stimulation (session one, κ = 0.512, 95%CI 0.363 to 0.66, p<0.001; session two, κ = 0.677, 95%CI 0.534 to 0.82) indicating inadequate assessor blinding. Conclusions: Our results suggest that blinding in studies using tDCS at intensities of 2 mA is inadequate. Positive results from such studies should be interpreted with caution.GLM is supported by the National Health & Medical Research Council of Australia ID 571090
Multicentre, double-blind, randomised, sham-controlled trial of 10 kHz high- frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP): a trial protocol
No full textIntroduction: chronic neuropathic low back pain (CNLBP) is a debilitating condition in which established medical treatments seldom alleviate symptoms. Evidence demonstrates that high-frequency 10 kHz spinal cord stimulation (SCS) reduces pain and improves health-related quality of life in patients with failed back surgery syndrome (FBSS), but evidence of this effect is limited in individuals with CNLBP who have not had surgery. The aim of this multicentre randomised trial is to assess the clinical and cost-effectiveness of 10 kHz SCS for this population.Methods: this is a multicentre, double-blind, randomised, sham-controlled trial with a parallel economic evaluation. A total of 96 patients with CNLBP who have not had spinal surgery will be implanted with an epidural lead and a sham lead outside the epidural space without a screening trial. Patients will be randomised 1:1 to 10 kHz SCS plus usual care (intervention group) or to sham 10 kHz SCS plus usual care (control group) after receiving the full implant. The SCS devices will be programmed identically using a cathodal cascade. Participants will use their handheld programmer to alter the intensity of the stimulation as per routine practice. The primary outcome will be a 7-day daily pain diary. Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5 L, and health and social care costs. Outcomes will be assessed at baseline (pre-randomisation) and at 1 month, 3 months and 6 months after device activation. The primary analyses will compare primary and secondary outcomes between groups at 6 months, while adjusting for baseline outcome scores. Incremental cost per quality-adjusted life year (QALY) will be calculated at 6 months and over the lifetime of the patient.Discussion: the outcomes of this trial will inform clinical practice and healthcare policy on the role of high-frequency 10 kHz SCS for use in patients with CNLBP who have not had surgery.Trial registration: Clinicaltrials.gov, NCT03470766. Registered on 20 March 2018.Disclaimer: the views expressed here are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The NIHR had no role in the study design, writing of the manuscript or the decision to submit for publication.Roles and Responsibilities: AK, SP, DP, SW, RST, AC, SE, LM, RD and JF all contributed to the trial design and to securing trial funding. AK, JR, SP, DP, and SE are involved in the recruitment, the intervention and the follow-up. SW will perform data collection and analysis. RST will be responsible for the statistical analysis, and RD will be responsible for the health economic analysis. All authors read and approved the final manuscript.<br/
Phantom limb pain: a review of pharmacological management
No full textIntroduction:Phantom limb pain (PLP) is a complex condition resulting in pain in the missing limb affecting 60–80% amputees. Increasing number of patients are undergoing amputations. Approximately 1 per every 1000 people in the United Kingdom is an amputee. Incidence of PLP can be as high as 80% following amputation. PLP can be severe and difficult to treat. A range of pharmacological interventions exist yet little is known about them in respect to PLP. This article will address the effectiveness of both single pharmacological, therapy as well as drug combination therapy.Methods:We reviewed all literature looking at the evidence for the efficacy of both single and combined pharmacological therapy in the management of phantom limb pain. Not all commonly prescribed analgesic agents have been studied in the use of PLP and in these cases, the evidence of their efficacy in neuropathic pain was reviewedConclusion:It is difficult to draw definitive conclusions on the pharmacological management of PLP based on current available evidence. Most trials involved small cohorts and were not specific to the PLP. The trials which looked specifically at the PLP population gave conflicting results. Only the N-methyl-d-aspartate (NMDA) receptor antagonist class demonstrated consistent positive results. Most notably ketamine did produce a reduction in pressure pain thresholds and pain windup associated with PLP, although the numbers in these studies remain small. This benefit was not demonstrated across all NMDA receptor antagonists. Combination therapy has demonstrated effectiveness in previous studies for neuropathic pain but this has never been tested specifically against a PLP cohort. Therefore, combination treatment of agents with proven efficacy in PLP such as opioid and gabapentin deserves a closer examination in a controlled study against a placebo as well as single drug therapy</jats:sec
Fear of movement is related to trunk stiffness in low back pain
No full textBackground: Psychological features have been related to trunk muscle activation patterns in low back pain (LBP). We hypothesised higher pain-related fear would relate to changes in trunk mechanical properties, such as higher trunk stiffness
Peripheral Nerve Field Stimulation for Chronic Back Pain: Therapy Outcome Predictive Factors
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