Understanding Fatigue-Related Disability in Rheumatoid Arthritis and Ankylosing Spondylitis: The Importance of Daily Correlates.

OBJECTIVE: Fatigue is common among people with inflammatory arthritis but is hard to manage. The aim of this study was to investigate how daily fluctuations in psychological variables correspond with changes in fatigue-related disability in the daily lives of people with inflammatory arthritis and to identify factors to target in psychological interventions and routine clinical practice. METHODS: A cohort of 143 patients with rheumatoid arthritis (n = 97) or ankylosing spondylitis (n = 46) participated in a 10-day online diary study. Each evening participants completed a diary questionnaire assessing their fatigue, pain, fatigue-related disability, and 4 components of psychological flexibility (valued activity, mindfulness, cognitive fusion, and fatigue avoidance). RESULTS: On days when participants were more engaged in valued activities or more mindful, they reported less disability due to fatigue, even when controlling for levels of fatigue and pain that day. The daily psychological flexibility variables explained a total of 15.6% of the variance in daily fatigue-related disability. CONCLUSION: Psychological flexibility variables are directly associated with fatigue-related disability in the daily lives of inflammatory arthritis patients. Further research is needed to investigate whether interventions that target psychological flexibility are effective at reducing fatigue-related disability.

Complementary medicine for the management of knee and hip osteoarthritis - A patient perspective.

BACKGROUND: Complementary medicines and therapies (CMT) are recommended in osteoarthritis (OA) treatment guidelines; however, there are few studies on CMT use in the community. The present study explored the use and perceptions of CMT for OA management in a New Zealand population. METHODS: Nineteen middle- to older-aged adults with hip or knee OA, recruited from a public hospital research database, engaged in focus groups exploring CMT knowledge, factors influencing CMT use, and the role of medical professionals in the decision-making process. Participants were organized into four groups, further to explore the impact of age or OA duration on CMT use. RESULTS: Thematic analysis resulted in five themes, consistent across all groups: participants' perceptions of CMT; reasons for taking CMT; reasons for not taking CMT; sources and credibility of CMT information; and medical professionals' role in CMT use. Participants indicated a range of CMT use, yet were unclear what defined a product as 'CMT'. CMT use was influenced by symptom severity, previous experiences of themselves or trusted others, and perceived CMT effectiveness. General practitioners were identified as participants' preferred source of CMT information, owing to both their professional knowledge and lack of commercial gain from promoting CMT use. CONCLUSION: Participants supported CMT for OA management, based on evidence and/or experience of effectiveness. Proactive general practitioner dialogue and subsidized CMT products recommended as part of a clinical treatment plan would encourage further CMT uptake. Additionally, the development of standardized CMT terminology would facilitate patient-doctor communication regarding CMT use and promote inter-professional dialogue regarding multidisciplinary patient treatment.

Yoga for the management of pain and sleep in rheumatoid arthritis: a pilot randomized controlled trial.

OBJECTIVE: The aim of the present study was to determine the feasibility of a relaxation-based yoga intervention for rheumatoid arthritis, designed and reported in accordance with Delphi recommendations for yoga interventions for musculoskeletal conditions. METHODS: Participants were recruited from a hospital database, and randomized to either eight weekly 75-min yoga classes or a usual care control. Feasibility was determined by recruitment rates, retention, protocol adherence, participant satisfaction and adverse events. Secondary physical and psychosocial outcomes were assessed using self-reported questionnaires at baseline (week 0), week 9 (primary time point) and week 12 (follow-up). RESULTS: Over a 3-month period, 26 participants with mild pain, mild to moderate functional disability and moderate disease activity were recruited into the study (25% recruitment rate). Retention rates were 100% for yoga participants and 92% for usual care participants at both weeks 9 and 12. Protocol adherence and participant satisfaction were high. Yoga participants attended a median of seven classes; additionally, seven of the yoga participants (54%) reported continuing yoga at home during the follow-up period. No serious adverse events were related to the study. Secondary outcomes showed no group effects of yoga compared with usual care. CONCLUSIONS: A relaxation-based yoga programme was found to be feasible and safe for participants with rheumatoid arthritis-related pain and functional disability. Adverse events were minor, and not unexpected from an intervention including physical components. This pilot provides a framework for larger intervention studies, and supports further exploration of yoga as a complex intervention to assist with the management of rheumatoid arthritis.

A randomized double-blind placebo-controlled trial to investigate the effectiveness and safety of a novel green-lipped mussel extract -BioLex® -for managing pain in moderate to severe osteoarthritis of the hip and knee.

BACKGROUND: Extracts from perna canaliculus, the Green Lipped Mussel (GLM) are widely used as a complimentary therapy by patients with osteoarthritis (OA). The current study investigated the potential of a novel GLM formulation as a treatment for OA. A randomized double-blind placebo-controlled trial was undertaken to assess potential impacts on pain and quality of life following 12 weeks of treatment. METHODS: Eighty patients with moderate to severe OA of the hip or knee were randomized to receive either 600 mg of BioLex®-GLM daily or placebo for 12 weeks. Entry criteria included a minimum 100 mm Visual Analogue Scale pain score (VAS) of 30 mm at baseline. The primary outcome was patient reported pain, measured by the Western Ontario and McMasters OA Index (WOMAC) pain subscale and VAS pain scale. Secondary outcomes included: quality of life (OAQol), total WOMAC score, WOMAC -20 responder criteria, and change in medication use over the study period. Participants were assessed at baseline, 12 weeks (end of therapy) and 15 weeks (3-weeks post-intervention). RESULTS: At week 12, there were no significant differences in VAS or WOMAC pain subscale between active and placebo groups, nor significant improvement in the WOMAC-20 responder criteria or OAQol. Joint stiffness (measured by WOMAC-B stiffness) in the GLM group improved compared with placebo (p = 0.046). There was a significant difference in paracetamol use between the GLM treated group and the placebo group after week 12 (p = 0.001). CONCLUSIONS: BioLex® -GLM extract did not confer clinical benefit in moderate to severe OA over the intervention period, however, a significant difference in paracetamol use in the post-intervention period was observed between the BioLex® -GLM group and placebo group. Higher doses and/or longer treatment periods are worthy of future investigation. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry: no. ACTRN12611000256976 .

An open-label six-month extension study to investigate the safety and efficacy of an extract of Artemisia annua for managing pain, stiffness and functional limitation associated with osteoarthritis of the hip and knee.

AIMS: This six-month single-centre open-label extension study, conducted at the University of Otago, Dunedin, follows from a previously published 12-week pilot double-blind randomised placebo-controlled study of dietary supplement, Arthrem® (ART) in patients with osteoarthritis (OA) of the hip or knee. The pilot double-blind study showed that treatment with ART 150 mg twice-daily was associated with clinically relevant pain reduction. The extension study aims were to assess longer-term safety and efficacy during six months' treatment following the pilot trial. METHOD: Patients who completed the pilot double-blind study had the option to continue on open-label treatment with ART for a further six months. Safety was assessed by adverse event monitoring and laboratory tests at three and six months. Efficacy was assessed at three and six months using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®). RESULTS: Thirty-four patients entered the optional extension and 28 completed six months' treatment. ART was well tolerated when taken for up to nine months. Improvements in WOMAC® efficacy parameters reported in the double-blind phase of the study were maintained over six months. CONCLUSION: ART appears to be a safe and effective alternative for managing the symptoms of OA over an extended period.

A pilot randomized, placebo-controlled clinical trial to investigate the efficacy and safety of an extract of Artemisia annua administered over 12 weeks, for managing pain, stiffness, and functional limitation associated with osteoarthritis of the hip and knee.

The objective of this study was to investigate the safety and efficacy of a dietary supplement, Arthrem, containing an extract from the medicinal plant Artemisia annua, on pain, stiffness, and functional limitation in osteoarthritis (OA) of the hip or knee. Forty-two patients were randomized to one of three groups (n = 14 in each group): 150-mg Artemisia annua extract (ART) twice daily (BD) (ART low dose), 300-mg ART BD (ART high dose), or placebo BD administered over 12 weeks. Efficacy was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®) and visual analog scale (VAS) for pain. Participants treated with ART low dose demonstrated significant improvement in WOMAC total scores from baseline to 12 weeks (mean change, -12.2; standard deviation, [SD] 13.84; p = 0.0159); improvement was not shown in the placebo group (mean change, -7.8; SD, 19.80; p = 0.1029). Statistically significant reductions were seen from baseline in the ART low-dose group for individual WOMAC components stiffness and physical function. VAS pain scores were statistically significantly reduced from baseline to 12 weeks in the ART low-dose group (mean change, -21.4 mm; SD, 23.48 mm; p = 0.0082) but not the placebo group (mean change, -11.5 mm; SD, 28.97 mm, p = 0.1757). No statistically significant changes occurred from baseline in the placebo or ART high-dose groups for any parameter. ART low dose was well tolerated. ART has potential as an anti-inflammatory/analgesic in OA. Treatment with ART 150 mg BD is associated with clinically relevant reductions in pain over 12 weeks. Further studies are warranted.

Components and reporting of yoga interventions for musculoskeletal conditions: a systematic review of randomised controlled trials.

OBJECTIVES: To identify the content and reporting details of randomised controlled trials of yoga for musculoskeletal conditions through a systematic review of the literature. DESIGN: Twenty electronic databases were searched to identify randomised controlled trials (RCTs) of yoga interventions for musculoskeletal conditions. Eligibility criteria were full-text, peer reviewed articles, of RCTs with yoga as a primary intervention, on a population aged 18 years and over, with a clinical diagnosis of a musculoskeletal condition. Data relating to study characteristics, yoga styles, yoga practices, home practice, and reporting were extracted and summarised. RESULTS: Seventeen articles met inclusion criteria, representing five musculoskeletal conditions: low back pain, osteoarthritis, rheumatoid arthritis, kyphosis, and fibromyalgia. 15 studies were non-residential, and two were residential. Study duration ranged from 1 to 24 weeks; weekly dosage of yoga ranged from 1 to 56h. Five styles of posture-based Hatha yoga were specified. Intervention content included seven yoga practises: postures, breathing, relaxation, meditation, philosophy, chanting, and cleansing practises. Ten studies either encouraged or requested home practice. Reporting details included class plans, posture lists, and diagrams. Due to insufficient detail regarding delivery of the yoga intervention only eight of the 17 interventions were considered replicable as reported. CONCLUSIONS: Evaluation of study characteristics and yoga components indicated several areas of homogeneity across studies, suggesting an existing degree of standardisation. However, heterogeneity related to intervention content and reporting impeded determination of intervention content and delivery. Standardisation of content, nomenclature, and reporting details is recommended to enhance protocol transparency, replication, and comparison of intervention effectiveness.

Establishing key components of yoga interventions for musculoskeletal conditions: a Delphi survey.

BACKGROUND: Evidence suggests yoga is a safe and effective intervention for the management of physical and psychosocial symptoms associated with musculoskeletal conditions. However, heterogeneity in the components and reporting of clinical yoga trials impedes both the generalization of study results and the replication of study protocols. The aim of this Delphi survey was to address these issues of heterogeneity, by developing a list of recommendations of key components for the design and reporting of yoga interventions for musculoskeletal conditions. METHODS: Recognised experts involved in the design, conduct, and teaching of yoga for musculoskeletal conditions were identified from a systematic review, and invited to contribute to the Delphi survey. Forty-one of the 58 experts contacted, representing six countries, agreed to participate. A three-round Delphi was conducted via electronic surveys. Round 1 presented an open-ended question, allowing panellists to individually identify components they considered key to the design and reporting of yoga interventions for musculoskeletal conditions. Thematic analysis of Round 1 identified items for quantitative rating in Round 2; items not reaching consensus were forwarded to Round 3 for re-rating. RESULTS: Thirty-six panellists (36/41; 88%) completed the three rounds of the Delphi survey. Panellists provided 348 comments to the Round 1 question. These comments were reduced to 49 items, grouped under five themes, for rating in subsequent rounds. A priori group consensus of ≥80% was reached on 28 items related to five themes concerning defining the yoga intervention, types of yoga practices to include in an intervention, delivery of the yoga protocol, domains of outcome measures, and reporting of yoga interventions for musculoskeletal conditions. Additionally, a priori consensus of ≥50% was reached on five items relating to minimum values for intervention parameters. CONCLUSIONS: Expert consensus has provided a non-prescriptive reference list for the design and reporting of yoga interventions for musculoskeletal conditions. It is anticipated future research incorporating the Delphi guidelines will facilitate high quality international research in this field, increase homogeneity of intervention components and parameters, and enhance the comparison and reproducibility of research into the use of yoga for the management of musculoskeletal conditions.

Yoga for functional ability, pain and psychosocial outcomes in musculoskeletal conditions: a systematic review and meta-analysis.

OBJECTIVES: Musculoskeletal conditions (MSCs) are the leading cause of disability and chronic pain in the developed world, impacting both functional ability and psychosocial health. The current review investigates the effectiveness of yoga on primary outcomes of functional ability, pain and psychosocial outcomes across a range of MSCs. METHODS: A comprehensive search of 20 databases was conducted for full-text, randomized controlled trials of yoga in clinically diagnosed MSCs. RESULT: Seventeen studies met the inclusion criteria, involving 1,626 participants with low back pain (LBP), osteoarthritis (OA), rheumatoid arthritis (RA), kyphosis or fibromyalgia. Studies were quality rated, and analysed for the effect of yoga on primary outcomes, immediately post-intervention. Twelve studies were rated as good quality. Yoga interventions resulted in a clinically significant improvement in functional outcomes in mild-to-moderate LBP and fibromyalgia, and showed a trend to improvement in kyphosis. Yoga significantly improved pain in OA, RA and mild-to-severe LBP. Psychosocial outcomes were significantly improved in mild-to-moderate LBP and OA. Meta-analysis of good-quality studies showed a moderate treatment effect for yoga of -0.64 (95%CI -0.89 to -0.39) for functional outcomes and -0.61 (95%CI -0.97 to -0.26) for pain outcomes. CONCLUSIONS: Evidence suggests that yoga is an acceptable and safe intervention, which may result in clinically relevant improvements in pain and functional outcomes associated with a range of MSCs. Future analysis of outcomes which take into account the amount of yoga received by participants may provide insight into any putative duration or dosage effects of yoga interventions for MSCs.

The suitability of yoga as a potential therapeutic intervention for rheumatoid arthritis: a focus group approach.

OBJECTIVES: The aim of this study was to explore the views of patients with rheumatoid arthritis (RA) regarding the suitability of yoga as a potential therapeutic intervention in the management of RA. METHODS: Twenty-two participants with RA were recruited from outpatient clinics at a regional hospital in New Zealand and divided into four focus groups. Heterogeneity between groups in terms of age, gender, duration of RA and functional ability provided opinions from a cross-section of RA patients. Transcripts were analysed using thematic analysis, with four themes predominating. RESULTS: Firstly, participants described their experience of symptoms related to their RA in three independent but linked categories of physical, mental and social well-being. Secondly, participants perceived the management of their RA to be prescriptive, medicalized and failing to address their wider health concerns. Thirdly, participants perceived yoga as a safe, adaptable therapy that may allow self-management of their RA. However, there was some concern that functional limitations may inhibit ability to practise the physical aspects of yoga. Fourthly, requirements for a yoga intervention that would be feasible for people with RA were presented by participants. CONCLUSIONS: Patients with RA perceive a disparity between their personal experience of living with RA and their current medical management. Yoga is perceived as a potential therapy to address this disparity. Based on opinions expressed by participants, future research regarding a yoga intervention as an adjunctive therapy for managing RA should meet patients' views on feasibility and test outcome measures reflecting the domains of physical, mental and social well-being.