The Specific Challenges of Conducting High Quality Clinical Trials to Assess Conservative Non Pharmacological Treatments of Osteoarthritis
Page: 3-12 (10)
Author: M. Marty
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There is a need for health providers to disseminate the results of high quality trials to justify health care policy. Non pharmacological treatments (NPT) are recommended for the treatment of osteoarthritis (OA). NPT (including medical devices, technical interventions, participative interventions, and nutraceuticals) represent a wide range of treatments for OA. While the reference study design to evaluate the effects of NPT is the randomized controlled trial (RCT), other study designs are also appropriate. Specific methodological issues are associated with RCTs designed for the assessment of the efficacy of NPTs in OA. The key points of a high quality clinical trial protocol to assess the efficacy of NPT for the treatment of OA are presented and justified. The methodology proposed is mostly in line with the International Conference of Harmonization (ICH) guidelines, European Agency for the Evaluation of Medicinal Products (EMEA) recommendations and the recommended efficacy core sets for assessment of OA. Grading quality for RCT assessing NPT in OA is challenging. Four features represent specific challenges to conducting high quality RCTs assessing NPT in comparison with those assessing pharmacological treatment : 1) the potential influence of care providers on treatment (e.g. experience of a therapist for a physical therapy intervention), 2) the choice of comparator (waiting list, usual care, sham intervention, another NPT, or a pharmacological treatment), 3) the blinding of the intervention and 4) the methods of randomization and assignation of the intervention. Depending on the nature of the NPT, bias can be limited using adapted methodological issues but are often not fully avoided.
Page: 13-20 (8)
Author: S. Perrot
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Non-pharmacological approaches are highly recommended for osteoarthritis (OA) treatment to reduce pain and improve function and quality of life. Based on international recommendations for the management of OA, we summarize herein the non-pharmacological treatments that may exhibit some analgesic effects in knee and hip OA. Studies on analgesic non-pharmacological approaches in OA include exercise, patient education, orthoses, acupuncture, physical agents and balneotherapy. Even though many of the published studies have methodological issues, it can be concluded that some of these approaches demonstrate analgesic effects with fewer side effects compared with pharmacological treatments. More evidence is available for knee OA than for hip OA for most of the nonpharmacological treatments. In all cases, these approaches should be individualised to each patient and can be combined together as well as combined with pharmacological management.
Non-Pharmacological Therapies for the Management of Osteoarthritis in Guidelines: Discrepancies and Translating Evidence in Practices
Page: 21-34 (14)
Author: Y. Henrotin
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Osteoarthritis (OA) refers to a syndrome of joint pain accompanied by functional limitation and reduced quality of life. The treatment of OA syndrome is dominated by pharmacological treatments, including analgesics and non-steroidal anti-inflammatory drugs that relieve symptoms but fail to modify disease progression. However, according to the most popular guidelines for good management of OA, the optimal treatment requires a combination of non-pharmacological and pharmacological treatments. The chapter gives a critical analysis of the most popular recommendations for the non-pharmacological management of knee, hip and hand OA. This chapter provides useful guidance and support for health care professionals making treatment decisions. It also describes the barriers to implement OA guidelines in clinical practice.
Page: 35-39 (5)
Author: P. Richette
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Obesity is the most modifiable risk factor for knee Osteoarthritis (OA). The mechanisms by which obesity contributes to the onset of knee OA are not fully understood, but the increase in biomechanical loading to cartilage seems to play a major role. Recent data have also suggested that metabolic factors and low-grade inflammation in obese patients might contribute to the genesis of the OA process. Weight loss is recommended by international bodies (EULAR and OARSI) as a treatment modality for obese patients with knee OA. RCTs have demonstrated that moderate dietary weight loss of about 5% improves function but pain only slightly. Few open studies have investigated the effect of massive weight loss induced by bariatric surgery in knee OA. Although the results from these studies should be cautiously interpreted, it seems that drastic weight loss could be more effective to reduce pain and disability in obese patients. Moderate weight loss significantly reduces several markers of systemic inflammation (TNFα, IL-6 and CRP) but the search for a correlation between these changes and an improvement in clinical outcomes has remained elusive in different studies.
Page: 40-63 (24)
Author: K. Bennell, M. Hunt and R. Hinman
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This chapter covers the role of two commonly used modalities, land-based exercise and manual therapy, in the management of OA. It summarises available evidence for the effectiveness of these modalities and discusses practical issues related to their application in the clinical setting. Exercise is the cornerstone of management for OA and is recommended by all clinical guidelines. There is strong evidence to show short-term beneficial effects of exercise on pain and function for knee OA. While the type of exercise does not seem to influence treatment outcome, a combination of strengthening, aerobic and functional exercise is recommended. As therapist contact appears to improve outcomes, a period of supervised exercise delivered either individually or in a group setting followed by a home program may be most appropriate. Strategies to facilitate long-term adherence to exercise are needed given that the benefits of exercise decline over time principally due to a lack of adherence. Given the limited research into the effects of exercise for hip and hand OA, further studies are needed at these sites. Manual therapy is delivered by health practitioners from a range of disciplines and may include techniques such as manipulation, mobilisation, stretching, myofascial techniques and massage. Limited research suggests that manual therapy techniques may be beneficial in the management of large joint OA particularly at the hip and as an adjunct to core treatment strategies of exercise and education. No studies have investigated the effects of manual therapy techniques, other than massage, for OA of the hand so the benefits for this patient group are largely unknown.
Page: 64-80 (17)
Author: R. Forestier and A. Françon
This chapter reports on a systematic review of the literature of crenobalneotherapy in the management of knee OA. Crenobalneotherapy is defined as the spectrum of techniques based on mineral or tap water and its derivatives, as used in a medical context. We searched Medline using the following keywords: ‘‘spa therapy’’, ‘‘mud’’, ‘‘radon’’, ‘‘balneotherapy’’, and ‘‘hydrotherapy’’ in combination with ‘‘OA’’, ‘‘arthrosis’’, and ‘‘gonarthrosis’’. We also reviewed the reference lists of articles retrieved by the Medline search. All studies that compared crenobalneotherapy to any other intervention or to no intervention were selected, and a checklist was used to assess their internal validity, external validity and the quality of the statistical analysis. We analyzed separately some components of crenobalneotherapy and comparators and four types of outcome criteria (pain, function, stiffness and quality of life). We calculated standardized response mean. There is middle level evidence that “multiple mineral interventions” that combine two or more components of crenobalneotherapy are superior to no treatment, high level evidence that its combination with home exercises is superior to home exercises alone and low level evidence that it is superior to short wave. There is high level but conflicting evidence that water exercise is superior to no treatment. There is a high level of evidence that water exercise is similar to land based exercise (but the studies noted that it is better tolerated). There is middle level evidence that massage is superior to no treatment. There is low level and conflicting evidence that bathing in mineral water is superior to or similar to bathing in tap water and that mineral mud and bathing in mineral water is superior to hot water. The only study evaluating heat (heat sleeve vs regular sleeve) found no differences but was a pilot study with insufficient sample size. Crenobalneotherapy seems to improve, pain, function, stiffness and quality of life in lower limb OA. As a whole treatment, its efficacy has a high level of evidence but efficacy of each component has middle level (massage) and sometimes high but conflicting level of evidence (exercise in water). There is low level evidence that chemical composition of water has a clinical relevant effect. More studies with higher methodology quality and sufficient sample size are needed in these fields.
Page: 81-93 (13)
Author: K. Sanchez, S. Poiraudeau and F. Rannou
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Acupuncture is recommended as a non-pharmacological treatment option for patients with knee and hip osteoarthritis (OA). Acupuncture is a Chinese philosophy which aims to restore the body to normal health. The explained mechanisms consider that acupuncture nociceptive pathways are essential for acupuncture analgesia, which is mediated by different endogenous neurotransmitters, such as enkephalin and dynorphin, and probably decreases the local inflammatory response via N-methyl-daspartate receptors. Acupuncture increases pain threshold gradually, with a peak effect at 20-40 min; a tolerance mediated by choleystokinin octapeptide could be observed if a prolonged period of acupuncture stimulation is performed. Immunocytochemistry and imaging studies indicate that both pain and acupuncture activate the hypothalamicpituitary-adrenocortical axis.
The literature review shows that clinical effects are small when acupuncture is compared with sham for treating OA patients; however, few if any other commonly used treatments for OA meet the threshold for clinically relevant benefits. On the other hand, acupuncture exceeds the thresholds for clinical relevance when compared with a waiting list control and with some other active treatment control, but the absence of sham treatment as a control suggests that benefits are primarily due to expectation or placebo effects.
Page: 94-102 (9)
Author: J. Beaudreuil
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Bracing for osteoarthritis (OA) involves the use of splints, tape, sleeves, and unloading knee braces. It is part of recommended non-pharmacological treatment for osteoarthritis of the thumb base and knee. Randomized clinical trials back these recommendations. Evidence that splints improve pain and disability in patients with thumb base OA is now provided. Weaker evidence appears for knee bracing including taping, sleeves and unloading braces. Low rate of adherence and safety issues should also be considered before using current unloading knee braces for knee OA. If bracing is to be used, a health professional should check to ensure the suitability of the device and provide patient education. Patient education includes knowledge of the aims of treatment, and encouragement to contact the therapist if they feel that the splint needs adjustment, or if they have any side effect or questions.
Page: 103-114 (12)
Author: R.S. Hinman and K.L. Bennell
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This chapter will review relevant research surrounding the use of insoles and footwear for knee osteoarthritis (OA). In particular, concepts relevant to the clinical application of these treatment techniques will be discussed. This chapter will examine the effects of common insole and footwear types on knee load, OA symptoms and disease progression. Increased joint loading increases the risk of OA progression, but is amenable to change. Given the prevalence of medial compartment OA, insoles and footwear largely aim to reduce the knee adduction moment, an indicator of medial compartment load. Lateral wedged insoles can reduce this moment but do not appear, at present, to slow disease progression. Whilst non- and quasi-experimental studies report favourable effects of lateral wedges on symptoms, most clinical trials have not been confirmatory. Medial wedged insoles show promise in relieving symptoms of lateral compartment disease. Walking in shoes increases joint load compared to barefeet. Shoes with a flat or low heel and that are flexible rather than stabilising in nature may be optimal for patients with knee OA, however effects of off-the-shelf shoes on OA symptoms are unknown. Promising shoe modifications currently under development include shoes that promote foot mobility and those with variable-stiffness or laterally wedged soles. In summary, insoles and footwear offer great potential as simple, inexpensive treatment strategies for knee OA. Further research is needed to evaluate their efficacy, particularly regarding their effects on knee symptoms and structural disease progression, and to determine which patient subgroups are most responsive.
Page: 115-126 (12)
Author: A. Mobasheri, K. Asplin, A. Clutterbuck and M. Shakibaei
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In this chapter we define the term “nutraceutical” and its relevance to arthritic diseases, and summarize recent research on nutraceuticals for joint disorders, particularly osteoarthritis (OA). The nutraceutical industry is not regulated. Consequently there are concerns about the purity, labeling and advertising of nutraceuticals. Manufacturers of nutraceuticals have a duty to communicate the benefits of their products with supporting scientific and clinical evidence. Nutraceutical products should be clearly labelled and advertising campaigns should be truthful and well balanced. The public and the scientific community require greater transparency and uniformity of commercially produced nutraceuticals. Consumers need to be able to make an informed choice about nutraceuticals based on evidence. We advocate greater regulation and regular independent testing of these products in order to ensure uniformity and greater reliability. The intended audience for this article include clinicians, basic researchers, producers of nutraceuticals and functional foods and advertising and marketing companies worldwide, particularly multi-national companies requiring information on issues relating to nutraceutical regulation.
Page: 127-129 (3)
Author: K. Bennell, F. Rannou and Y. Henrotin
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The previous chapters have covered a range of non pharmacological therapies for the management of OA. This chapter will briefly outline some areas that are of recent interest in the literature and that warrant further consideration and research attention.
Page: 130-131 (2)
Author: Yves Henrotin, Kim Bennell and Francois Rannou
Osteoarthritis is a chronic disease prevalent among the elderly. Its most prominent feature is the progressive destruction of articular cartilage which results in impaired joint motion, severe pain and ultimately disability. Its prevalence and its impact on daily life pose a significant public health problem. Today, a cure for osteoarthritis remains elusive and the management of the disease is largely palliative, focusing on the alleviation of symptoms. Current recommendations include a combination of pharmacological and non-pharmacological treatments. The term “non-pharmacological” includes physical therapy and rehabilitation, but also nutraceuticals. All guidelines on osteoarthritis management highlight the importance of weight loss and physical activity to improve the functional status of patients. A number of alternative therapies are also commonly suggested by physicians and physiotherapists in their daily practice. The efficacy of these therapies is not evidenced by strong clinical trials. This category includes education, information, electrotherapy, ultrasound, electromagnetic field, spa, hydrotherapy, acupuncture, etc. Non Pharmacological Therapies in the Management of Osteoarthritis reviews the clinical relevance of these therapies and the difficulties in conducting high quality trials assessing their efficacy. This e-book presents supportive scientific evidence for their efficacy and explains the mechanism of action of nutraceuticals targeting osteoarthritis. It also includes many example of exercises, mobilization and manipulation techniques directly useful for medical professionals.