H-Wave® Device Stimulation: A Critical Review

Pain treatments have historically centered on drugs, but an “opioid crisis” has necessitated new standards of care, with a paradigm shift towards multi-modal pain management emphasizing early movement, non-narcotics, and various adjunctive therapies. Electrotherapies remain understudied and most lack high-quality clinical trials, despite a desperate need for effective adjunctive options. A systematic search of human clinical studies on H-Wave® device stimulation (HWDS) was conducted as well as a comprehensive review of articles articulating possible HWDS mechanisms of action. Studies unrelated to H-Wave were excluded. Data synthesis summarizes outcomes and study designs, categorized as pre-clinical or clinical. Pre-clinical studies demonstrated that HWDS utilizes a biphasic waveform to induce non-fatiguing muscle contractions which positively affect nerve function, blood and lymph flow. Multiple clinical studies have reported significant benefits for diabetic and non-specific neuropathic pain, where function also improved, and pain medication usage substantially dropped. In conclusion, low- to moderate-quality HWDS studies have reported reduced pain, restored functionality, and lower medication use in a variety of disorders, although higher-quality research is needed to verify condition-specific applicability. HWDS has enough reasonable evidence to be considered as an adjunctive component of non-opioid multi-modal pain management, given its excellent safety profile and relative low cost. Level of Evidence: III.

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Opioids and Breast Cancer Recurrence: A Systematic Review

Cancers ◽

10.3390/cancers13215499 ◽

2021 ◽

Vol 13 (21) ◽

pp. 5499

Author(s):

Merlino Lucia ◽

Titi Luca ◽

Del Prete Federica ◽

Galli Cecilia ◽

Mandosi Chiara ◽

...

Keyword(s):

Breast Cancer ◽

Systematic Review ◽

Pain Management ◽

Postoperative Period ◽

Clinical Studies ◽

In Vivo Studies ◽

Standards Of Care ◽

Surgical Time ◽

Pubmed Database ◽

Opioid Administration

Breast cancer has the greatest epidemiological impact in women. Opioids represent the most prescribed analgesics, both in surgical time and in immediate postoperative period, as well as in chronic pain management as palliative care. We made a systematic review analyzing the literature’s evidence about the safety of opioids in breast cancer treatment, focusing our attention on the link between opioid administration and increased relapses. The research has been conducted using the PubMed database. Preclinical studies, retrospective and prospective clinical studies, review articles and original articles were analyzed. In the literature, there are several preclinical in vitro and in vivo studies, suggesting a possible linkage between opioids administration and progression of cancer disease. Nevertheless, these results are not confirmed by clinical studies. The most recent evidence reassures the safety of opioids during surgical time as analgesic associated with anesthetics drugs, during postoperative period for optimal cancer-related pain management and in chronic use. Currently, there is controversial evidence suggesting a possible impact of opioids on breast cancer progression, but to date, it remains an unresolved issue. Although there is no conclusive evidence, we hope to arouse interest in the scientific community to always ensure the best standards of care for these patients.

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Electrochemical treatment of ex vivo human abdominal skin and potential use in scar management: A pilot study

Scars Burns & Healing ◽

10.1177/2059513120988532 ◽

2021 ◽

Vol 7 ◽

pp. 205951312098853

Author(s):

Dana M Hutchison ◽

Amir A Hakimi ◽

Avin Wijayaweera ◽

Soohong Seo ◽

Ellen M Hong ◽

...

Keyword(s):

Color Change ◽

Ex Vivo ◽

Low Cost ◽

Histological Evaluation ◽

Ph Change ◽

Level Of Evidence ◽

Abdominal Skin ◽

Electrochemical Therapy ◽

Mean Width ◽

Scar Management

Introduction: Scar treatments aim to address pathologic collagen deposition; however, they can be expensive or difficult to control. Electrochemical therapy (ECT) offers a simple alternative treatment. The purpose of this study is to examine the acid-base and histological changes in ex vivo human abdominal skin following ECT. Methods: Forty-two ex vivo human panniculus tissue sections collected from six individuals were tumesced with normal saline. ECT was performed by inserting two platinum needle electrodes connected to a DC power supply into each specimen. Voltage was varied (3–6 V) and applied for 5 minutes. Each specimen was sectioned across both electrode insertion sites and immediately stained with pH sensitive dye. The width of dye color change for each dosimetry pair was calculated. Hematoxylin and eosin staining was used to evaluate samples. Results and Discussion: ECT caused a spatially localised and dose-dependent increased area of acidic and basic pH around the anode and cathode, respectively. A significantly greater mean width of pH change was generated at the cathode compared to the anode in all treatment groups. Histological evaluation displayed broad condensation and hyalinisation of dermal collagen. Conclusion: ECT triggered dermal pH alterations and changed the underlying structural framework of the specimen. This technology may serve as a low-cost, minimally invasive local soft-tissue remodeling technique with potential application in scar management. Level of Evidence: 5 Lay Summary Electrochemical therapy is a novel treatment that causes spatially selective dermal injury in areas of interest. This study measures the effects of electrochemical therapy when applied to abdominal skin. Electrochemical therapy appears to have beneficial effects by causing a highly localised reduction in collagen content or local softening of tissue, which is consistent with other studies on scar therapies, including chemexfoliation, radiofrequency technologies, and lasers. However, electrochemical therapy can be performed at a fraction of the costs of these aforementioned modalities.

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Topical Treatments and Their Molecular/Cellular Mechanisms in Patients with Peripheral Neuropathic Pain—Narrative Review

Pharmaceutics ◽

10.3390/pharmaceutics13040450 ◽

2021 ◽

Vol 13 (4) ◽

pp. 450

Author(s):

Magdalena Kocot-Kępska ◽

Renata Zajączkowska ◽

Joanna Mika ◽

David J. Kopsky ◽

Jerzy Wordliczek ◽

...

Keyword(s):

Neuropathic Pain ◽

Pain Management ◽

Clinical Studies ◽

Neuronal Cells ◽

Case Series ◽

Narrative Review ◽

Peripheral Sensitization ◽

Cellular Mechanisms ◽

Peripheral Neuropathic Pain ◽

Topical Treatments

Neuropathic pain in humans results from an injury or disease of the somatosensory nervous system at the peripheral or central level. Despite the considerable progress in pain management methods made to date, peripheral neuropathic pain significantly impacts patients’ quality of life, as pharmacological and non-pharmacological methods often fail or induce side effects. Topical treatments are gaining popularity in the management of peripheral neuropathic pain, due to excellent safety profiles and preferences. Moreover, topical treatments applied locally may target the underlying mechanisms of peripheral sensitization and pain. Recent studies showed that peripheral sensitization results from interactions between neuronal and non-neuronal cells, with numerous signaling molecules and molecular/cellular targets involved. This narrative review discusses the molecular/cellular mechanisms of drugs available in topical formulations utilized in clinical practice and their effectiveness in clinical studies in patients with peripheral neuropathic pain. We searched PubMed for papers published from 1 January 1995 to 30 November 2020. The key search phrases for identifying potentially relevant articles were “topical AND pain”, “topical AND neuropathic”, “topical AND treatment”, “topical AND mechanism”, “peripheral neuropathic”, and “mechanism”. The result of our search was 23 randomized controlled trials (RCT), 9 open-label studies, 16 retrospective studies, 20 case (series) reports, 8 systematic reviews, 66 narrative reviews, and 140 experimental studies. The data from preclinical studies revealed that active compounds of topical treatments exert multiple mechanisms of action, directly or indirectly modulating ion channels, receptors, proteins, and enzymes expressed by neuronal and non-neuronal cells, and thus contributing to antinociception. However, which mechanisms and the extent to which the mechanisms contribute to pain relief observed in humans remain unclear. The evidence from RCTs and reviews supports 5% lidocaine patches, 8% capsaicin patches, and botulinum toxin A injections as effective treatments in patients with peripheral neuropathic pain. In turn, single RCTs support evidence of doxepin, funapide, diclofenac, baclofen, clonidine, loperamide, and cannabidiol in neuropathic pain states. Topical administration of phenytoin, ambroxol, and prazosin is supported by observational clinical studies. For topical amitriptyline, menthol, and gabapentin, evidence comes from case reports and case series. For topical ketamine and baclofen, data supporting their effectiveness are provided by both single RCTs and case series. The discussed data from clinical studies and observations support the usefulness of topical treatments in neuropathic pain management. This review may help clinicians in making decisions regarding whether and which topical treatment may be a beneficial option, particularly in frail patients not tolerating systemic pharmacotherapy.

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Revision Rates After Total Ankle Replacement: A Comparison of Clinical Studies and Arthroplasty Registers

Foot & Ankle International ◽

10.1177/10711007211053862 ◽

2021 ◽

pp. 107110072110538

Author(s):

Georg Hauer ◽

Reinhard Hofer ◽

Markus Kessler ◽

Jan Lewis ◽

Lukas Leitner ◽

...

Keyword(s):

Clinical Studies ◽

Revision Rate ◽

Mobile Bearing ◽

Total Ankle Replacement ◽

Second Step ◽

Fixed Bearing ◽

Inclusion Criteria ◽

Level Of Evidence ◽

Ankle Replacement ◽

Significant Difference

Background: The aim of this study was to assess the outcome of total ankle replacement (TAR) regarding revision rates by comparing clinical studies of the last decade to data displayed in arthroplasty registers. The secondary aim was to evaluate whether dependent clinical studies show a superior outcome to independent publications. Additionally, revision rates of mobile bearing implants (MB-TARs) were compared to those of fixed bearing implants (FB-TARs). Methods: Clinical studies on TARs between 2010 and 2020 were systematically reviewed, with the endpoint being a revision for any reason. The parameter “revision rate per 100 observed component years (CYs)” was calculated for each publication. The pooled revision rate for clinical studies was compared to the data reported in arthroplasty registers. In a second step, revision rates were subdivided and analyzed for independent and dependent publications and for FB-TARs and MB-TARs. Results: A total of 43 publications met the inclusion criteria comprising 5806 TARs. A revision rate of 1.8 per 100 observed CYs was calculated, corresponding to a 7-year revision rate of 12.6%. The 3 arthroplasty registers included showed revision rates ranging from 8.2% to 12.3% after 7 years. No significant difference between dependent and independent publications nor between FB-TARs and MB-TARs was detected. Conclusion: Revision rates of clinical studies and arthroplasty registers are comparable. Surgeons can compare their own revision rates with those from this study. Dependent studies do not seem to be biased, and no superiority for one bearing type can be described. Level of Evidence: Level III, systematic review of level III studies

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Stroke Rehabilitation - An Overview of Existing Guidelines and Standards of Care

European Neurological Review ◽

10.17925/enr.2011.06.03.170 ◽

2011 ◽

Vol 6 (3) ◽

pp. 170 ◽

Cited By ~ 1

Author(s):

Richard D Zorowitz ◽

Keyword(s):

Stroke Rehabilitation ◽

Healthcare Providers ◽

Standards Of Care ◽

Interdisciplinary Management ◽

Stroke Survivors ◽

Level Of Evidence ◽

The Us ◽

Guidelines And Standards ◽

Complications Of Stroke ◽

The Uk

Over seven million stroke survivors live in the US today. Despite the publication of the first post-stroke rehabilitation clinical practice guideline in 1995, many healthcare providers are unaware not only of stroke survivors’ potential for functional recovery, but also common secondary complications of stroke. This article summarises the best available evidence-based recommendations for the interdisciplinary management of stroke survivors and caregivers from five sources: two in the US, one in Canada, and two in the UK. Unique characteristics of each guideline are described, followed by a list of common clinical recommendations found in most, if not all, of the guidelines. Despite the advances in stroke rehabilitation over the past 16 years, much research still needs to be done to improve the level of evidence in stroke rehabilitation.

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Improving pain management for children having dental extractions under general anaesthesia

Annals of The Royal College of Surgeons of England ◽

10.1308/rcsann.2020.0172 ◽

2020 ◽

Vol 102 (9) ◽

pp. 733-736

Author(s):

S Marshall ◽

A Ondhia ◽

C Mearns ◽

T Kandiah

Keyword(s):

Pain Management ◽

General Anaesthesia ◽

Case Note ◽

Standards Of Care ◽

Day Case ◽

Full Compliance ◽

Analgesic Regimen ◽

High Standards ◽

Audit Standards ◽

Case Note Review

Children provided with general anaesthesia for dental extractions at East Surrey Hospital were audited to determine the percentage of children who were prescribed adequate pain management in accordance with guidance published by the Association of Paediatric Anaesthetists of Great Britain and Ireland. Three audit cycles were completed. Data were collected retrospectively through case note review. The results from the first cycle showed that only 47% of children were prescribed with a recommended analgesic regimen. Implementation of change included the development of a protocol for analgesic delivery, which was disseminated to the anaesthetic and dental teams. Full compliance with the audit standards was then demonstrated in the second and third cycles. This audit demonstrates the importance of multidisciplinary collaboration in order to provide high standards of care for children undergoing dental extractions under general anaesthesia. The protocol developed could be applied to other surgical day case procedures for children to improve the patient experience.

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Improving the Quality of Care for Acute Pain Management in Recovery Room at the Georgetown Public Hospital Corporation

Journal of Advances in Medicine and Medical Research ◽

10.9734/jammr/2019/v30i1230258 ◽

2019 ◽

pp. 13-14

Author(s):

Dorette Husbands-Anderson ◽

Jennifer Szerb ◽

Alexandra Harvey

Keyword(s):

Pain Management ◽

Pain Assessment ◽

Health Care Professionals ◽

Assessment Tool ◽

Standards Of Care ◽

Average Dose ◽

Management Intervention ◽

Pain Medications ◽

Post Operative Pain ◽

Pain Intervention

Objectives: To observe the method of pain assessment and pain management intervention performed by nurses in the PACU. Methods and Design: A QI prospective observational study was conducted to observe nurse’s pain assessment and management of thirty (30) patients from the time of PACU admission to discharge. The sample size was determined using the sealed envelope power calculator. Data Collection Included: patients demographics, the method and frequency of pain assessments as well as modalities of the pain intervention and the type and average dose of pain medications administered by PACU nurses. Data analysis was done using Microsoft excel. Results: No validated pain assessment tool was used in the PACU. The majority of patients 67%, n=20) had no pain assessments or pain interventions. When performed, the frequency of pain assessments recorded were low, 70% of patients had 1-2 assessments. The principal pain management intervention was pharmacological with the use of opioids, accounting for 96%. Conclusion: Post-operative pain management in the PACU at GPHC does not meet accepted standards of care. More frequent nursing pain assessment using a validated pain assessment tool is required. Monotherapy with the opioid was the main pain intervention for pain management. Recommendations: Effective pain management begins with the appropriate pain assessment; therefore pain management education programs for health care professionals are essential. Also, the implementation of a standardized pain assessment tool, a standardized post anesthetic order sheet with a multimodal approach to pain management and restructuring the post-anesthetic record to allow for documentation of pain assessment will greatly improve pain management in the PACU.

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Value-Based Interventional Pain Management: A Review of Medicare National and Local Coverage Determination Policies

January 2018 - Pain Physician ◽

10.36076/ppj.2013/16/e145 ◽

2013 ◽

Vol 3;16 (3;5) ◽

pp. E145-E180 ◽

Cited By ~ 1

Author(s):

Laxmaiah Manchikanti

Keyword(s):

Pain Management ◽

Randomized Clinical Trials ◽

Medical Community ◽

Final Decision ◽

Evidence Based ◽

Level Of Evidence ◽

General Acceptance ◽

Medical Needs ◽

Medicare Coverage ◽

Interventional Pain Management

Major policies, regulations, and practice patterns related to interventional pain management are dependent on Medicare policies which include national coverage policies – national coverage determinations (NCDs), and local coverage policies – local coverage determinations (LCDs). The NCDs are Medicare coverage policies issued by the Centers for Medicare and Medicaid Services (CMS). The process used by the CMS in deciding what is and what is not medically necessary is lengthy, involving a review of evidence-based literature on the subject, expert opinion, and public comments. In contrast, LCDs are rules and Medicare coverage that are issued by regional contractors and fiscal intermediaries when an NCD has not addressed the policy at issue. The evidence utilized in preparing LCDs includes the highest level of evidence which is based on published authoritative evidence derived from definitive randomized clinical trials or other definitive studies, and general acceptance by the medical community (standard of practice), as supported by sound medical evidence. In addition, the intervention must be safe and effective and appropriate including duration and frequency that is considered appropriate for the item or service in terms of whether it is furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function. In addition, the safe and effective provision includes that service must be furnished in a setting appropriate to the patient’s medical needs and condition, ordered and furnished by qualified personnel, the service must meet, but does not exceed, the patient’s medical need, and be at least as beneficial as an existing and available medically appropriate alternative. The LCDs are prepared with literature review, state medical societies, and carrier advisory committees (CACs) of which interventional pain management is a member. The LCDs may be appealed by beneficiaries. The NCDs are prepared by the CMS following a request for a national coverage decision after an appropriate national coverage request along with a draft decision memorandum, and public comments. After the request, the staff review, external technology assessment, Medicare Evidence Development and Coverage Advisory Committee (MedCAC) assessment, public comments, a draft decision memorandum may be posted which will be followed by a final decision and implementation instructions. This decision may be appealed to the department appeals board, but may be difficult to reverse. This manuscript describes NCDs and LCDs and the process of development, their development, issues related to the development, and finally their relation to interventional pain management. Key words: Interventional pain management, interventional techniques, national coverage determinations (NCDs), local coverage determinations (LCDs), contractor medical director (CMD), Centers for Medicare and Medicaid Services (CMS), Department of Health and Human Services (HHS), guidelines, evidence-based medicine, evidence development with coverage

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A comprehensive review of post-market clinical studies performed in adults with an Asian probiotic formulation

Beneficial Microbes ◽

10.3920/bm2008.1005 ◽

2010 ◽

Vol 1 (1) ◽

pp. 93-106 ◽

Cited By ~ 17

Author(s):

T. Tompkins ◽

X. Xu ◽

J. Ahmarani

Keyword(s):

Clinical Trials ◽

Clinical Studies ◽

Clinical Findings ◽

Chronic Diarrhoea ◽

Helicobacter Pylori Eradication ◽

Asian Populations ◽

Post Market ◽

Improve Compliance ◽

Irritable Bowel ◽

Study Designs

Probiotics as dietary supplements have been readily accepted by Asian populations. Use of certain probiotic preparations is widespread and the number of clinical trials undertaken with such products is unparalleled in western scientific literature. One such preparation, containing a combination of Enterococcus faecium R0026 and Bacillus subtilis R0179, has 23 publications on post-market clinical studies involving over 1,800 adults. The majority of these publications are printed in Chinese and Korean journals. This review examines the clinical findings with this probiotic combination. As mono-therapy, it has been used to overcome symptoms associated with chronic diarrhoea and irritable bowel syndrome. It has been used as co-adjuvant therapy with sulfasalazine and mesalazine to improve remission times in mild to moderate Ulcerative Colitis and to improve compliance with conventional triple therapy for Helicobacter pylori eradication. While the much of the data is preliminary and the study designs require refinement, the contribution of these trials should not be ignored. The information derived in this review will provide practitioners with practical information on appropriate applications for probiotic supplements, expected outcomes, dosing regimes, safety and reported adverse events. Furthermore, identification of problems in these trials should help researchers design better clinical trials when investigating probiotic products.

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