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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
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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.