No added value of duloxetine for patients with chronic pain due to hip or knee osteoarthritis: a cluster randomised trial

IntroductionOsteoarthritis (OA) is a highly prevalent painful condition of the musculoskeletal system. The effectiveness of current analgesic options has proven to be limited and improved analgesic treatment is needed. Several randomised placebo-controlled trials have now demonstrated the efficacy of duloxetine, an antidepressant with a centrally acting effect, in the treatment of OA pain. The aim of the current study is to investigate if duloxetine is effective and cost-effective as a third-choice analgesic added to usual care for treating chronic pain compared with usual care alone in general practice.Methods and analysisA pragmatic open, cluster randomised trial is conducted. Patients with pain due to hip or knee OA on most days of the past 3 months with insufficient benefit of non-steroidal anti-inflammatory drugs or contraindications or intolerable side effects are included. General practices are randomised to either (1) duloxetine and usual care or (2) usual care only. Primary outcome is pain at 3 months measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. Secondary outcomes at 3 months and 1 year are pain (WOMAC, at 1 year), function (WOMAC), adverse reactions, quality of life and modification of the response to treatment by the presence of centrally sensitised pain (modified PainDETECT). At 1 year, medical and productivity costs will be assessed. Analyses will be performed following the intention-to-treat principle taking the cluster design into account.Ethics and disseminationThe study is approved by the local Medical Ethics Committee (2015–293). Results will be published in a scientific peer-reviewed journal and will be communicated at conferences.Trial registration numberDutch Trial Registry(ntr4798); Pre-results.

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Can an intervention on clinical inertia have an impact on the perception of pain, functionality and quality of life in patients with hip and/or knee osteoarthritis? Results from a cluster randomised trial

Atención Primaria ◽

10.1016/j.aprim.2011.01.007 ◽

2012 ◽

Vol 44 (2) ◽

pp. 65-72 ◽

Cited By ~ 5

Author(s):

Alejandro Tejedor Varillas ◽

Fernando León Vázquez ◽

David Lora Pablos ◽

Álvaro Pérez Martín ◽

Francisco Vargas Negrín ◽

...

Keyword(s):

Quality Of Life ◽

Knee Osteoarthritis ◽

Randomised Trial ◽

Clinical Inertia ◽

Cluster Randomised Trial ◽

Cluster Randomised

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The added value of frequent physical activity group sessions in a combined lifestyle intervention: A cluster randomised trial in primary care

Preventive Medicine Reports ◽

10.1016/j.pmedr.2020.101204 ◽

2020 ◽

Vol 20 ◽

pp. 101204

Author(s):

Brenda A.J. Berendsen ◽

Marike R.C. Hendriks ◽

Geert M. Rutten ◽

Stef P.J. Kremers ◽

Hans H.C.M. Savelberg ◽

...

Keyword(s):

Physical Activity ◽

Primary Care ◽

Lifestyle Intervention ◽

Randomised Trial ◽

Added Value ◽

Cluster Randomised Trial ◽

Activity Group ◽

Cluster Randomised ◽

Group Sessions ◽

Physical Activity Group

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Results of the German part of OptiBIRTH (ISRCTN10612254): A cluster randomised trial to increase vaginal birth after one previous caesarean section

10.1055/s-0037-1607690 ◽

2017 ◽

Author(s):

MM Gross ◽

S Grylka-Baeschlin ◽

F Bahlmann ◽

M Fleisch ◽

P Hillemanns ◽

...

Keyword(s):

Caesarean Section ◽

Randomised Trial ◽

Vaginal Birth ◽

Cluster Randomised Trial ◽

Previous Caesarean Section ◽

Cluster Randomised ◽

German Part

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The Acceptability and Utility of Accelerometers to Estimate Physical Activity and Sleep Characteristics in People with Advanced Dementia: A Feasibility Cluster Randomised Trial (NAMASTE)

10.26226/morressier.5c76c8bbe2ea5a72376125fb ◽

2019 ◽

Author(s):

Katherine Froggatt

Keyword(s):

Physical Activity ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Advanced Dementia ◽

Cluster Randomised

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Refining the Namaste Care Intervention for People with Advanced Dementia Prior to a Feasibility Cluster Randomised Trial: A Novel Four Stage Process

10.26226/morressier.5c76c8b8e2ea5a72376123de ◽

2019 ◽

Author(s):

Catherine Walshe

Keyword(s):

Randomised Trial ◽

Cluster Randomised Trial ◽

Advanced Dementia ◽

Cluster Randomised ◽

Care Intervention ◽

Stage Process

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Faculty Opinions recommendation of Implementation of the Canadian C-Spine Rule: prospective 12 centre cluster randomised trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.3268956.2955055 ◽

2010 ◽

Author(s):

Carlos Bagley

Keyword(s):

Randomised Trial ◽

Cluster Randomised Trial ◽

Cluster Randomised

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Faculty Opinions recommendation of Xpert MTB/RIF versus sputum microscopy as the initial diagnostic test for tuberculosis: a cluster-randomised trial embedded in South African roll-out of Xpert MTB/RIF.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.725942556.793512079 ◽

2015 ◽

Author(s):

Anthony Harries

Keyword(s):

South African ◽

Diagnostic Test ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Cluster Randomised ◽

Sputum Microscopy ◽

Roll Out

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The RATIONS (Reducing Activation of Tuberculosis by Improvement of Nutritional Status) study: a cluster randomised trial of nutritional support (food rations) to reduce TB incidence in household contacts of patients with microbiologically confirmed pulmonary tuberculosis in communities with a high prevalence of undernutrition, Jharkhand, India

BMJ Open ◽

10.1136/bmjopen-2020-047210 ◽

2021 ◽

Vol 11 (5) ◽

pp. e047210

Author(s):

Anurag Bhargava ◽

Madhavi Bhargava ◽

Banurekha Velayutham ◽

Kannan Thiruvengadam ◽

Basilea Watson ◽

...

Keyword(s):

Risk Factor ◽

Nutritional Status ◽

G Proteins ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Household Contacts ◽

Cluster Randomised ◽

High Prevalence ◽

Secondary Outcomes ◽

The Impact

IntroductionIndia has the largest burden of cases and deaths related to tuberculosis (TB). Undernutrition is the leading risk factor accounting for TB incidence, while severe undernutrition is a common risk factor for mortality in patients with TB in India. The impact of nutritional supplementation on TB incidence is unknown, while few underpowered studies have assessed its impact on TB mortality. We designed an open-label, field-based cluster randomised trial to assess the impact of nutritional supplementation (with food rations) on TB incidence in a group at higher risk of TB infection and disease, viz household contacts (HHC) of patients with microbiologically confirmed pulmonary TB (PTB) in Jharkhand, a state with a high prevalence of undernutrition.Methods and analysisWe shall enrol 2800 adult patients with PTB of the national TB programme, across 28 treatment units in 4 districts, and their approximately 11 200 eligible contacts. The sample size has 80% power to detect the primary outcome of 50% reduction in incidence of active TB in HHC over 2 years of follow-up. Patients and HHC in both the arms will undergo nutritional assessment and counselling. Patients will receive monthly food rations (supplying 1200 kcal and 52 g proteins/day) and multivitamins along with antitubercular treatment. The HHC in the intervention arm will receive food rations (supplying 750 kcal and 23 g proteins/day) and multivitamins while HHC in control arm will be on usual diet. The secondary outcomes in HHC will include effects on nutritional status, non-TB infections. Secondary outcomes in patients are effects on TB mortality, adherence, adverse effects, nutritional and performance status. Substudies will examine micronutrient status and effects on dietary intake, body composition, muscle strength and immune function.Ethics and disseminationThe institutional ethics committee of ICMR-NIRT, Chennai, approved the study (289/NIRT-IEC/2018). The results will be disseminated in publications and presentations.Trial registration numberClinical Trial Registry of India: CTRI/2019/08/020490.

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