Osteoarthritis, KneeNCT00010647
Cost-Effectiveness of and Long-Term Outcomes Following Acupuncture Treatment for Osteoarthritis of the Knee
A study testing Acupuncture in people with Osteoarthritis, Knee, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to estimate the cost-effectiveness of acupuncture and to determine the long-term outcomes and health care utilization of people with osteoarthritis (OA) of the knee. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Aug 1999to Jul 2004
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of osteoarthritis (OA)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Baltimore
Baltimore, Maryland, 21207
About this study
The purpose of this study is to estimate the cost-effectiveness of acupuncture and to determine the long-term outcomes and health care utilization of people with osteoarthritis (OA) of the knee.
Read the detailed description
Osteoarthritis (OA) makes up a large proportion of the disability and economic costs in the U.S. The knee is the most common site of OA and is a common cause of disability and the leading indication of total knee replacement in the elderly. There are presently no curative therapies for OA. Recently, increased attention has focused on the use of complementary and alternative medicine (CAM) therapies, such as acupuncture, especially for patients who have failed to respond to more standard therapy. Little is known of the long-term health services utilization and outcomes of patients with knee OA. This study will evaluate the cost effectiveness and overall outcomes of acupuncture for OA treatment.
Participants in this study will be randomly assigned to receive either acupuncture or placebo. Surveys and questionnaires will be used to assess participants. Data will be collected on the short- and long-term utilization of health services as well as on pain and physical function.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Acupuncture
- Medical subject headings
- Osteoarthritis, Knee
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 posted25 Mar 2004 (estimated)
- Study startAug 1999
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Dr. Marc C. Hochberg, Principal investigator, University of Maryland Osteoporosis Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00010647
- Sponsor's protocol ID
- P50AT000084-01P1
- Other IDs
- P50AT000084-01
- Status last verified
- Aug 2006
- First submitted
- 2 Feb 2001
- Last updated
- 18 Aug 2006
- Results posted
- No
Publications
Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM, Hochberg MC. Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med. 2004 Dec 21;141(12):901-10. doi: 10.7326/0003-4819-141-12-200412210-00006.
PubMed 15611487
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Effectiveness of and Long-Term Outcomes Following Acupuncture Treatment for Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00010647
- Acronym / sponsor ID
- P50AT000084-01P1
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Aug 1999
- Study completion
- Jul 2004
- First posted
- 25 Mar 2004 (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 purpose of this study is to estimate the cost-effectiveness of acupuncture and to determine the long-term outcomes and health care utilization of people with osteoarthritis (OA) of the knee.
Detailed description
Osteoarthritis (OA) makes up a large proportion of the disability and economic costs in the U.S. The knee is the most common site of OA and is a common cause of disability and the leading indication of total knee replacement in the elderly. There are presently no curative therapies for OA. Recently, increased attention has focused on the use of complementary and alternative medicine (CAM) therapies, such as acupuncture, especially for patients who have failed to respond to more standard therapy. Little is known of the long-term health services utilization and outcomes of patients with knee OA. This study will evaluate the cost effectiveness and overall outcomes of acupuncture for OA treatment.
Participants in this study will be randomly assigned to receive either acupuncture or placebo. Surveys and questionnaires will be used to assess participants. Data will be collected on the short- and long-term utilization of health services as well as on pain and physical function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of osteoarthritis (OA)
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 18 Aug 2006.
- Results publication: PubMed 15611487Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM, Hochberg MC. Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med. 2004 Dec 21;141(12):901-10. doi: 10.7326/0003-4819-141-12-200412210-00006.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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. Marc C. Hochberg principal investigator
University of Maryland Osteoporosis Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Osteoarthritis, Knee, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site 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 1 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 18 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 NCT00010647, which also lists 1 linked publication.
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 18 Aug 2006.