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| Tracking Information | |||||
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| First Received Date ICMJE | February 2, 2001 | ||||
| Last Updated Date | August 16, 2006 | ||||
| Start Date ICMJE | August 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00010647 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cost-Effectiveness of and Long-Term Outcomes Following Acupuncture Treatment for Osteoarthritis of the Knee | ||||
| Official Title ICMJE | Cost-Effectiveness of and Long-Term Outcomes Following Acupuncture Treatment for Osteoarthritis of the Knee | ||||
| Brief Summary | The purpose of this study is to estimate the cost-effectiveness of acupuncture and to determine the long-term outcomes and health care utilization of people with osteoarthritis (OA) of the knee. |
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| Detailed Description | Osteoarthritis (OA) makes up a large proportion of the disability and economic costs in the U.S. The knee is the most common site of OA and is a common cause of disability and the leading indication of total knee replacement in the elderly. There are presently no curative therapies for OA. Recently, increased attention has focused on the use of complementary and alternative medicine (CAM) therapies, such as acupuncture, especially for patients who have failed to respond to more standard therapy. Little is known of the long-term health services utilization and outcomes of patients with knee OA. This study will evaluate the cost effectiveness and overall outcomes of acupuncture for OA treatment. Participants in this study will be randomly assigned to receive either acupuncture or placebo. Surveys and questionnaires will be used to assess participants. Data will be collected on the short- and long-term utilization of health services as well as on pain and physical function. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized | ||||
| Condition ICMJE | Osteoarthritis, Knee | ||||
| Intervention ICMJE | Procedure: Acupuncture | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM, Hochberg MC. Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med. 2004 Dec 21;141(12):901-10. Summary for patients in: Ann Intern Med. 2004 Dec 21;141(12):I20. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | July 2004 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00010647 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | P50 AT000084-01P1, P50 AT000084-01 | ||||
| Study Sponsor ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Verification Date | August 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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