Osteoarthritis, KneePhase 3NCT00010946
Acupuncture Safety/Efficacy in Knee Osteoarthritis
A Phase 3 study testing Acupuncture in people with Osteoarthritis, Knee, run by National Center for Complementary and Integrative Health (NCCIH) at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Sep 1998to Aug 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kernan Hospital Mansion
Baltimore, Maryland, 21207
Catonsville Clinic
Catonsville, Maryland, 21228
Hospital for Special Surgery
New York, New York
About this study
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)
- Conditions
- Osteoarthritis, Knee
- Being tested
- Acupuncture
- Keywords
- acupuncture, osteoarthritis, elderly
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2001 (estimated)
- Study startSep 1998
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Dr. Brian Berman, Principal investigator, University of Maryland/Complementary Medicine Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00010946
- Sponsor's protocol ID
- U01 AT000171-01M
- Other IDs
- 1U01AT000171-01
- Status last verified
- Mar 2008
- First submitted
- 2 Feb 2001
- Last updated
- 7 Mar 2008
- Results posted
- No
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 10378713Berman 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Safety/Efficacy in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00010946
- Acronym / sponsor ID
- U01 AT000171-01M
- Conditions
- Osteoarthritis, Knee
- Keywords
- acupuncture, osteoarthritis, elderly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Sep 1998
- Study completion
- Aug 2003
- First posted
- 5 Feb 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2008.
- Background: PubMed 10378713Berman 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.
- Background: PubMed 7584319Berman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Brian Berman principal investigator
University of Maryland/Complementary Medicine Program
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acupuncture in people with Osteoarthritis, Knee, run by National Center for Complementary and Integrative Health (NCCIH) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00010946, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2008.