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

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/DESIGN:We will recruit 260 patients with clinical knee OA, significant knee pain and effusion-synovitis present on MRI in five Australian cities (Hobart, Melbourne, Sydney, Adelaide and Perth). These patients will be randomly allocated to the two arms of the study, receiving 2?g/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 2?g/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. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry, ACTRN12616000726459. Registered on 02 June 2016. Universal Trial Number (UTN) U1111-1181-7087.

SUBMITTER: Laslett LL

PROVIDER: S-EPMC6961372 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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

Laslett L L LL Antony B B Wluka A E AE Hill C C March L L Keen H I HI Otahal P P Cicuttini F M FM Jones G G

Trials 20200114 1

<h4>Background</h4>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.<h4>Methods/design</h4>We will recruit 260 patients with clinical knee ...[more]

PMID: 31937352

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Project description:IntroductionKnee osteoarthritis is a common form of arthritis in elderly patients that is characterised by pain and functional limitation. Moxibustion has been employed to relieve chronic pain as an alternative therapy for knee osteoarthritis. However, the evidence of its efficacy is equivocal due to the low methodological quality in most clinical studies. Therefore, we are performing a double-blinded, double-placebo, randomised controlled trial to evaluate the efficacy of moxibustion in participants with knee osteoarthritis.Methods and analysisThis is a multicentre, double-blinded, double-placebo, randomised controlled clinical trial. 144 eligible participants with knee osteoarthritis will be randomly assigned to two different groups in a 1:1 ratio. Participants in the moxibustion group will undergo active moxibustion plus placebo gel, whereas participants in the control group will receive diclofenac sodium gel plus placebo moxibustion. Each participant will receive 12 sessions of active/placebo moxibustion at three acupoints (ST35, ST36 and EX-LE4) as well as 2 months of follow-up. Diclofenac sodium gel or placebo gel at a dose of 4 g per knee will be applied three times per day for 4 weeks. The primary outcome measure will be the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score change at the end of the intervention period from baseline. The secondary outcome measures include changes of other subscales (pain, stiffness and function) of WOMAC, visual analogue scale and patient globalassessment. The safety of moxibustion and diclofenac sodium gel will be assessed at every visit.Ethics and disseminationThis trial has been approved by the Sichuan Regional Ethics Review Committee (permission number: 2015KL-014). The results of this study are expected to provide clinical evidence on the efficacy of moxibustion for pain relief and physical function improvement in patients with knee osteoarthritis. The findings will be submitted for publication in peer-reviewed medical journals and presented at relevant academic conferences.Trial registration numberNCT02769572.

Project description:IntroductionChronic inflammation plays a key role in knee osteoarthritis pathophysiology and increases risk of comorbidities, yet most interventions do not typically target inflammation. Our study will investigate if an anti-inflammatory dietary programme is superior to a standard care low-fat dietary programme for improving knee pain, function and quality-of-life in people with knee osteoarthritis.Methods and analysisThe eFEct of an Anti-inflammatory diet for knee oSTeoarthritis study is a parallel-group, assessor-blinded, superiority randomised controlled trial. Following baseline assessment, 144 participants aged 45-85 years with symptomatic knee osteoarthritis will be randomly allocated to one of two treatment groups (1:1 ratio). Participants randomised to the anti-inflammatory dietary programme will receive six dietary consultations over 12 weeks (two in-person and four phone/videoconference) and additional educational and behaviour change resources. The consultations and resources emphasise nutrient-dense minimally processed anti-inflammatory foods and discourage proinflammatory processed foods. Participants randomised to the standard care low-fat dietary programme will receive three dietary consultations over 12 weeks (two in-person and one phone/videoconference) consisting of healthy eating advice and education based on the Australian Dietary Guidelines, reflecting usual care in Australia. Adherence will be assessed with 3-day food diaries. Outcomes are assessed at 12 weeks and 6 months. The primary outcome will be change from baseline to 12 weeks in the mean score on four Knee injury and Osteoarthritis Outcome Score (KOOS4) subscales: knee pain, symptoms, function in daily activities and knee-related quality of life. Secondary outcomes include change in individual KOOS subscale scores, patient-perceived improvement, health-related quality of life, body mass and composition using dual-energy X-ray absorptiometry, inflammatory (high-sensitivity C reactive protein, interleukins, tumour necrosis factor-α) and metabolic blood biomarkers (glucose, glycated haemoglobin (HbA1c), insulin, liver function, lipids), lower-limb function and physical activity.Ethics and disseminationThe study has received ethics approval from La Trobe University Human Ethics Committee. Results will be presented in peer-reviewed journals and at international conferences.Trial registration numberACTRN12622000440729.

Project description:INTRODUCTION:There is a lack of curative medical treatment for patients with knee osteoarthritis (KOA). Acupuncture represents an important alternative therapy. According to the theory of traditional Chinese medicine and preliminary clinical evidence, the patients' acupoints and tender points may become sensitised when the body suffers from a disease state; stimulation of such sensitive points could lead to a disease improvement. It is thus hypothesised that acupuncture at highly sensitised points on patients with KOA would achieve better treatment outcomes than acupuncture at low/non-sensitised points. Previously, we conducted a pilot trial to prove the feasibility of further investigation. METHODS AND ANALYSIS:A three-arm, parallel, multicentre randomised controlled trial of 666 patients will be conducted at four hospitals of China. Eligible patients with KOA who consent to participate will be randomly assigned to a high-sensitisation group (patients receive acupuncture treatment at high-sensitive points), a low/non-sensitisation group (patients receive acupuncture treatment at low/non-sensitive points) or a waiting-list group (patients receive standard acupuncture treatment after the study is concluded) via a central randomisation system using 1:1:1 ratio. The primary outcome is the change of Western Ontario and McMaster Universities Osteoarthritis Index total score from baseline to 16 weeks. Outcome assessors and data analysts will be blinded and participants will be asked not to reveal their allocation to assessors. The outcome analyses will be performed both on the intention-to-treat and per-protocol population. The primary analyses will test if acupuncture at highly sensitised points would achieve statistically better treatment outcomes than acupuncture at low/non-sensitised points and no acupuncture (ie, waiting list), respectively. A small number of prespecified subgroup analyses will be conducted. ETHICS AND DISSEMINATION:Ethics approval has been granted by the Bioethics Subcommittee of West China Hospital, Sichuan University: 2017 (Number 228). Results will be expected to be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT03299439.

Project description:BACKGROUND:It is not yet clear which of the various electrophysical modalities used in clinical practice is the one that contributes most positively when added to an exercise program in patients with knee osteoarthritis (OA). The aim of the present study was to analyze the clinical effects of the inclusion of interferential current therapy (ICT), shortwave diathermy therapy (SDT) and photobiomodulation (PHOTO) into an exercise program in patients with knee OA. METHODS:This prospective, five-arm, randomised, placebo-controlled trial was carried out with blinded participants and examiners. We recruited 100 volunteers aged 40 to 80?years with knee OA. Participants were allocated into five groups: exercise, exercise + placebo, exercise + ICT, exercise + SDT, and exercise + PHOTO. The outcome measures included Western Ontario and McMaster Universities (WOMAC), numerical rating pain scale (NRPS), pressure pain threshold (PPT), self-perceived fatigue and sit-to-stand test (STST), which were evaluated before and after 24 treatment sessions at a frequency of three sessions per week. RESULTS:In all groups, there was a significant improvement (p?<?0.05) in all variables over time, except pressure pain threshold. We observed significant differences (p?<?0.05) between the groups for WOMAC function (exercise vs. exercise + placebo, mean difference [MD]?=?5.55, 95% confidence interval [CI]?=?3.63 to 7.46; exercise vs. exercise + ICT, MD?=?3.40, 95% CI?=?1.46 to 5.33; exercise vs. exercise + SDT, MD?=?4.75, 95% CI?=?1.85 to 7.64; exercise vs. exercise + PHOTO, MD?=?5.45, 95% CI?=?3.12 to 7.77) and WOMAC pain, with better scores achieved by the exercise group. However, these differences were not clinically relevant when considering the minimum clinically important difference. CONCLUSION:The addition of ICT, SDT or PHOTO into an exercise program for individuals with knee OA is not superior to exercise performed in isolation in terms of clinical benefit. clinicaltrials.gov: NCT02636764, registered on March 29, 2014.

Project description:INTRODUCTION:Osteoarthritis (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 ANALYSIS:We 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 DISSEMINATION:The oral resveratrol in knee osteoarthritis (ARTHROL) trial has been authorised by the AgenceNationale de Sécurité du Médicament et des Produits de Santé and ethics were approved by the Comité deProtection des Personnes Île-de-France III. 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 NUMBER:ClinicalTrials.gov identifier: NCT02905799. Pre-results. First received: 14 September 2016. Last updated: 16 September 2016. Status: not yet recruiting.

Dataset Information

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

Publications

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

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