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The Effects of Reflexology in Reducing the Symptoms of Fatigue in People with Rheumatoid Arthritis: A Preliminary Study

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... Estas intervenciones consisten en aplicar presión/masaje, con los pulgares, sobre puntos reflejos de la planta, el dorso, o el borde interno y externo de los pies. Tanto la frecuencia de aplicación terapéutica como la duración de cada sesión varían notablemente en los ensayos clínicos identificados, entre 1 [5] a 30 [6] sesiones; de 20 [7] a 45 minutos de duración cada una [8]. Los dos abordajes terapéuticos de mayor uso internacional son los métodos Ingham y Rwo Shur. ...
... Más concretamente, las indicaciones clínicas en las que se ha evaluado a la reflexología podal, mediante ensayos clínicos de calidad variable, son numerosas y heterogéneas. Entre ellas se incluyen el tratamiento de: estrés postoperatorio [14,15], cefaleas [16], asma [13,14], síndrome premenstrual [15], anovulación [16], hiperactividad del detrusor [8], diabetes tipo 2 [5], ictus cerebral [17,18], pacientes oncológicos en cuidados paliativos [5,6,11,19,20 [29]. Por otro lado, algunos autores han alertado sobre el riesgo de tratar con reflexoterapia a pacientes afectados por enfermedades graves [30]. ...
... Un total de 45 estudios se realizaron exclusivamente en adultos [7,8,11,16,19 9), con un rango de edad que osciló entre 3 y 89 años. ...
Article
Introduction Foot reflexology is a type of complementary manual therapy that consists of applying pressure or massage to the sole of the foot to produce various therapeutic effects in other body areas or organs. This technique has been used in many different clinical indications, but there is uncertainty about its real effect. A health technology assessment (HTA) was conducted to analyze the efficacy and safety of foot reflexology within the framework of the “Health Protection Plan Against Pseudo-Therapies,” which was established in 2018 by the Spanish Ministry of Health and the Ministry of Science and Innovation. Methods A systematic review and metanalysis was conducted to synthesize the available scientific literature on the efficacy and safety of foot reflexology in people of any age with any disease or medical condition. Results Sixty-eight randomized controlled studies were included. Pooled estimates indicated that foot reflexology had no effect on pain, fatigue, depression, quality of life, quality of sleep, or blood pressure, compared with non-reflexological foot massage. Improvements in pain (standardized mean difference [SMD] −1.11, 95% CI: −1.70 - −0.52), fatigue (SMD −0.93, 95% CI: −1.36 - −0.51), sleep quality (SMD −1.11, 95% CI: −1.68 - −0.34), and systolic (mean difference [MD] −7.36, 95% CI: −8.49 - −6.23) and diastolic (MD −5.07, 95% CI: −0.98 - −0.22) blood pressure were obtained when reflexology was compared with usual care or no intervention. In the case of anxiety levels, the benefit obtained with foot reflexology compared with any comparator (SMD −0.6, 95% CI: −0.98 - −0.22) was attenuated when compared with non-reflexological foot massage (SMD −0.2, 95% CI: −0.36 - −0.03). Very few studies reported on the safety of foot reflexology. Conclusions There was no evidence for any specific effect of reflexology for any condition when compared with non-reflexological foot massage, except for a positive effect on anxiety levels.
... In foot reflexotherapy it is believed that reflex arcs that begin from specific sites on the feet are related to internal organs of the body. Research data reported by Otter et al. [3], Özdelikara and Tan [4], and Stephenson et al. [5] indicate the importance of foot reflexotherapy in relieving pain, psychological stress and fatigue in different illnesses such as rheumatoid arthritis [3], cancer [4,5], among others (reviewed in Embong et al. [6]). Reflexological treatment was found to alleviate pain in patients who suffered from low back pain [7]. ...
... In foot reflexotherapy it is believed that reflex arcs that begin from specific sites on the feet are related to internal organs of the body. Research data reported by Otter et al. [3], Özdelikara and Tan [4], and Stephenson et al. [5] indicate the importance of foot reflexotherapy in relieving pain, psychological stress and fatigue in different illnesses such as rheumatoid arthritis [3], cancer [4,5], among others (reviewed in Embong et al. [6]). Reflexological treatment was found to alleviate pain in patients who suffered from low back pain [7]. ...
Article
Background and purpose: Symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) can occur in association with enuresis nocturia. Alternative therapies may be effective in addressing the maladies of children with ADHD comorbidities. The purpose of this study was to investigate the effects of foot reflexotherapy in a child with ADHD and enuresis nocturia. Materials and methods: The patient was an 8-year-old child with ADHD and enuresis nocturia. Pre- and post-tests for ADHD were completed using Vanderbilt ADHD Diagnostic Teacher Rating Scale. The subject was treated with foot reflexotherapy for 20-min per session twice per week for a period of 8 weeks. Results: The child showed improvement in ADHD symptoms and his enuresis nocturia disappeared completely after foot reflexotherapy. Conclusion: Foot reflexotherapy was effective in improving inattention, hyperactivity in the child with ADHD. The results of this novel study suggest that foot reflexotherapy can be effective in treating ADHD child with enuresis nocturia.
... In the meta-analysis study conducted by Lee et al., [2011], it was concluded that foot reflexology was a useful nursing practice that had a more positive effect on fatigue and sleep than pain [14]. In another study, it was stated that foot reflexology had a mitigating effect on the symptoms of fatigue in RA patients [15]. ...
... It was found that both hand and foot reflexology had a positive effect on pain and quality of life in RA patients [2]. In a study, it was concluded that foot reflexology was a more effective method in reducing pain symptoms compared to aromatherapy [15]. It was determined that reflexology applied to RA patients for six weeks as one session per week has a positive effect on the foot pain scores perceived by the patients [9]. ...
... Literatür incelendiğinde RA'da ağrı ve yorgunluğun üzerine re eksolojinin etkisi ile ilgili iki çalışmaya rastlanmıştır. (Tablo 1) [48,49] Khan ve arkadaşlarının RA'lı hastalarda yürüttükleri re eksoloji çalışmasında, altı hafta boyunca, haftada bir defa yaklaşık bir saat süreyle uygulanan re eksolojinin RA'lı hastada ağrıyı azalttığı ve etkisini 2-3 gün devam ettirdiği belirtilmiştir. Ayrıca, araştırma sonunda hastaların ayak ağrılarının azalmasının, yaşam kalitesinde olumlu gelişmeler sağlayabileceği ifade edilmiştir. ...
... [48] Otter ve arkadaşları tarafından gerçekleştirilen re eksoloji ile ayak masajının karşılaştırıldığı randomize kontrollü başka bir çalışmada, haftada bir seans 45 dakika boyunca, toplam altı hafta uygulanan re eksolojinin, RA tanısı alan kadın hastalarda ağrı ve yorgunluk skorlarını azalttığı ve uyku düzeninde iyileşme sağladığı belirlenmiştir. [49] ...
Article
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Rheumatoid arthritis is a multi-systemic, autoimmune and chronic disease, characterized by in� ammation. Rheumatoid arthritis reduces the quality of life by causing pain, fatigue, morning stiffness, limitation of movement, dif culties in daily life, deterioration in social relations, and depression. Despite using pharmacological methods for management the symptoms of rheumatoid arthritis, there is no complete cure of the disease today. Patients frequently experience side effects such as toxicity, nausea, vomiting, loss of appetite, anemia or systemic infection due to used pharmacological treatment. Patients with rheumatoid arthritis are applying to complementary and alternative medicine because of side effects of the treatment, incomplete treatment, and chronic pain and fatigue. Aromatherapy and re� exology, which are often preferred and commonly used among patients with rheumatoid arthritis and health care professionals has a positive effect on the management of patients’ pain and fatigue, and on increasing the quality of life. This review article is written in order to inform nurses about the use of aromatherapy and re� exology in rheumatoid arthritis.
... Foot pain and deformity is very common in patients with rheumatoid arthritis (RA). The considerable physical and psychosocial malaise that can be provoked includes neuropathy due to reduced sensitivity, ulcers (which develop in 10% of patients), the psychosocial impact of impaired self-image, sexuality and personal relationships, weight gain, increased fatigue and deformities such as hallux valgus and metatarsus primus varus [1][2][3][4][5]. Epidemiology studies consistently report a 90% prevalence of foot pain in these patients, despite advances in pharmacological therapy [1,6]. ...
Article
Full-text available
Background: Epidemiological studies consistently report a 90% prevalence of foot pain. Mechanical and other non-pharmacological interventions such as orthoses and footwear can play an important role in managing foot pathology in patients whose systemic disease is controlled. The effectiveness of treatment with insoles has been examined in various randomised controlled trials, which have reported immediate clinical improvements, with reduced foot pain and disability and enhanced functionality. The aim of this systematic review is to determine the effectiveness of foot orthoses in patients with rheumatoid arthritis (RA), in comparison with other treatments, in terms of enhanced disability and reduced pain. Methods: A systematic review and meta-analysis was conducted of a number of randomised controlled trials focusing on patients with RA. The search was conducted in Cochrane, CINAHL, PubMed, EMBASE, SCOPUS and Cuiden, by means of an independent peer review. The Mesh terms and fields used were foot, ankle, joint, RA, foot, orthosis, insole and foot orthosis. Results: Of the initial 118 studies considered, 5 were included in the final systematic review and meta-analysis. These five studies had enrolled a total of 301 participants, with follow-up periods ranging from 4 to 36 months. Although the use of orthoses seems to alleviate foot pain, our meta-analysis did not reveal statistically significant differences between control and intervention groups regarding long- and short-term pain relief and/or reduced disability. Conclusions: Foot orthoses can relieve pain and disability and enhance patients, but no significant differences were found between control and intervention groups.
... 2 It is also effective in reducing symptoms of fatigue. 3 It is speculated that the mechanisms by which foot reflexotherapy affect body functions are due to the mediation of balance between sympathetic and parasympathetic divisions of the autonomic nervous system,and also, stimulation of the release of mediators that act on local and distant sites to regulate physiological processes. 2,4 However, electrophysiological basis of this complementary medicine technique is not completely known. ...
... Foot pain and deformity is very common in patients with rheumatoid arthritis (RA). The considerable physical and psychosocial malaise that can be provoked includes neuropathy due to reduced sensitivity, ulcers (which develop in 10% of patients), the psychosocial impact of impaired self-image, sexuality and personal relationships, weight gain, increased fatigue and deformities such as hallux valgus and metatarsus primus varus [1][2][3][4][5]. Epidemiology studies consistently report a 90% prevalence of foot pain in these patients, despite advances in pharmacological therapy [1,6]. ...
Conference Paper
Background Foot pain and deformity is almost ubiquitous in RA and results in considerable physical and psychosocial impairment [1]. Epidemiological studies consistently suggest a 90% prevalence of foot pain despite advances in pharmacological therapy [2]. Mechanical and other non-pharmacological interventions such as orthoses and footwear, have an important role in managing foot pathology in patients with their systemic disease controlled [1,3]. The effectiveness of treatment with insoles, especially in early periods, was studied in a randomized controlled trial, which results suggested an immediate clinical improvement, reducing foot pain, disability and limited functionality.[1] Objectives The aim of this study is the effectiveness of foot orthosis in patients with rheumatoid arthritis in terms of quality of life and pain. Methods A systematic review and meta-analysis was conducted of randomized controlled trials. Participants: Patients with rheumatoid arthritis were included. The criteria of exclusion were Juvenile Rheumatoid Arthritis, analysis of gait, Intervention: Studies had to compare foot orthosis Comparison: Other type of treatments, other type of foot orthosis, sham Outcomes: Evaluation of Pain or Quality of life with any tool that measure this outcomes The search was conducted in Cochrane, CINAHL, PubMed, EMBASE, LILACS, and Cuiden. An independent peer review was carried out. The Mesh term and fields used were foot, ankle, joint, rheumatoid arthritis, foot, orthosis, insole, foot orthosis. Results After the analysis of 71 studies, 4 were included for the systematic review. The 4 studies enrolled 285 participants. Follow-up periods varied from 6 to 30 months. Only two studies were included in the meta-analysis [4,5], both of them with pain (measured with Foot Function Index) as the selected outcome. A meta-analysis of the two trials showed that use of FO resulted in a non-significant improvement in disability compared with control (MD (95% CI): 4.37 (-6.24, 14.98); N=64) (Figure 1). • Download figure • Open in new tab • Download powerpoint Conclusions Foot orthoses showed improvements in pain and disability/quality of life, but no significant differences between groups were found.Future research needs to increase the number of RCTs in this topic because results are not conclusive. References • Woodburn J, Barker S, Helliwell PS. A randomized controlled trial of foot orthoses in rheumatoid arthritis. J Rheumatol. 2002;29:1377–83. • Otter SJ, Lucas K, Springett K, Moore A, Davies K, Young A, et al. Comparison of foot pain and foot care among rheumatoid arthritis patients taking and not taking anti-TNFalpha therapy: an epidemiological study. Rheumatol Int. 2011;31:1515–9. • Hennessy K, Woodburn J, Steultjens MPM. Custom foot orthoses for rheumatoid arthritis: A systematic review. Arthritis Care Res (Hoboken). 2012;64:311–20. • Conrad KJ, Budiman-Mak E, Roach KE, Hedeker D, Caraballada R, Burks D, Moore H. Impacts of foot orthoses on pain and disability in rheumatoid arthritics. J Clin Epidemiol. 1996 Jan;49(1):1–7. • Novak P, Burger H, Tomsic M, Marincek C, Vidmar G. Influence of foot orthoses on plantar pressures, foot pain and walking ability of rheumatoid arthritis patients–a randomised controlled study. Disabil Rehabil. 2009;31(8):638–45. References Disclosure of Interest None declared
... (2010)'nın çalışmasında ayak refleksolojisinin RA hastalarında yorgunluk semptomunu hafifletici etkisi olduğu belirtilmiştir. 39 Khan ve ark. (2006) tarafından yapılan çalışmada; RA hastalarında haftada bir seans olmak üzere altı hafta boyunca uygulanan refleksolojinin hastaların algıladıkları ayak ağrı skorlarını olumlu yönde etkilediği saptanmıştır (Tablo 2). ...
Article
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ABSTRACT Rheumatoid arthritis (RA) patients are most likely to come close to pain, fatigue and insomnia. The main goal in treatment is; Reducing pain and inflammation, minimizing joint damage , preventing disturbance, protecting the patient's functions and improving quality of life. In addition to intensive medical treatment, they also resort to alternative methods. The purpose of this review is to assess the effect of reflexology on RA patients. Medline/PubMed, EBSCO, Cochrane databases were searched for studies related to reflexology on RA patients regardless of date. The keywords "reflexology, rheumatoid arthritis, reflexology and rheumatoid arthritis" were used for searching. As a result of browsing carried out with the keywords four articles were reached. Re-flexology have been found to be effective intervention in nearly all of the examined articles. It was seen that the sampling, research method and data collection tools were adequate and reliable in the studies. The results of the studies have been clearly expressed. K Ke ey yw wo or rd ds s: : Reflexology; arthritis, rheumatoid; nurses
Article
This article provides an overview of nonpharmacologic options for the treatment of pain in patients with inflammatory arthritis, such as peripheral spondyloarthritis, psoriatic arthritis, ankylosing spondylitis, and rheumatoid arthritis. The experience of pain in chronic disease is a complex process influenced by multiple domains of health. The discussion focuses on the establishment of a framework for pain control that engages with factors that influence the experience of pain and explores the evidence base that supports specific modalities of nonpharmacologic pain control, such as mindfulness, cognitive behavioral therapy, exercise, massage, splinting, and heat therapy. Rheumatoid and spondyloarthritides are considered separately.
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Background: and purpose: Sensorineural hearing impairment (SNHL) is one of hearing impairments. The incidence of hearing loss is 1-3 per 1000 births. Complementary therapies may be effective in addressing the maladies of infant with hearing loss. The aim of this study was to assess the efficacy of foot reflexotherapy in an infant with SNHL. Materials and methods: The patient was a 3-month-old infant with SNHL. Pre- and post-tests for hearing loss were completed using audiologic method (auditory brain-stem responses, ABR), combined with behavioural audiometry. The subject was treated with foot reflexotherapy for 30-min per session four times per week for a period of 24 weeks. Conclusion: Foot reflexotherapy was effective on auditory recuperation of infant with SNHL. The results of this novel study suggest that foot reflexotherapy can be an effective complementary treatment of infants with SNHL, especially for 3-month to 9 -month age.
Article
Introduction This study was conducted to determine the effects of sleep hygiene education and reflexology on sleep quality and fatigue in the patients receiving chemotherapy. Methods The sample of the study consisted of 167 patients (84 in the experimental and 83 in the control group). The data were collected between October 2016 and November 2017 using an Introductory Information Form, the Pittsburgh Sleep Quality Index (PSQI) and the Fatigue Severity Scale (FSS). Results The mean ‐test score from the PSQI was 5.5 ± 2.1 for the experimental group and 13 ± 2.4 for the control group. The mean post‐ test score from the FSS was 22.6 ± 1.9 for the experimental group and 41.0 ± 4.2 for the control group. The difference between the mean scores of the groups was statistically significant (p = 0.000). Conclusion The patients receiving chemotherapy had lower mean scores from the PSQI and the FSS while they had increased sleep quality and decreased fatigue after sleep hygiene education and reflexology.
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Nonpharmacologic interventions for symptom management in patients with rheumatoid arthritis are underinvestigated. Limited data suggest that aromatherapy massage and reflexology may help to reduce pain and fatigue in patients with rheumatoid arthritis. The aim of this study was to examine and compare the effects of aromatherapy massage and reflexology on pain and fatigue in patients with rheumatoid arthritis. The study sample was randomly assigned to either an aromatherapy massage (n = 17), reflexology (n = 17) or the control group (n = 17). Aromatherapy massage was applied to both knees of subjects in the first intervention group for 30 minutes. Reflexology was administered to both feet of subjects in the second intervention group for 40 minutes during weekly home visits. Control group subjects received no intervention. Fifty-one subjects with rheumatoid arthritis were recruited from a university hospital rheumatology clinic in Turkey between July 2014 and January 2015 for this randomized controlled trial. Data were collected by personal information form, DAS28 index, Visual Analog Scale and Fatigue Severity Scale. Pain and fatigue scores were measured at baseline and within an hour after each intervention for 6 weeks. Pain and fatigue scores significantly decreased in the aromatherapy massage and reflexology groups compared with the control group (p < .05). The reflexology intervention started to decrease mean pain and fatigue scores earlier than aromatherapy massage (week 1 vs week 2 for pain, week 1 vs week 4 for fatigue) (p < .05). Aromatherapy massage and reflexology are simple and effective nonpharmacologic nursing interventions that can be used to help manage pain and fatigue in patients with rheumatoid arthritis.
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This study was a randomized controlled trial designed to evaluate the effect of foot reflexology applied on infants on acute pain that may arise after vaccine injection. The sample consisted of 1- to 12-month-old infants registered in a family health center in Istanbul, Turkey, for healthcare follow-up. A total of 60 infants who met the criteria of the sample group were included in the study; 30 infants constituted the reflexology group and the other 30 constituted the control group. Although questionnaire forms were used to determine the descriptive characteristics of infant-mother pairs, the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale was used to evaluate pain level. Infants in the reflexology group received reflexology treatment for an average of 20-30 minutes before vaccination, depending on the physical size of the infant's foot. Pain, heart rate, oxygen saturation levels, and crying periods of infants in the reflexology and control groups were evaluated before and after vaccination. The FLACC pain score was observed to be statistically similar between groups. After reflexology was applied to infants in the reflexology group before vaccination, it was determined that the pain score was reduced to .50 ± 1.14. In the examination performed after vaccination, FLACC pain score was found to be 5.47 ± 2.11 in the reflexology group and 9.63 ± .85 in the control group. A statistically significant difference was observed between the mean FLACC pain scores of infants in the reflexology and control groups (p = .000). The infants in the reflexology group also had lower heart rates, higher oxygen saturation, and shorter crying periods than the infants in the control group (p <.001). Reflexology before vaccine reduced the pain level experienced after vaccination. Future research needs to explore different interventional practices. © 2015 Sigma Theta Tau International.
Article
Fatigue is a common and potentially distressing symptom for people with rheumatoid arthritis with no accepted evidence based management guidelines. Non-pharmacological interventions, such as physical activity and psychosocial interventions, have been shown to help people with a range of other long-term conditions to manage subjective fatigue. To evaluate the benefit and harm of non-pharmacological interventions for the management of fatigue in people with rheumatoid arthritis. This included any intervention that was not classified as pharmacological in accordance with European Union (EU) Directive 2001/83/EEC. The following electronic databases were searched up to October 2012, Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; AMED; CINAHL; PsycINFO; Social Science Citation Index; Web of Science; Dissertation Abstracts International; Current Controlled Trials Register; The National Research Register Archive; The UKCRN Portfolio Database. In addition, reference lists of articles identified for inclusion were checked for additional studies and key authors were contacted. Randomised controlled trials were included if they evaluated a non-pharmacological intervention in people with rheumatoid arthritis with self-reported fatigue as an outcome measure. Two review authors selected relevant trials, assessed risk of bias and extracted data. Where appropriate, data were pooled using meta-analysis with a random-effects model. Twenty-four studies met the inclusion criteria, with a total of 2882 participants with rheumatoid arthritis. Included studies investigated physical activity interventions (n = 6 studies; 388 participants), psychosocial interventions (n = 13 studies; 1579 participants), herbal medicine (n = 1 study; 58 participants), omega-3 fatty acid supplementation (n = 1 study; 81 participants), Mediterranean diet (n = 1 study; 51 participants), reflexology (n = 1 study; 11 participants) and the provision of Health Tracker information (n = 1 study; 714 participants). Physical activity was statistically significantly more effective than the control at the end of the intervention period (standardized mean difference (SMD) -0.36, 95% confidence interval (CI) -0.62 to -0.10; back translated to mean difference of 14.4 points lower, 95% CI -4.0 to -24.8 on a 100 point scale where a lower score means less fatigue; number needed to treat for an additional beneficial outcome (NNTB) 7, 95% CI 4 to 26) demonstrating a small beneficial effect upon fatigue. Psychosocial intervention was statistically significantly more effective than the control at the end of the intervention period (SMD -0.24, 95% CI -0.40 to -0.07; back translated to mean difference of 9.6 points lower, 95% CI -2.8 to -16.0 on a 100 point scale, lower score means less fatigue; NNTB 10, 95% CI 6 to 33) demonstrating a small beneficial effect upon fatigue. For the remaining interventions meta-analysis was not possible and there was either no statistically significant difference between trial arms or findings were not reported. Only three studies reported any adverse events and none of these were serious, however, it is possible that the low incidence was in part due to poor reporting. The quality of the evidence ranged from moderate quality for physical activity interventions and Mediterranean diet to low quality for psychosocial interventions and all other interventions. This review provides some evidence that physical activity and psychosocial interventions provide benefit in relation to self-reported fatigue in adults with rheumatoid arthritis. There is currently insufficient evidence of the effectiveness of other non-pharmacological interventions.
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Except for the mildest cases, rheumatoid arthritis cannot be adequately managed by one specialist in isolation from others. Most people with rheumatoid arthritis cope better if they understand their condition and have realistic expectations of the benefits and disadvantages of treatment. Therefore, education of patients is an important aspect of treatment. Specialist rheumatology nurses have become well established in many rheumatology departments; their role includes monitoring drugs used to treat rheumatoid arthritis and differentiating minor or unrelated symptoms from those that require action. #### Goals of treatment in rheumatoid arthritis In a physiotherapy department local measures such as heat, cold, and electrotherapy may be used to reduce pain and generally form part of a rehabilitation programme of exercises designed to improve muscle strength and encourage mobility in affected joints. The aims of occupational therapy are to educate patients; to protect joints; to analyse function and to improve it by means of exercise and use of aids and appliances; and to provide splints when necessary. #### Role of physiotherapy for rheumatoid arthritis Few of the individual techniques used in physiotherapy and occupational therapy have been subjected to controlled trials, but there is no doubt that therapists who are skilled in handling atrophied, inflamed, and stiff tissues and familiar with the problems faced by patients with arthritis greatly help in treatment and rehabilitation. #### Role of podiatry for rheumatoid arthritis The aims of surgery are to relieve pain and to restore function. Indications …
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As last year, a consensus group to consider the use of tumour necrosis factor (TNF) blocking agents was formed by an organising committee constituted of rheumatologists from the Universities of Erlangen, Leiden and Vienna in Europe in cooperation with universities in the United States. Pharmaceutical support was obtained from a number of companies, but these institutions had no part in the decisions regarding this specific programme nor with regard to the participants or attendees at this conference. The approximately 100 rheumatologists and bioscientists from 25 countries who attended the consensus conference were chosen from a worldwide group of people felt to have experience or interest in the use of TNF blocking treatment for rheumatoid arthritis (RA). Unfortunately, the number of attendees and participants were limited so that not everyone who might have been appropriate could be invited. During the past year increasing amounts of data on the use of TNF blocking agents in RA have been published. Consequently it was felt appropriate to update the provisional consensus statement published last year (Ann Rheum Dis 1999;58 (suppl 1):I129–30). During this revision it became clear that there are still large areas where knowledge is lacking. In an effort to clarify, for the readers, evidence on which the consensus statement is based, statements with supporting data have been referenced. When a statement is not referenced it will have arisen from the consensus process: small group discussions, large group discussions and repeated drafts of the consensus statement to allow input from all participants. We feel that this statement represents an updated, although still provisional, consensus view of the use of TNF blockade in RA. However, it will …
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Background: Insomnia is a prevalent health complaint that is often difficult to evaluate reliably. There is an important need for brief and valid assessment tools to assist practitioners in the clinical evaluation of insomnia complaints.Objective: This paper reports on the clinical validation of the Insomnia Severity Index (ISI) as a brief screening measure of insomnia and as an outcome measure in treatment research. The psychometric properties (internal consistency, concurrent validity, factor structure) of the ISI were evaluated in two samples of insomnia patients.Methods: The first study examined the internal consistency and concurrent validity of the ISI in 145 patients evaluated for insomnia at a sleep disorders clinic. Data from the ISI were compared to those of a sleep diary measure. In the second study, the concurrent validity of the ISI was evaluated in a sample of 78 older patients who participated in a randomized-controlled trial of behavioral and pharmacological therapies for insomnia. Change scores on the ISI over time were compared with those obtained from sleep diaries and polysomnography. Comparisons were also made between ISI scores obtained from patients, significant others, and clinicians.Results: The results of Study 1 showed that the ISI has adequate internal consistency and is a reliable self-report measure to evaluate perceived sleep difficulties. The results from Study 2 also indicated that the ISI is a valid and sensitive measure to detect changes in perceived sleep difficulties with treatment. In addition, there is a close convergence between scores obtained from the ISI patient's version and those from the clinician's and significant other's versions.Conclusions: The present findings indicate that the ISI is a reliable and valid instrument to quantify perceived insomnia severity. The ISI is likely to be a clinically useful tool as a screening device or as an outcome measure in insomnia treatment research.
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Not all patients with rheumatoid arthritis can tolerate or respond to methotrexate, a standard treatment for this disease. There is evidence that antitumour necrosis factor alpha (TNFalpha) is efficacious in relief of signs and symptoms. We therefore investigated whether infliximab, a chimeric human-mouse anti-TNFalpha monoclonal antibody would provide additional clinical benefit to patients who had active rheumatoid arthritis despite receiving methotrexate. In an international double-blind placebo-controlled phase III clinical trial, 428 patients who had active rheumatoid arthritis, who had received continuous methotrexate for at least 3 months and at a stable dose for at least 4 weeks, were randomised to placebo (n=88) or one of four regimens of infliximab at weeks 0, 2, and 6. Additional infusions of the same dose were given every 4 or 8 weeks thereafter on a background of a stable dose of methotrexate (median 15 mg/week for > or =6 months, range 10-35 mg/wk). Patients were assessed every 4 weeks for 30 weeks. At 30 weeks, the American College of Rheumatology (20) response criteria, representing a 20% improvement from baseline, were achieved in 53, 50, 58, and 52% of patients receiving 3 mg/kg every 4 or 8 weeks or 10 mg/kg every 4 or 8 weeks, respectively, compared with 20% of patients receiving placebo plus methotrexate (p<0.001 for each of the four infliximab regimens vs placebo). A 50% improvement was achieved in 29, 27, 26, and 31% of infliximab plus methotrexate in the same treatment groups, compared with 5% of patients on placebo plus methotrexate (p<0.001). Infliximab was well-tolerated; withdrawals for adverse events as well as the occurrence of serious adverse events or serious infections did not exceed those in the placebo group. During 30 weeks, treatment with infliximab plus methotrexate was more efficacious than methotrexate alone in patients with active rheumatoid arthritis not previously responding to methotrexate.
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To compare two therapeutic strategies for patients with recent-onset rheumatoid arthritis. Open, randomized clinical trial. Outpatient clinics of six clinical centers. 238 consecutive patients with recently diagnosed rheumatoid arthritis. Delayed or immediate introduction of treatment with slow-acting antirheumatic drugs (SAARDs). Primary end points were functional disability, pain, joint score, and erythrocyte sedimentation rate at 6 and 12 months and progression of radiologic abnormalities at 12 months. Statistically significant advantages at 12 months for patients receiving the SAARD strategy (immediate treatment with SAARDs) with regard to all primary end points that may be clinically important are indicated by the differences in improvements from baseline and their 95% CIs. These differences were 0.3 (95% CI, 0.2 to 0.6) for disability (range, 0 to 3), 10 mm (CI, 1 to 19 mm) for pain (range, 0 to 100 mm), 39 (CI, 4 to 74) for joint score (range, 0 to 534), and 11 mm/h (CI, 3 to 19 mm/h) for erythrocyte sedimentation rate (range, 1 to 140 mm/h), all in favor of SAARD treatment. The SAARD strategy also appears to be advantageous at 6 months. Radiologic abnormalities progressed at an equal rate in the SAARD and the non-SAARD groups; the difference in progression (range, 0 to 448) was 1 (CI, -3 to 5). Analyses were based on the intention-to-treat principle and thus included 29% of patients in the non-SAARD group who discontinued the non-SAARD treatment strategy; treatment was usually discontinued because of insufficient effectiveness. The SAARD strategy including two alternative SAARDs could not be continued by 8% of patients, usually because of adverse reactions. Early introduction of SAARDs may be more beneficial than delayed introduction for patients with recently diagnosed rheumatoid arthritis.
Article
Patients treated with methotrexate for rheumatoid arthritis often improve but continue to have active disease. This study was undertaken to determine whether the addition of etanercept, a soluble tumor necrosis factor receptor (p75):Fc fusion protein (TNFR:Fc), to methotrexate therapy would provide additional benefit to patients who had persistent rheumatoid arthritis despite receiving methotrexate. In a 24-week, double-blind trial, we randomly assigned 89 patients with persistently active rheumatoid arthritis despite at least 6 months of methotrexate therapy at a stable dose of 15 to 25 mg per week (or as low as 10 mg per week for patients unable to tolerate higher doses) to receive either etanercept (25 mg) or placebo subcutaneously twice weekly while continuing to receive methotrexate. The primary measure of clinical response was the American College of Rheumatology criteria for a 20 percent improvement in measures of disease activity (ACR 20) at 24 weeks. The addition of etanercept to methotrexate therapy resulted in rapid and sustained improvement. At 24 weeks, 71 percent of the patients receiving etanercept plus methotrexate and 27 percent of those receiving placebo plus methotrexate met the ACR 20 criteria (P<0.001); 39 percent of the patients receiving etanercept plus methotrexate and 3 percent of those receiving placebo plus methotrexate met the ACR 50 criteria (for a 50 percent improvement) (P<0.001). Patients receiving etanercept plus methotrexate had significantly better outcomes according to all measures of disease activity. The only adverse events associated with etanercept were mild injection-site reactions, and no patient withdrew from the study because of adverse events associated with etanercept. In patients with persistently active rheumatoid arthritis, the combination of etanercept and methotrexate was safe and well tolerated and provided significantly greater clinical benefit than methotrexate alone.
Article
This study outlines the design and validation of a new self-administered instrument for assessing foot pain and disability. The 19-item questionnaire was tested on 45 rheumatology patients, 33 patients who had attended their general practitioner with a foot-related problem and 1000 responders to a population survey of foot disorders. Levels of reported disability were found to be greatest for rheumatology patients and least for community subjects. In addition, the instrument was able to detect differences in disability levels reported by community subjects who did and did not consult with a health care professional and those who did and did not have a history of past and current foot pain. A good level of agreement was found when items on the questionnaire were compared with similar items on the ambulation sub-scale of the Functional Limitation Profile questionnaire. A Cronbach's alpha value of 0.99 and item-total correlation values between 0.25 and 0.62 confirmed the internal consistency of the instrument. Finally the results of a principal components analysis identified three constructs that reflected disabilities that are associated with foot pain: functional limitation, pain intensity and personal appearance. The design of the foot disability questionnaire makes it a suitable instrument for assessing the impact of painful foot conditions in both community and clinical populations.
Article
For patients with rheumatoid arthritis, a new era in treatment has begun. This optimistic view, shared widely by rheumatologists, reflects the introduction in the past two years of novel agents to treat this painful and debilitating condition. These agents, including the tumor necrosis factor (TNF) blockers, are the fruits of biotechnology and bring improvements in efficacy and safety. Furthermore, children will be among the candidates for these new treatments, since as shown by the results reported by Lovell et al. in this issue of the Journal, 1 children with juvenile rheumatoid arthritis, like adults, have an impressive response to TNF blockade. . . .
Article
To multidimensionally assess fatigue in rheumatoid arthritis (RA) and to evaluate the impact of fatigue on health-related quality of life (HRQOL). The study was conducted in 1999 among 490 RA patients with varying disease duration. Fatigue was measured with the Multidimensional Fatigue Inventory (MFI-20) and HRQOL with a validated Dutch version of the RAND 36-Item Health Survey. We evaluated the impact of fatigue on HRQOL by multiple linear regression analyses taking into account RA-related pain and depressive symptoms. Different aspects of fatigue selectively explained different dimensions of HRQOL. The MFI-20 was entered last to the linear regression models, resulting in an additional increase of explained variance of 1% (mental health) to 14% (vitality). The multidimensional portrayal of RA-related fatigue can be used to develop intervention strategies targeted to specific aspects of fatigue. Fatigue, supplementary to RA-related pain and depressive symptoms, appears to be a feasible and treatable target in the clinical management of RA to increase HRQOL.
Article
Fatigue is commonly reported by patients with rheumatoid arthritis (RA) but is rarely a treatment target. The aim of this study was to explore the concept of fatigue as experienced by patients with RA. Fifteen patients with RA and fatigue (> or =7 on a 10-cm visual analog scale) were individually interviewed and asked about the description, cause, consequence, and management of fatigue. Transcripts were systematically analyzed by 2 researchers independently, relevant phrases were coded, and earlier transcripts were checked for the emerging codes. A random sample of analyses were independently reviewed. A total of 191 codes arising from the data were grouped into 46 categories and overarching themes. Vivid descriptions reflect 2 types of fatigue: severe weariness and dramatic overwhelming fatigue. RA fatigue is different from normal tiredness because it is extreme, often not earned, and unresolving. Participants described physical, cognitive, and emotional components and attributed fatigue to inflammation, working the joints harder, and unrefreshing sleep. Participants described far-reaching effects on physical activities, emotions, relationships, and social and family roles. Participants used self-management strategies but with limited success. Most did not discuss fatigue with clinicians but when they did, they felt it was dismissed. Participants held negative views on the management of fatigue. The data show that RA fatigue is important, intrusive, and overwhelming, and patients struggle to manage it alone. These data on the complexity of fatigue experiences will help clinicians design measures, interventions, and self-managment guidance.
Impact of fatigue on health-related quality of life
  • Rupp I Boshuizen Hc
  • Jacobi
  • Ce
Rupp I, Boshuizen HC, Jacobi CE, et al. Impact of fatigue on health-related quality of life Arthritis Care Res 2004;51: 578–585.
Rheumatic diseases-collected reports 1959-1983. London: Arthritis and Rheumatism Council for Research
  • M Thompson
  • G Holti
Thompson M, Holti G. Arthritis and the skin. In: Hawkins C, Curry HLF, editors. Rheumatic diseases-collected reports 1959-1983. London: Arthritis and Rheumatism Council for Research; 1983. p. 127-30.