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| Descriptive Information Fields | |||||
| Brief Title † | Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability | ||||
| Official Title † | Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability | ||||
| Brief Summary | The purpose of this study is to investigate the feasibility, effectiveness, and duration of treatment response of periosteal electro-acupuncture (osteopuncture) for osteoarthritis (OA)-associated chronic knee pain. |
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| Detailed Description | Knee osteoarthritis (OA) is painful in 6.8% of men and 11.4% of women age 63-93, with over 20 million Americans affected nationwide, and may lead to a variety of untoward consequences including limitations in physical function, postural instability, sleep disturbance, psychosocial disability, and substantial utilization of health care resources. While oral analgesics represent the mainstay of treatment for chronic pain associated with knee OA, non-responders with limiting comorbidities may have few therapeutic alternatives. The aims of this research study are to (1) reduce pain severity and disability in community-dwelling older adults with OA-associated chronic knee pain using periosteal electroacupuncture (osteopuncture), and (2) improve the physical performance, psychosocial function, sleep, and appetite of these individuals. 88 older adults with persistent knee pain and x-ray evidence of OA, no other rheumatologic disorders, no history of knee surgery, and no prominent pain in sites other than the knee(s) will be randomized to receive either osteopuncture or control osteopuncture once a week for 6 weeks. All outcome measures for pain and disability, as well as physical performance, psychosocial function, sleep, and appetite, will be collected pre-treatment, at the completion of the 6-week protocol, and 3 months later. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | changes in pain and disability, measured with the Western Ontario and McMaster Universities Osteoarthritis Index | ||||
| Secondary Outcome Measure † | changes in physical performance psychosocial function (mood, self-efficacy, coping, fear, self-rated health) sleep and appetite |
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| Condition † | Osteoarthritis | ||||
| Intervention † | Device: periosteal electro-acupuncture (osteopuncture). | ||||
| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 88 | ||||
| Start Date † | October 2004 | ||||
| Completion Date | August 2006 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00417313 | ||||
| Organization ID | AG0073 | ||||
| Secondary IDs †† | 5R21AG024288-02 | ||||
| Study Sponsor † | National Institute on Aging (NIA) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute on Aging (NIA) | ||||
| Verification Date | December 2006 | ||||
| First Received Date † | December 28, 2006 | ||||
| Last Updated Date | December 28, 2006 | ||||