AcupunctureNCT03008668
A Pilot Trial of Acupuncture for Knee Osteoarthritis With Differential Functional Status of Acupoints
A study testing acupuncture in people with Acupuncture and Knee Osteoarthritis, run by West China Hospital.
Trial summary
The investigators plan to undertake a rigorous multicentre randomised controlled trial, comparing acupuncture on sensitized acupoints with low/non-sensitive points or no acupuncture (waiting-list), to test if acupuncture on sensitized acupoints may result in improved treatment outcomes in patients with Knee… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Acupuncture, Knee Osteoarthritis, Randomized Controlled Trial
- What is being tested?
- acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Mar 2017
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients are those aged 40 years or older who are diagnosed with KOA and have signed the informed consent.
- The diagnosis of KOA will follow the diagnostic criteria according to the Chinese Guidelines for the Medical Management of Osteoarthritis:
- refractory knee pain for most days in the last month;
- joint space narrowing, sclerosis or cystic change in subchondral bone (as indicated by X-ray);
- laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times) and white blood cell count < 2000/mm3;
- age 40 years or older;
- morning stiffness continues less than 30 minutes;
- bone sound exists when joints was taking flexion and/or extension. A person is confirmed to be diagnosed with KOA if meeting the either of the three criteria set: (1 and 2), or (1,3 and 5), or (1,4,5 and 6).
Who cannot join
- Patients will be excluded if they:
- Can not adhere to the study protocol in the future 6 months;
- Are diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumors or rheumatism of knee/bone joint, rheumatoid arthritis;
- Have sprain or other trauma;
- Are unable to walk properly due to foot deformity or pain;
- Are present with mental disorders;
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- Have comorbidities including severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus or blood disorder;
- Females who are pregnant or lactating;
- Were using physiotherapy treatments for osteoarthritis knee pain;
- Had used intra-articular injection of glucocorticoid or viscosupplementation in the past 6 months;
- Received knee-replacement surgery;
- Were participating or had participated in the other clinical trials.
About this study
Official title: Acupuncture for Knee Osteoarthritis With Sensitized Acupoints: a Pilot Randomized Controlled Trial
The investigators plan to undertake a rigorous multicentre randomised controlled trial, comparing acupuncture on sensitized acupoints with low/non-sensitive points or no acupuncture (waiting-list), to test if acupuncture on sensitized acupoints may result in improved treatment outcomes in patients with Knee osteoarthritis (KOA).The current pilot study aimed to assess the feasibility of performing the definitive randomised controlled trial.
Read the detailed description
Patients in the intervention group received acupuncture treatment on the 5 most sensitized points/ acupoints.Patients in the control group received acupuncture treatment on the 5 least /non-sensitized points. All other treatment settings were the same as in the intervention group.
- 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.
acupunctureOther
a stimulation of the body or auricular points
| Study group | Role | What they receive |
|---|---|---|
| experimental group: Acupuncture | Experimental | acupuncture on 5 most sensitized points/ acupoints Receives: Other: acupuncture |
| Control group: Acupuncture | Active comparator | acupuncture on 5 least low/non-sensitized points Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Western Ontario and McMaster Universities Osteoarthritis index total score from baseline to 16 weeks
It consists of 24 items assessing the knee osteoarthritis patients pain, stiffness, and physical function. Each of the 24 items will be graded on a visual analog scale ranging from 0 to 10, with higher scores reflecting more pain, stiffness and poorer physical function
Measured: Assessments will be conducted at baseline and 16 weeks after randomization
Secondary outcomes (1)
The change of Short Form (SF)-12 health survey score from baseline to 16 weeks
It includes 12 items: 2 items on physical functioning, 2 items on role limitations because of physical health problems,
1 item on bodily pain, 1 item on general health perceptions, 1 item on vitality (energy/fatigue), 1 item on social functioning, 2 items on role limitations because of emotional problems, and 2 items on general mental health (psychological distress and psychological well-being)
Measured: Assessments will be conducted at baseline and 16 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startOct 2016
- Primary completionDec 2016
- Study completionMar 2017
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 AcupunctureStudies of the same condition, open and under way.
- More trials run by West China 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Xin, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008668
- Sponsor's protocol ID
- 201681590955
- Status last verified
- Jul 2018
- First submitted
- 26 Dec 2016
- Last updated
- 19 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jia P, Liu J, Li L, Luo Y, Li Y, Zhao L, Liang F, Liu Z, Zou K, Tang L, Sun X. Acupuncture for knee osteoarthritis with sensitized acupoints: results from a pilot, feasibility randomized controlled trial. Pilot Feasibility Stud. 2020 Sep 28;6:144. doi: 10.1186/s40814-020-00687-x. eCollection 2020.
PubMed 33005432
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Knee Osteoarthritis With Sensitized Acupoints: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03008668
- Acronym / sponsor ID
- 201681590955
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 2 Jan 2017 (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 investigators plan to undertake a rigorous multicentre randomised controlled trial, comparing acupuncture on sensitized acupoints with low/non-sensitive points or no acupuncture (waiting-list), to test if acupuncture on sensitized acupoints may result in improved treatment outcomes in patients with Knee osteoarthritis (KOA).The current pilot study aimed to assess the feasibility of performing the definitive randomised controlled trial.
Detailed description
Patients in the intervention group received acupuncture treatment on the 5 most sensitized points/ acupoints.Patients in the control group received acupuncture treatment on the 5 least /non-sensitized points. All other treatment settings were the same as in the intervention group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group: Acupuncture | Experimental | Other: acupunctureacupuncture on 5 most sensitized points/ acupoints |
| Control group: Acupuncture | Active comparator | Other: acupunctureacupuncture on 5 least low/non-sensitized points |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Eligible patients are those aged 40 years or older who are diagnosed with KOA and have signed the informed consent.
- The diagnosis of KOA will follow the diagnostic criteria according to the Chinese Guidelines for the Medical Management of Osteoarthritis:
- refractory knee pain for most days in the last month;
- joint space narrowing, sclerosis or cystic change in subchondral bone (as indicated by X-ray);
- laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times) and white blood cell count < 2000/mm3;
Key exclusion criteria (12 listed)
- Can not adhere to the study protocol in the future 6 months;
- Are diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumors or rheumatism of knee/bone joint, rheumatoid arthritis;
- Have sprain or other trauma;
- Are unable to walk properly due to foot deformity or pain;
- Are present with mental disorders;
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 |
|---|---|---|
| acupuncturea stimulation of the body or auricular points | Other | Control group: Acupuncture, experimental group: Acupuncture |
Primary outcome
The change of Western Ontario and McMaster Universities Osteoarthritis index total score from baseline to 16 weeks
Time frame: Assessments will be conducted at baseline and 16 weeks after randomization
It consists of 24 items assessing the knee osteoarthritis patients pain, stiffness, and physical function. Each of the 24 items will be graded on a visual analog scale ranging from 0 to 10, with higher scores reflecting more pain, stiffness and poorer physical function
1 secondary outcome
The change of Short Form (SF)-12 health survey score from baseline to 16 weeks
Time frame: Assessments will be conducted at baseline and 16 weeks after randomization
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 19 Jul 2018.
- Derived from this study: PubMed 33005432Jia P, Liu J, Li L, Luo Y, Li Y, Zhao L, Liang F, Liu Z, Zou K, Tang L, Sun X. Acupuncture for knee osteoarthritis with sensitized acupoints: results from a pilot, feasibility randomized controlled trial. Pilot Feasibility Stud. 2020 Sep 28;6:144. doi: 10.1186/s40814-020-00687-x. eCollection 2020.
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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.
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 in people with Acupuncture and Knee Osteoarthritis, run by West China 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 8 inclusion and 12 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 19 Jul 2018. 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?
The change of Western Ontario and McMaster Universities Osteoarthritis index total score from baseline to 16 weeks (time frame: Assessments will be conducted at baseline and 16 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03008668, 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 19 Jul 2018.