Medication vs. Meditation for Chronic Knee Osteoarthritis

NCT07837284 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 00006443
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Knee Osteoarthristis

Keywords

mindfulness; NSAID; knee osteoarthritis; chronic pain

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Secondary Outcomes (6)

• Post-Randomization Treatment Expectancy

  Immediately prior to intervention exposure at laboratory visit; post-randomization.

• Post-Intervention Treatment Credibility

  30 minutes and 3 hours post-intervention.

• Adverse Events During the Laboratory Period

  Intervention onset through 3 hours post-intervention.

• Change in Acute Pain Intensity

  Pre-intervention baseline through 3 hours post-intervention.

• Timed Up and Go Test (TUG)

  During the 3-hour post-intervention laboratory period.

Other Outcomes (18)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Baseline to 6-months post-intervention

• Patient Global Impression of Change (PGIC)

  Baseline to 6-months post-intervention

• WHO Quality of Life-2 (WHO-2)

  Baseline to 6-month post-intervention

Study Arms (2)

Medication

EXPERIMENTAL

Drug: Oral diclofenac potassium 50 mg

Meditation

EXPERIMENTAL

Behavioral: Mindfulness meditation

Interventions

Oral diclofenac potassium 50 mg DRUG

Oral diclofenac 50mg 100 tablets.

Medication

Mindfulness meditation BEHAVIORAL

Mindfulness meditation

Meditation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Florida State University: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain

Interventions

Diclofenac; Mindfulness

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.