The effects of wheel-running using the upper limbs following immobilization after inducing arthritis in the knees of rats.

This study investigated the effects of wheel-running using the upper limbs following immobilization after inducing arthritis in the knees of rats. Forty male Wistar rats (aged 8 weeks) divided into four groups randomly: arthritis (AR), immobilization after arthritis (Im), wheel-running exercise with the upper limbs following immobilization after arthritis induction (Im+Ex) and sham arthritis induction (Con). The knee joints of the Im and Im+Ex groups were immobilized with a cast for 4 weeks. In the Im+Ex group, wheel-running exercise was administered for 60 min/day (5 times/week). The swelling and the pressure pain threshold (PPT) of the knee joint were evaluated for observing the condition of inflammatory symptoms in affected area, and the paw withdraw response (PWR) was evaluated for observing the condition of secondary hyperalgesia in distant area. Especially, in order to evaluate histological inflammation in the knee joint, the number of macrophage (CD68-positive cells) in the synovium was examined. The expression of calcitonin gene-related peptide (CGRP) in the spinal dorsal horn (L2-3 and L4-5) was examined to evaluate central sensitization. The Im+Ex group showed a significantly better recovery than the Im group in the swelling, PPTs, and PWRs. Additionally, CGRP expression of the spinal dorsal horn (L2-3 and L4-5) in the Im+Ex group was significantly decreased compared with the Im group. According to the results, upper limb exercise can decrease pain in the affected area, reduce hyperalgesia in distant areas, and suppress the central sensitization in the spinal dorsal horn by triggering exercise-induced hypoalgesia (EIH).

Developing an Innovative Tablet-Based Walking Program to Improve Arthritis Fatigue.

Fatigue associated with arthritis is highly prevalent and interferes with patients' daily routines. An interdisciplinary research team developed the Tablet-based Cognitive Behavioral Intervention (Tab-CBI) for older adults with arthritis fatigue. The goal of the Tab-CBI is to alleviate fatigue by promoting a simple walking activity. The Tab-CBI application used off-the-shelf technologies and was implemented on a mini-tablet computer. The four key components of Tab-CBI are: (a) multimedia cognitive-behavioral therapy (CBT)-based educational modules; (b) videoconferencing communication; (c) individualized goal setting; and (d) electronic data submission. Experts perceived that the Tab-CBI was engaging and user friendly, and effective in improving simple walking routines and alleviating fatigue. Experts' feedback was incorporated into refining the Tab-CBI. The current study demonstrated that the Tab-CBI has potential to be a useful innovation for fatigue management in older adults. [Journal of Gerontological Nursing, 46(10), 13-18.].

Rehabilitation in warm climate for young adults with inflammatory arthritis: A 12-month randomized controlled trial.

OBJECTIVES: To investigate if an intensive rehabilitation programme, including intensive exercise and patient education, for young adults with inflammatory arthritis, conducted in a warm climate, has long-term effects on general health status compared with usual care. DESIGN: Open randomized controlled trial. PATIENTS: A total of 64 patients with inflammatory arthritis, aged 20-35 years. METHODS: Patients underwent randomized allocation to an intensive 17-day rehabilitation programme in a warm climate (intervention group) or to usual care with no structured rehabilitation (control group). The primary outcomes were physical function, assessed by the "30-second Sit to Stand test"(30sSTS), and coping, measured by the "Effective Musculoskeletal Consumer Scale" (EC17). RESULTS: A total of 64 patients (mean age 27.5 years, 62.5% female) were randomized. Thirty out of 32 patients completed the intervention. At 12-month follow-up, 7 patients were lost to follow-up; 4 from the intervention group and 3 from the control group. The intervention group showed significant improvement in the physical function test at 3 months; estimated mean difference (95% confidence interval): 5.5 (2.8-8.1), 6 months 3.6 (0.4-6.8) and 12 months 4.0 (0.0-7.9), compared with the control group. There were no differences in coping between the 2 groups at 3, 6 or 12 months. CONCLUSION: Rehabilitation in a warm climate improves physical functioning, but not coping, in young adults with inflammatory arthritis.

Enjoyment of exercise among people with arthritis: An inductive thematic analysis.

Past research into exercise among people with long-term health conditions has paid surprisingly little attention to the concept of enjoyment. This study explored enjoyment of exercise among people with arthritis. Semi-structured interviews were held with 12 participants aged 20-85 years. The transcripts were analysed using inductive thematic analysis. Four themes were identified: enjoyment of exercise in relation to other people, benefits of exercise in relation to enjoyment, working around barriers to enjoy exercise and finding an enjoyable balance to exercise. These themes highlight the relevance of enjoyment and how it could feature in advice about exercise for people with arthritis.

Thumbs up: Imagined hand movements counteract the adverse effects of post-surgical hand immobilization. Clinical, behavioral, and fMRI longitudinal observations.

Motor imagery (M.I.) training has been widely used to enhance motor behavior. To characterize the neural foundations of its rehabilitative effects in a pathological population we studied twenty-two patients with rhizarthrosis, a chronic degenerative articular disease in which thumb-to-fingers opposition becomes difficult due to increasing pain while the brain is typically intact. Before and after surgery, patients underwent behavioral tests to measure pain and motor performance and fMRI measurements of brain motor activity. After surgery, the affected hand was immobilized, and patients were enrolled in a M.I. training. The sample was split in those who had a high compliance with the program of scheduled exercises (T+, average compliance: 84%) and those with low compliance (T-, average compliance: 20%; cut-off point: 55%). We found that more intense M.I. training counteracts the adverse effects of immobilization reducing pain and expediting motor recovery. fMRI data from the post-surgery session showed that T+ patients had decreased brain activation in the premotor cortex and the supplementary motor area (SMA); meanwhile, for the same movements, the T- patients exhibited a reversed pattern. Furthermore, in the post-surgery fMRI session, pain intensity was correlated with activity in the ipsilateral precentral gyrus and, notably, in the insular cortex, a node of the pain matrix. These findings indicate that the motor simulations of M.I. have a facilitative effect on recovery by cortical plasticity mechanisms and optimization of motor control, thereby establishing the rationale for incorporating the systematic use of M.I. into standard rehabilitation for the management of post-immobilization syndromes characteristic of hand surgery.

Validation of the Chinese Manchester foot pain and disability index (C-MFPDI) among patients with inflammatory arthritis.

BACKGROUND: The Manchester Foot Pain and Disability Index (MFPDI) is a patient-reported outcome tool used to measure foot pain and foot-related disability. The English version of the MFPDI has been successfully translated into other European languages, but there was no Chinese version to use in Chinese-speaking communities. The cross-sectional correlational study aimed to translate the MFPDI from English into simplified Chinese (C-MFPDI) and to test its psychometric properties among people with inflammatory arthritis in Singapore. METHODS: The MFPDI was translated from English into Chinese using a forward-backward translation framework and was administered to 100 Chinese-speaking people with inflammatory arthritis. From the original 100 participants, 30 participants re-evaluated the C-MFPDI after 2 weeks. A Visual Analogue Scale and the Taiwan Chinese Foot Function Index in simplified Chinese were used to evaluate concurrent validity with the C-MFPDI. Health-related quality of life was assessed using the Chinese version of the European Quality of Life-5 Dimension to test construct validity. RESULTS: The C-MFPDI had a high translation equivalent rate (96.3%) and content validity index (0.92), good internal consistency (Cronbach's α = 0.90) and test-retest reliability (ICC = 0.87). The concurrent validity of the C-MFPDI was demonstrated to be acceptable through its significantly moderate to strong positive correlations with the Taiwan Chinese Foot Function Index (r = 0.62-0.72, p < 0.01) and Visual Analogue Scale foot pain (r = 0.65, p < 0.01). The C-MFPDI total scores were moderately negatively associated with Chinese European Quality of Life-5 Dimension utility scores (r = - 0.40, p < 0.01). CONCLUSION: The C-MFPDI had good psychometric properties. The C-MFPDI can be used to assess disabling foot pain, impairment and disability in Chinese-speaking people with inflammatory arthritis.

Facing Multiple Barriers to Exercise: Does Stronger Efficacy Help Individuals with Arthritis?

BACKGROUND: Research about exercise adherence amongst adults with arthritis has been largely correlational, and theoretically based causal studies are needed. We used an experimental design to test the social cognitive theory premise that high self-efficacy helps to overcome challenging barriers to action. METHODS: Exercising individuals (N = 86; female = 78%; M age = 53; BMI = 27) with differential self-regulatory efficacy for managing salient, non-disease barriers were randomly assigned to many or few barrier conditions. Individuals responded about the strength of their anticipated persistence to continue exercise, and their self-regulatory efficacy to use exercise-enabling coping strategies. RESULTS: In the many barriers condition, higher barriers-efficacy individuals expressed (a) greater persistence (Cohen's d = 0.75 [-0.029, 1.79]) and (b) more confidence in their coping solutions (Cohen's d = 0.65 [-0.30, 1.60]) than lower barriers-efficacy counterparts. CONCLUSION: Experimental support was obtained for the theoretical premise that when facing the greatest barrier challenge, individuals highest in self-regulatory efficacy still view exercise as possible. Findings suggest that identifying lower efficacy exercisers with arthritis to tailor their exercise to increase self-regulatory efficacy might also improve their adherence.

Using Physical Activity Trackers in Arthritis Self-Management: A Qualitative Study of Patient and Rehabilitation Professional Perspectives.

OBJECTIVE: To compare and contrast the perspectives of patients with arthritis and those of rehabilitation professionals regarding starting and sustaining use of physical activity trackers (PATs). METHODS: We conducted focus group sessions with patients, physiotherapists, and occupational therapists in Ontario, Alberta, or British Columbia, Canada. To be eligible, patients must have self-reported a diagnosis of inflammatory or osteoarthritis. Rehabilitation professionals reported that at least 40% of their caseload was dedicated to arthritis care. Participants had any level of experience with PATs. A thematic analytic approach was used. RESULTS: The following 3 themes were identified: 1) anticipating sharing objective measures of physical activity. Participants agreed that use of PATs had the potential to improve consultations between patients with arthritis and rehabilitation professionals but were uncertain how to achieve this potential; 2) perceived or experienced barriers to start or continue using a PAT. Participants shared doubts about whether existing PATs would meet specific needs of patients with arthritis and expressed concerns about possible negative impacts; and 3) bolstering motivation? Although there was agreement that use of PATs could bolster the motivation of patients who were already active, patients and rehabilitation professionals had different opinions regarding whether use of PATs alone would motivate patients to start increasing activity levels. CONCLUSION: Our study highlights similarities and differences between the perspectives of patients and rehabilitation professionals regarding the potential value and risks of integrating PATs into arthritis self-management. Despite agreement about the potential of PATs, participants were uncertain how to effectively incorporate these tools to enhance patient-clinician consultations and had differing views about whether use of PATs would support a patient's motivation to be active.

Educational Attainment, Health Status, and Program Outcomes in Latino Adults With Arthritis Participating in a Walking Program.

INTRODUCTION: Latinos are disproportionately likely to lack a high school diploma, compared with non-Hispanic whites, a trend associated with worse outcomes in arthritis and indicating a need for health interventions. Camine Con Gusto (CCG) is the Spanish version of the evidence-based Walk With Ease program for arthritis. This study compared baseline health status and examined differences in program efficacy and adherence among Latino adults with and without a high school diploma enrolled in a pre-post evaluation of CCG. METHODS: CCG participants (n = 233) were classified into 2 groups: high school diploma or more (n = 129) and less than high school diploma (n = 104). We used logistic regression to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for associations of education with measures of baseline health and program adherence. We computed effect sizes for the difference between education groups by using mean change scores for arthritis symptoms, physical function, and psychosocial variables. RESULTS: The group without a high school diploma was more likely to report worse general health (OR = 2.40; 95% CI, 1.28-4.53) and lower levels of arthritis self-efficacy (OR = 1.95; 95% CI, 1.05-3.63) than the group with a high school diploma. CCG improved outcomes for both groups, with no significant between-group differences. The group without a high school diploma was less likely to read most of the program workbook (OR = 0.51; 95% CI, 0.27-0.97), but we found no significant differences in the amount of walking between the 2 groups. CONCLUSION: CCG was equally effective among Latinos with and without a high school diploma; however, education did affect participants' engagement with the program workbook. Adaptation of interventions for Latinos should consider how information can best be conveyed to those with lower levels of formal education.

Improvement of Outcomes During the First Two Years Following Total Ankle Arthroplasty.

BACKGROUND: Many studies of total ankle arthroplasty (TAA) have focused on the range of motion and functional outcomes at the time of intermediate-term follow-up. The purpose of our study was to analyze the progression of ankle hindfoot range of motion and patient-reported measures through the first 2 years following TAA. METHODS: The charts of 134 patients who had been treated with a TAA by a single surgeon were retrospectively reviewed, and 107 (109 TAAs) were included in the study. The overall range of motion in the sagittal plane was measured as the change in the position of the tibia relative to the floor on dedicated weight-bearing lateral radiographs made with the ankle in maximum plantar flexion and dorsiflexion preoperatively and at 3 months, 6 months, 1 year, and 2 years postoperatively. In addition, patients completed a visual analogue scale (VAS) for pain, the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) and Sports Subscales, and the Short Form-12 (SF-12) Physical (PCS) and Mental (MCS) Component Summary scores at each time interval. RESULTS: The mean overall range of motion in the sagittal plane was 20.7° preoperatively and improved to 28.3°, 34.3°, 33.3°, and 33.3° at 3 months, 6 months, 1 year, and 2 years, respectively (p < 0.001). At each postoperative time point, the median VAS score was improved (p < 0.001) compared with the preoperative VAS score. Similarly, the FAAM and SF-12 scores were improved, compared with the preoperative score, at 6 months and later (p < 0.001). An increased range of motion correlated with a lower VAS score preoperatively (ρ = -0.31, p = 0.035) and at 1 year (ρ = -0.36, p = 0.003) postoperatively. An increased range of motion correlated with a higher FAAM ADL score at 3 months (ρ = 0.50, p = 0.012), 1 year (ρ = 0.26, p = 0.040), and 2 years (ρ = 0.39, p = 0.003) postoperatively. CONCLUSIONS: Patients who underwent TAA had improvement, compared with preoperatively, in the overall sagittal plane range of motion up to 6 months and maintained improvement in pain and function scores up to 2 years. Pain scores remained improved throughout the 2-year follow-up period. A better range of motion was correlated with less pain as measured with the VAS. An increased range of motion postoperatively was correlated with better function as measured with the FAAM. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Training with Hybrid Assistive Limb for walking function after total knee arthroplasty.

BACKGROUND: The Hybrid Assistive Limb (HAL, CYBERDYNE) is a wearable robot that provides assistance to patients while walking, standing, and performing leg movements based on the intended movement of the wearer. We aimed to assess the effect of HAL training on the walking ability, range of motion (ROM), and muscle strength of patients after total knee arthroplasty (TKA) for osteoarthritis and rheumatoid arthritis, and to compare the functional status after HAL training to the conventional training methods after surgery. METHODS: Nine patients (10 knees) underwent HAL training (mean age 74.1 ± 5.7 years; height 150.4 ± 6.5 cm; weight 61.2 ± 8.9 kg), whereas 10 patients (11 knees) underwent conventional rehabilitation (mean age 78.4 ± 8.0 years; height 150.5 ± 10.0 cm; weight 59.1 ± 9.8 kg). Patients underwent HAL training during 10 to 12 (average 14.4 min a session) sessions over a 4-week period, 1 week after TKA. There was no significant difference in the total physical therapy time including HAL training between the HAL and control groups. Gait speed, step length, ROM, and muscle strength were evaluated. RESULTS: The nine patients completed the HAL training sessions without adverse events. The walking speed and step length in the self-selected walking speed condition, and the walking speed in the maximum walking speed condition were greater in the HAL group than in the control group at 4 and 8 weeks (P < 0.05). The step length in the maximum walking speed condition was greater in the HAL group than in the control group at 2, 4, and 8 weeks (P < 0.05). The extension lag and knee pain were lower in the HAL group than in the control group at 2 weeks (P < 0.05). The muscle strength of knee extension in the HAL group was greater than that in the control group at 8 weeks (P < 0.05). CONCLUSION: HAL training after TKA can improve the walking ability, ROM, and muscle strength compared to conventional physical therapy for up to 8 weeks after TKA. Since the recovery of walking ability was earlier in the HAL group than in the control group and adverse events were not observed in this pilot study, HAL training after TKA can be considered a safe and effective rehabilitation intervention. TRIAL REGISTRATION: UMIN, UMIN000017623 . Registered 19 May 2015.

2018 EULAR recommendations for physical activity in people with inflammatory arthritis and osteoarthritis.

Regular physical activity (PA) is increasingly promoted for people with rheumatic and musculoskeletal diseases as well as the general population. We evaluated if the public health recommendations for PA are applicable for people with inflammatory arthritis (iA; Rheumatoid Arthritis and Spondyloarthritis) and osteoarthritis (hip/knee OA) in order to develop evidence-based recommendations for advice and guidance on PA in clinical practice. The EULAR standardised operating procedures for the development of recommendations were followed. A task force (TF) (including rheumatologists, other medical specialists and physicians, health professionals, patient-representatives, methodologists) from 16 countries met twice. In the first TF meeting, 13 research questions to support a systematic literature review (SLR) were identified and defined. In the second meeting, the SLR evidence was presented and discussed before the recommendations, research agenda and education agenda were formulated. The TF developed and agreed on four overarching principles and 10 recommendations for PA in people with iA and OA. The mean level of agreement between the TF members ranged between 9.8 and 8.8. Given the evidence for its effectiveness, feasibility and safety, PA is advocated as integral part of standard care throughout the course of these diseases. Finally, the TF agreed on related research and education agendas. Evidence and expert opinion inform these recommendations to provide guidance in the development, conduct and evaluation of PA-interventions and promotion in people with iA and OA. It is advised that these recommendations should be implemented considering individual needs and national health systems.

Independent factors associated with wearing different types of outdoor footwear in a representative inpatient population: a cross-sectional study.

BACKGROUND: Footwear can have both a positive and negative impact on lower limb health and mobility across the lifespan, influencing the risk of foot pain, ulceration, and falls in those at risk. Choice of footwear can be influenced by disease as well as sociocultural factors, yet few studies have investigated the types of footwear people wear and the profiles of those who wear them. The aim of this study was to investigate the prevalence and factors associated with outdoor footwear type worn most often in a representative inpatient population. METHODS: This study was a secondary data analysis of a cohort of 733 inpatients that is highly representative of developed nations' hospitalised populations; 62 ± 19 years, 55.8% male, and 23.5% diabetes. Socio-demographic, medical history, peripheral arterial disease, peripheral neuropathy, foot deformity, foot ulcer history, amputation history and past foot treatment variables were collected. Participants selected the footwear type they mostly wore outside the house in the previous year from 16 types of footwear. Multivariate logistic regression identified independent factors associated with outdoor footwear types selected. RESULTS: The most common outdoor footwear types were: running shoes (20%), thongs/flip flops (14%), walking shoes (14%), sandals (13%) and boots (11%). Several socio-demographic, medical history and foot-related factors were independently associated (Odds Ratio; 95% Confidence Interval)) with different types of footwear. Running shoes were associated with male sex (2.7; 1.8-4.1); thongs with younger age (0.95 for each year; 0.94-0.97), being female (2.0; 1.2-3.1) and socio-economic status (3.1; 1.2-7.6); walking shoes with arthritis (1.9; 1.2-3.0); sandals with female sex (3.8; 2.3-6.2); boots with male sex (9.7; 4.3-21.6) and inner regional (2.6; 1.3-5.1) and remote (3.4; 1.2-9.5) residence (all, p < 0.05). CONCLUSIONS: We profiled the types of outdoor footwear worn most in a large diverse inpatient population and the factors associated with wearing them. Sex was the most consistent factor associated with outdoor footwear type. Females were more likely to wear thongs and sandals and males boots and running shoes. Overall, this data gives insights into the socio-demographic, medical and other health factors that are related to footwear choice in a large diverse population primarily of older age.

Clinician and Patient Views About Self-Management Support in Arthritis: A Cross-Sectional UK Survey.

OBJECTIVE: To establish receipt and provision of self-management support for patients with inflammatory arthritis in the UK, and to establish whether receipt of self-management support is associated with patient's knowledge, skills, and confidence to self-manage. METHODS: Questionnaires for patients and health care professionals were sent to members and associates of the National Rheumatoid Arthritis Society. Patients completed the Patient Activation Measure (PAM), and questions about receipt of self-management support. Health care professionals completed the Clinician Support PAM and questions about provision of self-management support. RESULTS: A total of 886 patients and 117 health care professionals completed the survey. Only 15% of patients had attended a structured self-management program. More than half of the patients reported having the skills, confidence, and knowledge to self-manage, and this skill set was associated with receipt of self-management support that was embedded in routine care. All health care professionals felt that patients should be actively involved in their own care, but 60% were unable to offer structured self-management support. Health care professionals reported engaging in more embedded self-management support than patients reported receiving in routine care. CONCLUSION: Only a small proportion of patients with arthritis have attended a structured support program. Although health care professionals report engaging in self-management support embedded in routine care, patients do not necessarily agree, and these differences could impact the experience of patients with arthritis. When embedded self-management support does occur, it is a significant predictor of patients' knowledge, skills, and confidence to self-manage, as opposed to attendance at a structured program.

Physical activity behaviour in men with inflammatory joint disease: a cross-sectional register-based study.

Objectives: Physical activity is recommended as an essential part of the non-pharmacological management of inflammatory joint disease, but previous research in this area has predominantly included women. The aim of this study was to examine physical activity behaviour in men with inflammatory joint disease. Methods: The study was conducted as a cross-sectional register-based study. Data on physical activity behaviour in men with RA, PsA and AS were matched with sociodemographic and clinical variables extracted from the DANBIO registry. Logistic regression analyses using multiple imputations were performed to investigate demographic and clinical variables associated with regular engagement in physical activity (moderate-vigorous ⩾2 h/week). Descriptive statistics were applied to explore motivation, barriers and preferences for physical activity. Results: A total of 325 men were included of whom 129 (40%) engaged in regular physical activity. In univariate analyses, higher age, visual analogue scale (VAS) for pain, VAS fatigue, VAS patient's global, CRP level, disease activity, functional disability and current smoking were negatively associated with regular engagement in physical activity. In the final multivariable regression model only a high VAS fatigue score (⩾61 mm) (OR = 0.228; CI: 0.119, 0.436) remained significantly independently associated with regular physical activity. Conclusion: A majority of men with inflammatory joint disease do not meet the recommendations of regular physical activity. Both sociodemographic and clinical parameters were associated with engagement in physical activity, and fatigue especially seems to play a pivotal role in explaining suboptimal physical activity behaviour in this patient group.

Initial validation of the exercise chronic pain acceptance questionnaire.

BACKGROUND AND AIMS: Pain acceptance, measured by the chronic pain acceptance questionnaire (CPAQ), is related to exercise adherence for those with arthritis. The CPAQ measure has 20 items comprising two subscales -- pain willingness and activities engagement about pursuing "valued daily activities" despite pain. However, exercise is not specified as a valued activity and respondents may be considering other activities raising generalizability and strength of prediction concerns. METHODS: Accordingly, a modified CPAQ solely for exercise (CPAQ-E) was developed to heighten salience to pursuit of exercise in the face of pain. An exercising sample with arthritis (N=98) completed the CPAQ-E at baseline and exercise 2 weeks later. Exploratory factor analysis of the CPAQ-E was performed using Mplus. Regression was used to predict exercise. RESULTS: Analysis revealed a two-factor, 14 item model with good psychometric properties reflecting pain willingness and activities engagement subscales (χ2=85.695, df=64, p<.037; RMSEA=.055; CFI=.967; TLI=.954). Both subscales and the total score positively predicted future weekly exercise bouts (range ps from <.05 to <.001). Activities engagement predicted future weekly exercise volume (p<.05). CONCLUSIONS: This study offers preliminary support for the factorial and predictive validity of the CPAQ-E among exercising individuals with arthritis. IMPLICATIONS: This measure could help researchers increase the specificity and sensitivity of pain acceptance responses to exercising among individuals with arthritis. A more sensitive measure might help clinicians interpret patient responses to exercise for pain self-management.

Points to consider for designing trials in systemic sclerosis patients with arthritic involvement.

Although musculoskeletal involvement is quite common in SSc (arthritic in particular), there have been few trials and even fewer controlled trials of therapeutic agents in arthritis in SSc. In addition, there have been only three outcome measures that have been validated for use in trials of SSc arthritis: the HAQ Disability Index, the Cochin Hand Function Scale and the Hand Mobility in SSc scale. The purpose of this article is to present evidence-based points to consider for the design of trials in SSc patients with musculoskeletal involvement (joints in particular). In addition, we make an argument for including outcome variables that can be validated within a given trial for use in future trials.