AcupunctureNCT03299439
Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points
A study testing acupuncture in people with Acupuncture and Knee Osteoarthritis, run by West China Hospital at 4 sites in China.
Trial summary
The investigators plan to investigate the effectiveness of acupuncture at highly sensitive points, compared with lowly/non-sensitive points or no acupuncture (waiting-list), in improving pain, joint function and quality of life, among patients with KOA. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Acupuncture, Knee Osteoarthritis, Sensitive Acupoints
- What is being tested?
- acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 666 participants
- Where
- 4 sitesChina
- Study dates
- 25 Oct 2017to 20 Nov 2020
- 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
- Participants aged 40 years or older and diagnosed with mild or moderate knee osteoarthritis(KOA) are eligible to participate in the study
- The following criteria are used for diagnosis of KOA:
- refractory knee pain for most days in the last month;
- joint space narrowing, sclerosis or cystic change in subchondral bone (as demonstrated in X-ray);
- laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times) and white blood cell count < 2000/mm3;
- morning stiffness continues less than 30 minutes;
- bone sound exists when joints was taking flexion and/or extension. If a patient meets criteria 1 and 2, or criteria 1, 3, 4, and 5, a diagnosis of KOA is confirmed.
Who cannot join
- Patients will be excluded if they meet any of the following:
- diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumors or rheumatism of the knee joint and rheumatoid arthritis;
- present sprain or trauma in the lower limb;
- unable to walk properly due to foot deformity or pain;
- present with mental disorders;
- present with comorbidities including severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus, blood disorder or skin disease;
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- females who are pregnant or lactating;
- using physiotherapy treatments for osteoarthritis knee pain;
- have used intra-articular injection of glucocorticoid or viscosupplementation in the past six months;
- received knee-replacement surgery;
- diagnosed with severe (stage 4, according to Kellgren and Lawrence radiographic classification) or late clinical stage of KOA;
- have a swollen knee or positive result of floating patella test; or'
- are participating or have participated in the other clinical trials.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610075
Wuhan Integrated Traditional Chinese Medicine and Western Medicine Hospital
Wuhan, Hubei, 430022
the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450003
About this study
Official title: A Multi-center Randomized Controlled Trial of Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points
The investigators plan to investigate the effectiveness of acupuncture at highly sensitive points, compared with lowly/non-sensitive points or no acupuncture (waiting-list), in improving pain, joint function and quality of life, among patients with KOA. The safety of acupuncture will also be assessed during the study period.
Read the detailed description
Participants in the high sensitization group receive acupuncture treatment at the five highly sensitive points; Participants in the low/non-sensitization group receive acupuncture treatment at the five low/non-sensitive points and all other treatment settings will be the same as in the high sensitization group. Patients in the waiting-list group will receive standard acupuncture treatment after the study is completed.
- Conditions
- Acupuncture, Knee Osteoarthritis, Sensitive Acupoints, Tender Points
- 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 |
|---|---|---|
| acupuncture at highly sensitive points | Experimental | Sterile, single-use filiform acupuncture needles (Hwato Needles, Sino-foreign Joint Venture Suzhou Hwato Medical Instruments Co., China) with a length of 40 mm and a diameter of 0.30 mm will be inserted to a depth of 15-30mm in five highly sensitive points. Receives: Other: acupuncture |
| acupuncture at lowly/non-sensitive points | Active comparator | Sterile, single-use filiform acupuncture needles (Hwato Needles, Sino-foreign Joint Venture Suzhou Hwato Medical Instruments Co., China) with a length of 40 mm and a diameter of 0.30 mm will be inserted to a depth of 15-30mm in five low/non-sensitive points. Receives: Other: acupuncture |
| no acupuncture (waiting-list) | No intervention | Patients in the waiting-list group will not receive any acupuncture intervention during the study. |
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 (3)
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
The changes of knee ranges of motion (ROMs) from baseline to 16 weeks
The knee ROMs will be assessed both actively and passively by using a standard goniometer. It will include flexion, extension, internal rotation and external rotation.
Measured: Assessments will be conducted at baseline and 16 weeks after randomization
The changes of pressure-pain threshold of the five selected acupuncture points from baseline to 16 weeks
The pressure-pain threshold of the five selected acupuncture points will be measured using the electronic von Frey detector.
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 posted3 Oct 2017
- Study start25 Oct 2017
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 666 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
- Investigators
- Xin Sun, Phd, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299439
- Sponsor's protocol ID
- 20178159950025
- Status last verified
- Dec 2021
- First submitted
- 27 Sep 2017
- Last updated
- 30 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu J, Li Y, Li L, Luo X, Li N, Yang X, Zhang H, Liu Z, Kang D, Luo Y, Liu Y, Jia Y, Ren Y, Yao M, Wang Y, Chen J, Maiji M, Zou K, Zhao L, Liang F, Sun X. Effects of acupuncture at acupoints with lower versus higher pain threshold for knee osteoarthritis: a multicenter randomized controlled trial. Chin Med. 2022 Jun 8;17(1):67. doi: 10.1186/s13020-022-00626-3.
PubMed 35676697Tang L, Jia P, Zhao L, Kang D, Luo Y, Liu J, Li L, Zheng H, Li Y, Li N, Guyatt G, Sun X. Acupuncture treatment for knee osteoarthritis with sensitive points: protocol for a multicentre randomised controlled trial. BMJ Open. 2018 Oct 2;8(10):e023838. doi: 10.1136/bmjopen-2018-023838.
PubMed 30282686
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Randomized Controlled Trial of Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points
- ClinicalTrials.gov ID
- NCT03299439
- Acronym / sponsor ID
- 20178159950025
- Conditions
- Acupuncture, Knee Osteoarthritis, Sensitive Acupoints, Tender Points
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 666 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 3 Oct 2017 (actual)
- 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 investigate the effectiveness of acupuncture at highly sensitive points, compared with lowly/non-sensitive points or no acupuncture (waiting-list), in improving pain, joint function and quality of life, among patients with KOA. The safety of acupuncture will also be assessed during the study period.
Detailed description
Participants in the high sensitization group receive acupuncture treatment at the five highly sensitive points; Participants in the low/non-sensitization group receive acupuncture treatment at the five low/non-sensitive points and all other treatment settings will be the same as in the high sensitization group. Patients in the waiting-list group will receive standard acupuncture treatment after the study is completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acupuncture at highly sensitive points | Experimental | Other: acupunctureSterile, single-use filiform acupuncture needles (Hwato Needles, Sino-foreign Joint Venture Suzhou Hwato Medical Instruments Co., China) with a length of 40 mm and a diameter of 0.30 mm will be inserted to a depth of 15-30mm in five highly sensitive points. |
| acupuncture at lowly/non-sensitive points | Active comparator | Other: acupunctureSterile, single-use filiform acupuncture needles (Hwato Needles, Sino-foreign Joint Venture Suzhou Hwato Medical Instruments Co., China) with a length of 40 mm and a diameter of 0.30 mm will be inserted to a depth of 15-30mm in five low/non-sensitive points. |
| no acupuncture (waiting-list) | No intervention | –Patients in the waiting-list group will not receive any acupuncture intervention during the study. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants aged 40 years or older and diagnosed with mild or moderate knee osteoarthritis(KOA) are eligible to participate in the study
- The following criteria are used for diagnosis of KOA:
Key exclusion criteria (13 listed)
- diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumors or rheumatism of the knee joint and rheumatoid arthritis;
- present sprain or trauma in the lower limb;
- unable to walk properly due to foot deformity or pain;
- present with mental disorders;
- present with comorbidities including severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus, blood disorder or skin disease;
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 | acupuncture at highly sensitive points, acupuncture at lowly/non-sensitive points |
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.
3 secondary outcomes
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
The changes of knee ranges of motion (ROMs) from baseline to 16 weeks
Time frame: Assessments will be conducted at baseline and 16 weeks after randomization
The changes of pressure-pain threshold of the five selected acupuncture points 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 30 Dec 2021.
- Derived from this study: PubMed 35676697Liu J, Li Y, Li L, Luo X, Li N, Yang X, Zhang H, Liu Z, Kang D, Luo Y, Liu Y, Jia Y, Ren Y, Yao M, Wang Y, Chen J, Maiji M, Zou K, Zhao L, Liang F, Sun X. Effects of acupuncture at acupoints with lower versus higher pain threshold for knee osteoarthritis: a multicenter randomized controlled trial. Chin Med. 2022 Jun 8;17(1):67. doi: 10.1186/s13020-022-00626-3.
- Derived from this study: PubMed 30282686Tang L, Jia P, Zhao L, Kang D, Luo Y, Liu J, Li L, Zheng H, Li Y, Li N, Guyatt G, Sun X. Acupuncture treatment for knee osteoarthritis with sensitive points: protocol for a multicentre randomised controlled trial. BMJ Open. 2018 Oct 2;8(10):e023838. doi: 10.1136/bmjopen-2018-023838.
- Individual participant dataSharing planned: No
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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.
Xin Sun, Phd study chair
West China Hospital
4 sites 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 Acupuncture and Knee Osteoarthritis, run by West China Hospital at 4 sites in China.
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 7 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 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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.
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 NCT03299439, which also lists 2 linked publications.
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 30 Dec 2021.