Orthopaedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA 02115, USA.
Osteoarthritis Cartilage. 2013 Sep;21(9):1264-71. doi: 10.1016/j.joca.2013.04.013.
Osteoarthritis (OA) is a debilitating chronic condition requiring long-term treatment of pain and functional impairment. Our objective was to characterize studies addressing management of OA-related pain with respect to the breadth of interventions, trial duration and size, outcome measures, and funding sources.
We identified studies focused on 'pain' and 'osteoarthritis' from ClinicalTrals.gov and abstracted data on study status, sample size, design, funding source, duration, outcomes measured, and interventions evaluated. We examined associations among intervention type, funding source, sample size, duration, and outcomes measured.
We identified 287 registered studies, of which 69% investigated pharmacologic interventions, 11% behavioral interventions, and 5% surgical procedures or devices, while the remainder examined other types of interventions. Eighty-seven percent evaluated knee OA. The average sample size was 290 subjects and average study duration was 7.4 months, with 52% using durations ≤3 months and 21% ≥12 months. Industry funded 64% of studies, either fully or partially. Of 180 completed studies, 139 were pharmacologic studies. Of these, 34 (24%) posted results to the registry. Among the studies funded by industry, 60% had durations ≤3 months as compared with 36% among non-industry funded studies (P < 0.0001). Behavioral intervention trials tended to be of longer duration than pharmacologic trials and were less likely to be funded by industry.
Over half of OA pain studies and >80% of those funded by industry used trial durations of less than 6 months. Future studies should take into consideration the need for long-term pain management for OA when designing trial protocols.
骨关节炎（OA）是一种使人虚弱的慢性疾病，需要长期治疗疼痛和功能障碍。我们的目标是描述针对 OA 相关疼痛管理的研究，重点关注干预措施的广度、试验持续时间和规模、结局测量指标以及资金来源。
我们从 ClinicalTrials.gov 中确定了专注于“疼痛”和“骨关节炎”的研究，并提取了研究状态、样本量、设计、资金来源、持续时间、测量的结局和评估的干预措施等数据。我们检查了干预类型、资金来源、样本量、持续时间和测量的结局之间的关联。
我们确定了 287 项已注册的研究，其中 69%的研究调查了药物干预措施，11%的研究调查了行为干预措施，5%的研究调查了手术程序或设备，其余研究则调查了其他类型的干预措施。87%的研究评估了膝关节 OA。平均样本量为 290 例，平均研究持续时间为 7.4 个月，其中 52%的研究持续时间≤3 个月，21%的研究持续时间≥12 个月。工业界资助了 64%的研究，要么是全额资助，要么是部分资助。在已完成的 180 项研究中，有 139 项是药物研究。其中，34 项（24%）向登记处公布了结果。在工业界资助的研究中，60%的研究持续时间≤3 个月，而非工业界资助的研究中这一比例为 36%（P<0.0001）。行为干预试验往往比药物试验持续时间更长，且不太可能得到工业界的资助。
超过一半的 OA 疼痛研究和超过 80%的由工业界资助的研究使用了少于 6 个月的试验持续时间。未来的研究在设计试验方案时应考虑到 OA 长期疼痛管理的需求。
