Osteoarthritis of the KneePhase 1/2NCT00325663
Acupuncture in Osteoarthritis of the Knee
A Phase 1/2 study testing Acupuncture in people with Osteoarthritis of the Knee, run by Heidelberg University.
Trial summary
The aim of this study was to evalute three different acupuncture techniques, including one sham control, in its effect on osteoarthitis of the knee Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Apr 2005
- Phase
- Phase 1/2
- 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 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above age 35
- knee osteoarthritis grade II or III according to the Kellgren classification.
Who cannot join
- orthopedic deformations of the knee,
- malignant disease
- auto-immune disorders
- surgery including arthroscopy during the past 12 months
- pain medication with steroids
- physical therapy or acupuncture within the last for weeks
- no or a pain medication in continuous dosage
About this study
Official title: Specific and Non-Specific Effects of Acupuncture: A Double-Blinded, Randomized, Controlled Trial in Patients With Osteoarthritis of the Knee
The aim of this study was to evalute three different acupuncture techniques, including one sham control, in its effect on osteoarthitis of the knee
Read the detailed description
Background: Acupuncture is one of the most frequently used complementary therapeutic approaches in the treatment of osteoarthritis of the knee. Due to methodological shortcomings of previous randomized controlled studies, controversy persists whether the observed effects are specific to acupuncture or non-specific consequences of needling.
Objective: To compare classical Chinese acupuncture, semi-standardized modern acupuncture and non-specific needling by means of a double-blinded repeated measures cross-over design.
Intervention: Within three weeks all patients receive three treatment modalities in a random order in a double-blind study design.
Main outcome measures: Improvement in knee flexibility according to the neutral-zero method, defining a success as improvement by 10 degrees or more.
Secondary parameter: improvement in pain according to the reduced WOMAC score by 50 percent or more.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Acupuncture
- Keywords
- acupuncture, double-blind, sham control, osteoarthritis, pain
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Main outcome measures: Improvement in knee flexibility according to the neutral-zero method, defining a success as improvement by 10 degrees or more.
Secondary outcomes (1)
Secondary parameter: improvement in pain according to the reduced WOMAC score by 50 percent or more.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2006 (estimated)
- Study startApr 2004
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 125 participants
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- The German Society for Traditional Chinese Medicine (DGTCM)
- Investigators
- Max Karner, MD, Principal investigator, University HeidelbergJohannes Greten, MD, Study director, German Society of Traditional Chinese MedicineOliver Gerlach, MD, Study chair, Shen-Centre for Traditional Chinese Medicine, Erlangen, GermanyFrank Brazkiewicz, MD, Study chair, Centre for Chinese Medicine, Bremen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325663
- Sponsor's protocol ID
- AKOK1
- Status last verified
- Apr 2004
- First submitted
- 12 May 2006
- Last updated
- 15 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific and Non-Specific Effects of Acupuncture: A Double-Blinded, Randomized, Controlled Trial in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00325663
- Acronym / sponsor ID
- AKOK1
- Conditions
- Osteoarthritis of the Knee
- Keywords
- acupuncture, double-blind, sham control, osteoarthritis, pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- The German Society for Traditional Chinese Medicine (DGTCM)
- Study start
- Apr 2004
- Study completion
- Apr 2005
- First posted
- 15 May 2006 (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 aim of this study was to evalute three different acupuncture techniques, including one sham control, in its effect on osteoarthitis of the knee
Detailed description
Background: Acupuncture is one of the most frequently used complementary therapeutic approaches in the treatment of osteoarthritis of the knee. Due to methodological shortcomings of previous randomized controlled studies, controversy persists whether the observed effects are specific to acupuncture or non-specific consequences of needling.
Objective: To compare classical Chinese acupuncture, semi-standardized modern acupuncture and non-specific needling by means of a double-blinded repeated measures cross-over design.
Intervention: Within three weeks all patients receive three treatment modalities in a random order in a double-blind study design.
Main outcome measures: Improvement in knee flexibility according to the neutral-zero method, defining a success as improvement by 10 degrees or more.
Secondary parameter: improvement in pain according to the reduced WOMAC score by 50 percent or more.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients above age 35
- knee osteoarthritis grade II or III according to the Kellgren classification.
Key exclusion criteria (7 listed)
- orthopedic deformations of the knee,
- malignant disease
- auto-immune disorders
- surgery including arthroscopy during the past 12 months
- pain medication with steroids
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
Main outcome measures: Improvement in knee flexibility according to the neutral-zero method, defining a success as improvement by 10 degrees or more.
1 secondary outcome
Secondary parameter: improvement in pain according to the reduced WOMAC score by 50 percent or more.
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 15 May 2006.
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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.
Max Karner, MD principal investigator
University Heidelberg
Johannes Greten, MD study director
German Society of Traditional Chinese Medicine
Oliver Gerlach, MD study chair
Shen-Centre for Traditional Chinese Medicine, Erlangen, Germany
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Acupuncture in people with Osteoarthritis of the Knee, run by Heidelberg University.
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 7 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 15 May 2006. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Main outcome measures: Improvement in knee flexibility according to the neutral-zero method, defining a success as improvement by 10 degrees or more.. 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 15 May 2006.