Acupuncture Safety/Efficacy in Knee Osteoarthritis
2 other identifiers
interventional
N/A
1 country
3
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 education/attention 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 education/attention 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 racial/ethnic 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 1998
Longer than P75 for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1998
CompletedFirst Submitted
Initial submission to the registry
February 2, 2001
CompletedFirst Posted
Study publicly available on registry
February 5, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2003
CompletedMarch 7, 2008
March 1, 2008
February 2, 2001
March 5, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of osteoarthritis of the knee (fulfilling ACR criteria) for at least 6 months duration
- At least moderate pain in the knee for most days in the last month
- Must be taking analgesic or nonsteroidal anti-inflammatory agents for control of pain
- Documented radiographic changes of osteoarthritis (Kellgren-Lawrence grade\>2) at the time of rheumatological screening
- Signed informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Kernan Hospital Mansion
Baltimore, Maryland, 21207, United States
Catonsville Clinic
Catonsville, Maryland, 21228, United States
Hospital for Special Surgery
New York, New York, United States
Related Publications (2)
Berman BM, Singh BB, Lao L, Langenberg P, Li H, Hadhazy V, Bareta J, Hochberg M. A randomized trial of acupuncture as an adjunctive therapy in osteoarthritis of the knee. Rheumatology (Oxford). 1999 Apr;38(4):346-54. doi: 10.1093/rheumatology/38.4.346.
PMID: 10378713BACKGROUNDBerman BM, Lao L, Greene M, Anderson RW, Wong RH, Langenberg P, Hochberg MC. Efficacy of traditional Chinese acupuncture in the treatment of symptomatic knee osteoarthritis: a pilot study. Osteoarthritis Cartilage. 1995 Jun;3(2):139-42. doi: 10.1016/s1063-4584(05)80046-9. No abstract available.
PMID: 7584319BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Brian Berman
University of Maryland/Complementary Medicine Program
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
February 2, 2001
First Posted
February 5, 2001
Study Start
September 1, 1998
Study Completion
August 1, 2003
Last Updated
March 7, 2008
Record last verified: 2008-03