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CompletedNCT00010946Updated Mar 7, 2008

Acupuncture Safety/Efficacy in Knee Osteoarthritis

A Phase 3 interventional study of Acupuncture in Osteoarthritis, Knee, sponsored by National Center for Complementary and Integrative Health (NCCIH). Completed at 3 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2008-03-07.

Sponsored by National Center for Complementary and Integrative Health (NCCIH) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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)

02

Conditions studied

  • Osteoarthritis, Knee

Keywords

  • acupuncture
  • osteoarthritis
  • elderly
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

Browse Osteoarthritis studies →

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH) is the lead sponsor of 218 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Masking
Single

Interventions

  • ProcedureAcupuncture
06

Study locations

3 sites
  • 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
07

References and documents

Publications

  • 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. PubMed 10378713 ↗
  • 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. PubMed 7584319 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00010946
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
First posted
Feb 5, 2001
Start date
Sep 1998
Completion
Aug 2003
Last update
Mar 7, 2008

Study contacts

Dr. Brian Berman
principal investigator · University of Maryland/Complementary Medicine Program
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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