Pain relief for osteoarthritis through combined treatment (PROACT): Protocol for a randomized controlled trial of mindfulness meditation combined with transcranial direct current stimulation in non-Hispanic black and white adults with knee osteoarthritis.

Abstract:

:Knee osteoarthritis (OA) is a leading cause of late life pain and disability, and non-Hispanic black (NHB) adults experience greater OA-related pain and disability than non-Hispanic whites (NHWs). Recent evidence implicates psychosocial stress, cognitive-attentional processes, and altered central pain processing as contributors to greater OA-related pain and disability among NHBs. To address these ethnic/race disparities, this clinical trial will test whether a mindfulness intervention (Breathing and Attention Training, BAT) combined with transcranial direct current stimulation (tDCS) will enhance pain modulatory balance and pain-related brain function, reduce clinical pain, and attenuate ethnic differences therein, among NHBs and NHWs with knee OA. Participants will complete assessments of clinical pain, function, psychosocial measures, and quantitative sensory testing (QST), including mechanical temporal summation and conditioned pain modulation. Neuroimaging will be performed to examine pain-related brain structure and function. Then, participants will be randomized to one of four groups created by crossing two BAT conditions (Real vs. Sham) with two tDCS conditions (Real vs. Sham). Participants will then undergo five treatment sessions during which the assigned BAT and tDCS interventions will be delivered concurrently for 20 min over one week. After the fifth intervention session, participants will undergo assessments of clinical pain and function, QST and neuroimaging identical to the pretreatment measures, and monthly follow-up assessments of pain will be conducted for three months. This will be the first study to determine whether mindfulness and tDCS treatments will show additive or synergistic effects when combined, and whether treatment effects differ across ethnic/race groups.

journal_name

Contemp Clin Trials

authors

Fillingim RB,Woods AJ,Ahn H,Wu SS,Redden DT,Lai S,Deshpande H,Deutsch G,Sibille KT,Staud R,Zeidan F,Goodin BR

doi

10.1016/j.cct.2020.106159

subject

Has Abstract

pub_date

2020-11-01 00:00:00

pages

106159

eissn

1551-7144

issn

1559-2030

pii

S1551-7144(20)30237-8

journal_volume

98

pub_type

杂志文章
  • Improving depression treatment for women: integrating a collaborative care depression intervention into OB-GYN care.

    abstract:BACKGROUND:Women have higher rates of depression and often experience depression symptoms during critical reproductive periods, including adolescence, pregnancy, postpartum, and menopause. Collaborative care intervention models for mood disorders in patients receiving care in an OB-GYN clinic setting have not been eval...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1016/j.cct.2013.08.001

    authors: LaRocco-Cockburn A,Reed SD,Melville J,Croicu C,Russo JE,Inspektor M,Edmondson E,Katon W

    更新日期:2013-11-01 00:00:00

  • Recruitment issues when primary care population clusters are used in randomised controlled clinical trials: climbing mountains or pushing boulders uphill?

    abstract::Cluster randomised controlled trials for health promotion, education, public health or organisational change interventions are becoming increasingly common to inform evidence-based policy. However, there is little published methodological evidence on recruitment strategies for primary care population clusters. In this...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2006.08.004

    authors: Hoddinott P,Britten J,Harrild K,Godden DJ

    更新日期:2007-05-01 00:00:00

  • The Mexican-American Trial of Community Health workers (MATCH): design and baseline characteristics of a randomized controlled trial testing a culturally tailored community diabetes self-management intervention.

    abstract:OBJECTIVES:Community Health Workers (CHWs) have been recommended to reduce diabetes disparities, but few robust trials of this approach have been conducted. Limitations of prior studies include: unspecified a priori outcomes; lack of blinded outcome assessments; high participant attrition rates; and lack of attention t...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2011.10.013

    authors: Rothschild SK,Martin MA,Swider SM,Lynas CT,Avery EF,Janssen I,Powell LH

    更新日期:2012-03-01 00:00:00

  • The safety of tai chi: A meta-analysis of adverse events in randomized controlled trials.

    abstract:OBJECTIVES:To review current publications to examine safety of tai chi (TC). DESIGN:Cochrane Library, EBSCO host and MEDLINE/PubMed were searched for randomized controlled trials (RCTs) including TC as the core intervention and reporting adverse events (AEs). Data were extracted considering active vs. inactive control...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,meta分析

    doi:10.1016/j.cct.2019.06.004

    authors: Cui H,Wang Q,Pedersen M,Wang Q,Lv S,James D,Larkey L

    更新日期:2019-07-01 00:00:00

  • Time-dependent effect of non-Hodgkin's lymphoma grade on disease-free survival of relapsed/refractory patients treated with high-dose chemotherapy plus autotransplantation.

    abstract::Evaluation of time to event outcomes usually is examined by the Kaplan-Meier method and Cox proportional hazards models. We developed a modified statistical model based on histologic grade and other variables to describe the time-dependent outcome for autologous stem cell transplant (autotransplant) performed for non-...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2007.07.005

    authors: Fu P,van Heeckeren WJ,Wadhwa PD,Bajor DJ,Creger RJ,Xu Z,Cooper BW,Laughlin MJ,Gerson SL,Koç ON,Lazarus HM

    更新日期:2008-03-01 00:00:00

  • Study to promote innovation in rural integrated telepsychiatry (SPIRIT): Rationale and design of a randomized comparative effectiveness trial of managing complex psychiatric disorders in rural primary care clinics.

    abstract:OBJECTIVE:Managing complex psychiatric disorders like PTSD and bipolar disorder is challenging in Federally Qualified Health Centers (FQHCs) delivering care to U.S residents living in underserved rural areas. This protocol paper describes SPIRIT, a pragmatic comparative effectiveness trial designed to compare two appro...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2019.105873

    authors: Fortney JC,Heagerty PJ,Bauer AM,Cerimele JM,Kaysen D,Pfeiffer PN,Zielinski MJ,Pyne JM,Bowen D,Russo J,Ferro L,Moore D,Nolan JP,Fee FC,Heral T,Freyholtz-London J,McDonald B,Mullins J,Hafer E,Solberg L,Unützer J

    更新日期:2020-03-01 00:00:00

  • The Lifestyle Intervention for the Treatment of Diabetes study (LIFT Diabetes): Design and baseline characteristics for a randomized translational trial to improve control of cardiovascular disease risk factors.

    abstract::The prevalence of type 2 diabetes continues to increase in minority and underserved patients, who are also more likely to have poorer control of diabetes and related risk factors for complications. Although the Look AHEAD trial has demonstrated improved risk factor control among overweight or obese diabetes patients w...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2016.12.005

    authors: Katula JA,Kirk JK,Pedley CF,Savoca MR,Effoe VS,Bell RA,Bertoni AG,LIFT Diabetes Team.

    更新日期:2017-02-01 00:00:00

  • An RCT of the effect of motivational interviewing on medication adherence in hypertensive African Americans: rationale and design.

    abstract:BACKGROUND:Hypertension disproportionately affects African Americans compared to whites, and it is the single most common explanation for the disparity in mortality between African Americans and whites. Adherence with antihypertensive medications can help reduce risk of negative hypertension-related outcomes. Motivatio...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2006.04.002

    authors: Ogedegbe G,Schoenthaler A,Richardson T,Lewis L,Belue R,Espinosa E,Spencer J,Allegrante JP,Charlson ME

    更新日期:2007-02-01 00:00:00

  • Evaluation of the ability of clinical research participants to comprehend informed consent form.

    abstract:BACKGROUND:The comprehension of informed consent is an integral part of clinical trials. Though India is rapidly becoming a hub of clinical trials very few studies have dealt with the issue of comprehension of informed consent by the patients participating in these trials. METHODS:Patients who were invited to particip...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,多中心研究

    doi:10.1016/j.cct.2009.03.005

    authors: Bhansali S,Shafiq N,Malhotra S,Pandhi P,Singh I,Venkateshan SP,Siddhu S,Sharma YP,Talwar KK

    更新日期:2009-09-01 00:00:00

  • Design of a nurse-run, telephone-based intervention to improve lipids in diabetics.

    abstract::This randomized, controlled trial tested the effectiveness of a nurse-run, telephone-based intervention to improve lipid control in patients with diabetes. Our patient population is predominantly low-income and Latino. Using our diabetes registry, we randomly assigned 381 patients to continue with their usual care and...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2008.05.011

    authors: Fischer H,Mackenzie T,McCullen K,Everhart R,Estacio RO

    更新日期:2008-09-01 00:00:00

  • Vitamin C to Decrease the Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP): Rationale, design, and methods of a randomized, controlled trial of vitamin C supplementation in pregnancy for the primary prevention of effects of in utero tobacco

    abstract::Despite strong anti-smoking efforts, at least 12% of American women cannot quit smoking when pregnant resulting in >450,000 smoke-exposed infants born yearly. Smoking during pregnancy is the largest preventable cause of childhood respiratory illness including wheezing and asthma. Recent studies have shown a protective...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2017.05.008

    authors: McEvoy CT,Milner KF,Scherman AJ,Schilling DG,Tiller CJ,Vuylsteke B,Shorey-Kendrick LE,Spindel ER,Schuff R,Mitchell J,Peters D,Metz J,Haas D,Jackson K,Tepper RS,Morris CD

    更新日期:2017-07-01 00:00:00

  • Integrating palliative care into self-management of breast cancer: Protocol for a pilot randomized controlled trial.

    abstract:BACKGROUND:Despite evidence that palliative care increases quality and length of life, many patients and families remain uninformed about its nature and benefits. The purpose of this study is to test a psycho-educational intervention, Managing Cancer Care: A Personal Guide (MCC), intended to improve breast cancer patie...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2016.04.009

    authors: Schulman-Green D,Linsky S,Jeon S,Kapo J,Blatt L,Chagpar A

    更新日期:2016-05-01 00:00:00

  • Integration of patient-reported outcomes in multiregional confirmatory clinical trials.

    abstract:INTRODUCTION:The increasing complexities of conducting multiregional trials and an evolving regulatory environment contribute to unprecedented new challenges for use of patient-reported outcome measures (PROMs)(1) within clinical trials. This paper presents these challenges and potential solutions. METHODS:Real-world ...

    journal_title:Contemporary clinical trials

    pub_type: 临床试验,杂志文章

    doi:10.1016/j.cct.2013.02.006

    authors: Gnanasakthy A,DeMuro C,Boulton C

    更新日期:2013-05-01 00:00:00

  • Rationale and design of the STAR randomized controlled trial to accelerate adoption of childhood obesity comparative effectiveness research.

    abstract:BACKGROUND:Comparative effectiveness research (CER) evidence on childhood obesity provides the basis for effective screening and management strategies in pediatric primary care. The uses of health information technology including decision support tools in the electronic health records (EHRs), as well as remote and mobi...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1016/j.cct.2012.10.005

    authors: Taveras EM,Marshall R,Horan CM,Gillman MW,Hacker K,Kleinman KP,Koziol R,Price S,Simon SR

    更新日期:2013-01-01 00:00:00

  • Informatics tools to improve clinical research study implementation.

    abstract:BACKGROUND:There are numerous potential sources of problems when performing complex clinical research trials. These issues are compounded when studies are multi-site and multiple personnel from different sites are responsible for varying actions from case report form design to primary data collection and data entry. M...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2005.11.013

    authors: Brandt CA,Argraves S,Money R,Ananth G,Trocky NM,Nadkarni PM

    更新日期:2006-04-01 00:00:00

  • Design of the DREPAGREFFE trial: A prospective controlled multicenter study evaluating the benefit of genoidentical hematopoietic stem cell transplantation over chronic transfusion in sickle cell anemia children detected to be at risk of stroke by transcr

    abstract:BACKGROUND:Children with sickle cell anemia (SCA) have an 11% risk of stroke by the age of 18. Chronic transfusion applied in patients detected to be at risk by transcranial Doppler allows a significant reduction of stroke risk. However, chronic transfusion exposes to several adverse events, including alloimmunization ...

    journal_title:Contemporary clinical trials

    pub_type: 临床试验,杂志文章,多中心研究

    doi:10.1016/j.cct.2017.08.008

    authors: Chevret S,Verlhac S,Ducros-Miralles E,Dalle JH,de Latour RP,de Montalembert M,Benkerrou M,Pondarré C,Thuret I,Guitton C,Lesprit E,Etienne-Julan M,Elana G,Vannier JP,Lutz P,Neven B,Galambrun C,Paillard C,Runel C,Jube

    更新日期:2017-11-01 00:00:00

  • Concordance of Medicaid and pharmacy record data in inner-city children with asthma.

    abstract:BACKGROUND:Management of asthma involves adherence to medication regimens. Assessing adherence is difficult for health care providers and researchers. Self-reported medication use is subjective, so objective methods of data collection for medication use are frequently used in asthma research. The aim of this project is...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2007.05.002

    authors: Mudd KE,Bollinger ME,Hsu VD,Manning A,Tsoukleris MG,Butz AM

    更新日期:2008-01-01 00:00:00

  • Reducing breast cancer recurrence with weight loss, a vanguard trial: the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial.

    abstract::Breast cancer is the most common invasive cancer among women in developed countries. Obesity is a major risk factor for breast cancer recurrence and mortality in both pre- and postmenopausal women. Co-morbid medical conditions are common among breast cancer survivors. The Exercise and Nutrition to Enhance Recovery and...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2012.12.003

    authors: Rock CL,Byers TE,Colditz GA,Demark-Wahnefried W,Ganz PA,Wolin KY,Elias A,Krontiras H,Liu J,Naughton M,Pakiz B,Parker BA,Sedjo RL,Wyatt H,Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial Group.

    更新日期:2013-03-01 00:00:00

  • Minority participation in a school-based randomized clinical trial of tooth decay prevention in the United States.

    abstract:PURPOSE:To describe the strategies-based on the social triad concept of a partnership of researchers, school personnel and community-employed to recruit low-income, minority parent/caregivers of kindergarten children into a school-based tooth decay prevention trial in the United States. METHODS:The study site was an u...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1016/j.cct.2011.09.012

    authors: Nelson S,Milgrom P

    更新日期:2012-01-01 00:00:00

  • A hybrid approach of handling missing data under different missing data mechanisms: VISIBLE 1 and VARSITY trials for ulcerative colitis.

    abstract::Missing data is common in clinical trials. Depending on the volume and nature of missing data, it may reduce statistical power for detecting treatment difference, introduce potential bias and invalidate conclusions. Non-responder imputation (NRI), where patients with missing information to determine endpoint status ar...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2020.106226

    authors: Chen J,Hunter S,Kisfalvi K,Lirio RA

    更新日期:2020-11-22 00:00:00

  • A sequential multiple assignment randomized trial (SMART) protocol for empirically developing an adaptive preventive intervention for college student drinking reduction.

    abstract::College student alcohol use and associated negative consequences are clear public health problems with consequences including damage to self, others, and institutions. This paper describes the protocol of a research study designed to answer a number of important questions in the development of an adaptive preventive i...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2020.106089

    authors: Patrick ME,Boatman JA,Morrell N,Wagner AC,Lyden GR,Nahum-Shani I,King CA,Bonar EE,Lee CM,Larimer ME,Vock DM,Almirall D

    更新日期:2020-09-01 00:00:00

  • A randomized controlled trial of the efficacy and cost-effectiveness of a brief intensified cognitive behavioral therapy and/or pharmacotherapy for mood and anxiety disorders: design and methods.

    abstract:BACKGROUND:Anxiety and mood disorders involve a high disease burden and are associated with high economic costs. A stepped-care approach intervention and abbreviated diagnostic method are assumed to increase effectiveness and efficiency of the mental healthcare and are expected to reduce economic costs. METHODS:Presen...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2012.05.002

    authors: Meuldijk D,Carlier IV,van Vliet IM,van den Akker-Marle ME,Zitman FG

    更新日期:2012-09-01 00:00:00

  • Growing Right Onto Wellness (GROW): a family-centered, community-based obesity prevention randomized controlled trial for preschool child-parent pairs.

    abstract::Growing Right Onto Wellness (GROW) is a randomized controlled trial that tests the efficacy of a family-centered, community-based, behavioral intervention to prevent childhood obesity among preschool-aged children. Focusing on parent-child pairs, GROW utilizes a multi-level framework, which accounts for macro (i.e., b...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2013.08.013

    authors: Po'e EK,Heerman WJ,Mistry RS,Barkin SL

    更新日期:2013-11-01 00:00:00

  • Healthy Living Partnerships to Prevent Diabetes (HELP PD): design and methods.

    abstract::Although the Diabetes Prevention Program (DPP) developed a lifestyle weight loss intervention that has been demonstrated to prevent type 2 diabetes in high-risk individuals, it has yet to be widely adopted at the community level. The Healthy Living Partnership to Prevent Diabetes study (HELP PD) was designed to transl...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2009.09.002

    authors: Katula JA,Vitolins MZ,Rosenberger EL,Blackwell C,Espeland MA,Lawlor MS,Rejeski WJ,Goff DC

    更新日期:2010-01-01 00:00:00

  • Statistical evaluation of HIV vaccines in early clinical trials.

    abstract::The HIV pandemic is a pressing threat to global public health; HIV vaccine development is critical. Clinical evaluation of HIV vaccine candidates differs from the standard therapeutics trial framework primarily due to the fact that healthy individuals are studied. We present an early stage evaluation program developed...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2005.11.008

    authors: Moodie Z,Rossini AJ,Hudgens MG,Gilbert PB,Self SG,Russell ND

    更新日期:2006-04-01 00:00:00

  • Use of deception to achieve double-blinding in a clinical trial of Melaleuca alternifolia (tea tree) oil for the treatment of recurrent herpes labialis.

    abstract::Double-blinding is an important and widely implemented feature of clinical trials although its success is rarely assessed. In a randomized, placebo-controlled trial of tea tree oil, an aromatic essential oil, for the treatment of recurrent herpes labialis (RHL), or cold sores, deception was used to prevent volunteers ...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2007.04.006

    authors: Carson CF,Smith DW,Lampacher GJ,Riley TV

    更新日期:2008-01-01 00:00:00

  • Fit and Strong! Plus: design of a comparative effectiveness evaluation of a weight management program for older adults with osteoarthritis.

    abstract::Osteoarthritis (OA) is the most common chronic condition and principal cause of disability among older adults. The current obesity epidemic has contributed to this high prevalence rate. Fortunately both OA symptoms and obesity can be ameliorated through lifestyle modifications. Physical activity (PA) combined with wei...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.cct.2013.11.014

    authors: Smith-Ray RL,Fitzgibbon ML,Tussing-Humphreys L,Schiffer L,Shah A,Huber GM,Braunschweig C,Campbell RT,Hughes SL

    更新日期:2014-03-01 00:00:00

  • A novel diagram and complement to the CONSORT chart for presenting multimodal clinical trials.

    abstract::We developed a novel diagram to depict patient flow and outcomes in clinical trials. In contrast to flow diagrams such as the CONSORT chart, our diagram enables individual patient histories to be traced and depicts important patterns of treatment administration and outcomes, such as response and adverse events. Also, ...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2009.01.010

    authors: Schuller JC,Mayer M,Lanz D,Schmitz SF,Brauchli P,Leupin N

    更新日期:2009-05-01 00:00:00

  • Assessing the success probability of a Phase III clinical trial based on Phase II data.

    abstract::Assessing the probability that a Phase III clinical trial will demonstrate clinically relevant efficacy based on Phase II data is an important topic in clinical drug development. An accurate estimate of how likely a Phase III trial will succeed based on available data will inform the decision on whether to move an exp...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2010.08.008

    authors: Su Z

    更新日期:2010-11-01 00:00:00

  • DIETFITS study (diet intervention examining the factors interacting with treatment success) - Study design and methods.

    abstract::Numerous studies have attempted to identify successful dietary strategies for weight loss, and many have focused on Low-Fat vs. Low-Carbohydrate comparisons. Despite relatively small between-group differences in weight loss found in most previous studies, researchers have consistently observed relatively large between...

    journal_title:Contemporary clinical trials

    pub_type: 杂志文章

    doi:10.1016/j.cct.2016.12.021

    authors: Stanton MV,Robinson JL,Kirkpatrick SM,Farzinkhou S,Avery EC,Rigdon J,Offringa LC,Trepanowski JF,Hauser ME,Hartle JC,Cherin RJ,King AC,Ioannidis JP,Desai M,Gardner CD

    更新日期:2017-02-01 00:00:00