Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010946
Status:
COMPLETED
Last Update Posted:
2008-03-07
First Post:
2001-02-02
Brief Title:
Acupuncture SafetyEfficacy in Knee Osteoarthritis
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Acupuncture SafetyEfficacy in Knee Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this research is to determine the efficacy and safety of Traditional Chinese Acupuncture TCA in patients with osteoarthritis of the knee A three arm randomized controlled trial RCT using sham TCA true TCA and an educationattention comparison group with a total sample of 525 is proposed Primary hypothesis to be tested is that patients randomized to true TCA will have significantly more improvement in pain and function as measured by the Womac Pain Function Scales and patient global assessments than patients randomized to the sham acupuncture and educationattention control groups
Secondary aims of the study are to 1 determine if improvement with TCA differs between patients below age 65 vs those aged 65 and above 2 to determine if improvement with TCA differs by racialethnic group ie Caucasian Black Hispanic and 3 to determine if improvement with TCA differs by stage of radiographic severity of knee OA at baseline KL grade 2 3 or 4
Secondary aims of the study are to 1 determine if improvement with TCA differs between patients below age 65 vs those aged 65 and above 2 to determine if improvement with TCA differs by racialethnic group ie Caucasian Black Hispanic and 3 to determine if improvement with TCA differs by stage of radiographic severity of knee OA at baseline KL grade 2 3 or 4
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1U01AT000171-01 | NIH | None | httpsreporternihgovquickSearch1U01AT000171-01 |