Medication vs. Meditation for Chronic Knee Osteoarthritis

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.