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Is Phytalgic？ a goldmine for osteoarthritis patients or is there something fishy about this nutraceutical? A summary of findings and risk-of-bias assessment
Robin Christensen, Henning Bliddal
Arthritis Research & Therapy , 2010, DOI: 10.1186/ar2909
Abstract: Given the modest results of ordinary pharmacological therapy for osteoarthritis (OA), it was of great interest to see the results by Jacquet and colleagues [1] in the previous issue of Arthritis Research & Therapy. The authors tested a new nutraceutical, a food supplement marketed as Phytalgic？, in a randomized controlled trial (RCT) design. The protocol of this trial was registered in ClinicalTrials.gov (NCT00666523) [2]. However, one aspect of concern is whether the registration was pre specified. The registration claims that exactly 81 patients will be randomly assigned. How can a protocol registration foresee a random assignment of 41 patients to one group and 40 to the other group when it is a consequence of excluding 14 non-eligible patients, as presented in the CONSORT (CONsolidated Standards of Reporting Trials) Statement?The authors present data for Phytalgic？ [1] which are considerably more promising than expected and thus should be scrutinized for clinical effect and possible bias [3]. According to the authors, Phytalgic？ consists of capsules containing fish oils, urtica dioica, zinc, and vitamin E. Jacquet and colleagues [1] randomly assigned some 81 OA patients to receive either Phytalgic？ or a matching placebo consisting of 'non-fish oil'. Participants were an average of 57 years of age (range of 28 to 84 years) at entry, had either knee or hip OA, and were regular users of nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics. The primary outcome of this 3-month trial was use of NSAIDs or analgesics at follow-up. According to ClinicalTrials.gov [2], Jacquet and colleagues [1] considered the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) function scale a secondary outcome measure, and none of the other WOMAC subscales is mentioned in the trial registration. In accordance with recent standards on how to evaluate the results of OA trials [3,4], Figure 1 presents a summary of findings as generic effect sizes (ESs) based on th
The Influence of Radiographic Severity on the Relationship between Muscle Strength and Joint Loading in Obese Knee Osteoarthritis Patients
Jens Aaboe,Henning Bliddal,Tine Alkjaer,Mikael Boesen,Marius Henriksen
Arthritis , 2011, DOI: 10.1155/2011/571519
Abstract: Objective. To investigate the relationship between knee muscle strength and the external knee adduction moment during walking in obese knee osteoarthritis patients and whether disease severity influences this relationship. Methods. This cross-sectional study included 136 elderly obese (BMI>30) adults with predominant medial knee osteoarthritis. Muscle strength, standing radiographic severity as measured by the Kellgren and Lawrence scale, and the peak external knee adduction moment were measured at self-selected walking speed. Results. According to radiographic severity, patients were classified as “less severe” (KL 1-2, =73) or “severe” (KL 3-4, =63). A significant positive association was demonstrated between the peak knee adduction moment and hamstring muscle strength in the whole cohort (=.047). However, disease severity did not influence the relationship between muscle strength and dynamic medial knee joint loading. Severe patients had higher peak knee adduction moment and more varus malalignment (<.001). Conclusion. Higher hamstring muscle strength relates to higher estimates of dynamic knee joint loading in the medial compartment. No such relationship existed for quadriceps muscle strength. Although cross sectional, the results suggest that hamstrings function should receive increased attention in future studies and treatments that aim at halting disease progression.
Radiographs and low field MRI (0.2T) as predictors of efficacy in a weight loss trial in obese women with knee osteoarthritis
Henrik Gudbergsen, Mikael Boesen, Robin Christensen, Arne Astrup, Henning Bliddal
BMC Musculoskeletal Disorders , 2011, DOI: 10.1186/1471-2474-12-56
Abstract: In this study we hypothesize that imaging variables assessed with radiographs and MRI scans pre-treatment can predict the symptomatic changes following a recommended clinically significant weight reduction Patients were recruited from the Department of Rheumatology, Frederiksberg Hospital, Denmark. Eligibility criteria were: age >18 years; primary osteoarthritis according to ACR; BMI > 28 kg/m2; motivation for weight loss. Subjects were randomly assigned to either intervention by low-energy diet (LED) for 8 weeks followed by another 24 weeks of dietary instruction or control-group. MRI scans and radiographs were scored for structural changes and these parameters were examined as independent predictors of changes in osteoarthritis symptoms after 32 weeks. The outcome assessor and statistician were blinded to group allocation.No significant correlations were found between imaging variables and changes in Western Ontario and McMaster Universities Index of Osteoarthritis (Spearman's test, r < 0.33 and P > 0.07).Only the LED group achieved a weight loss, with a mean difference of 16.3 kg (95%CI: 13.4-19.2;P < 0.0001) compared to the control group. The total WOMAC index showed a significant difference favouring LED, with a group mean difference of - 321.3 mm (95%CI: -577.5 to -65.1 mm; P = 0.01). No significant adverse events were reported.Stage of joint destruction, assessed on either radiographs or low-field MRI (0.2T), does not preclude a symptoms relief following a clinically relevant weight loss in elderly obese female patients with knee osteoarthritis.Knee osteoarthritis (KOA) is a multi factorial disease characterized by joint-stiffness, pain and loss of function [1]. With an increasing prevalence of elderly and obese citizens, the problems of KOA is likely to escalate in the future [2-4], and as new potential treatments arise, there is a need to examine MRI evaluated structural changes in clinical trials.A drug/treatment that can efficiently halt the degenerative
The Associations between Pain Sensitivity and Knee Muscle Strength in Healthy Volunteers: A Cross-Sectional Study
Marius Henriksen,Louise Klokker,Cecilie Bartholdy,Thomas Graven-Nielsen,Henning Bliddal
Pain Research and Treatment , 2013, DOI: 10.1155/2013/787054
Abstract: Objectives. To investigate associations between muscle strength and pain sensitivity among healthy volunteers and associations between different pain sensitivity measures. Methods. Twenty-eight healthy volunteers (21 females) participated. Pressure pain thresholds (PPTs) were obtained from 1) computer-controlled pressure algometry on the vastus lateralis and deltoid muscles and on the infrapatellar fat pad and 2) computerized cuff pressure algometry applied on the lower leg. Deep-tissue pain sensitivity (intensity and duration) was assessed by hypertonic saline injections into the vastus lateralis, deltoid, and infrapatellar fat pad. Quadriceps and hamstring muscle strength was assessed isometrically at 60-degree knee flexion using a dynamometer. Associations between pain sensitivity and muscle strength were investigated using multiple regressions including age, gender, and body mass index as covariates. Results. Knee extension strength was associated with computer-controlled PPT on the vastus lateralis muscle. Computer-controlled PPTs were significantly correlated between sites ( ) and with cuff PPT ( ). Saline induced pain intensity and duration were correlated between sites ( ) and with all PPTs ( ). Conclusions. Pressure pain thresholds at the vastus lateralis are positively associated with knee extensor muscle strength. Different pain sensitivity assessment methods are generally correlated. The cuff PPT and evoked infrapatellar pain seem to reflect the general pain sensitivity. This trial is registered with ClinicalTrials.gov: NCT01351558. 1. Introduction Musculoskeletal pain is very common. In Europe, as many as 1 out of 5 reports frequent and persistent musculoskeletal pain [1], and among those with musculoskeletal pain 50% have constant pain [2]. Thus, musculoskeletal pain is a significant challenge to society. While pain is the cardinal symptom in many musculoskeletal diseases, impaired muscle function is also a typical sign of musculoskeletal diseases, such as fibromyalgia and osteoarthritis [3, 4]. Adequate muscle function is crucial to maintain an independent life style, and reduced knee muscle strength is further associated with elevated risks of disability and mortality [5]. In recent years, many musculoskeletal diseases have been associated with increased pain sensitivity. Among patients with fibromyalgia, the increased pain sensitivity has been reported [6], and widespread increased pain sensitivity have also been demonstrated in subgroups of patients with osteoarthritis, lateral epicondylitis, and low back pain [7–9]. Jespersen et al.
Point of no return for improvement of cartilage quality indicated by dGEMRIC before and after weight loss in patients with knee osteoarthritis: a cohort study
Carl Johan Tiderius,Henning Bliddal,Henrik Gudbergsen,Janus D Nybing,Marie Skougaard,Mikael Boesen,Stine Hangaard
- , 2018, DOI: 10.1177/0284185117720857
Abstract: It has been demonstrated that weight loss improves symptoms in obese subjects with knee osteoarthritis (KOA). A parallel change in cartilage morphology remains to be demonstrated. To demonstrate a parallel change in cartilage morphology. Obese patients with KOA were examined before and after weight loss over 16 weeks. Target knee joints were radiographically assessed by the Kellgren/Lawrence grading (KLG) system. Patients with KLG-1 and 2 changes in the lateral compartment were included. Delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) was performed using intra-articular contrast. Nine patients with lateral KLG-1 and ten patients with lateral KLG-2 were studied. There were no group differences regarding the lateral compartment baseline dGEMRIC T1 values: median？=？497？ms (KLG-1) and 533？ms (KLG-2) (P？=？0.12), or regarding reduction in body mass index (BMI) after 16 weeks: 12.8% versus 11.4% (P？=？0.74). In the KLG-1 group, several cases of increased dGEMRIC T1 values were seen and median value decreased significantly less than in KLG-2 group (15？ms versus 41？ms, P？=？0.03) after weight loss. Improvement of cartilage quality, assessed with dGEMRIC, after weight loss might be possible in early stage KOA (KLG-1), but not in later stage KOA (KLG-2). The results may suggest a point of no return for improvement of cartilage quality that should be tested in larger trials
Acoustic Myography in Assessment of Isokinetic and Isometric Muscle Strength in a Healthy Danish Population  [PDF]
Else Marie Bartels, Waqas Ahmed, Jack Kvistgaard Olsen, Eva Littrup Andersen, Bente Danneskiold-Sams？e, Lars-Erik Kristensen, Henning Bliddal, Cecilie R？dgaard Bartholdy, Adrian P. Harrison
Journal of Biomedical Science and Engineering (JBiSE) , 2020, DOI: 10.4236/jbise.2020.1312022
Abstract: Isokinetic and isometric force measurements involving a dynamometer setup are widely used in training and in muscle assessment. For further understanding of the method, we investigated the activation of key functional muscles during isokinetic and isometric movements. During force measurements in an isokinetic Biodex System 3 ProTM, acoustic myography (AMG) was applied. Ten healthy subjects (5 men/5 women) in each decade from 20 to 69 years of age participated in the study. Measurements were carried out during extension and flexion of the ankle, knee and elbow joints. Muscle fibre use was measured by efficiency (E-score) and fibre recruitment (temporal (T-score) and spatial (S-score) summation). AMG measurements showed good reproducibility, and the recruitment pattern of muscle fibres did not change with gender or age. Overall, a significantly higher E-score (P < 0.05) was found at the lower angular velocities than at the higher ones, indicating a lower level of muscle efficiency at higher velocities. Muscles used for knee movement exhibited higher scores than muscles associated with the ankle and elbow joints, most likely related to the greater degree of force production at this joint compared to the ankle and elbow. The ability to activate and inactivate muscle fibres during periods of isokinetic activity becomes increasingly more difficult as the velocity increases. When assessing training effects in sports or rehabilitation, AMG in parallel with isokinetic measurements adds important additional information by giving a measure of possible improvements in efficiency and fibre use.
Dynamic Contrast Enhanced MRI Can Monitor the Very Early Inflammatory Treatment Response upon Intra-Articular Steroid Injection in the Knee Joint: A Case Report with Review of the Literature
Mikael Boesen,Olga Kubassova,Marco A. Cimmino,Mikkel stergaard,Peter Taylor,Bente Danneskiold-Samsoe,Henning Bliddal
Arthritis , 2011, DOI: 10.1155/2011/578252
Abstract: Dynamic contrast-enhanced MRI in inflammatory arthritis, especially in conjunction with computer-aided analysis using appropriate dedicated software, seems to be a highly sensitive tool for monitoring the early inflammatory treatment response in patients with rheumatoid arthritis. This paper gives a review of the current knowledge of the emerging technique. The potential of the technique is demonstrated and discussed in the context of a case report following the early effect of an intra-articular steroid injection in a patient with rheumatoid arthritis flare in the knee.
Test-retest of computerized health status questionnaires frequently used in the monitoring of knee osteoarthritis: a randomized crossover trial
Henrik Gudbergsen, Else M Bartels, Peter Krusager, Eva E W？hrens, Robin Christensen, Bente Danneskiold-Sams？e, Henning Bliddal
BMC Musculoskeletal Disorders , 2011, DOI: 10.1186/1471-2474-12-190
Abstract: Participants were recruited from an ongoing trial (http://ClinicalTrials.Gov webcite Identifier: NCT00655941). 20 female participants, mean age 67 (SD 7), completed KOOS, VAS pain, function and patient global, SF-36, Physical Activity Scale, painDETECT, and the ADL Taxonomy. Patients were randomly assigned to one of two subgroups, completing either the paper or touch screen version first. Mean, mean differences (95% CI), median, median differences and Intraclass Correlation Coefficients (ICCs) were calculated for all questionnaires.ICCs between data based on computerized and paper versions ranged from 0.86 to 0.99. Analysis revealed a statistically significant difference between versions of the ADL Taxonomy, but not for the remaining questionnaires. Age, computer experience or education-level had no significant impact on the results. The computerized questionnaires were reported to be easier to use.The computerized questionnaires gave comparable results to answers given on paper. Patient characteristics did not influence results and implementation was feasible.In the Rheumatology clinic, self-administered Health Status Questionnaires (HSQs) are an important part of the overall evaluation of patients [1,2]. Several questionnaires are applied in the self-assessment process, and data handling can be tedious, expensive and open to errors, when data are being transferred manually from paper into electronic systems. Implementation of computerized methods of data collection based on touch-screen would be more cost-effective and decrease the risk of error.Touch screen is a new tool applied in places like libraries and shops, as well as in health care settings [3-5]. However, prior to implementation of data collection based on touch screen, it is crucial to evaluate if questionnaires based on paper and touch screen provide similar information. Furthermore, as clinical studies often include several questionnaires it is relevant to validate multiple computerized questionnaires
Dynamic Contrast Enhanced MRI Can Monitor the Very Early Inflammatory Treatment Response upon Intra-Articular Steroid Injection in the Knee Joint: A Case Report with Review of the Literature
Mikael Boesen,Olga Kubassova,Marco A. Cimmino,Mikkel ？stergaard,Peter Taylor,Bente Danneskiold-Samsoe,Henning Bliddal
Arthritis , 2011, DOI: 10.1155/2011/578252
Abstract: Dynamic contrast-enhanced MRI in inflammatory arthritis, especially in conjunction with computer-aided analysis using appropriate dedicated software, seems to be a highly sensitive tool for monitoring the early inflammatory treatment response in patients with rheumatoid arthritis. This paper gives a review of the current knowledge of the emerging technique. The potential of the technique is demonstrated and discussed in the context of a case report following the early effect of an intra-articular steroid injection in a patient with rheumatoid arthritis flare in the knee. 1. Background Imaging modalities aiming to identify perfusion characteristics in inflammatory joint disease are receiving increasing attention after results from a recent publication have shown that measures of perfusion detected with ultrasound Doppler in the wrist joints of rheumatoid arthritis patients with low disease activity scores (DAS28) had the highest predictive value of future erosive outcome [1] compared to both clinical measures and conventional contrast enhanced MRI. dynamic contrast-enhanced MRI (DCE-MRI) is such an imaging technique based on sequential acquisition of rapid MRI sequences before and during the infusion of a contrast agent. It can be used to evaluate synovial activity in patients with rheumatoid arthritis (RA) and has been shown to correlate closely to synovial vascularity and inflammation [2–4]. An enhancement curve is obtained, where the initial rate of enhancement and the resulting plateau and potential washout depends on the inflammatory vasodilation, neoangiogenesis, and perfusion. The early enhancement rate determined by DCE-MRI has shown to be more sensitive to change after intraarticular steroid injection [5] and has a closer relation to histological inflammatory activity than measures of the synovial volumes [4, 6], making DCE-MRI a promising tool for assessing the early inflammatory response to treatment, potentially even before volume changes, and thus changes in the semiquantitative synovitis score occur [7]. DCE-MRI has been tested on low-field [8] and high-field [4, 6] scanners and is capable of discriminating patients with clinically active disease from those in remission. Conventionally, DCE-MRI data is analysed using region of interest- (ROI-) based technique, where a small, few millimetre ROI is placed in the most enhancing part of the synovium, as perceived by an observer [8]. It has been shown that the size and position of ROI have a great impact on diagnostic accuracy and ROI misplacement by only a few millimetres might give a 20%–30%
The Relationship between Mechanical Hyperalgesia Assessed by Manual Tender Point Examination and Disease Severity in Patients with Chronic Widespread Pain: A Cross-Sectional Study
Kirstine Amris,Eva Ejlersen W？hrens,Anders Jespersen,Anders Stockmarr,Robert Bennett,Henning Bliddal,Bente Danneskiold-Sams？e
International Journal of Rheumatology , 2014, DOI: 10.1155/2014/417596
Abstract: The clinical utility of tender point (TP) examination in patients reporting chronic widespread pain (CWP) is the subject of contemporary debate. The objective of this study was to assess the relationship between mechanical hyperalgesia assessed by manual TP examination and clinical disease severity. 271 women with CWP were recruited from a clinical setting. Data collection included patient-reported symptoms, health-related quality of life variables, and observation-based measures of functional ability, muscle strength, 6-minute walk, and pressure pain thresholds measured by cuff algometry. TP examination was conducted according to ACR-guidelines. Relationships between disease variables and TP count (TPC) were analyzed with logistic regression in a continuum model, allowing the TPC to depend on the included disease variables and two regression models carried out for a TPC threshold level, varying between 1 and 17. The threshold analyses indicated a TPC threshold at 8, above which a large number of disease variables became consistently significant explanatory factors, whereas none of the disease variables reached a significance level in the continuum model. These results support the premise that the presence of mechanical hyperalgesia influences symptomatology in CWP and that the severity of clinical expression is related to a threshold of TPs, rather than being part of a continuum. 1. Introduction Fibromyalgia is a characterized subgroup of patients presenting with chronic widespread pain (CWP) and widespread mechanical hyperalgesia. These characteristics are enshrined in the 1990-ACR criteria [1] that have been the cornerstone for research studies of the past 2 decades. Contemporary research in subjects fulfilling 1990-ACR criteria has provided persuasive evidence for augmented central pain processing in terms of sensitization of nociceptive neurons and ascending spinal tracts accompanied by dysfunction of descending pain inhibitory pathways [2]. The underlying pain mechanisms in subjects with CWP with fewer than 11 tender points (TP) are less well described [2]. Mechanical hyperalgesia is a clinical manifestation of central sensitization and, although an imperfect measure, the manual TP examination has been considered a primary identifier of pain hypersensitivity [3–6]. In the development of the 1990 ACR classification criteria for fibromyalgia, TPs were found to be the most powerful discriminator between fibromyalgia and control subjects; the best separation occurred at about the 13 TPs for mild tenderness (the subject state that palpation is painful)
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