Complete Rotator Cuff Tear: An Evidence-Based Conservative Management Approach

Rotator cuff disease accounts for 10% of all shoulder pain and major shoulder disability, with limited information concerning the natural history and treatment approaches for the disorder. Our objective is to assess the available evidence for the efficacy and morbidity of commonly used systemic medications, physiotherapy, and injections alongside evaluating any negative long-term effects. Although there is conflicting literature, there appears to be some consensus on the best indicators for choosing to treat a full-thickness tears (FTT) non-operatively to reduce pain and improve function. The risks associated with these tears include the potential of the progression of the tear, a diminished healing potential due to age or longer symptom duration, muscle atrophy, and fatty infiltration. The indications for surgery following conservative treatment are becoming more defined, and an outline regarding what scenarios warrant a transition from an initial conservative treatment plan has been developed. The developing benefits of using mesenchymal stem cells (MSCs) and other biologics have the potential to be disruptive to current treatment protocols in the approaches to healing rotator cuff tears (RCTs). With improved imaging modalities, diagnostic accuracy, and sensitivity, practitioners of the future will hopefully be able to intervene earlier in the disease pathogenesis cycle

Bone Marrow Concentrate (BMC) Therapy in Musculoskeletal Disorders: Evidence-Based Policy Position Statement of American Society of Interventional Pain Physicians (ASIPP)

BACKGROUND: The use of bone marrow concentrate (BMC) for treatment of musculoskeletal disorders has become increasingly popular over the last several years, as technology has improved along with the need for better solutions for these pathologies. The use of cellular tissue raises a number of issues regarding the US Food and Drug Administration\u27s (FDA) regulation in classifying these treatments as a drug versus just autologous tissue transplantation. In the case of BMC in musculoskeletal and spine care, this determination will likely hinge on whether BMC is homologous to the musculoskeletal system and spine. OBJECTIVES: The aim of this review is to describe the current regulatory guidelines set in place by the FDA, specifically the terminology around minimal manipulation and homologous use within Regulation 21 CFR Part 1271, and specifically how this applies to the use of BMC in interventional musculoskeletal medicine. METHODS: The methodology utilized here is similar to the methodology utilized in preparation of multiple guidelines employing the experience of a panel of experts from various medical specialties and subspecialties from differing regions of the world. The collaborators who developed these position statements have submitted their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these position statements. The literature pertaining to BMC, its effectiveness, adverse consequences, FDA regulations, criteria for meeting the standards of minimal manipulation, and homologous use were comprehensively reviewed using a best evidence synthesis of the available and relevant literature. RESULTS/Summary of Evidence: In conjunction with evidence-based medicine principles, the following position statements were developed: Statement 1: Based on a review of the literature in discussing the preparation of BMC using accepted methodologies, there is strong evidence of minimal manipulation in its preparation, and moderate evidence for homologous utility for various musculoskeletal and spinal conditions qualifies for the same surgical exemption. Statement 2: Assessment of clinical effectiveness based on extensive literature shows emerging evidence for multiple musculoskeletal and spinal conditions. • The evidence is highest for knee osteoarthritis with level II evidence based on relevant systematic reviews, randomized controlled trials and nonrandomized studies. There is level III evidence for knee cartilage conditions. • Based on the relevant systematic reviews, randomized trials, and nonrandomized studies, the evidence for disc injections is level III. • Based on the available literature without appropriate systematic reviews or randomized controlled trials, the evidence for all other conditions is level IV or limited for BMC injections. Statement 3: Based on an extensive review of the literature, there is strong evidence for the safety of BMC when performed by trained physicians with the appropriate precautions under image guidance utilizing a sterile technique. Statement 4: Musculoskeletal disorders and spinal disorders with related disability for economic and human toll, despite advancements with a wide array of treatment modalities. Statement 5: The 21st Century Cures Act was enacted in December 2016 with provisions to accelerate the development and translation of promising new therapies into clinical evaluation and use. Statement 6: Development of cell-based therapies is rapidly proliferating in a number of disease areas, including musculoskeletal disorders and spine. With mixed results, these therapies are greatly outpacing the evidence. The reckless publicity with unsubstantiated claims of beneficial outcomes having putative potential, and has led the FDA Federal Trade Commission (FTC) to issue multiple warnings. Thus the US FDA is considering the appropriateness of using various therapies, including BMC, for homologous use. Statement 7: Since the 1980\u27s and the description of mesenchymal stem cells by Caplan et al, (now called medicinal signaling cells), the use of BMC in musculoskeletal and spinal disorders has been increasing in the management of pain and promoting tissue healing. Statement 8: The Public Health Service Act (PHSA) of the FDA requires minimal manipulation under same surgical procedure exemption. Homologous use of BMC in musculoskeletal and spinal disorders is provided by preclinical and clinical evidence. Statement 9: If the FDA does not accept BMC as homologous, then it will require an Investigational New Drug (IND) classification with FDA (351) cellular drug approval for use. Statement 10: This literature review and these position statements establish compliance with the FDA\u27s intent and corroborates its present description of BMC as homologous with same surgical exemption, and exempt from IND, for use of BMC for treatment of musculoskeletal tissues, such as cartilage, bones, ligaments, muscles, tendons, and spinal discs. CONCLUSIONS: Based on the review of all available and pertinent literature, multiple position statements have been developed showing that BMC in musculoskeletal disorders meets the criteria of minimal manipulation and homologous use. KEY WORDS: Cell-based therapies, bone marrow concentrate, mesenchymal stem cells, medicinal signaling cells, Food and Drug Administration, human cells, tissues, and cellular tissue-based products, Public Health Service Act (PHSA), minimal manipulation, homologous use, same surgical procedure exemption

Musculoskeletal physical examination : an evidence-based approach [cd]/ Malanga

xiii, 353 hal.: ill, tab.; 23 cm

Musculoskeletal physical examination : an evidence-based approach/ Malanga

xiii, 353 hal.: ill, tab.; 23 cm

Musculoskeletal physical examination : an evidence-based approach/ Malanga

xiii, 353 hal.: ill, tab.; 23 cm

Musculoskeletal physical examination : an evidence-based approach [cd]/ Malanga

xiii, 353 hal.: ill, tab.; 23 cm

The Role of Low-Intensity Pulsed Ultrasound on Cartilage Healing in Knee Osteoarthritis: A Review

Ultrasound (US) is a therapeutic modality that has been used in the treatment of musculoskeletal conditions for decades. In recent years, there have been technological advancements using low-intensity pulsed ultrasound (LIPUS) as a clinical modality. The purpose of this review was to critically examine the medical literature to determine the effects of LIPUS on the chondrogenic properties of knee osteoarthritis. A literature search of 3 major databases (PubMed, Scopus, and EMBASE) was performed. Two independent physician reviewers screened titles and abstracts, yielding a total of 18 relevant articles after the inclusion and exclusion criteria were applied. Results favored that LIPUS has a promising effect on the cellular elements in articular cartilage, specifically on chondrocytes in knee osteoarthritis. Although the use of LIPUS is encouraging based on basic science and preclinical data, there is a paucity of evidence with respect to humans. Consequently, there is insufficient evidence to recommend for or against LIPUS in clinical OA populations. We suggest future directions for research centered on LIPUS in both human and animal models to delineate the effect on the biologic properties of cartilage in knee osteoarthritis