Knee OsteoarthritisNCT03099317
Sinew Acupuncture for Knee Osteoarthritis
A study testing Sinew acupuncture in people with Knee Osteoarthritis, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The study aims to exam whether sinew acupuncture can relieve pain and symptoms of KOA and improve functional movement by Visual Analog Scale (VAS), Western Ontario and McMasters University Osteoarthritis Index (WOMAC), Timed up \& Go Test (TUG) and 8-step Stair Climb Test (SCT) assessment, and Quality of life by Short… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Sinew acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2017to 30 Sep 2018
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hong Kong permanent residents aged on or above 50, both male and female;
- meet the Clinical Classification Criteria for Osteoarthritis of the Knee by history, physical examination and radiographic findings (recommended by the American College of Rheumatology): history and physical examination: pain in the knee and one of the following (1. Over 50 years of age; 2. Less than 30 minutes of morning stiffness; 3. Crepitus on active motion and osteophytes) and radio graphical findings (Kellgren and Lawrence Grades 2-4):
- with unilateral knee pain or bilateral knee pain;
- in chronic stage (pain of at least 6 month's duration);
- with rated knee pain >40 mm on a visual analog scale (VAS; 0 to 100 mm) within 7 days;
- with X-ray or other radiographic reports are preferable (not necessary);
- who volunteer to participate and sign the consent form;
- able to write and read Chinese.
Who cannot join
- Patients who are unable to walk;
- with serious infection of knee;
- with suspected tears of ligaments, menisci or acute inflammation of synovial capsule;
- with trauma, ligament damage, fracture, or surgery on the knee(s) within 6 months, as the cause of pain or functional problems (history of knee replacement will be excluded);
- with history of local tumor/malignancy at knee;
- with physical or laboratory findings indicating infection, presence of autoimmune disease or inflammatory arthritis;
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- with knee pain caused by radiculopathy / herniation of intervertebral disc;
- with end-stage of diseases and other suspected severe conditions such as deep vein thrombosis of the lower limb, edema related to cancer or cancer treatment, severe blood coagulation disorders, uncontrolled systemic arterial hypertension and severe diabetes;
- with history of prolotherapy, with injections of hyaluronic acid or cortisone within 3 months;
- received acupuncture, electro-acupuncture, Tui-na therapy, massage, physiotherapy for 8 weeks prior to the trial;
- with more severe pain in other regions;
- have severe mental disorders;
- oversensitive to needles;
- insensitive to pain due to advanced diabetes, neuropathy or using strong painkillers;
- fail to be complaint with the treatment protocol.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Hong Kong Tuberculosis, Association The University of Hong Kong Clinical Centre for Teaching and Research in Chinese Medicine (Wan Chai)
Wan Chai
About this study
Official title: Sinew Acupuncture for Knee Osteoarthritis (KOA): A Randomized, Sham Controlled, Patient and Assessor Blinded, Pilot Trial
The study aims to exam whether sinew acupuncture can relieve pain and symptoms of KOA and improve functional movement by Visual Analog Scale (VAS), Western Ontario and McMasters University Osteoarthritis Index (WOMAC), Timed up \& Go Test (TUG) and 8-step Stair Climb Test (SCT) assessment, and Quality of life by Short Form-36 (SF-36). A randomized, sham acupuncture controlled, patient and assessor blinded, pilot study will be employed.
Read the detailed description
Objective:
The proposal aims to examine the efficacy and safety of sinew acupuncture for knee osteoarthritis (KOA).
Hypothesis to be tested:
Sinew acupuncture can reduce pain intensity, and improve knee function and health-related quality of life without significant side effects for KOA subjects compared to a sham acupuncture.
Design:
A randomized, subject- and assessor-blind, sham acupuncture-controlled clinical trial
Participants:
Subjects (N=86) will be randomized into sinew acupuncture or sham acupuncture group (in 1:1 ratio).
Study instrument:
Visual Analog Scale (VAS), Western Ontario and McMasters University Osteoarthritis Index (WOMAC), Timed up \& Go Test (TUG), 8-step Stair Climb Test (SCT) assessment, and the Short Form-36 (SF-36).
Intervention:
Sinew acupuncture group will receive 10 sessions of needling in 4 weeks. Sham group will receive the non-invasive intervention with the same procedures. All subjects are followed up for 6 weeks.
Main outcome measures:
VAS for knee pain intensity at week 4 serves as the primary outcome. VAS at other time points, WOMAC score, TUG, SCT and SF-36 will be analyzed as the secondary outcomes.
Data analysis:
Analysis will be on the 'intention to treat' principle. T-test and mixed-effect model analysis will be used to measure primary and secondary outcomes respectively.
Expected results:
Sinew acupuncture treatment can significantly reduce knee pain intensity, and improve knee function and quality of life without obvious side effects.
- Conditions
- Knee Osteoarthritis
- Being tested
- Sinew acupuncture, Sham acupuncture
- Keywords
- Knee Osteoarthritis, Sinew Acupuncture, Pain
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinew acupunctureOther
Sinew acupuncture: subject will sit on chair with knee joint flexion with a most comfortable angle nearest to 90 degrees. Acupoints (1-2cm away from the point of tenderness or pain) near the knee will be punctured through the skin by using sterile needles of size 0.30mm × 40mm at the angle of 0-10 degrees pointing along the pain direction and meridian sinew. Immediately, needles will be retreated back just under the skin and inserted 10mm-20mm forward smoothly with minimal pain sensation. Walking and stepping will be advised and governed during acupuncture. The acupoint will be covered with non-allergic bandages to ensure sufficient blinding to the subject. The treatment will last 20 minutes for each session.
Sham acupunctureOther
Sham acupuncture: subject will receive the same procedures as the sinew acupuncture without penetrating the skin. The needle will be used to puncture on the acupoint slightly without passing through the skin. The acupoint will be covered with non-allergic bandages to ensure sufficient blinding to the subject.
| Study group | Role | What they receive |
|---|---|---|
| Sinew acupuncture | Experimental | Subject in the arm will receive real acupuncture intervention. Receives: Other: Sinew acupuncture |
| Sham acupuncture | Sham comparator | Subject in the arm will receive sham acupuncture intervention. Receives: Other: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured by VAS
Pain intensity will be measured by VAS
Measured: Week 4
Secondary outcomes (4)
WOMAC
Western Ontario and McMasters University Osteoarthritis Index
Measured: Weeks 0, 1, 2, 3, 4, 6 and 10
TUG
Timed up and go test
Measured: Weeks 0, 2, 4, 6 and 10
8-step SCT
Stair Climb Test
Measured: Weeks 0, 2, 4, 6 and 10
Quality of life measured by SF-36
Short Form-36
Measured: Weeks 0, 4, and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Jun 2017
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
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 Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Model description
- A randomized sham controlled, single blinded trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haiyong Chen, PhD, Principal investigator, The University of Hong KongKwok Yin Au, PhD, Principal investigator, The Hong Kong Tuberculosis Association Chinese Medicine Clinic cum Training Centre of the University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099317
- Sponsor's protocol ID
- UHongKong-UW16-2007
- Status last verified
- Dec 2018
- First submitted
- 28 Mar 2017
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lam WC, Au KY, Qin Z, Wu FM, Chong CO, Jiang F, He Y, Ng BFL, Yeung WF, Lao L, Chen H. Superficial Needling Acupuncture vs Sham Acupuncture for Knee Osteoarthritis: A Randomized Controlled Trial. Am J Med. 2021 Oct;134(10):1286-1294.e2. doi: 10.1016/j.amjmed.2021.05.002. Epub 2021 Jun 11.
PubMed 34126097Au KY, Chen H, Lam WC, Chong CO, Lau A, Vardhanabhuti V, Mak KC, Jiang F, Lam WY, Wu FM, Chan HN, Ng YW, Ng BF, Ziea ET, Lao L. Sinew acupuncture for knee osteoarthritis: study protocol for a randomized sham-controlled trial. BMC Complement Altern Med. 2018 Apr 23;18(1):133. doi: 10.1186/s12906-018-2195-8.
PubMed 29685141
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sinew Acupuncture for Knee Osteoarthritis (KOA): A Randomized, Sham Controlled, Patient and Assessor Blinded, Pilot Trial
- ClinicalTrials.gov ID
- NCT03099317
- Acronym / sponsor ID
- UHongKong-UW16-2007
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Sinew Acupuncture, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 4 Apr 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 study aims to exam whether sinew acupuncture can relieve pain and symptoms of KOA and improve functional movement by Visual Analog Scale (VAS), Western Ontario and McMasters University Osteoarthritis Index (WOMAC), Timed up \& Go Test (TUG) and 8-step Stair Climb Test (SCT) assessment, and Quality of life by Short Form-36 (SF-36). A randomized, sham acupuncture controlled, patient and assessor blinded, pilot study will be employed.
Detailed description
Objective:
The proposal aims to examine the efficacy and safety of sinew acupuncture for knee osteoarthritis (KOA).
Hypothesis to be tested:
Sinew acupuncture can reduce pain intensity, and improve knee function and health-related quality of life without significant side effects for KOA subjects compared to a sham acupuncture.
Design:
A randomized, subject- and assessor-blind, sham acupuncture-controlled clinical trial
Participants:
Subjects (N=86) will be randomized into sinew acupuncture or sham acupuncture group (in 1:1 ratio).
Study instrument:
Visual Analog Scale (VAS), Western Ontario and McMasters University Osteoarthritis Index (WOMAC), Timed up \& Go Test (TUG), 8-step Stair Climb Test (SCT) assessment, and the Short Form-36 (SF-36).
Intervention:
Sinew acupuncture group will receive 10 sessions of needling in 4 weeks. Sham group will receive the non-invasive intervention with the same procedures. All subjects are followed up for 6 weeks.
Main outcome measures:
VAS for knee pain intensity at week 4 serves as the primary outcome. VAS at other time points, WOMAC score, TUG, SCT and SF-36 will be analyzed as the secondary outcomes.
Data analysis:
Analysis will be on the 'intention to treat' principle. T-test and mixed-effect model analysis will be used to measure primary and secondary outcomes respectively.
Expected results:
Sinew acupuncture treatment can significantly reduce knee pain intensity, and improve knee function and quality of life without obvious side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized sham controlled, single blinded trial
| Arm | Type | Receives |
|---|---|---|
| Sinew acupuncture | Experimental | Other: Sinew acupunctureSubject in the arm will receive real acupuncture intervention. |
| Sham acupuncture | Sham comparator | Other: Sham acupunctureSubject in the arm will receive sham acupuncture intervention. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Hong Kong permanent residents aged on or above 50, both male and female;
- meet the Clinical Classification Criteria for Osteoarthritis of the Knee by history, physical examination and radiographic findings (recommended by the American College of Rheumatology): history and physical examination: pain in the knee and one of the following (1. Over 50 years of age; 2. Less than 30 minutes of morning stiffness; 3. Crepitus on active motion and osteophytes) and radio graphical findings (Kellgren and Lawrence Grades 2-4):
- with unilateral knee pain or bilateral knee pain;
- in chronic stage (pain of at least 6 month's duration);
- with rated knee pain >40 mm on a visual analog scale (VAS; 0 to 100 mm) within 7 days;
Key exclusion criteria (15 listed)
- Patients who are unable to walk;
- with serious infection of knee;
- with suspected tears of ligaments, menisci or acute inflammation of synovial capsule;
- with trauma, ligament damage, fracture, or surgery on the knee(s) within 6 months, as the cause of pain or functional problems (history of knee replacement will be excluded);
- with history of local tumor/malignancy at knee;
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 |
|---|---|---|
| Sinew acupunctureSinew acupuncture: subject will sit on chair with knee joint flexion with a most comfortable angle nearest to 90 degrees. Acupoints (1-2cm away from the point of tenderness or pain) near the knee will be punctured through the skin by using sterile needles of size 0.30mm × 40mm at the angle of 0-10 degrees pointing along the pain direction and meridian sinew. Immediately, needles will be retreated back just under the skin and inserted 10mm-20mm forward smoothly with minimal pain sensation. Walking and stepping will be advised and governed during acupuncture. The acupoint will be covered with non-allergic bandages to ensure sufficient blinding to the subject. The treatment will last 20 minutes for each session. | Other | Sinew acupuncture |
| Sham acupunctureSham acupuncture: subject will receive the same procedures as the sinew acupuncture without penetrating the skin. The needle will be used to puncture on the acupoint slightly without passing through the skin. The acupoint will be covered with non-allergic bandages to ensure sufficient blinding to the subject. | Other | Sham acupuncture |
Primary outcome
Pain intensity measured by VAS
Time frame: Week 4
Pain intensity will be measured by VAS
4 secondary outcomes
WOMAC
Time frame: Weeks 0, 1, 2, 3, 4, 6 and 10
TUG
Time frame: Weeks 0, 2, 4, 6 and 10
8-step SCT
Time frame: Weeks 0, 2, 4, 6 and 10
Quality of life measured by SF-36
Time frame: Weeks 0, 4, and 10
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 13 Dec 2018.
- Derived from this study: PubMed 34126097Lam WC, Au KY, Qin Z, Wu FM, Chong CO, Jiang F, He Y, Ng BFL, Yeung WF, Lao L, Chen H. Superficial Needling Acupuncture vs Sham Acupuncture for Knee Osteoarthritis: A Randomized Controlled Trial. Am J Med. 2021 Oct;134(10):1286-1294.e2. doi: 10.1016/j.amjmed.2021.05.002. Epub 2021 Jun 11.
- Derived from this study: PubMed 29685141Au KY, Chen H, Lam WC, Chong CO, Lau A, Vardhanabhuti V, Mak KC, Jiang F, Lam WY, Wu FM, Chan HN, Ng YW, Ng BF, Ziea ET, Lao L. Sinew acupuncture for knee osteoarthritis: study protocol for a randomized sham-controlled trial. BMC Complement Altern Med. 2018 Apr 23;18(1):133. doi: 10.1186/s12906-018-2195-8.
- Individual participant dataSharing planned: Undecided
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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.
Haiyong Chen, PhD principal investigator
The University of Hong Kong
Kwok Yin Au, PhD principal investigator
The Hong Kong Tuberculosis Association Chinese Medicine Clinic cum Training Centre of the University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sinew acupuncture in people with Knee Osteoarthritis, run by The University of Hong Kong at 1 site in Hong Kong.
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 15 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 13 Dec 2018. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?
Pain intensity measured by VAS (time frame: Week 4). 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 NCT03099317, 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 13 Dec 2018.