Survey of Osteoarthritis Real World Therapies (SORT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,261
- 主要终点
- Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline
研究概览
简要总结
This was a study to estimate the proportion of participants with osteoarthritis of the knee(s) who were treated with oral or topical analgesics for their symptoms, who did and did not report adequate pain relief at Baseline and to characterize their pain level over a 12-month follow-up period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of primary osteoarthritis of the knee(s)
- •Presently receiving prescribed oral or topical analgesics for a minimum duration of two weeks prior to enrollment
排除标准
- •Arthritis other than primary osteoarthritis
- •Treatment with disease-modifying antirheumatic drugs (DMARDS), methotrexate or biologics
- •Subtotal or total joint replacement in the affected knee
- •Chronic severe pain of other causes that in the opinion of the investigator may require long-term analgesia or confound the present study
- •Currently enrolled in a clinical trial or who have participated in a clinical trial within the past 30 days
研究组 & 干预措施
All Enrolled Participants
All participants will be treated according to standard medical guidelines or usual clinical practice standards of the investigating physician.
干预措施: Standard of care for treatment of osteoarthritis (OA) of knee(s) (Drug)
结局指标
主要结局
Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline
时间窗: Baseline (Day 1)
Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain due to osteoarthritis in the affected knee in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of \<=4 on question 5 of the BPI. Inadequate pain control was defined as a score \>4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable).
Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Month 12
时间窗: Month 12
Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of \<=4 on question 5 of the BPI. Inadequate pain control was defined as a score \>4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable).
次要结局
- Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 1(Month 1)
- Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 3(Month 3)
- Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 9(Month 9)
- Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 12(Month 12)
- Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Baseline (Day 1)(Baseline (Day 1))
- Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 6(Month 6)