Background: Early stage of osteoarthritis (OA) is characterized by joint stiffness and pain as we... more 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 ...
Alternative therapies in health and medicine, 2019
Background Current therapeutic modalities for fibromyalgia (FM) do not provide satisfactory resul... more Background Current therapeutic modalities for fibromyalgia (FM) do not provide satisfactory results and new approaches have to be explored. Objectives To assess efficacy and safety of adding a phytotherapy treatment (Fib-19-01) to the current therapeutic regimen in patients with FM. Methods Double-blind controlled trial: women with active FM (Fibromyalgia Index Questionnaire FIQ > 40) were randomised to receive Fib-19-01 or a food supplement (FS) undistinguishable from Fib-19-01 or no supplementary treatment (NoST). All continued the conventional therapy throughout the 6 month follow-up. Primary endpoint: change in FIQ between Day 0 and month 6 (M6). Secondary Criteria: variation over time FIQ ( repeated measurements), change in Pichot fatigue scale, Pittsburgh Sleep Quality Index (PSQI), SF-12 and Hospital Anxiety and Depression (HAD) scales. Results 100 patients (Intent-To-Treat population) were analyzed. FIQ decreased significantly only in the Fib-19-01 group (P < .001) at ...
Objectives This work studied if and how current clinical practice agrees with European Viscosuppl... more Objectives This work studied if and how current clinical practice agrees with European Viscosupplementation Consensus Group (EUROVISCO) recommendations and how this agreement might be different according to physician’s specialization. In addition, this work aimed to identify key decision factors that practitioners consider in their decision to retreat or not a patient with hyaluronic acid viscosupplementation. Methods Practitioners have been invited by e-mail to participate in an online exercise on viscosupplementation retreatment. They received a fictional patient case at random among a set of predefined fictional cases. The platform asked the practitioner if he/she would retreat the patient with viscosupplementation or not. To take a decision, the practitioner could select questions among a list of predefined questions. Among them, some were related to criteria used in the EUROVISCO decision tree and others served as confounding factors. Results A total of 506 practitioners partic...
OBJECTIVE This pragmatic, multicenter, open-label, randomized controlled trial (RCT) aimed to com... more OBJECTIVE This pragmatic, multicenter, open-label, randomized controlled trial (RCT) aimed to compare the effectiveness, safety, and cost-utility of a custom-made knee brace versus usual care over 1 year in medial knee osteoarthritis (OA). DESIGN 120 patients with medial knee OA (VAS pain at rest >40/100), classified as Kellgren-Lawrence grade II-IV, were randomized into two groups: ODRA plus usual care (ODRA group) and usual care alone (UCA group). The primary effectiveness outcome was the change in VAS pain between M0 and M12. Secondary outcomes included changes over 1 year in KOOS (function) and OAKHQOL (quality of life) scores. Drug consumption, compliance, safety of the knee brace, and cost-utility over 1 year were also assessed. RESULTS The ODRA group was associated with a higher improvement in: VAS pain (adjusted mean difference of -11.8; 95% CI: -21.1 to -2.5); all KOOS subscales (pain: +8.8; 95% CI: 1.4-16.2); other symptoms (+10.4; 95% CI: 2.7-18); function in activities of daily living (+9.2; 95% CI: 1.1-17.2); function in sports and leisure (+12.3; 95% CI: 4.3-20.3); quality of life (+9.9; 95% CI: 0.9-15.9), OAKHQOL subscales (pain: +14.8; 95% CI: 5.0-24.6); and physical activities (+8.2; 95% CI: 0.6-15.8), and with a significant decrease in analgesics consumption at M12 compared with the UCA group. Despite localized side-effects, observance was good at M12 (median: 5.3 hours/day). The ODRA group had a more than 85% chance of being cost-effective for a willingness-to-pay threshold of €45 000 per QALY. CONCLUSIONS The ERGONOMIE RCT demonstrated significant clinical benefits of an unloader custom-made knee brace in terms of improvements in pain, function, and some aspects of quality of life over 1 year in medial knee OA, as well as its potential cost-utility from a societal perspective.
The usefulness of viscosupplementation in the treatment of nee osteoarthritis is finally receivin... more The usefulness of viscosupplementation in the treatment of nee osteoarthritis is finally receiving support from a rapidly ncreasing number of recommendations and metaanalyses [1,2]. far less convincing body of literature exists about hyaluronic cid injections into other joints. After the knee, the joints most ften treated with viscosupplementation are the hip, ankle, shouler, and trapeziometacarpal joint, for which the published data are herefore most abundant. Most studies were done in small populations, often with fewer han 100 patients per group. The wide variations in treatment rotocols and products across studies generate considerable hetrogeneity in the results. In addition, an open-label design was enerally used, and, among the few controlled studies, the vast ajority fail to meet the quality criteria needed to obtained valid esults. Finally, not all studies used, or clearly defined, fluoroscopy r ultrasonography to guide the injections, which is crucial to nsure delivery-site accuracy. As a result, published data do not orm a sound basis on which to build an assessment of the effeciveness of viscosupplementation at sites other than the knee. In articular, the few published metaanalyses and systematic reviews rovide no firm conclusions, for the reasons described above [3,4]. evertheless, a closer look at these studies teaches a number of very nteresting lessons, which should help clinicians to make treatment ecisions and to participate in developing high-quality, large-scale, ontrolled studies with sufficiently long follow-ups. The first essential lesson that can be drawn from a careful review f the literature is that the number of injections needed to obtain a ignificant therapeutic effect is dependent, not on the joint, but on he product. In other words, a joint that is smaller than the knee
Background: Early stage of osteoarthritis (OA) is characterized by joint stiffness and pain as we... more 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 ...
Alternative therapies in health and medicine, 2019
Background Current therapeutic modalities for fibromyalgia (FM) do not provide satisfactory resul... more Background Current therapeutic modalities for fibromyalgia (FM) do not provide satisfactory results and new approaches have to be explored. Objectives To assess efficacy and safety of adding a phytotherapy treatment (Fib-19-01) to the current therapeutic regimen in patients with FM. Methods Double-blind controlled trial: women with active FM (Fibromyalgia Index Questionnaire FIQ > 40) were randomised to receive Fib-19-01 or a food supplement (FS) undistinguishable from Fib-19-01 or no supplementary treatment (NoST). All continued the conventional therapy throughout the 6 month follow-up. Primary endpoint: change in FIQ between Day 0 and month 6 (M6). Secondary Criteria: variation over time FIQ ( repeated measurements), change in Pichot fatigue scale, Pittsburgh Sleep Quality Index (PSQI), SF-12 and Hospital Anxiety and Depression (HAD) scales. Results 100 patients (Intent-To-Treat population) were analyzed. FIQ decreased significantly only in the Fib-19-01 group (P < .001) at ...
Objectives This work studied if and how current clinical practice agrees with European Viscosuppl... more Objectives This work studied if and how current clinical practice agrees with European Viscosupplementation Consensus Group (EUROVISCO) recommendations and how this agreement might be different according to physician’s specialization. In addition, this work aimed to identify key decision factors that practitioners consider in their decision to retreat or not a patient with hyaluronic acid viscosupplementation. Methods Practitioners have been invited by e-mail to participate in an online exercise on viscosupplementation retreatment. They received a fictional patient case at random among a set of predefined fictional cases. The platform asked the practitioner if he/she would retreat the patient with viscosupplementation or not. To take a decision, the practitioner could select questions among a list of predefined questions. Among them, some were related to criteria used in the EUROVISCO decision tree and others served as confounding factors. Results A total of 506 practitioners partic...
OBJECTIVE This pragmatic, multicenter, open-label, randomized controlled trial (RCT) aimed to com... more OBJECTIVE This pragmatic, multicenter, open-label, randomized controlled trial (RCT) aimed to compare the effectiveness, safety, and cost-utility of a custom-made knee brace versus usual care over 1 year in medial knee osteoarthritis (OA). DESIGN 120 patients with medial knee OA (VAS pain at rest >40/100), classified as Kellgren-Lawrence grade II-IV, were randomized into two groups: ODRA plus usual care (ODRA group) and usual care alone (UCA group). The primary effectiveness outcome was the change in VAS pain between M0 and M12. Secondary outcomes included changes over 1 year in KOOS (function) and OAKHQOL (quality of life) scores. Drug consumption, compliance, safety of the knee brace, and cost-utility over 1 year were also assessed. RESULTS The ODRA group was associated with a higher improvement in: VAS pain (adjusted mean difference of -11.8; 95% CI: -21.1 to -2.5); all KOOS subscales (pain: +8.8; 95% CI: 1.4-16.2); other symptoms (+10.4; 95% CI: 2.7-18); function in activities of daily living (+9.2; 95% CI: 1.1-17.2); function in sports and leisure (+12.3; 95% CI: 4.3-20.3); quality of life (+9.9; 95% CI: 0.9-15.9), OAKHQOL subscales (pain: +14.8; 95% CI: 5.0-24.6); and physical activities (+8.2; 95% CI: 0.6-15.8), and with a significant decrease in analgesics consumption at M12 compared with the UCA group. Despite localized side-effects, observance was good at M12 (median: 5.3 hours/day). The ODRA group had a more than 85% chance of being cost-effective for a willingness-to-pay threshold of €45 000 per QALY. CONCLUSIONS The ERGONOMIE RCT demonstrated significant clinical benefits of an unloader custom-made knee brace in terms of improvements in pain, function, and some aspects of quality of life over 1 year in medial knee OA, as well as its potential cost-utility from a societal perspective.
The usefulness of viscosupplementation in the treatment of nee osteoarthritis is finally receivin... more The usefulness of viscosupplementation in the treatment of nee osteoarthritis is finally receiving support from a rapidly ncreasing number of recommendations and metaanalyses [1,2]. far less convincing body of literature exists about hyaluronic cid injections into other joints. After the knee, the joints most ften treated with viscosupplementation are the hip, ankle, shouler, and trapeziometacarpal joint, for which the published data are herefore most abundant. Most studies were done in small populations, often with fewer han 100 patients per group. The wide variations in treatment rotocols and products across studies generate considerable hetrogeneity in the results. In addition, an open-label design was enerally used, and, among the few controlled studies, the vast ajority fail to meet the quality criteria needed to obtained valid esults. Finally, not all studies used, or clearly defined, fluoroscopy r ultrasonography to guide the injections, which is crucial to nsure delivery-site accuracy. As a result, published data do not orm a sound basis on which to build an assessment of the effeciveness of viscosupplementation at sites other than the knee. In articular, the few published metaanalyses and systematic reviews rovide no firm conclusions, for the reasons described above [3,4]. evertheless, a closer look at these studies teaches a number of very nteresting lessons, which should help clinicians to make treatment ecisions and to participate in developing high-quality, large-scale, ontrolled studies with sufficiently long follow-ups. The first essential lesson that can be drawn from a careful review f the literature is that the number of injections needed to obtain a ignificant therapeutic effect is dependent, not on the joint, but on he product. In other words, a joint that is smaller than the knee
Uploads