Knee OsteoarthristisEarly Phase 1NCT07837284
Medication vs. Meditation for Chronic Knee Osteoarthritis
A Early Phase 1 study testing Oral diclofenac potassium 50 mg and Mindfulness meditation in people with Knee Osteoarthristis, run by Florida State University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- Oral diclofenac potassium 50 mg and Mindfulness meditation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to May 2028
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to speak and read English sufficiently to complete study procedures and provide informed consent.
- Current diagnosis of knee osteoarthritis (KOA) in one or both knees.
- Average knee pain intensity of ≥ 4 on a 0-10 numeric rating scale during the previous week.
- KOA-related pain duration of ≥ 6 months.
- No prior formal mindfulness training or regular mindfulness meditation practice, defined as no previous participation in structured programs such as MBSR or MORE.
- No prior use of topical diclofenac or oral diclofenac products.
- Willingness to refrain from taking aspirin or other NSAIDs during the study's treatment period.
- Willingness to comply with all study procedures, including randomization to either the mindfulness or oral diclofenac arm.
Who cannot join
- Known pregnancy.
- Current use of aspirin or other NSAID medications.
- Known hypersensitivity, allergy, or clinically significant adverse reaction to NSAIDs or diclofenac.
- 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.
- 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.
- 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.
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- Laboratory or clinical findings suggesting clinically significant renal or hepatic dysfunction, including but not limited to: estimated GFR < 60 mL/min/1.73 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.
- Severe neurologic or vascular disease affecting the lower extremities.
- Knee trauma, knee surgery, or intra-articular corticosteroid injection within the previous 3 months.
- Pain primarily attributable to active cancer or ongoing cancer treatment.
- 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.
About this study
Official title: Measuring the Pain Relief of Medication vs Meditation for Knee Osteoarthritis
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.
- Conditions
- Knee Osteoarthristis
- Being tested
- Oral diclofenac potassium 50 mg, Mindfulness meditation
- Keywords
- mindfulness, NSAID, knee osteoarthritis, chronic pain
- Medical subject headings
- Osteoarthritis, Knee, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral diclofenac potassium 50 mgDrug
Oral diclofenac 50mg 100 tablets.
Mindfulness meditationBehavioural
Mindfulness meditation
| Study group | Role | What they receive |
|---|---|---|
| Medication | Experimental | Not described Receives: Drug: Oral diclofenac potassium 50 mg |
| Meditation | Experimental | Not described Receives: Behavioral: Mindfulness meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through 6 months post-intervention.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the 3-hour post-intervention laboratory period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Hanley, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837284
- Sponsor's protocol ID
- 00006443
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data and protocol information will be shared with qualified individuals upon request.