Recommendations of the French Society of Rheumatology for the management in current practice of patients with polymyalgia rheumatica.

OBJECTIVE: To develop recommendations for the routine management of patients with polymyalgia rheumatica (PMR). METHODS: Following standard procedures, a systematic review of the literature by five supervised junior rheumatologists, based on the questions selected by the steering committee (5 senior rheumatologists), was used as the basis for working meetings, followed by a one-day plenary meeting with the working group (15 members), leading to the development of the wording and determination of the strength of the recommendations and the level of agreement of the experts. RESULTS: Five general principles and 19 recommendations were drawn up. Three recommendations relate to diagnosis and the use of imaging, and five to the assessment of the disease, its activity and comorbidities. Non-pharmacological therapies are the subject of one recommendation. Three recommendations concern initial treatment based on general corticosteroid therapy, five concern the reduction of corticosteroid therapy and follow-up, and two concern corticosteroid dependence and steroid-sparing treatments (anti-IL-6). CONCLUSION: These recommendations take account of current data on PMR, with the aim of reducing exposure to corticosteroid therapy and its side effects in a fragile population. They are intended to be practical, to help practitioners in the day-to-day management of patients with PMR.

What We Should Expect from an Innovative Intra-Articular Hyaluronic Acid Product: Expert Opinion Based on a Comprehensive Review of the Literature.

BACKGROUND: Intra-articular hyaluronic acid (IAHA) products are often used in the treatment of adults with mild-to-moderate knee osteoarthritis (KOA). The International Symposium on Intra-Articular Treatment (ISIAT) convened a multidisciplinary technical expert panel to define characteristics for an innovative IAHA product that should answer unmet needs in the clinical management of adults with mild-to-moderate KOA. METHODS: An initial set of evidence-based statements was developed based on data extracted from articles identified through a comprehensive literature search. A Delphi panel comprising 19 experts in KOA voted in 3 rounds to rate their degree of agreement with accepted statements. RESULTS: The final set of 13 accepted statements focus on the effect of an innovative IAHA across 5 key domains of nociceptive pain, joint function, quality of life, joint structure and integrity, and adverse effects. The statements set thresholds for clinically meaningful improvements that exceed those generally achievable by currently available IAHA products. CONCLUSION: The characteristics described by these statements from the ISIAT set new standards for what should be expected from an innovative IAHA. These statements should serve as a framework for driving the development of innovative IAHA products that will surpass the actual outcomes achieved by current viscosupplements in patients with mild-to-moderate KOA.

Early Osteoarthritis Questionnaire (EOAQ): a tool to assess knee osteoarthritis at initial stage.

Background: Early stage of osteoarthritis (OA) is characterized by joint stiffness and pain as well as by subclinical structural changes that may affect cartilage, synovium, and bone. At the moment, the lack of a validated definition of early osteoarthritis (EOA) does not allow to make an early diagnosis and adopt a therapeutic strategy to slow disease progression. Also, no questionnaires are available to evaluate the early stage, and therefore this remains an unmet need. Objective: Therefore, the purpose of the technical experts panel (TEP) of 'International Symposium of intra-articular treatment' (ISIAT) was to create a specific questionnaire to evaluate and monitor the follow-up and clinical progress of patients affected by early knee OA. Design: The items for the Early Osteoarthritis Questionnaire (EOAQ) were identified according to the following steps: items generation, items reduction, and pre-test submission. Methods: During the first step, literature has been reviewed and a comprehensive list of items about pain and function in knee EOA was drafted. Then, during the ISIAT (5th edition 2019), the draft has been discussed by the board, which reformulated, deleted, or subdivided some of the items. After the ISIAT symposium, the draft was submitted to 24 subjects affected by knee OA. A score based on the importance and the frequency was created and the items with a score ⩾0.75 were selected. After intermediate evaluation made by a sample of patients, the second and final version of the questionnaire EOAQ was submitted to the whole board for final analysis and acceptance in a second meeting (29 January 2021). Results: After an exhaustive elaboration, the final version of the questionnaire contains two domains (Clinical Features and Patients Reported Outcome) with respectively 2 and 9 questions, for a total of 11 questions. Questions mainly explored the fields of early symptoms and patients reported outcomes. Marginally, the need of the symptoms treatment and the use of painkillers were investigated. Conclusions: Adoption of diagnostic criteria of early OA is strongly encouraged and a specific questionnaire for the whole management of the clinical features and patients' outcome might really improve the evolution of OA in the early stages of the disease, when the treatment is expected to be more effective.

Validation of the Portuguese version of the Functional Index for Hand Osteoarthritis (FIHOA).

INTRODUCTION: Hand osteoarthritis (HOA) is a prevalent rheumatic disease that may cause significant disability. The Functional index for HOA (FIHOA) is a validated questionnaire to evaluate loss of function in patients with HOA. OBJECTIVE: To undertake a cross-cultural adaptation and validation of FIHOA into Portuguese. PATIENTS AND METHODS: First, the original French version of FIHOA had been forward-backward translated into Portuguese, according to the guidelines for cross-cultural adaptation. Secondly, patients with primary HOA were consecutively recruited in three Portuguese rheumatology outpatient clinics between May 2016 and April 2018. The final consensual Portuguese version of FIHOA was administered to 52 patients. A numerical rating scale (NRS - 0 to 100mm) for hand pain and for perceived hand dysfunction was also registered. Ten randomly selected patients were re-administered the same tools 5 to 15 days later. Internal consistency, test-retest reliability, internal construct validity and external validity related to dysfunction NRS were evaluated. RESULTS: Fifty-two patients were evaluated: all right-handed, 96% women, mean age of 63 (10) years and 8 (6) years of disease duration. Mean (SD) pain and dysfunction were 47 (25) and 46 (25), respectively, with 68% patients being symptomatic. Mean (SD) FIHOA was 7 (5). Cronbach's alpha for internal consistency was high and adequate (0.87) and corrected item-total correlation revealed adequate performance. For reliability, Spearman's rho coefficient was 0.88 and total intraclass correlation coefficient (ICC) between test and retest was 0.87, showing good reliability. Factor analysis revealed three factors accounting for 71% of the variance of the score, with the first one (including questions 1, 2, 3 and 10) being responsible for 47% of the variance. Spearman's rho between FIHOA and dysfunction NRS was 0.5, showing a moderate but significant correlation and moderate external validity. CONCLUSION: The Portuguese version of FIHOA is a consistent, reliable, and valid instrument to measure loss of function in HOA Portuguese patients.

Management of hand osteoarthritis: from an US evidence-based medicine guideline to a European patient-centric approach.

Hand osteoarthritis is the most common joint condition and is associated with significant morbidity. It is of paramount importance that patients are thoroughly assessed and examined when complaining of hand stiffness, pain, deformity or disability and that the patient's concerns and expectations are addressed by the healthcare professional. In 2019 the American College of Rheumatology and Arthritis Foundation (ACR/AF) produced guidelines which included recommendations for the treatment of hand osteoarthritis. An ESCEO expert working group (including patients) was convened and composed this paper with the aim to assess whether these guidelines were appropriate for the treatment of hand osteoarthritis therapy in Europe and whether they met with the ESCEO patient-centered approach. Indeed, patients are the key stakeholders in healthcare and eliciting the patient's preference is vital in the context of an individual consultation but also for informing research and policy-making. The patients involved in this working group emphasised the often-neglected area of aesthetic changes in hand osteoarthritis, importance of developing pharmacological therapies which can alleviate pain and disability and the need of the freedom to choose which approach (out of pharmacological, surgical or non-pharmacological) they wished to pursue. Following robust appraisal, it was recommended that the ACR/AF guidelines were suitable for a European context (as described within the body of the manuscript) and it was emphasised that patient preferences are key to the success of individual consultations, future research and future policy-making.

Cross-cultural adaptation and validation of the Thai version of the functional index for hand osteoarthritis (FIHOA).

BACKGROUND: The Functional Index for Hand Osteoarthritis (FIHOA) is a simple tool to assess functional impairment for hand OA patients. The purpose of this study was to translate the FIHOA into the Thai language, and validate it in Thai hand OA patients. METHODS: The FIHOA was translated into Thai (T-FIHOA) according to the principles of cross-cultural adaptation and administered to 102 hand OA patients recruited between September 2020 and July 2021 together with the modified Health Assessment Questionnaire (mHAQ), Disabilities of the Arm, Shoulder and Hand (DASH), and visual analogue scale (VAS) for hand pain. Spearman's correlation coefficient and intraclass correlation coefficient (ICC) were used to check the test-retest reliability of each item and the total scores in the translated questionnaire. The internal consistency reliability was evaluated using Cronbach's alpha. The external construct validity was assessed using correlations between the T-FIHOA, mHAQ, DASH and hand pain VAS. RESULTS: The T-FIHOA had a unidimensional structure. The ICC was > 0.9 and the Cronbach's alpha of 0.92 indicated excellent reliability and internal consistency, respectively. The external validity tests indicated moderate correlation with the hand pain VAS (r = 0.37, P <  0.01) and moderate to strong correlations with the mHAQ (r = 0.63, P <  0.01), and DASH score (r = 0.52, P <  0.01). The T-FIHOA had the highest effect size (ES) and standardized response mean (SRM) (- 0.37 and - 0.58 respectively) among all questionnaires except for the VAS when assessing changes between baseline and week 4. CONCLUSIONS: The T-FIHOA is a good and reliable assessment tool freely available for practitioners/researchers to evaluate functional impairment in Thai hand OA patients.

Transcutaneous vagus nerve stimulation in erosive hand osteoarthritis: protocol for the randomised, double-blind, sham-controlled ESTIVAL trial.

INTRODUCTION: Patients with erosive hand osteoarthritis (EHOA) experience pain and inflammation, two features that can be targeted by vagus nerve stimulation using electrical auricular transcutaneous vagus nerve stimulation (tVNS). A pilot study demonstrated the feasibility of the procedure, so we designed a randomised sham-controlled trial to determine the safety and efficacy of tVNS in EHOA. METHODS AND ANALYSIS: ESTIVAL Study (Essai randomisé comparant la STImulation auriculaire transcutanée du nerf Vague versus sham stimulation dans l'Arthrose DigitaLe Érosive symptomatique et inflammatoire) is a superiority, randomised, double-blind sham-controlled trial comparing two parallel arms: active and sham tVNSs in a 1:1 ratio. Patients with symptomatic EHOA (score ≥40/100 mm on a visual analogue scale (VAS) for pain of 0-100 mm) and inflammatory EHOA (≥1 clinical and ultrasonography-determined interphalangeal synovitis) are included in 18 hospital centres (17 rheumatology and 1 rehabilitation departments) in France. Active and sham tVNSs use an auricular electrode connected to the Vagustim device, with no electric current delivered in the sham group. Patients undergo stimulation for 20 min/day for 12 weeks. The follow-up visits take place at weeks 4, 8 and 12. The enrolment duration is 2 years and started in April 2021; 156 patients are scheduled to be included. The primary outcome is the difference in self-reported hand pain in the previous 48 hours measured on a VAS of 0-100 mm between baseline and week 12. Secondary outcomes include other pain outcomes, function, quality of life, serum biomarker levels, compliance and tolerance. For a subset of patients, MRI of the hand is performed at baseline and week 12 to compare the change in Outcome Measures in Rheumatology/Hand Osteoarthritis MRI Scoring System subscores. The primary analysis will be performed at the end of the study according to the intent-to-treat principle. ETHICS AND DISSEMINATION: Ethics approval was obtained from the institutional review board (Comité de Protection des Personnes, 2020-A02213-36). All participants will be required to provide written informed consent. The findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04520516; Pre-results. PROTOCOL VERSION AND NUMBER: V.2 of 11 March 2021.

Effect of Transcutaneous Vagus Nerve Stimulation in Erosive Hand Osteoarthritis: Results from a Pilot Trial.

Beyond its effect on vegetative functions, the activation of the vagus nerve inhibits inflammation and reduces pain signaling. The aim of this open-label pilot study was to determine the efficacy and tolerance of transcutaneous auricular VNS (taVNS) on erosive hand osteoarthritis (EHOA) symptoms. Symptomatic EHOA patients with hand pain VAS ≥ 40/100 mm and ≥1 interphalangeal swollen joint(s) were included. The taVNS was performed for 4 weeks using an auricular electrode applied one hour per day and connected to a TENS device with pre-established settings. Clinical efficacy was evaluated by changes between baseline and at 4 weeks with hand pain VAS and the functional index FIHOA score, using a Wilcoxon t-test. The treatment tolerance was also evaluated. Eighteen patients (median age 69 years old, 83% women) were analyzed. At baseline, hand pain VAS was 60 mm [IQR 50; 78.2] and FIHOA 15 [10.7; 20.2]. After 4 weeks, taVNS significantly reduced hand pain VAS, with a median decrease of 23.5 mm [7.7; 37.2] (p = 0.001), as well as FIHOA, with a median decrease of 2 points [0.75; 5.2] (p = 0.01). No serious adverse events were reported. One patient stopped taVNS because of auricular discomfort. This first proof-of-concept trial indicated that taVNS is feasible and may decrease joint inflammation and clinical symptoms in EHOA, arguing for a randomized controlled study versus sham stimulation.

Development of radiographic classification criteria for hand osteoarthritis: a methodological report (Phase 2).

OBJECTIVES: In Phase 1 of developing new hand osteoarthritis (OA) classification criteria, features associated with hand OA were identified in a population with hand complaints. Radiographic findings could better discriminate patients with hand OA and controls than clinical examination findings. The objective of Phase 2 was to achieve consensus on the features and their weights to be included in three radiographic criteria sets of overall hand OA, interphalangeal OA and thumb base OA. METHODS: Multidisciplinary, international expert panels were convened. Patient vignettes were used to identify important features consistent with hand OA. A consensus-based decision analysis approach implemented using 1000minds software was applied to identify the most important features and their relative importance influencing the likelihood of symptoms being due to hand OA. Analyses were repeated for interphalangeal and thumb base OA. The reliability and validity of the proposed criteria sets were tested. RESULTS: The experts agreed that the criteria sets should be applied in a population with pain, aching or stiffness in hand joint(s) not explained by another disease or acute injury. In this setting, five additional criteria were considered important: age, morning stiffness, radiographic osteophytes, radiographic joint space narrowing and concordance between symptoms and radiographic findings. The reliability and validity were very good. CONCLUSION: Radiographic features were considered critical when determining whether a patient had symptoms due to hand OA. The consensus-based decision analysis approach in Phase 2 complemented the data-driven results from Phase 1, which will form the basis of the final classification criteria sets.

Wearable transcutaneous electrical nerve stimulation (actiTENS®) is effective and safe for the treatment of knee osteoarthritis pain: a randomized controlled trial versus weak opioids.

INTRODUCTION: Despite their poor tolerance, especially in the elderly, weak opioids (WO) remain commonly prescribed for patients with knee osteoarthritis (KOA). We compared the efficacy and safety of a new wearable transcutaneous electrical nerve stimulation (W-TENS) device with WO for the treatment of moderate-to-severe, nociceptive KOA chronic pain. METHODS: The study was a non-inferiority, multicentric, prospective, randomized, single-blind, controlled, 2-parallel groups Trial. A total of 110 patients with KOA were included (Kellgren-Lawrence radiographic grade ⩾2; American College of Rheumatology criteria), with chronic moderate-to-severe nociceptive pain (mean 8-day pain intensity (PI) ⩾ 4 on an 11-point numerical rating scale), in failure to non-opioid analgesics, including nonsteroidal anti-inflammatory drugs (NSAIDs). Patients with neuropathic pain were excluded. The co-primary endpoints were mean PI at 3 months (M3) and number of potentially treatment-related adverse events (TRAEs). Secondary outcomes included Western Ontario MAC Master University function subscale (range, 0-68), additional pain and quality of life measures, and responder rates. RESULTS: The non-inferiority of W-TENS was demonstrated in both the per protocol (PP) and intent-to-treat (ITT) populations. At M3, PI in PP population was 3.87 (2.12) compared with 4.66 (2.37) [delta: -0.79 (0.44); 95% CI (-1.65, 0.08)] in W-TENS and WO groups, respectively. A planned superiority analysis showed a significant superiority of W-TENS over WO on PI at M3 (p = 0.0124). The number of TRAEs was significantly lower in the W-TENS group (n = 7) than in the WO group (n = 36) (p < 0.001). Other secondary outcomes also favored W-TENS. CONCLUSION: W-TENS was more effective and better tolerated than WO in the treatment of chronic nociceptive KOA pain and offers an interesting non-pharmacological analgesic alternative in the management of KOA.Trial Registration: ClinicalTrials.gov: NCT03902340.

Cross-cultural adaptation and validation of the Turkish version of the Functional Index for Hand Osteoarthritis (FIHOA).

BACKGROUND: To perform reliability and validity study of the Functional Index for Hand Osteoarthritis (FIHOA) in the Turkish language. METHODS: FIHOA was translated into Turkish following the principles of cross-cultural adaptation. Our translation was firstly tested in 40 patients with hand osteoarthritis. Adapted FIHOA questionnaire was then administrated to 100 hand OA patients successively with Modified Health Assessment Questionnaire (mHAQ), Numerical Rating Scale (NRS), and Short Form-36 (SF-36). Patients filled out the FIHOA questionnaire one more time after five days for test-retest assessment. Patients were divided into two groups as symptomatic or asymptomatic, with a NRS score of 5 or above defining symptomatic OA. Internal consistency was assessed by Cronbach's alpha and intraclass correlation coefficient (ICC) of test-retest reliability. Spearman correlation analysis was used to determine the correlation and validity between data. External construct validity was assessed using the correlation between FIHOA, mHAQ, hand pain NRS, and negative correlation with SF-36 subgroups. RESULTS: According to the total score, Cronbach-alpha was found as 0.90, while ICC was determined as 0.98 for test-retest reliability. When the correlations between the FIHOA questionnaire, mHAQ, and NRS questionnaires were examined, significant correlations were determined, and negative correlations between FIHOA and SF-36 subgroups were observed. CONCLUSION: Turkish FIHOA is a reliable and valid method for assessing functionality in Turkish patients with hand osteoarthritis.

Non-steroidal anti-inflammatory drugs in the pharmacological management of osteoarthritis in the very old: prescribe or proscribe?

Osteoarthritis (OA) is the most common form of arthritis worldwide, and ranges in the top 5-10 most disabling diseases. Contrary to common opinion, this disease is severe, often symptomatic, and may lead to loss of mobility and independence, as well as being responsible for increased frailty and excess mortality [standardized ratio: 1.55 (95% confidence interval, CI: 1.41-1.70)]. The incidence of OA increases dramatically with age in an increasingly ageing world. Therefore, practitioners involved in the management of OA often have to manage very old patients, aged 75-80 years and above, as part of their daily practice. Treatment options are limited. In addition to education and physical treatments, which are at the forefront of all treatment recommendations but require a low level of symptoms to be implemented, many pharmacological options are proposed. Nonsteroidal anti-inflammatory drugs (NSAIDs) can be used as a second-line treatment but with great caution. However, the precise incidence of cardiovascular, renal, and gastrointestinal adverse events in very elderly patients is unclear. All of these risks are increased in the elderly. The relative risks can be extrapolated from various studies. However, what is the absolute risk according to age categorization? The answer to this question is important because NSAIDs should be used in very elderly patients with OA only if full information has been provided and the decision to prescribe this treatment is shared between the patient and their doctor. This article reviews the risks and currently available recommendations, and proposes practical options and warnings to allow for a responsible and limited use of NSAIDs in the very old. PLAIN LANGUAGE SUMMARY: NSAIDS in the very Old : Prescribe or Proscribe? Osteoarthritis (OA) in the very old is a serious disease leading to loss of independence, frailty, and excess mortality. Quantitative data from clinical trials and population-based observational studies on the risk of NSAID-related side effects allow the prescriber to provide more accurate information to each patient. If there is no contraindication, the decision to initiate NSAID therapy in a very old OA patient should be made in a shared manner, with the patient fully informed of the risks.

The DIGICOD cohort: A hospital-based observational prospective cohort of patients with hand osteoarthritis - methodology and baseline characteristics of the population.

OBJECTIVE: Despite its prevalence, there are few worldwide hand osteoarthritis (HOA) cohorts. The main objective of DIGItal COhort Design (DIGICOD) cohort is to investigate prognostic clinical, biological, genetic and imaging factors of clinical worsening after 6years follow-up. METHODS: DIGICOD is a hospital-based prospective cohort including patients>35years-old with symptomatic HOA fulfilling: (i) ACR criteria for HOA with≥2 symptomatic joints among proximal/distal interphalangeal joints or 1st interphalangeal joint with Kellgren-Lawrence (KL)≥2; or (ii) symptomatic thumb base OA with KL≥2. Main exclusion criteria were inflammatory arthritis and crystal arthropathies. Annual clinical evaluations were scheduled with imaging (X-rays of the hands and of other OA symptomatic joints) and biological sampling every 3years. Hand radiographs are scored using KL and anatomical Verbruggen-Veys scores. Follow-up visits are ongoing. Cohort methodology and baseline characteristics are presented. RESULTS: Between April 2013 and June 2017, from the 436 HOA included patients, 426 have been analysed of whom 357 (84%) are women. Mean age±standard deviation was 66.7±7.3years and mean disease duration was 12.6±9.6years. Metabolic syndrome affected 151 (36.5%) patients. Mean Visual Analog Scale (VAS) hand pain (0-100mm) was 44.4±26.7mm at activity. Mean FIHOA (0-100) was 19.9±18.6. Elevated serum CRP level (≥5mg/L) involved 10% patients. Mean KL score (0-128) was 46.7±18 and the mean number of joint with KL≥2 was 15.1±6.3. Erosive HOA (defined as≥1 Erosive or Remodeling phase joint according to Verbruggen-Veys score) involved 195/426 (45.8%) patients and the median number (interquartile range) of erosive joints in erosive patients was 3.0 (1.0-5.0). CONCLUSION: DIGICOD is a unique prospective HOA cohort with a long-term 6years standardized assessment and has included severe radiologically HOA patients with a high prevalence of erosive disease.

Cross-cultural adaptation and validation of the Arabic version of the functional index for hand osteoarthritis.

BACKGROUND: The Functional Index of Hand Osteoarthritis (FIHOA) is a clinically and methodologically validated score used to assess functional impact in patients with hand osteoarthritis (OA). The aim of the study was to translate the FIHOA into classical Arabic, and to validate the psychometric properties of the translated version. METHODS: The FIHOA was translated into Arabic (FIHOA-AR) according to cross-cultural adaptation guidelines. The FIHOA-AR was administrated to patients diagnosed with hand OA according to the criteria of the American College of Rheumatology (ACR). A 5-day test-retest reliability and internal consistency study was performed using the intra-class correlation coefficient (ICC) and the Cronbach's alpha coefficient. External validity was measured by correlations between FIHOA-AR, hand pain visual analog scale (VAS) and the Health Assessment Questionnaire (HAQ). RESULTS: The sample consisted of 101 patients with hand OA. The obtained ICC > 0.9 and Cronbach's alpha of 0.93 indicated excellent reliability and internal consistency respectively. The evaluation of external validity showed strong correlation with hand pain VAS (r = 0.88, p < 0.001), and strong correlation with HAQ score (r = 0.86, p < 0.001). CONCLUSION: The FIHOA-AR is a reliable and valid score to assess functional disability in Arabic- speaking patients with hand OA.

Development of classification criteria for hand osteoarthritis: comparative analyses of persons with and without hand osteoarthritis.

OBJECTIVES: Further knowledge about typical hand osteoarthritis (OA) characteristics is needed for the development of new classification criteria for hand OA. METHODS: In a cross-sectional multi-centre international study, a convenience sample of patients from primary and secondary/tertiary care with a physician-based hand OA diagnosis (n = 128) were compared with controls with hand complaints due to inflammatory or non-inflammatory conditions (n = 70). We examined whether self-reported, clinical, radiographic and laboratory findings were associated with hand OA using logistic regression analyses. Discrimination between groups was assessed by calculating the area under receiver operating curves (AUC). RESULTS: Strong associations with hand OA were observed for radiographic osteophytes (OR = 1.62, 95% CI 1.40 to 1.88) and joint space narrowing (JSN) (OR = 1.57, 95% CI 1.36 to 1.82) in the distal interphalangeal (DIP) joints with excellent discrimination (AUC = 0.82 for both). For osteophytes and JSN, we found acceptable discrimination between groups in the proximal interphalangeal joints (AUC = 0.77 and 0.78, respectively), but poorer discrimination in the first carpometacarpal joints (AUC = 0.67 and 0.63, respectively). Painful DIP joints were associated with hand OA, but were less able to discriminate between groups (AUC = 0.67). Age and family history of OA were positively associated with hand OA, whereas negative associations were found for pain, stiffness and soft tissue swelling in metacarpophalangeal joints, pain and marginal erosions in wrists, longer morning stiffness, inflammatory biomarkers and autoantibodies. CONCLUSIONS: Differences in symptoms, clinical findings, radiographic changes and laboratory tests were found in patients with hand OA versus controls. Radiographic OA features, especially in DIP joints, were best suited to discriminate between groups.

Cross-cultural translation, adaptation and validation of a Japanese version of the functional index for hand osteoarthritis (J-FIHOA).

BACKGROUND: Hand osteoarthritis (OA) has a wide spectrum of clinical presentations and physical function is one of the core domains where patients suffer. The Functional Index for Hand Osteoarthritis (FIHOA) is a leading assessment tool for hand OA-related functional impairment. Our objective was to make a Japanese version of FIHOA (J-FIHOA) and validate it among Japanese hand OA patients. METHODS: Forward and backward translation processes were completed to create a culturally adapted J-FIHOA. A prospective, observational multicenter study was undertaken for the validation process. Seventeen collaborating hospitals recruited Japanese hand OA patients who met the American College of Rheumatology criteria. A medical record review and responses to the following patient-rated questionnaires were collected: J-FIHOA, Hand20, Health Assessment Questionnaire (HAQ), numerical rating scale for pain (NRS pain) and Short Form 36 Health Survey (SF-36). We explored the structure of J-FIHOA using factor analysis. Cronbach's alpha coefficients and item-total correlations were calculated. Correlations between J-FIHOA and other questionnaires were evaluated for construct validity. Participants in clinically stable conditions repeated J-FIHOA at a one- to two-week interval to assess test-retest reliability. To evaluate responsiveness, symptomatic patients who started new pharmacological treatments had a 1-month follow-up visit and completed the questionnaires twice. Effect size (ES) and standardized response mean (SRM) were calculated with pre- and post-treatment data sets. We assessed responsiveness, comparing ES and SRM of J-FIHOA with other questionnaires (construct approach). RESULTS: A total of 210 patients participated. J-FIHOA had unidimensional structure. Cronbach's alphas (0.914 among females and 0.929 among males) and item-total correlations (range, 0.508 to 0.881) revealed high internal consistency. Hand20, which measures upper extremity disability, was strongly correlated with J-FIHOA (r = 0.82) while the mental and role-social components of SF-36 showed no correlations (r = - 0.24 and - 0.26, respectively). Intraclass correlation coefficient for test-retest reliability was 0.83 and satisfactory. J-FIHOA showed the highest ES and SRM (- 0.68 and - 0.62, respectively) among all questionnaires, except for NRS pain. CONCLUSIONS: Our results showed J-FIHOA had good measurement properties to assess physical function in Japanese hand OA patients both for ambulatory follow-up in clinical practice, and clinical research and therapeutic trials.

A retrospective observational study of glucosamine sulfate in addition to conventional therapy in hand osteoarthritis patients compared to conventional treatment alone.

BACKGROUND: The optimal management of hand osteoarthritis (HOA) is still challenging. AIM: To evaluate the effects of glucosamine sulfate (GS) in addition to conventional therapy compared to conventional therapy alone in HOA. METHODS: This 6-month retrospective study included 108 patients with concomitant knee and hand OA. Fifty-five patients (GS Group) were treated for six consecutive months with crystalline GS (1500 mg once/day) in addition to conventional therapy for HOA [exercise combined with acetaminophen and/or non-steroidal anti-inflammatory drugs (NSAIDs)] and 53 patients (Control Group) with the conventional therapy alone. Primary outcomes were the difference between groups in the change of hand pain on a Visual Analogue Scale (VAS) and in the Functional Index for Hand Osteoarthritis (FIHOA) from baseline to 6 months. Secondary outcomes were Health Assessment Questionnaire (HAQ), medical outcomes study 36-item short form (SF-36) and symptomatic drug consumption. RESULTS: The patients who received GS presented a significant decrease (p < 0.001) in VAS pain and FIHOA scores compared with the Control Group at 3 and 6 months. Furthermore, GS therapy was associated to a significant improvement of HAQ score and to a significant reduction of acetaminophen and NSAID consumption during the follow-up. No differences in the number of side effects were observed between the groups. DISCUSSION: GS could represent a potential successful therapy for HOA and should be tried in large randomized placebo and active controlled trials. CONCLUSIONS: The combination of GS with conventional treatment seems to be more effective in improving pain and function than conventional HOA treatment alone. TRIAL REGISTRATION: ClinicalTrials.gov, http://www.clinicaltrials.gov date of registration: April 9, 2019, NCT03911570. The present trial was retrospectively registered.

A single intra-articular injection of 2.0% non-chemically modified sodium hyaluronate vs 0.8% hylan G-F 20 in the treatment of symptomatic knee osteoarthritis: A 6-month, multicenter, randomized, controlled non-inferiority trial.

OBJECTIVES: The aim of the study was to demonstrate the non-inferiority of a single intra-articular injection of 2.0% non-chemically modified sodium hyaluronate (SH) vs 0.8% hylan G-F 20 (control) in symptomatic knee osteoarthritis. DESIGN: This was a double-blind, randomized, controlled trial conducted in patients with painful tibiofemoral osteoarthritis (American College of Rheumatology criteria) with insufficient response or intolerance to first-line analgesics and regular non-steroidal anti-inflammatory drugs. Subjects received a single intra-articular injection of either SH or hylan G-F 20. The primary outcome was the 6-month change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index pain subscale (WOMAC A), with a pre-specified lower margin for non-inferiority of 8 mm. RESULTS: Of the 292 patients randomized (SH: 144), 288 received an injection (SH: 142), 266 completed the study (SH: 134). In the Per Protocol dataset (SH: 113, control: 112), the WOMAC A change at 6 months was -34.3 mm (95% confidence interval (CI): -37.8, -30.8) and -36.2 mm (95% CI: -40.3, -32.1) for the SH and hylan G-F 20 patients, respectively (P = 0.5). The intergroup difference was -1.9 mm (95% CI: -7.3, 3.5). Results were similar in the Full Analysis Set (SH: 139, control: 141) with a difference between the groups of -2.9 mm (95% CI: -7.9, 2.2). A total of 31.3% of the injected patients reported a treatment-emergent adverse event, including injection site reactions (pain, inflammation or effusion) which occurred in 8.5% of the SH patients vs 13.0% of the hylan G-F 20 patients. No serious reactions were reported. CONCLUSIONS: This clinical trial demonstrated the non-inferiority of a single intra-articular injection of SH vs hylan G-F 20 on the WOMAC A change from baseline at 6 months.

Type 2 diabetes mellitus and osteoarthritis.

OBJECTIVES: Type 2 diabetes mellitus (T2DM) and osteoarthritis (OA) are common diseases that frequently co-exist, along with overweight/obesity. While the mechanical impact of excess body weight on joints may explain lower limb OA, we sought to explore whether T2DM is linked to OA outside of excess weight and whether T2DM may play a role in OA pathophysiology. The consequence of T2DM on OA outcomes is a question of research interest. METHODS: We conducted a critical review of the literature to explore the association between T2DM and OA, whether any association is site-specific for OA, and whether the presence of T2DM impacts on OA outcomes. We also reviewed the literature to assess the safety of anti-OA treatments in patients with T2DM. RESULTS: T2DM has a pathogenic effect on OA through 2 major pathways involving oxidative stress and low-grade chronic inflammation resulting from chronic hyperglycemia and insulin resistance. T2DM is a risk factor for OA progression and has a negative impact on arthroplasty outcomes. Evidence is mounting for safety concerns with some of the most frequently prescribed anti-OA medications, including paracetamol, non-steroidal anti-inflammatory drugs, and corticosteroid injections, while other anti-OA medications may be safely prescribed in OA patients with T2DM, such as glucosamine and intra-articular hyaluronic acid. CONCLUSIONS: Future research is needed to better understand whether diabetes control and prevention can modulate OA occurrence and progression. The selection of therapy to treat OA symptoms in patients with T2DM may require careful consideration of the evidence based to avoid untoward safety issues.

Why we should definitely include intra-articular hyaluronic acid as a therapeutic option in the management of knee osteoarthritis: Results of an extensive critical literature review.

OBJECTIVES: There is a discrepancy between evidence in support of the widespread use of intra-articular hyaluronic acid (IAHA) to treat knee osteoarthritis (OA) in clinical practice, and the often discordant recommendations from multiple international guideline committees, which requires further investigation. METHODS: We conducted a literature review to determine the strength of evidence in support of the efficacy and safety of IAHA, from randomized controlled trials and meta-analyses. RESULTS: Our analysis shows that IAHA provides a moderate symptomatic benefit to knee OA patients and without major safety concerns. In fact, IAHA may offer one of the best benefit/risk ratios among pharmacologic options, as measured by improvements in knee OA health outcomes, overall gain in quality-adjusted life years and substantial delays in time to total knee replacement. CONCLUSIONS: We advocate for the consideration of recommending IAHA injection as a treatment option in the management of knee OA, tailored by disease stage and patient phenotype. Future research efforts should focus on identification of OA patient subgroups that demonstrate a more robust response to IAHA, determination of long-term effects of repeat IAHA injections on patient-reported outcomes and total knee replacement-sparing effect, further elucidation of disease-modifying effects, and the potential for combination therapy with other pharmacologic and non-pharmacologic therapies to optimize the management of knee OA.