E Losina1, E E Dervan, M E Daigle, J N Katz. 1. Orthopaedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA 02115, USA. elosina@partners.org
Abstract
OBJECTIVE: 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. DESIGN: 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. RESULTS: 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. CONCLUSION: 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.
OBJECTIVE: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. DESIGN: 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. RESULTS: 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. CONCLUSION: 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.
Authors: K M Jordan; N K Arden; M Doherty; B Bannwarth; J W J Bijlsma; P Dieppe; K Gunther; H Hauselmann; G Herrero-Beaumont; P Kaklamanis; S Lohmander; B Leeb; M Lequesne; B Mazieres; E Martin-Mola; K Pavelka; A Pendleton; L Punzi; U Serni; B Swoboda; G Verbruggen; I Zimmerman-Gorska; M Dougados Journal: Ann Rheum Dis Date: 2003-12 Impact factor: 19.103
Authors: A D Paltiel; A L Fuhlbrigge; B T Kitch; B Liljas; S T Weiss; P J Neumann; K M Kuntz Journal: J Allergy Clin Immunol Date: 2001-07 Impact factor: 10.793
Authors: Alexander B Kuntz; Jaclyn N Chopp-Hurley; Elora C Brenneman; Sarah Karampatos; Emily G Wiebenga; Jonathan D Adachi; Michael D Noseworthy; Monica R Maly Journal: PLoS One Date: 2018-04-17 Impact factor: 3.240