OsteoarthritisPhase 2NCT00417313
Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability
A Phase 2 study testing periosteal electro-acupuncture (osteopuncture). in people with Osteoarthritis, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The purpose of this study is to investigate the feasibility, effectiveness, and duration of treatment response of periosteal electro-acupuncture (osteopuncture) for osteoarthritis (OA)-associated chronic knee pain. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- periosteal electro-acupuncture (osteopuncture).
- Type of treatment
- Medical device
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Aug 2006
- Phase
- Phase 2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Radiographic evidence of knee OA on a standing AP X-ray
- Bilateral knee pain for at least 3 months with pain of at least moderate intensity every day or almost every day
Who cannot join
- Non-ambulatory, or severely impaired mobility (i.e., require the use of a walker)
- Folstein Mini-Mental State Examination score of less than 24
- Severe visual or hearing impairment
- Knee pain due to factors other than OA, e.g. rheumatoid or psoriatic arthritis, gout, pseudogout, metastatic cancer
- Significant pain in parts of the body other than the knee or acute knee pain
- A large knee effusion or severe mechanical instability of the knee
Show all 13Show fewer
- History of corticosteroid injection in the affected knee(s) during the preceding 3 months
- History of hyaluronic acid injection in the affected knee(s) during the preceding 3 months
- Acute or terminal illness
- Immune suppression
- Anticoagulation therapy
- Presence of a pacemaker
- Prior acupuncture treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Pain Evaluattion and Treatment Institute, Research Department
Pittsburgh, Pennsylvania, 15206
About this study
The purpose of this study is to investigate the feasibility, effectiveness, and duration of treatment response of periosteal electro-acupuncture (osteopuncture) for osteoarthritis (OA)-associated chronic knee pain.
Read the detailed description
Knee osteoarthritis (OA) is painful in 6.8% of men and 11.4% of women age 63-93, with over 20 million Americans affected nationwide, and may lead to a variety of untoward consequences including limitations in physical function, postural instability, sleep disturbance, psychosocial disability, and substantial utilization of health care resources. While oral analgesics represent the mainstay of treatment for chronic pain associated with knee OA, non-responders with limiting comorbidities may have few therapeutic alternatives.
The aims of this research study are to (1) reduce pain severity and disability in community-dwelling older adults with OA-associated chronic knee pain using periosteal electroacupuncture (osteopuncture), and (2) improve the physical performance, psychosocial function, sleep, and appetite of these individuals. 88 older adults with persistent knee pain and x-ray evidence of OA, no other rheumatologic disorders, no history of knee surgery, and no prominent pain in sites other than the knee(s) will be randomized to receive either osteopuncture or control osteopuncture once a week for 6 weeks. All outcome measures for pain and disability, as well as physical performance, psychosocial function, sleep, and appetite, will be collected pre-treatment, at the completion of the 6-week protocol, and 3 months later.
- Conditions
- Osteoarthritis
- Being tested
- periosteal electro-acupuncture (osteopuncture).
- Keywords
- knee pain, acupuncture /acupressure, alternative medicine, analgesia, arthritis therapy, chronic pain, functional ability
- Medical subject headings
- Osteoarthritis, Agnosia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periosteal electro-acupuncture (osteopuncture).Device
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in pain and disability, measured with the Western Ontario and McMaster Universities Osteoarthritis Index
Secondary outcomes (3)
changes in physical performance
psychosocial function (mood, self-efficacy, coping, fear, self-rated health)
sleep and appetite
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2007 (estimated)
- Study startOct 2004
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 88 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Debra K Weiner, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417313
- Sponsor's protocol ID
- AG0073
- Other IDs
- 5R21AG024288-02
- Status last verified
- Dec 2006
- First submitted
- 28 Dec 2006
- Last updated
- 1 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopuncture for Osteoarthritis-Associated Knee Pain & Disability
- ClinicalTrials.gov ID
- NCT00417313
- Acronym / sponsor ID
- AG0073
- Conditions
- Osteoarthritis
- Keywords
- knee pain, acupuncture /acupressure, alternative medicine, analgesia, arthritis therapy, chronic pain, functional ability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Oct 2004
- Study completion
- Aug 2006
- First posted
- 1 Jan 2007 (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 investigate the feasibility, effectiveness, and duration of treatment response of periosteal electro-acupuncture (osteopuncture) for osteoarthritis (OA)-associated chronic knee pain.
Detailed description
Knee osteoarthritis (OA) is painful in 6.8% of men and 11.4% of women age 63-93, with over 20 million Americans affected nationwide, and may lead to a variety of untoward consequences including limitations in physical function, postural instability, sleep disturbance, psychosocial disability, and substantial utilization of health care resources. While oral analgesics represent the mainstay of treatment for chronic pain associated with knee OA, non-responders with limiting comorbidities may have few therapeutic alternatives.
The aims of this research study are to (1) reduce pain severity and disability in community-dwelling older adults with OA-associated chronic knee pain using periosteal electroacupuncture (osteopuncture), and (2) improve the physical performance, psychosocial function, sleep, and appetite of these individuals. 88 older adults with persistent knee pain and x-ray evidence of OA, no other rheumatologic disorders, no history of knee surgery, and no prominent pain in sites other than the knee(s) will be randomized to receive either osteopuncture or control osteopuncture once a week for 6 weeks. All outcome measures for pain and disability, as well as physical performance, psychosocial function, sleep, and appetite, will be collected pre-treatment, at the completion of the 6-week protocol, and 3 months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Radiographic evidence of knee OA on a standing AP X-ray
- Bilateral knee pain for at least 3 months with pain of at least moderate intensity every day or almost every day
Key exclusion criteria (13 listed)
- Non-ambulatory, or severely impaired mobility (i.e., require the use of a walker)
- Folstein Mini-Mental State Examination score of less than 24
- Severe visual or hearing impairment
- Knee pain due to factors other than OA, e.g. rheumatoid or psoriatic arthritis, gout, pseudogout, metastatic cancer
- Significant pain in parts of the body other than the knee or acute knee pain
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 |
|---|---|---|
| periosteal electro-acupuncture (osteopuncture). | Device | – |
Primary outcome
changes in pain and disability, measured with the Western Ontario and McMaster Universities Osteoarthritis Index
3 secondary outcomes
changes in physical performance
psychosocial function (mood, self-efficacy, coping, fear, self-rated health)
sleep and appetite
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 1 Jan 2007.
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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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.
Debra K Weiner, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing periosteal electro-acupuncture (osteopuncture). in people with Osteoarthritis, run by National Institute on Aging (NIA) 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 2 inclusion and 13 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 1 Jan 2007. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
changes in pain and disability, measured with the Western Ontario and McMaster Universities Osteoarthritis Index. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jan 2007.