An Early Phase 1 interventional study of Oral diclofenac potassium 50 mg and Mindfulness meditation in Knee Osteoarthristis, sponsored by Florida State University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Florida State University · Early Phase 1, Interventional, and Treatment
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.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's planned enrollment of 30 is below the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Florida State University is the lead sponsor of 249 studies on the registry; 47 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Oral diclofenac potassium 50 mg
Behavioral: Mindfulness meditation
Oral diclofenac 50mg 100 tablets.
Mindfulness meditation
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.
Time frame: From initiation of recruitment through 6 months.
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.
Time frame: Through completion of the 33-day at-home intervention period.
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.
Time frame: During the 3-hour post-intervention laboratory period.
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.
Time frame: Through 6 months post-intervention.
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.
Time frame: Immediately prior to intervention exposure at laboratory visit; post-randomization.
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.
Time frame: 30 minutes and 3 hours post-intervention.
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.
Time frame: Intervention onset through 3 hours post-intervention.
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.
Time frame: Pre-intervention baseline through 3 hours post-intervention.
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.
Time frame: During the 3-hour post-intervention laboratory period.
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.
Time frame: During the 3-hour post-intervention laboratory period.
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.
Time frame: Baseline to 6-months post-intervention
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.
Time frame: Baseline to 6-months post-intervention
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/well-being. Items are scored according to the study questionnaire scoring instructions, with higher scores indicating better quality of life/well-being.
Time frame: Baseline to 6-month post-intervention
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.
Time frame: Baseline to 6-months post-intervention.
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.
Time frame: Baseline to 6-months post-intervention.
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.
Time frame: Baseline to 6-months post-intervention.
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/doctors, 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.
Time frame: Baseline to 6-months post-intervention.
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.
Time frame: Baseline to 6-months post-intervention.
Frequency, Intensity, and Burden of Side Effects Rating (FIBSER)
Medication/meditation 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.
Time frame: Baseline to 6-months post-intervention.
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.
Time frame: Baseline to 6-months post-intervention.
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.
Time frame: Directly pre-intervention to 30-minutes post-intervention. Secondary endpoint of 6 hours post-intervention.
Metacognitive Processes of Decentering Scale-State, 3-item version (MPoD-S / 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.
Time frame: Directly pre-intervention to 30-minutes post-intervention. Secondary endpoint is 6 hours post-intervention.
Nondual Awareness Dimensional Assessment-State, 3-item version (NADA-S / 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.
Time frame: Directly pre-intervention to 30-minutes post-intervention. Secondary endpoint of 6 hours post-intervention.
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.
Time frame: Once daily (7 PM) throughout the 33-day at-home intervention period.
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.
Time frame: Once daily (7 PM) throughout the 33-day at-home intervention period.
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.
Time frame: Once daily (8 PM) throughout the 33-day at-home intervention period.
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.
Time frame: Once daily (7 PM) throughout the 33-day at-home intervention period.
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.
Time frame: Once daily (7 PM) throughout the 33-day at-home intervention period.
No study locations are listed for this record.
Plan to share: Yes — Deidentified participant data and protocol information will be shared with qualified individuals upon request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: IPD will be available upon conclusion of the trial and will remain so indefinitely.
Access criteria: Deidentified participant data and protocol information will be shared with qualified individuals upon request.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Diclofenac