Measuring the Pain Relief of Medication vs Meditation for Knee Osteoarthritis
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Feasibility of Recruitment and Enrollment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Medication
干预措施: Oral diclofenac potassium 50 mg (Drug)
Meditation
干预措施: Mindfulness meditation (Behavioral)
结局指标
主要结局
Feasibility of Recruitment and Enrollment
时间窗: From initiation of recruitment through 6 months.
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)
时间窗: Through completion of the 33-day at-home intervention period.
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
时间窗: During the 3-hour post-intervention laboratory period.
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)
时间窗: Through 6 months post-intervention.
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.
次要结局
- 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.)
- Stair-Climb Task(During the 3-hour post-intervention laboratory period.)
研究者
Adam Hanley
Associate Professor
Florida State University