Acupuncture Safety/Efficacy in Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring acupuncture, osteoarthritis, elderly
Eligibility Criteria
Inclusion Criteria: 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
Sites / Locations
- Kernan Hospital Mansion
- Catonsville Clinic
- Hospital for Special Surgery
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00010946
First Posted
February 2, 2001
Last Updated
March 5, 2008
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00010946
Brief Title
Acupuncture Safety/Efficacy in Knee Osteoarthritis
Official Title
Acupuncture Safety/Efficacy in Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
acupuncture, osteoarthritis, elderly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Single
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Brian Berman
Organizational Affiliation
University of Maryland/Complementary Medicine Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kernan Hospital Mansion
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21207
Country
United States
Facility Name
Catonsville Clinic
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
10378713
Citation
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.
Results Reference
background
PubMed Identifier
7584319
Citation
Berman 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.
Results Reference
background
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Acupuncture Safety/Efficacy in Knee Osteoarthritis
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