Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial.

PURPOSE: The purpose of this study was to evaluate the safety and efficacy of transient genicular artery embolization (GAE) using an ethiodized oil-based emulsion for the treatment of knee osteoarthritis (KOA). MATERIALS AND METHODS: This prospective, single-arm, open-label, multicenter, first-in-human cohort trial was registered on ClinicalTrials.gov (NCT04733092). The main inclusion criterion was diagnosis of KOA according to a visual analogue scale (VAS) pain score ≥ 40 mm (score range: 0-100 mm), despite conservative treatment for at least three months. Treatment efficacy was assessed using changes in VAS pain score, Mean Western Ontario & McMaster Universities osteoarthritis (WOMAC) function score (normalized to 100; score ranging from 0 to100) and outcome measures in rheumatoid arthritis clinical trials (OMERACT)-Osteoarthritis Research Society (OARSI) set of responder criteria. RESULTS: Twenty-two consecutive participants (13 women; mean age, 66 ± 9 [standard deviation (SD)]) were included and underwent GAE. Emulsion consisted in a mixture of ioversol and ethiodized oil (ratio 1:3, respectively) prepared extemporaneously. The rate of serious adverse events attributed to GAE within one month was 5% (1/22), corresponding to reversible worsening of renal function. Immediate technical success rate was 100%. Mean VAS pain score dropped from 74.4 ± 16.5 (SD) mm at baseline to 37.2 ± 26.7 (SD) mm at three months (P < 0.001). Mean WOMAC function score (normalized to 100: score ranging from 0 to 100) decreased from 57.3 ± 17.1 (SD) at baseline to 33.5 ± 25.9 (SD) at three months (P < 0.001). At three months, 16 out of 22 participants (73%) were considered responders according to the OMERACT-OARSI set of responder criteria, including high improvement in either pain or WOMAC function, or improvement in both pain and WOMAC function. CONCLUSION: GAE using an ethiodized oil-based emulsion is safe and improves pain and function in participants with KOA for at least three months.

Effect of Osteopathic Manipulative Treatment vs Sham Treatment on Activity Limitations in Patients With Nonspecific Subacute and Chronic Low Back Pain: A Randomized Clinical Trial.

Importance: Osteopathic manipulative treatment (OMT) is frequently offered to people with nonspecific low back pain (LBP) but never compared with sham OMT for reducing LBP-specific activity limitations. Objective: To compare the efficacy of standard OMT vs sham OMT for reducing LBP-specific activity limitations at 3 months in persons with nonspecific subacute or chronic LBP. Design, Setting, and Participants: This prospective, parallel-group, single-blind, single-center, sham-controlled randomized clinical trial recruited participants with nonspecific subacute or chronic LBP from a tertiary care center in France starting February 17, 2014, with follow-up completed on October 23, 2017. Participants were randomly allocated to interventions in a 1:1 ratio. Data were analyzed from March 22, 2018, to December 5, 2018. Interventions: Six sessions (1 every 2 weeks) of standard OMT or sham OMT delivered by nonphysician, nonphysiotherapist osteopathic practitioners. Main Outcomes and Measures: The primary end point was mean reduction in LBP-specific activity limitations at 3 months as measured by the self-administered Quebec Back Pain Disability Index (score range, 0-100). Secondary outcomes were mean reduction in LBP-specific activity limitations; mean changes in pain and health-related quality of life; number and duration of sick leaves, as well as number of LBP episodes at 12 months; and consumption of analgesics and nonsteroidal anti-inflammatory drugs at 3 and 12 months. Adverse events were self-reported at 3, 6, and 12 months. Results: Overall, 200 participants were randomly allocated to standard OMT and 200 to sham OMT, with 197 analyzed in each group; the median (range) age at inclusion was 49.8 (40.7-55.8) years, 235 of 394 (59.6%) participants were women, and 359 of 393 (91.3%) were currently working. The mean (SD) duration of the current LBP episode was 7.5 (14.2) months. Overall, 164 (83.2%) patients in the standard OMT group and 159 (80.7%) patients in the sham OMT group had the primary outcome data available at 3 months. The mean (SD) Quebec Back Pain Disability Index scores for the standard OMT group were 31.5 (14.1) at baseline and 25.3 (15.3) at 3 months, and in the sham OMT group were 27.2 (14.8) at baseline and 26.1 (15.1) at 3 months. The mean reduction in LBP-specific activity limitations at 3 months was -4.7 (95% CI, -6.6 to -2.8) and -1.3 (95% CI, -3.3 to 0.6) for the standard OMT and sham OMT groups, respectively (mean difference, -3.4; 95% CI, -6.0 to -0.7; P = .01). At 12 months, the mean difference in mean reduction in LBP-specific activity limitations was -4.3 (95% CI, -7.6 to -1.0; P = .01), and at 3 and 12 months, the mean difference in mean reduction in pain was -1.0 (95% CI, -5.5 to 3.5; P = .66) and -2.0 (95% CI, -7.2 to 3.3; P = .47), respectively. There were no statistically significant differences in other secondary outcomes. Four and 8 serious adverse events were self-reported in the standard OMT and sham OMT groups, respectively, though none was considered related to OMT. Conclusions and Relevance: In this randomized clinical trial of patients with nonspecific subacute or chronic LBP, standard OMT had a small effect on LBP-specific activity limitations vs sham OMT. However, the clinical relevance of this effect is questionable. Trial Registration: ClinicalTrials.gov Identifier: NCT02034864.

Intensive spa and exercise therapy program for returning to work for low back pain patients: a randomized controlled trial.

We aimed to determine whether a 5-day intensive inpatient spa and exercise therapy and educational program is more effective than usual care in improving the rate of returning to work at 1 year for patients with subacute and chronic low back pain (LBP) on sick leave for 4 to 24 weeks. We conducted a 12-month randomized controlled trial. LBP patients were assigned to 5-day spa (2 hr/day), exercise (30 min/day) and education (45 min/day) or to usual care. The primary outcome was the percentage of patients returning to work at 1 year after randomization. Secondary outcomes were pain, disability and health-related quality of life at 1 year and number of sick leave days from 6 to 12 months. The projected recruitment was not achieved. Only 88/700 (12.6%) patients planned were enrolled: 45 in the spa therapy group and 43 in the usual care group. At 1 year, returning to work was 56.3% versus 41.9% (OR 1.69 [95% CI 0.60-4.73], p = 0.32) respectively. There was no significant difference for any of the secondary outcomes. However, our study lacked power.

A consensus statement on the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) algorithm for the management of knee osteoarthritis-From evidence-based medicine to the real-life setting.

The European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) published a treatment algorithm for the management of knee osteoarthritis (OA) in 2014, which provides practical guidance for the prioritization of interventions. Further analysis of real-world data for OA provides additional evidence in support of pharmacological interventions, in terms of management of OA pain and function, avoidance of adverse events, disease-modifying effects and long-term outcomes, e.g., delay of total joint replacement surgery, and pharmacoeconomic factors such as reduction in healthcare resource utilization. This article provides an updated assessment of the literature for selected interventions in OA, focusing on real-life data, with the aim of providing easy-to-follow advice on how to establish a treatment flow in patients with knee OA in primary care clinical practice, in support of the clinicians' individualized assessment of the patient. In step 1, background maintenance therapy with symptomatic slow-acting drugs for osteoarthritis (SYSADOAs) is recommended, for which high-quality evidence is provided only for the prescription formulations of patented crystalline glucosamine sulfate and chondroitin sulfate. Paracetamol may be added for rescue analgesia only, due to limited efficacy and increasing safety signals. Topical non-steroidal anti-inflammatory drugs (NSAIDs) may provide additional symptomatic treatment with the same degree of efficacy as oral NSAIDs without the systemic safety concerns. Oral NSAIDs maintain a central role in step 2 advanced management of persistent symptoms. However, oral NSAIDs are highly heterogeneous in terms of gastrointestinal and cardiovascular safety profile, and patient stratification with careful treatment selection is advocated to maximize the risk:benefit ratio. Intra-articular hyaluronic acid as a next step provides sustained clinical benefit with effects lasting up to 6 months after a short-course of weekly injections. As a last step before surgery, the slow titration of sustained-release tramadol, a weak opioid, affords sustained analgesia with improved tolerability.

The burden of osteoarthritis: development and validation of a new assessment tool (BONe'S).

OBJECTIVE: To develop and validate a specific individual burden questionnaire, BONe'S (Burden of Osteoarthritis New Scale), assessing osteoarthritis (OA) patients in the broadest sense. RESEARCH DESIGN AND METHODS: Items included in BONe'S were identified by literature review, and patient/healthcare practitioner interviews, and refined via item reduction and exploratory factor analysis (EFA). Internal consistency was calculated using Cronbach's α; concurrent validity was assessed by calculating the correlation between BONe'S and the Short Form (SF)-12 Health Survey and Psychological General Well-Being Index (PGWBI). Discriminant validity was analyzed by age, gender and number of OA locations. RESULTS: From an initial list of 56 items, the final BONe'S questionnaire consisted of 20 questions (5 dimensions) based on EFA. BONe'S was evaluated in patients with OA (n = 200; mean age 69.4 ± 7.0 years, 86% of patients aged >60 years, 91.5% women). BONe'S demonstrated excellent internal coherence (Cronbach's α: 0.86). Individual BONe'S dimensions correlated well with the overall BONe'S score (highest: 'Independence' [r = 0.91]; lowest: 'Hygiene & Beauty' [r = 0.56]), and to each other dimension, and also correlated well (inversely) with the SF-12 and, to a slightly lesser extent, the PGWBI. The only exception was 'Budget', but this dimension was important and relevant in the subpopulation of active OA patients (r = 0.40). The mean BONe'S score for subjects with one or two affected joints was significantly lower than for subjects with three or more affected joints. The BONe'S score also differed according to gender and age. The original French BONe'S has also been adapted (linguistically and culturally) to English, Russian and Portuguese. Limitations include the fact that BONe'S was developed in a predominantly female population, in patients receiving a pharmacological intervention, has not been evaluated in a large population and has not been compared with other OA tools, including WOMAC, Lequesne and KOOS. CONCLUSION: The BONe'S questionnaire is a short (20-item) validated tool for evaluating the specific individual burden of OA in a holistic manner.

Patients' and practitioners' views of knee osteoarthritis and its management: a qualitative interview study.

PURPOSE: To identify the views of patients and care providers regarding the management of knee osteoarthritis (OA) and to reveal potential obstacles to improving health care strategies. METHODS: We performed a qualitative study based on semi-structured interviews of a stratified sample of 81 patients (59 women) and 29 practitioners (8 women, 11 general practitioners [GPs], 6 rheumatologists, 4 orthopedic surgeons, and 8 [4 GPs] delivering alternative medicine). RESULTS: Two main domains of patient views were identified: one about the patient-physician relationship and the other about treatments. Patients feel that their complaints are not taken seriously. They also feel that practitioners act as technicians, paying more attention to the knee than to the individual, and they consider that not enough time is spent on information and counseling. They have negative perceptions of drugs and a feeling of medical uncertainty about OA, which leads to less compliance with treatment and a switch to alternative medicine. Patients believe that knee OA is an inevitable illness associated with age, that not much can be done to modify its evolution, that treatments are of little help, and that practitioners have not much to propose. They express unrealistic fears about the impact of knee OA on daily and social life. Practitioners' views differ from those of patients. Physicians emphasize the difficulty in elaborating treatment strategies and the need for a tool to help in treatment choice. CONCLUSIONS: This qualitative study suggests several ways to improve the patient-practitioner relationship and the efficacy of treatment strategies, by increasing their acceptability and compliance. Providing adapted and formalized information to patients, adopting more global assessment and therapeutic approaches, and dealing more accurately with patients' paradoxal representation of drug therapy are main factors of improvement that should be addressed.