scholarly journals KARAOKE: Krill oil versus placebo in the treatment of knee osteoarthritis: protocol for a randomised controlled trial

2019 ◽  
Author(s):  
Laura L Laslett ◽  
Benny Antony ◽  
Anita Wluka ◽  
Catherine Hill ◽  
Lyn March ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Disease Progression ◽  
Knee Pain ◽  
Controlled Trial ◽  
Safety Data ◽  
Treatment Compliance ◽  
Krill Oil ◽  
Knee Oa ◽  
Knee Effusion ◽  
Secondary Outcomes

Abstract Background: Knee osteoarthritis (OA) is a common and important cause of pain and disability, but interventions aimed at structural modification have been disappointing. While OA affects the whole joint, synovitis and effusion have been recognised as having a role in the pathogenesis of OA. Krill oil reduces knee pain and systemic inflammation and could be used for targeting inflammatory mechanisms of OA. Methods: 260 patients with clinical knee OA, significant knee pain and effusion-synovitis present on MRI will be recruited in 5 Australian cities (Hobart, Melbourne, Sydney, Adelaide and Perth). They will be randomly allocated to the two arms of the study, receiving 2g/day krill oil or inert placebo daily for 6 months. MRI of the study knee will be performed at screening, and after 6 months. Knee symptoms, function and MRI structural abnormalities will be assessed using validated methods. Safety data will be recorded. Primary outcomes are absolute change in knee pain (assessed by visual analog score) and change in size of knee effusion-synovitis over 24 weeks. Secondary outcomes include improvement in knee pain over 4, 8, 12, 16 and 20 weeks. The primary analyses will be intention-to-treat analyses of primary and secondary outcomes. Per protocol analyses adjusting for missing data and for treatment compliance will be performed as the secondary analyses. Discussion: This study will provide high-quality evidence to assess whether krill oil 2g/day reduces pain and effusion-synovitis size in older adults with clinical knee OA and knee effusion-synovitis. If krill oil is effective and confirmed to be safe, we will provide compelling evidence that krill oil improves pain and function, changes disease trajectory and slows disease progression in OA. Given the lack of approved therapies for slowing disease progression in OA, and moderate cost of krill oil, these findings will be readily translated into clinical practice.

scholarly journals KARAOKE: Krill oil versus placebo in the treatment of knee osteoarthritis: protocol for a randomised controlled trial

2019 ◽  
Author(s):  
Laura L Laslett ◽  
Benny Antony ◽  
Anita Wluka ◽  
Catherine Hill ◽  
Lyn March ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Disease Progression ◽  
Knee Pain ◽  
Controlled Trial ◽  
Safety Data ◽  
Treatment Compliance ◽  
Krill Oil ◽  
Knee Oa ◽  
Knee Effusion ◽  
Secondary Outcomes

Abstract Background: Knee osteoarthritis (OA) is a common and important cause of pain and disability, but interventions aimed at modifying structures visible on imaging have been disappointing. While OA affects the whole joint, synovitis and effusion have been recognised as having a role in the pathogenesis of OA. Krill oil reduces knee pain and systemic inflammation and could be used for targeting inflammatory mechanisms of OA. Methods: 260 patients with clinical knee OA, significant knee pain and effusion-synovitis present on MRI will be recruited in 5 Australian cities (Hobart, Melbourne, Sydney, Adelaide and Perth). They will be randomly allocated to the two arms of the study, receiving 2g/day krill oil or inert placebo daily for 6 months. MRI of the study knee will be performed at screening, and after 6 months. Knee symptoms, function and MRI structural abnormalities will be assessed using validated methods. Safety data will be recorded. Primary outcomes are absolute change in knee pain (assessed by visual analog score) and change in size of knee effusion-synovitis over 24 weeks. Secondary outcomes include improvement in knee pain over 4, 8, 12, 16 and 20 weeks. The primary analyses will be intention-to-treat analyses of primary and secondary outcomes. Per protocol analyses adjusting for missing data and for treatment compliance will be performed as the secondary analyses. Discussion: This study will provide high-quality evidence to assess whether krill oil 2g/day reduces pain and effusion-synovitis size in older adults with clinical knee OA and knee effusion-synovitis. If krill oil is effective and confirmed to be safe, we will provide compelling evidence that krill oil improves pain and function, changes disease trajectory and slows disease progression in OA. Given the lack of approved therapies for slowing disease progression in OA, and moderate cost of krill oil, these findings will be readily translated into clinical practice.

scholarly journals KARAOKE: Krill oil versus placebo in the treatment of knee osteoarthritis: protocol for a randomised controlled trial

2019 ◽  
Author(s):  
Laura L Laslett ◽  
Benny Antony ◽  
Anita Wluka ◽  
Catherine Hill ◽  
Lyn March ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Disease Progression ◽  
Knee Pain ◽  
Controlled Trial ◽  
Safety Data ◽  
Treatment Compliance ◽  
Krill Oil ◽  
Knee Oa ◽  
Knee Effusion ◽  
Secondary Outcomes

Abstract Background : Knee osteoarthritis (OA) is a common and important cause of pain and disability, but interventions aimed at modifying structures visible on imaging have been disappointing. While OA affects the whole joint, synovitis and effusion have been recognised as having a role in the pathogenesis of OA. Krill oil reduces knee pain and systemic inflammation and could be used for targeting inflammatory mechanisms of OA. Methods : 260 patients with clinical knee OA, significant knee pain and effusion-synovitis present on MRI will be recruited in 5 Australian cities (Hobart, Melbourne, Sydney, Adelaide and Perth). They will be randomly allocated to the two arms of the study, receiving 2g/day krill oil or inert placebo daily for 6 months. MRI of the study knee will be performed at screening, and after 6 months. Knee symptoms, function and MRI structural abnormalities will be assessed using validated methods. Safety data will be recorded. Primary outcomes are absolute change in knee pain (assessed by visual analog score) and change in size of knee effusion-synovitis over 24 weeks. Secondary outcomes include improvement in knee pain over 4, 8, 12, 16 and 20 weeks. The primary analyses will be intention-to-treat analyses of primary and secondary outcomes. Per protocol analyses adjusting for missing data and for treatment compliance will be performed as the secondary analyses. Discussion : This study will provide high-quality evidence to assess whether krill oil 2g/day reduces pain and effusion-synovitis size in older adults with clinical knee OA and knee effusion-synovitis. If krill oil is effective and confirmed to be safe, we will provide compelling evidence that krill oil improves pain and function, changes disease trajectory and slows disease progression in OA. Given the lack of approved therapies for slowing disease progression in OA, and moderate cost of krill oil, these findings will be readily translated into clinical practice.

scholarly journals Evolution of pain at 3 months by oral resveratrol in knee osteoarthritis (ARTHROL): protocol for a multicentre randomised double-blind placebo-controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e017652 ◽  
Author(s):  
Christelle Nguyen ◽  
Isabelle Boutron ◽  
Gabriel Baron ◽  
Emmanuel Coudeyre ◽  
Francis Berenbaum ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Knee Pain ◽  
Rating Scale ◽  
Controlled Trial ◽  
Tertiary Care ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Knee Oa ◽  
The Mean ◽  
Anti Inflammatory

IntroductionOsteoarthritis (OA) pathophysiology is driven in part by joint inflammation. Resveratrol has in vitro anti-inflammatory properties. We aim to assess the efficacy of oral resveratrol for knee pain at 3 months in people with knee OA.Methods and analysisWe will conduct a randomised double-blind placebo-controlled trial. Overall, 164 individuals with knee OA fulfilling 1986 American College of Rheumatology criteria will be recruited in three tertiary care centres in France and randomised to receive oral resveratrol, 40 mg (two caplets) two times per day for 1 week, then 20 mg (one caplet) two times per day or a matching placebo for a total of 6 months. Randomisation will be centralised and stratified by centre. The allocation ratio of assignments will be 1:1. The primary outcome will be the mean change from baseline in knee pain on a self-administered 11-point pain Numeric Rating Scale at 3 months. Secondary outcomes will be the mean change in knee pain at 6 months, the function subscore of the Western Ontario and McMaster Universities Arthritis Index score, patient global assessment, proportion of responders according to the Osteoarthritis Research Society International–Outcome Measures in Rheumatology criteria at 3 and 6 months, and self-reported number of intra-articular injections of corticosteroids or hyaluronic acid and consumption of analgesics and non-steroidal anti-inflammatory drugs since the last contact. Other interventions will be allowed and self-reported. Adherence will be monitored by capsule counts and a booklet and adverse events recorded at 3 and 6 months. Statisticians, treating physicians and participants will be blinded to the allocated treatment.Ethics and disseminationThe oral resveratrol in knee osteoarthritis (ARTHROL) trial has been authorised by theAgenceNationale de Sécurité du Médicament et des Produits de Santéand ethics were approved by theComité deProtection des Personnes Île-de-FranceIII. The findings of the study will be published in a peer-reviewed journal and disseminated at conferences. The design of ARTHROL will warrant the translation of its findings into clinical practice.Trial registration numberClinicalTrials.gov identifier:NCT02905799. Pre-results. First received: 14 September 2016. Last updated: 16 September 2016. Status: not yet recruiting.

scholarly journals Effects of a 12-Week Multifaceted Wearable-Based Program for People With Knee Osteoarthritis: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Linda C Li ◽  
Lynne M Feehan ◽  
Hui Xie ◽  
Na Lu ◽  
Christopher D Shaw ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Mean Difference ◽  
Knee Oa ◽  
Counseling Intervention ◽  
Randomized Controlled ◽  
Phone Calls ◽  
Secondary Outcomes

BACKGROUND Current guidelines emphasize an active lifestyle in the management of knee osteoarthritis (OA), but up to 90% of patients with OA are inactive. In a previous study, we demonstrated that an 8-week physiotherapist (PT)-led counseling intervention, with the use of a Fitbit, improved step count and quality of life in patients with knee OA, compared with a control. OBJECTIVE This study aimed to examine the effect of a 12-week, multifaceted wearable-based program on physical activity and patient outcomes in patients with knee OA. METHODS This was a randomized controlled trial with a delay-control design. The immediate group (IG) received group education, a Fitbit, access to FitViz (a Fitbit-compatible app), and 4 biweekly phone calls from a PT over 8 weeks. Participants then continued using Fitbit and FitViz independently up to week 12. The delay group (DG) received a monthly electronic newsletter in weeks 1 to 12 and started the same intervention in week 14. Participants were assessed in weeks 13, 26, and 39. The primary outcome was time spent in daily moderate-to-vigorous physical activity (MVPA; in bouts ≥10 min) measured with a SenseWear Mini. Secondary outcomes included daily steps, time spent in purposeful activity and sedentary behavior, Knee Injury and OA Outcome Score, Patient Health Questionnaire-9, Partners in Health Scale, Theory of Planned Behavior Questionnaire, and Self-Reported Habit Index. RESULTS We enrolled 51 participants (IG: n=26 and DG: n=25). Compared with the IG, the DG accumulated significantly more MVPA time at baseline. The adjusted mean difference in MVPA was 13.1 min per day (95% CI 1.6 to 24.5). A significant effect was also found in the adjusted mean difference in perceived sitting habit at work (0.7; 95% CI 0.2 to 1.2) and during leisure activities (0.7; 95% CI 0.2 to 1.2). No significant effect was found in the remaining secondary outcomes. CONCLUSIONS A 12-week multifaceted program with the use of a wearable device, an app, and PT counseling improved physical activity in people with knee OA. CLINICALTRIAL ClinicalTrials.gov NCT02585323; https://clinicaltrials.gov/ct2/show/NCT02585323

scholarly journals Arthroscopic partial meniscectomy versus placebo surgery for a degenerative meniscus tear: a 2-year follow-up of the randomised controlled trial

2017 ◽  
Vol 77 (2) ◽  
pp. 188-195 ◽  
Author(s):  
Raine Sihvonen ◽  
Mika Paavola ◽  
Antti Malmivaara ◽  
Ari Itälä ◽  
Antti Joukainen ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Knee Pain ◽  
Medial Meniscus ◽  
Controlled Trial ◽  
Partial Meniscectomy ◽  
Meniscus Tear ◽  
Arthroscopic Partial Meniscectomy ◽  
Serious Adverse Events ◽  
Secondary Outcomes

ObjectiveTo assess if arthroscopic partial meniscectomy (APM) is superior to placebo surgery in the treatment of patients with degenerative tear of the medial meniscus.MethodsIn this multicentre, randomised, participant-blinded and outcome assessor-blinded, placebo-surgery controlled trial, 146 adults, aged 35–65 years, with knee symptoms consistent with degenerative medial meniscus tear and no knee osteoarthritis were randomised to APM or placebo surgery. The primary outcome was the between-group difference in the change from baseline in the Western Ontario Meniscal Evaluation Tool (WOMET) and Lysholm knee scores and knee pain after exercise at 24 months after surgery. Secondary outcomes included the frequency of unblinding of the treatment-group allocation, participants' satisfaction, impression of change, return to normal activities, the incidence of serious adverse events and the presence of meniscal symptoms in clinical examination. Two subgroup analyses, assessing the outcome on those with mechanical symptoms and those with unstable meniscus tears, were also carried out.ResultsIn the intention-to-treat analysis, there were no significant between-group differences in the mean changes from baseline to 24 months in WOMET score: 27.3 in the APM group as compared with 31.6 in the placebo-surgery group (between-group difference, −4.3; 95% CI, −11.3 to 2.6); Lysholm knee score: 23.1 and 26.3, respectively (−3.2; −8.9 to 2.4) or knee pain after exercise, 3.5 and 3.9, respectively (−0.4; −1.3 to 0.5). There were no statistically significant differences between the two groups in any of the secondary outcomes or within the analysed subgroups.ConclusionsIn this 2-year follow-up of patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after APM were no better than those after placebo surgery. No evidence could be found to support the prevailing ideas that patients with presence of mechanical symptoms or certain meniscus tear characteristics or those who have failed initial conservative treatment are more likely to benefit from APM.

Does telephone-delivered exercise advice and support by physiotherapists improve pain and/or function in people with knee osteoarthritis? Telecare randomised controlled trial

2019 ◽  
Vol 54 (13) ◽  
pp. 790-797 ◽  
Author(s):  
Rana S Hinman ◽  
Penny K Campbell ◽  
Belinda J Lawford ◽  
Andrew M Briggs ◽  
Janette Gale ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Knee Osteoarthritis ◽  
Physical Function ◽  
Knee Pain ◽  
Rating Scale ◽  
Controlled Trial ◽  
Secondary Outcomes ◽  
Randomised Controlled ◽  
Support Cost

ObjectiveEvaluate a physiotherapist-led telephone-delivered exercise advice and support intervention for people with knee osteoarthritis.MethodsParticipant-blinded, assessor-blinded randomised controlled trial. 175 people were randomly allocated to (1) existing telephone service (≥1 nurse consultation for self-management advice) or (2) exercise advice and support (5–10 consultations with a physiotherapist trained in behaviour change for a personalised strengthening and physical activity programme) plus the existing service. Primary outcomes were overall knee pain (Numerical Rating Scale, range 0–10) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, range 0–68) at 6 months. Secondary outcomes, cost-effectiveness and 12-month follow-up were included.Results165 (94%) and 158 (90%) participants were retained at 6 and 12 months, respectively. At 6 months, exercise advice and support resulted in greater improvement in function (mean difference 4.7 (95% CI 1.0 to 8.4)), but not overall pain (0.7, 0.0 to 1.4). Eight of 14 secondary outcomes favoured exercise advice and support at 6 months, including pain on daily activities, walking pain, pain self-efficacy, global improvements across multiple domains (overall improvement, improved pain, improved function and improved physical activity) and satisfaction. By 12 months, most outcomes were similar between groups. Exercise advice and support cost $A514/participant and did not save other health service resources.ConclusionTelephone-delivered physiotherapist-led exercise advice and support modestly improved physical function but not the co-primary outcome of knee pain at 6 months. Functional benefits were not sustained at 12 months. The clinical significance of this effect is uncertain.Trial registration numberAustralian New Zealand Clinical Trials Registry (#12616000054415).

scholarly journals A Double-Blind, Placebo-Controlled Study of Ultrasound-Guided Pulsed Radiofrequency Treatment of the Saphenous Nerve for Refractory Osteoarthritis-Associated Knee Pain

2021 ◽  
Vol 24 (6) ◽  
pp. E761-E769
Keyword(s):  
Placebo Group ◽  
Knee Pain ◽  
Controlled Trial ◽  
Saphenous Nerve ◽  
Pulsed Radiofrequency ◽  
Ultrasound Guided ◽  
Knee Oa ◽  
Pulsed Radiofrequency Treatment ◽  
The Mean ◽  
Secondary Outcomes

BACKGROUND: While the efficacy of pulsed radiofrequency (PRF) for shoulder pain has been demonstrated, its efficacy on the saphenous nerves for knee osteoarthritis (OA)-associated pain has only been reported in observational studies. OBJECTIVES: The aim of this study was to compare saphenous nerve PRF to placebo for knee OA-associated pain. STUDY DESIGN: Patients, practitioners, and outcome assessor-blinded randomized placebo-controlled trial. SETTING: Pain management clinics at 2 hospitals in Japan. METHODS: Patients were randomly allocated to the PRF (n = 37) or placebo group (n = 33). Patients aged 40-85 years with refractory anteromedial knee pain. PRF in the saphenous nerve under ultrasound guidance. The placebo group underwent the same procedure, but with motor stimulation. The primary endpoint was the average pain intensity measured using the visual analog scale (VAS) at the 12-week post-treatment visit; secondary outcomes included the average VAS at 1 and 4 weeks, and pain intensities at rest, in flexion, at standing, and at walking. Other secondary outcomes were knee pain, symptoms, activities of daily living, knee-related quality of life, mobility, range of motion, and adverse events. RESULTS: In the PRF group, the mean VAS score was 52.41 ± 26.17 at 12 weeks, while in the sham group, the mean VAS score was 63.06 ± 27.12 (P < 0.05). There were no significant differences between the groups in any of the secondary outcomes. LIMITATIONS: Patients with comorbidities were excluded from this study. The follow-up time was limited to 12 weeks. CONCLUSIONS: Ultrasound-guided saphenous nerve PRF proved to be effective for at least 12 weeks in patients with knee OA and showed no adverse events. KEY WORDS: Pulsed radiofrequency treatment, knee osteoarthritis, saphenous nerve, ultrasound-guided, randomized controlled trial, pain, pain management, placebo

scholarly journals Efficacy of Leg Swing Versus Quadriceps Strengthening Exercise Among Patients With Knee Osteoarthritis: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Ruiyang Li ◽  
Pingping Sun ◽  
Yu Zhan ◽  
Xuetao Xie ◽  
Weibing Yan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Surgical Treatment ◽  
Knee Osteoarthritis ◽  
Physical Function ◽  
Knee Pain ◽  
Controlled Trial ◽  
Knee Oa ◽  
Randomized Controlled ◽  
Strengthening Exercise ◽  
Non Surgical Treatment

Abstract Background Knee osteoarthritis (OA) is a leading cause of global disability. According to guidelines, thus far, exercise is the most recommended and important non-surgical treatment for knee OA. However, the best type of exercise for this condition remains unclear. There is evidence showing that traditional Chinese exercises may be more effective. Therefore, the current prospective, two-armed, single-center randomized controlled trial (RCT) aimed to identify an effective physiotherapy for knee OA. Methods/design: In total, 128 patients with painful knee OA will be recruited from the orthopaedic outpatient department of Shanghai Jiao Tong University Affiliated Sixth People’s Hospital. To compare the therapeutic effect of two different home-based exercise programs, the participants will be randomly assigned into the experimental group (leg swing exercise) or the control group (quadriceps strengthening exercise). Each participant in both groups will be required to attend five individual sessions with a physiotherapist who will teach the exercise program and monitor progress. Participants will be instructed to perform the exercises at home every day for 12 weeks. Clinical outcomes will be assessed at baseline and 12 and 24 weeks after starting the intervention. The primary outcomes are average overall knee pain and physical function in daily life. The secondary outcomes include other measures of knee pain, physical function, patient-perceived satisfactory improvement, health-related quality of life, physical activity and performance, muscle strength of the lower limb, and adherence. Discussion This study will provide more evidence on the effects of traditional Chinese exercise on improving physical function and relieving joint pain among patients with knee OA. If proven effective, leg swing exercise can be used as a non-surgical treatment for knee OA in the future. Trial registration: Chinese Clinical Trial Registry reference: ChiCTR2000039005, registered 13/10/2020. http://www.chictr.org.cn/showproj.aspx?proj=62497

scholarly journals Effects of a 12-Week Multifaceted Wearable-Based Program for People With Knee Osteoarthritis: Randomized Controlled Trial

10.2196/19116 ◽  
2020 ◽  
Vol 8 (7) ◽  
pp. e19116 ◽  
Author(s):  
Linda C Li ◽  
Lynne M Feehan ◽  
Hui Xie ◽  
Na Lu ◽  
Christopher D Shaw ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Mean Difference ◽  
Knee Oa ◽  
Counseling Intervention ◽  
Randomized Controlled ◽  
Phone Calls ◽  
Secondary Outcomes

Background Current guidelines emphasize an active lifestyle in the management of knee osteoarthritis (OA), but up to 90% of patients with OA are inactive. In a previous study, we demonstrated that an 8-week physiotherapist (PT)-led counseling intervention, with the use of a Fitbit, improved step count and quality of life in patients with knee OA, compared with a control. Objective This study aimed to examine the effect of a 12-week, multifaceted wearable-based program on physical activity and patient outcomes in patients with knee OA. Methods This was a randomized controlled trial with a delay-control design. The immediate group (IG) received group education, a Fitbit, access to FitViz (a Fitbit-compatible app), and 4 biweekly phone calls from a PT over 8 weeks. Participants then continued using Fitbit and FitViz independently up to week 12. The delay group (DG) received a monthly electronic newsletter in weeks 1 to 12 and started the same intervention in week 14. Participants were assessed in weeks 13, 26, and 39. The primary outcome was time spent in daily moderate-to-vigorous physical activity (MVPA; in bouts ≥10 min) measured with a SenseWear Mini. Secondary outcomes included daily steps, time spent in purposeful activity and sedentary behavior, Knee Injury and OA Outcome Score, Patient Health Questionnaire-9, Partners in Health Scale, Theory of Planned Behavior Questionnaire, and Self-Reported Habit Index. Results We enrolled 51 participants (IG: n=26 and DG: n=25). Compared with the IG, the DG accumulated significantly more MVPA time at baseline. The adjusted mean difference in MVPA was 13.1 min per day (95% CI 1.6 to 24.5). A significant effect was also found in the adjusted mean difference in perceived sitting habit at work (0.7; 95% CI 0.2 to 1.2) and during leisure activities (0.7; 95% CI 0.2 to 1.2). No significant effect was found in the remaining secondary outcomes. Conclusions A 12-week multifaceted program with the use of a wearable device, an app, and PT counseling improved physical activity in people with knee OA. Trial Registration ClinicalTrials.gov NCT02585323; https://clinicaltrials.gov/ct2/show/NCT02585323

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