Knee Arthritis OsteoarthritisNCT02446756
Clinical Observation and MRI Influence of Acupuncture on Knee Osteoarthritis
A study testing acupuncture and physiotherapy in people with Knee Arthritis Osteoarthritis, run by Peking Union Medical College Hospital.
Trial summary
To observe the therapeutic effect of acupuncture on osteoarthritis(OA) and its efficacy on cartilage restoration,acupuncture and physiotherapy treatment were respectively given to two random groups. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Knee Arthritis Osteoarthritis
- What is being tested?
- acupuncture and physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Feb 2014
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed as knee osteoarthritis according to the OA criteria proposed by American College of Rheumatology in 1995.
Who cannot join
- Acute knee injury
- Had ever accepted therapy as hormone or injection in articulation cavity
- Had ever accepted treatment as oral medicine, physiotherapy, acupuncture or massage during the passed three months
- Had planted cardiac pacemaker or any metal matter in body
- Other severe diseases such as heart, lung, liver, kidney or cerebrum failure, tumors, gastrointestinal hemorrhage and so on
- Pregnant or lactating woman
- Anyone unable to tolerate or cooperate with treatment.
About this study
To observe the therapeutic effect of acupuncture on osteoarthritis(OA) and its efficacy on cartilage restoration,acupuncture and physiotherapy treatment were respectively given to two random groups. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to evaluate the motor function of knee joints, followed by magnetic resonance imaging (MRI) scanning to measure T2 values in ten cartilage sub-regions in tibiofemoral joints.
Read the detailed description
To observe the therapeutic effect of acupuncture on osteoarthritis and its efficacy on cartilage restoration,one hundred knees of 50 patients with knee osteoarthritis were randomly divided into acupuncture group and physiotherapy group which were respectively received acupuncture and physiotherapy treatment for four weeks. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to evaluate the motor function of knee joints, followed by magnetic resonance imaging (MRI) scanning to measure T2 values in ten cartilage sub-regions in tibiofemoral joints.
- Conditions
- Knee Arthritis Osteoarthritis
- Being tested
- acupuncture, physiotherapy
- Keywords
- Osteoarthritis, MRI, Cartilage, Acupuncture
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
physiotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| acupuncture group | Experimental | Acupuncture treatment was given once every other day and 20min each time for four weeks. Receives: Other: acupuncture |
| physiotherapy group | Active comparator | Physiotherapy treatment was given five times a week and 30min each time for four weeks. Receives: Other: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC scores
Measured: up to 24 months
T2 Values
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startJan 2010
- Primary completionJul 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthritis OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446756
- Sponsor's protocol ID
- PUMCH20150430
- Status last verified
- May 2015
- First submitted
- 6 May 2015
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation and MRI Influence of Acupuncture on Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02446756
- Acronym / sponsor ID
- PUMCH20150430
- Conditions
- Knee Arthritis Osteoarthritis
- Keywords
- Osteoarthritis, MRI, Cartilage, Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 18 May 2015 (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.
To observe the therapeutic effect of acupuncture on osteoarthritis(OA) and its efficacy on cartilage restoration,acupuncture and physiotherapy treatment were respectively given to two random groups. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to evaluate the motor function of knee joints, followed by magnetic resonance imaging (MRI) scanning to measure T2 values in ten cartilage sub-regions in tibiofemoral joints.
Detailed description
To observe the therapeutic effect of acupuncture on osteoarthritis and its efficacy on cartilage restoration,one hundred knees of 50 patients with knee osteoarthritis were randomly divided into acupuncture group and physiotherapy group which were respectively received acupuncture and physiotherapy treatment for four weeks. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to evaluate the motor function of knee joints, followed by magnetic resonance imaging (MRI) scanning to measure T2 values in ten cartilage sub-regions in tibiofemoral joints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture group | Experimental | Other: acupunctureAcupuncture treatment was given once every other day and 20min each time for four weeks. |
| physiotherapy group | Active comparator | Other: physiotherapyPhysiotherapy treatment was given five times a week and 30min each time for four weeks. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinically diagnosed as knee osteoarthritis according to the OA criteria proposed by American College of Rheumatology in 1995.
Key exclusion criteria (7 listed)
- Acute knee injury
- Had ever accepted therapy as hormone or injection in articulation cavity
- Had ever accepted treatment as oral medicine, physiotherapy, acupuncture or massage during the passed three months
- Had planted cardiac pacemaker or any metal matter in body
- Other severe diseases such as heart, lung, liver, kidney or cerebrum failure, tumors, gastrointestinal hemorrhage and so on
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 | Other | acupuncture group |
| physiotherapy | Other | physiotherapy group |
Primary outcome
WOMAC scores
Time frame: up to 24 months
T2 Values
Time frame: up to 30 months
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 May 2015.
Related trials for Knee Arthritis Osteoarthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and physiotherapy in people with Knee Arthritis Osteoarthritis, run by Peking Union Medical College Hospital.
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 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 18 May 2015. 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.
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?
WOMAC scores (time frame: up to 24 months). The study lists 2 primary outcomes in all. 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 18 May 2015.