[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657336":3},{"organization":4,"outcomesModule":7,"designInfo":110,"detailedDescription":113,"studyPopulation":113,"armGroups":117,"interventions":127,"overallOfficials":113,"centralContacts":113,"locations":113,"responsibleParty":137,"collaborators":113,"id":141,"slug":142,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":113,"eligibilityCriteria":147,"healthyVolunteers":143,"sex":148,"minAge":149,"maxAge":113,"enrollmentInfo":150,"targetDuration":113,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":164,"whyStopped":113,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":113},{"fullName":5,"class":6},"Florida State University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":48},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"Feasibility of Recruitment and Enrollment","Recruitment and enrollment feasibility will be assessed as the proportion of the planned sample enrolled within 6 months of initiating recruitment. The planned sample size is 30 participants. Feasibility will be demonstrated if the full planned sample is enrolled within 6 months.","From initiation of recruitment through 6 months.",{"measure":14,"description":15,"timeFrame":16},"Acceptability of Intervention Procedures as Assessed by the Theoretical Framework of Acceptability Questionnaire (TFA)","Acceptability of the assigned intervention and study procedures will be assessed using a questionnaire based on the Theoretical Framework of Acceptability (TFA). The TFA assesses domains including affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy.","Through completion of the 33-day at-home intervention period.",{"measure":18,"description":19,"timeFrame":20},"Completeness of Laboratory Visit Outcome Data","Laboratory data completeness will be assessed as the percentage of scheduled laboratory outcome assessments successfully completed during the 3-hour post-intervention laboratory period. Scheduled assessments include pain ratings, Timed Up and Go testing, and stair-climb testing. Feasibility will be demonstrated if at least 80% of scheduled laboratory outcome data are complete.","During the 3-hour post-intervention laboratory period.",{"measure":22,"description":23,"timeFrame":24},"Completeness of Follow-Up Data (Retention)","Follow-up data completeness will be assessed as the percentage of scheduled follow-up assessments completed by enrolled participants. Feasibility will be demonstrated if at least 80% of scheduled follow-up data are completed.","Through 6 months post-intervention.",[26,30,34,38,42,45],{"measure":27,"description":28,"timeFrame":29},"Post-Randomization Treatment Expectancy","Treatment expectancy will be assessed following randomization and before administration of the assigned intervention. Participants will rate how much benefit or improvement they expect from the assigned intervention. Higher scores indicate greater expected benefit from the assigned intervention.","Immediately prior to intervention exposure at laboratory visit; post-randomization.",{"measure":31,"description":32,"timeFrame":33},"Post-Intervention Treatment Credibility","Treatment credibility will be assessed after intervention administration. Participants will rate how credible the assigned intervention seems as a pain-management strategy. Higher scores indicate greater perceived treatment credibility. Credibility will be assessed at 30 minutes and 3 hours post-intervention.","30 minutes and 3 hours post-intervention.",{"measure":35,"description":36,"timeFrame":37},"Adverse Events During the Laboratory Period","Adverse events will be assessed through direct observation and standardized safety queries during the laboratory visit. The outcome will be the number of participants experiencing one or more adverse events during the 3-hour post-intervention laboratory period.","Intervention onset through 3 hours post-intervention.",{"measure":39,"description":40,"timeFrame":41},"Change in Acute Pain Intensity","Acute pain intensity will be assessed using a participant-reported 0-10 Numeric Rating Scale, with 0 indicating no pain and 10 indicating the worst pain imaginable. Higher scores indicate greater pain intensity. Change in pain intensity will be evaluated from the pre-intervention baseline through repeated assessments during the 3-hour post-intervention laboratory period.","Pre-intervention baseline through 3 hours post-intervention.",{"measure":43,"description":44,"timeFrame":20},"Timed Up and Go Test (TUG)","Physical function will be assessed using the Timed Up and Go Test. Participants begin seated in a standard chair, stand, walk 3 meters, turn around, return to the chair, and sit down. Time to task completion is recorded in seconds, with lower times indicating better physical function. The outcome will be the average completion time across the two Timed Up and Go trials performed during the 3-hour laboratory period.",{"measure":46,"description":47,"timeFrame":20},"Stair-Climb Task","Physical function will be assessed using a timed stair-climb task on a standardized flight of 12 stairs. Participants ascend and descend the stairs, and task completion time is recorded in seconds, with lower times indicating better physical function. The outcome will be the average completion time across the two stair-climb trials performed during the 3-hour laboratory period.",[49,53,56,60,64,67,70,73,76,79,82,86,90,93,97,100,104,107],{"measure":50,"description":51,"timeFrame":52},"Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)","Knee osteoarthritis symptoms and functioning will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index. The WOMAC assesses pain, stiffness, and physical function in individuals with knee or hip osteoarthritis. The commonly used Likert-scored version includes 24 items: 5 pain items, 2 stiffness items, and 17 physical function items. Items are scored from 0 to 4, with higher scores indicating worse symptoms or functional limitation. Subscale score ranges are 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function; the total score ranges from 0 to 96, with higher scores indicating worse osteoarthritis-related symptoms and disability.","Baseline to 6-months post-intervention",{"measure":54,"description":55,"timeFrame":52},"Patient Global Impression of Change (PGIC)","Participant-perceived overall change will be assessed using the Patient Global Impression of Change. The PGIC is a single-item patient-reported measure in which participants rate their overall change compared with a prior time point. It is commonly scored on a 7-point scale ranging from very much improved to very much worse. Scores will be interpreted so that response categories reflect the participant's perceived degree of improvement, no change, or worsening.",{"measure":57,"description":58,"timeFrame":59},"WHO Quality of Life-2 (WHO-2)","Quality of life will be assessed using the WHO Quality of Life-2. The WHO-2 is a brief 2-item self-report measure used to assess participant-reported quality of life\u002Fwell-being. Items are scored according to the study questionnaire scoring instructions, with higher scores indicating better quality of life\u002Fwell-being.","Baseline to 6-month post-intervention",{"measure":61,"description":62,"timeFrame":63},"Patient Health Questionnaire-2 (PHQ-2)","Depressive symptoms will be assessed using the Patient Health Questionnaire-2. The PHQ-2 is a 2-item self-report screening measure assessing depressed mood and anhedonia over the past 2 weeks. Each item is scored from 0 to 3, and total scores range from 0 to 6. Higher scores indicate greater depressive symptom severity. A score of 3 or greater is commonly used as a screening cutoff for clinically significant depressive symptoms.","Baseline to 6-months post-intervention.",{"measure":65,"description":66,"timeFrame":63},"Generalized Anxiety Disorder-2 (GAD-2)","Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-2 scale. The GAD-2 is a 2-item self-report screening measure assessing frequency of anxiety symptoms over the past 2 weeks. Each item is scored from 0 to 3, and total scores range from 0 to 6. Higher scores indicate greater anxiety symptom severity. A score of 3 or greater is commonly used as a screening cutoff for clinically significant anxiety symptoms.",{"measure":68,"description":69,"timeFrame":63},"Pain Catastrophizing Scale-6 (PCS-6)","Pain catastrophizing will be assessed using the 6-item short form of the Pain Catastrophizing Scale. The PCS-6 assesses catastrophic thinking related to pain. Items are rated from 0 to 4, and the total score ranges from 0 to 24. Higher scores indicate greater pain catastrophizing.",{"measure":71,"description":72,"timeFrame":63},"Multidimensional Health Locus of Control Scale","Health-related locus of control will be assessed using the Multidimensional Health Locus of Control Scale. This self-report measure assesses the extent to which participants attribute health outcomes to internal factors, chance, physicians\u002Fdoctors, or other powerful people. Form C includes 18 items and four subscales: Internal, Chance, Doctors, and Other Powerful People. Higher scores on each subscale indicate stronger endorsement of that locus-of-control belief.",{"measure":74,"description":75,"timeFrame":63},"Pain Self-Efficacy Questionnaire-10 (PSEQ-10)","Pain self-efficacy will be assessed using the Pain Self-Efficacy Questionnaire-10. The PSEQ-10 is a 10-item self-report measure assessing confidence in performing activities despite pain. Each item is scored from 0 to 6, with 0 indicating not at all confident and 6 indicating completely confident. Total scores range from 0 to 60. Higher scores indicate greater pain self-efficacy.",{"measure":77,"description":78,"timeFrame":63},"Frequency, Intensity, and Burden of Side Effects Rating (FIBSER)","Medication\u002Fmeditation side effects and tolerability will be assessed using the Frequency, Intensity, and Burden of Side Effects Rating. The FIBSER is a brief self-report measure assessing the frequency, intensity, and burden of side effects. Items assess how often side effects occurred, how intense they were, and how much they interfered with day-to-day functioning. The burden item is commonly used as the key summary indicator of side-effect impact, with higher scores indicating greater side-effect burden.",{"measure":80,"description":81,"timeFrame":63},"Five Facet Mindfulness Questionnaire-15 (FFMQ-15)","Mindfulness will be assessed using the Five Facet Mindfulness Questionnaire-15. The FFMQ-15 is a 15-item short form assessing five facets of mindfulness: observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. Items are typically rated on a 1-5 Likert scale. Total or facet scores may be calculated, with higher scores indicating greater mindfulness.",{"measure":83,"description":84,"timeFrame":85},"Positive and Negative Affect Schedule (PANAS)","State affect will be assessed using the Positive and Negative Affect Schedule. The PANAS assesses positive affect and negative affect using emotion adjectives rated on a 1-5 scale, with 1 indicating very slightly or not at all and 5 indicating extremely. Positive affect and negative affect scores are calculated separately by summing relevant items. Higher positive affect scores indicate greater positive affect, and higher negative affect scores indicate greater negative affect.","Directly pre-intervention to 30-minutes post-intervention. Secondary endpoint of 6 hours post-intervention.",{"measure":87,"description":88,"timeFrame":89},"Metacognitive Processes of Decentering Scale-State, 3-item version (MPoD-S \u002F MPoD-3)","State decentering will be assessed using the 3-item state version of the Metacognitive Processes of Decentering Scale. The MPoD-S assesses state levels of the metacognitive processes of decentering: meta-awareness, disidentification from internal experience, and nonreactivity to internal experience. Items are rated on 0-10 scales. The scale score ranges from 0 to 10, with higher scores indicating greater state decentering.","Directly pre-intervention to 30-minutes post-intervention. Secondary endpoint is 6 hours post-intervention.",{"measure":91,"description":92,"timeFrame":85},"Nondual Awareness Dimensional Assessment-State, 3-item version (NADA-S \u002F NADA-3)","State self-transcendence will be assessed using a 3-item state version of the Nondual Awareness Dimensional Assessment. The NADA assesses dimensions of nondual awareness, including self-transcendence and bliss. In this study, the brief state measure will assess momentary self-transcendent experience following intervention exposure. Items will be scored according to the study measure, with higher scores indicating greater state self-transcendence.",{"measure":94,"description":95,"timeFrame":96},"Daily Pain Intensity","Daily knee pain intensity will be assessed using Daily knee pain intensity will be assessed using questions #1 of the Pain, Enjoyment, and General Activity Scale (PEG-3), with higher scores indicating greater pain intensity.","Once daily (7 PM) throughout the 33-day at-home intervention period.",{"measure":98,"description":99,"timeFrame":96},"Daily Pain Interference","Daily pain interference will be assessed using questions #2 and #3 of the Pain, Enjoyment, and General Activity Scale (PEG-3). Higher scores indicate greater interference of pain with daily activities.",{"measure":101,"description":102,"timeFrame":103},"Daily Pain Medication Use","Participants will report use of diclofenac or other pain medication each day, including acetaminophen or other medications used for breakthrough pain. Pain medication use will be summarized as the number of days during the 33-day intervention period on which participants report using pain medication.","Once daily (8 PM) throughout the 33-day at-home intervention period.",{"measure":105,"description":106,"timeFrame":96},"Mindfulness Intervention Adherence","Among participants randomized to the mindfulness intervention, adherence will be assessed as the number of minutes of mindfulness practice completed each day.",{"measure":108,"description":109,"timeFrame":96},"Adverse Events During the At-Home Intervention Period","Participants will report adverse effects, symptoms, or other health concerns through the daily electronic diary. Adverse events will be reviewed by the study team and referred for clinical evaluation when indicated. The outcome will be the number and severity of adverse events reported during the 33-day at-home intervention period.",{"allocation":111,"interventionModel":112,"interventionModelDescription":113,"primaryPurpose":114,"observationalModel":113,"timePerspective":113,"maskingInfo":115},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":116,"maskingDescription":113,"whoMasked":113},"NONE",[118,123],{"label":119,"type":120,"description":113,"interventionNames":121},"Medication","EXPERIMENTAL",[122],"Drug: Oral diclofenac potassium 50 mg",{"label":124,"type":120,"description":113,"interventionNames":125},"Meditation",[126],"Behavioral: Mindfulness meditation",[128,133],{"type":129,"name":130,"description":131,"armGroupLabels":132,"otherNames":113},"DRUG","Oral diclofenac potassium 50 mg","Oral diclofenac 50mg 100 tablets.",[119],{"type":134,"name":135,"description":135,"armGroupLabels":136,"otherNames":113},"BEHAVIORAL","Mindfulness meditation",[124],{"type":138,"investigatorFullName":139,"investigatorTitle":140,"investigatorAffiliation":5,"oldNameTitle":113,"oldOrganization":113},"PRINCIPAL_INVESTIGATOR","Adam Hanley","Associate Professor","100657336","early-phase-1-medication-vs-meditation-for-chronic-knee-osteoarthritis-100657336",false,"NCT07837284","Medication vs. Meditation for Chronic Knee Osteoarthritis","Measuring the Pain Relief of Medication vs Meditation for Knee Osteoarthritis","Inclusion Criteria:\n\n1. Ability to speak and read English sufficiently to complete study procedures and provide informed consent.\n2. Current diagnosis of knee osteoarthritis (KOA) in one or both knees.\n3. Average knee pain intensity of ≥ 4 on a 0-10 numeric rating scale during the previous week.\n4. KOA-related pain duration of ≥ 6 months.\n5. No prior formal mindfulness training or regular mindfulness meditation practice, defined as no previous participation in structured programs such as MBSR or MORE.\n6. No prior use of topical diclofenac or oral diclofenac products.\n7. Willingness to refrain from taking aspirin or other NSAIDs during the study's treatment period.\n8. Willingness to comply with all study procedures, including randomization to either the mindfulness or oral diclofenac arm.\n\nExclusion Criteria:\n\n1. Known pregnancy.\n2. Current use of aspirin or other NSAID medications.\n3. Known hypersensitivity, allergy, or clinically significant adverse reaction to NSAIDs or diclofenac.\n4. Laboratory abnormalities suggesting increased bleeding risk or other clinically significant hematologic instability, including but not limited to clinically significant anemia, thrombocytopenia, markedly abnormal white blood cell count, or other CBC findings that, in the judgment of the study clinician, suggest the participant should not begin oral diclofenac.\n5. Current medications that, in the judgment of the study clinician, may increase risk with oral diclofenac use or interfere with safe participation. This includes, but is not limited to, anticoagulants, digoxin, or other clinically significant medication interactions.\n6. Medical conditions that are contraindicated for oral diclofenac use or that may substantially increase risk based on FDA labeling and black box warnings, including clinically significant cardiovascular disease or elevated cardiovascular risk, such as history of myocardial infarction, stroke, serious heart disease, coronary artery bypass graft surgery, uncontrolled hypertension, or other conditions that may increase risk of cardiovascular thrombotic events; and clinically significant gastrointestinal disease or elevated gastrointestinal bleeding risk, such as active or recent peptic ulcer disease, history of gastrointestinal bleeding or perforation, or other conditions that may increase risk of serious gastrointestinal bleeding, ulceration, or perforation.\n7. Laboratory or clinical findings suggesting clinically significant renal or hepatic dysfunction, including but not limited to: estimated GFR \\\u003C 60 mL\u002Fmin\u002F1.73 m²; serum creatinine above the laboratory reference range and judged clinically significant by the study clinician; AST or ALT \\> 2 times the upper limit of normal; other clinically significant abnormalities identified during healthcare provider review that may increase risk with NSAID exposure.\n8. Severe neurologic or vascular disease affecting the lower extremities.\n9. Knee trauma, knee surgery, or intra-articular corticosteroid injection within the previous 3 months.\n10. Pain primarily attributable to active cancer or ongoing cancer treatment.\n11. Unstable or severe medical or psychiatric illness that, in the judgment of the investigators, would interfere with safe participation, study adherence, or interpretation of results.","ALL","18 Years",{"count":151,"type":152},30,"ESTIMATED","INTERVENTIONAL",[155],"EARLY_PHASE1","The purpose of this research study is to improve pain management for individuals with chronic knee osteoarthritis pain. Specifically, we are comparing the effects of a mindfulness meditation practice with those of oral diclofenac, a common NSAID medication prescribed for knee osteoarthritis pain.",[158],"Knee Osteoarthristis",[160,161,162,163],"mindfulness","NSAID","knee osteoarthritis","chronic pain","NOT_YET_RECRUITING","2026-09-22",{"date":167,"type":168},"2026-09-23","ACTUAL",{"date":170,"type":152},"2026-10",{"date":172,"type":152},"2028-05",{"name":5,"class":6}]