Knee OsteoarthritisPSAKOANCT06675981
Placebo Response of Different Types of Sham Acupuncture for Knee Osteoarthritis
A study testing Real Acupuncture, Non-acupuncture at real-acupoint and Shallow acupuncture at real-acupoint in people with Knee Osteoarthritis, run by West China Hospital at 2 sites in China.
Trial summary
This study aims to conduct a randomized controlled trial to investigate the difference in clinical efficacy and blinding effect between real acupuncture and various sham acupuncture techniques. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Real Acupuncture, Non-acupuncture at real-acupoint and Shallow acupuncture at real-acupoint
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- 10 Nov 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Clinical diagnosis of knee osteoarthritis.
- Age over 40 years old.
Who cannot join
- Tuberculosis, tumors, rheumatism of the knee joint, and rheumatoid arthritis.
- Sprain or trauma in the lower limb.
- Mental disorders.
- Severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus, blood disorder or skin disease.
- Pregnancy or lactation.
- Use of physiotherapy for osteoarthritis knee pain in the past month; use of intra-articular injection of glucocorticoid or viscosupplementation in the past 6 months; received knee-replacement surgery; and positive floating patella test.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610041
Yaoguang Guo, newguoo@sina.com
Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi, 330000
About this study
This study aims to conduct a randomized controlled trial to investigate the difference in clinical efficacy and blinding effect between real acupuncture and various sham acupuncture techniques.
Read the detailed description
This study aimed to recruit 150 patients with knee osteoarthritis from the hospital outpatient department. Random coding was generated using a computer network-based random system, and the subjects will be divided into five groups: real acupuncture, non-acupuncture at real-acupoint, shallow acupuncture at real-acupoint, shallow acupuncture at non-meridian and non-acupoint, and waiting treatment group in a 1:1:1:1 ratio. Acupuncture sessions were conducted three times a week for two weeks. Patients in the waiting treatment group did not receive acupuncture therapy during the study period but received acupuncture treatment after the trial. Outcome measures included Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) score, Visual Analogue Pain (VAS) score, Massachusetts General Hospital Acupuncture Sensation Scale (MASS) needle sensation score, and blind evaluation scale. Data collection occurred at baseline, one week, and two weeks.
- Conditions
- Knee Osteoarthritis
- Being tested
- Real Acupuncture, Non-acupuncture at real-acupoint, Shallow acupuncture at real-acupoint, Shallow acupuncture at non-meridian and non-acupoint
- Keywords
- Sham acupuncture, Randomized controlled trial, Blinding effect, Placebo 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.
Real AcupunctureOther
Patients received 6 sessions of acupuncture (three sessions per week or every other day) for two consecutive weeks
Non-acupuncture at real-acupointOther
The acupuncture simulation device will be used to perform acupuncture at the same acupoints as those of the real acupuncture group.
Shallow acupuncture at real-acupointOther
At the same acupoint in the acupuncture group, the subcutaneous puncture is only 1-2 mm, no manipulation will be applied
Shallow acupuncture at non-meridian and non-acupointOther
At non-meridian and non-acupoint, the subcutaneous puncture is only 1-2 mm, no manipulation will be applied
| Study group | Role | What they receive |
|---|---|---|
| Real Acupuncture | Experimental | Acupuncture at nine acupoints. Patients received 6 sessions of acupuncture (three sessions per week or every other day) for two consecutive weeks Receives: Other: Real Acupuncture |
| Non-acupuncture at real-acupoint | Sham comparator | The acupuncture simulation device will be used to perform acupuncture at the same acupoints as those of the real acupuncture group. Receives: Other: Non-acupuncture at real-acupoint |
| Shallow acupuncture at real-acupoint | Sham comparator | At the same acupoint in the acupuncture group, the subcutaneous puncture is only 1-2 mm, no manipulation will be applied Receives: Other: Shallow acupuncture at real-acupoint |
| Shallow acupuncture at non-meridian and non-acupoint | Sham comparator | At non-meridian and non-acupoint, the subcutaneous puncture is only 1-2 mm, no manipulation will be applied Receives: Other: Shallow acupuncture at non-meridian and non-acupoint |
| Waiting-list group | No intervention | No acupuncture treatment will be given during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis index (WOMAC)
The WOMAC, a disease-specific scale with high reliability and validity, has been translated into different languages and used widely in clinical trials for KOA. The Chinese version of WOMAC contains 24 items that measure pain (5 items, scored 0-50), stiffness (2 items, scored 0-20) and physical function (17 items, scored 0-170), with a total score ranging from 0 to 240
Measured: 2 week
Secondary outcomes (3)
Visual analogue scale (VAS)
The Visual Analogue Scale (VAS) measures pain on a scale of 0 to 10, with a higher score indicating more severe symptoms.
Measured: 2 week
Blind Assessment Scale
The patients in the real acupuncture and sham acupuncture groups will be asked, "Do you think you are receiving real acupuncture treatment?" The patients' response options were "yes, no, and not sure."
Measured: 2 week
Massachusetts General Hospital Acupuncture Sensation Scale (MASS)
The scale consists of 13 items and measures the body sensation experienced during acupuncture, including sensations such as acid, numbness, distension, pain, and heat. Each of the 13 entries utilizes a Visual Analogue Scale (VAS) with a range from 0cm (indicating no needle sensation) to 10cm (representing strong to unbearable needle sensation).
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start10 Nov 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Participant
- Enrolment
- 150 participants (estimated)
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, Doctor, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675981
- Sponsor's protocol ID
- 82305045
- Other IDs
- 82305045
- Acronym
- PSAKOA
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared with other researchers with the agreement of the Coordinating Committee and the Ethics Committee.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Response of Different Types of Sham Acupuncture for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06675981
- Acronym / sponsor ID
- PSAKOA / 82305045
- Conditions
- Knee Osteoarthritis
- Keywords
- Sham acupuncture, Randomized controlled trial, Blinding effect, Placebo acupuncture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 10 Nov 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 6 Nov 2024 (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.
This study aims to conduct a randomized controlled trial to investigate the difference in clinical efficacy and blinding effect between real acupuncture and various sham acupuncture techniques.
Detailed description
This study aimed to recruit 150 patients with knee osteoarthritis from the hospital outpatient department. Random coding was generated using a computer network-based random system, and the subjects will be divided into five groups: real acupuncture, non-acupuncture at real-acupoint, shallow acupuncture at real-acupoint, shallow acupuncture at non-meridian and non-acupoint, and waiting treatment group in a 1:1:1:1 ratio. Acupuncture sessions were conducted three times a week for two weeks. Patients in the waiting treatment group did not receive acupuncture therapy during the study period but received acupuncture treatment after the trial. Outcome measures included Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) score, Visual Analogue Pain (VAS) score, Massachusetts General Hospital Acupuncture Sensation Scale (MASS) needle sensation score, and blind evaluation scale. Data collection occurred at baseline, one week, and two weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Real Acupuncture | Experimental | Other: Real AcupunctureAcupuncture at nine acupoints. Patients received 6 sessions of acupuncture (three sessions per week or every other day) for two consecutive weeks |
| Non-acupuncture at real-acupoint | Sham comparator | Other: Non-acupuncture at real-acupointThe acupuncture simulation device will be used to perform acupuncture at the same acupoints as those of the real acupuncture group. |
| Shallow acupuncture at real-acupoint | Sham comparator | Other: Shallow acupuncture at real-acupointAt the same acupoint in the acupuncture group, the subcutaneous puncture is only 1-2 mm, no manipulation will be applied |
| Shallow acupuncture at non-meridian and non-acupoint | Sham comparator | Other: Shallow acupuncture at non-meridian and non-acupointAt non-meridian and non-acupoint, the subcutaneous puncture is only 1-2 mm, no manipulation will be applied |
| Waiting-list group | No intervention | –No acupuncture treatment will be given during the study period. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of knee osteoarthritis.
- Age over 40 years old.
Key exclusion criteria (6 listed)
- Tuberculosis, tumors, rheumatism of the knee joint, and rheumatoid arthritis.
- Sprain or trauma in the lower limb.
- Mental disorders.
- Severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus, blood disorder or skin disease.
- Pregnancy or lactation.
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 |
|---|---|---|
| Real AcupuncturePatients received 6 sessions of acupuncture (three sessions per week or every other day) for two consecutive weeks | Other | Real Acupuncture |
| Non-acupuncture at real-acupointThe acupuncture simulation device will be used to perform acupuncture at the same acupoints as those of the real acupuncture group. | Other | Non-acupuncture at real-acupoint |
| Shallow acupuncture at real-acupointAt the same acupoint in the acupuncture group, the subcutaneous puncture is only 1-2 mm, no manipulation will be applied | Other | Shallow acupuncture at real-acupoint |
| Shallow acupuncture at non-meridian and non-acupointAt non-meridian and non-acupoint, the subcutaneous puncture is only 1-2 mm, no manipulation will be applied | Other | Shallow acupuncture at non-meridian and non-acupoint |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis index (WOMAC)
Time frame: 2 week
The WOMAC, a disease-specific scale with high reliability and validity, has been translated into different languages and used widely in clinical trials for KOA. The Chinese version of WOMAC contains 24 items that measure pain (5 items, scored 0-50), stiffness (2 items, scored 0-20) and physical function (17 items, scored 0-170), with a total score ranging from 0 to 240
3 secondary outcomes
Visual analogue scale (VAS)
Time frame: 2 week
Blind Assessment Scale
Time frame: 2 week
Massachusetts General Hospital Acupuncture Sensation Scale (MASS)
Time frame: 2 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No. Data can be shared with other researchers with the agreement of the Coordinating Committee and the Ethics Committee.
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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.
Xin Sun, Doctor study chair
West China Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real Acupuncture, Non-acupuncture at real-acupoint and Shallow acupuncture at real-acupoint in people with Knee Osteoarthritis, run by West China Hospital at 2 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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Sun, Doctor (18980606047, sunx79@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) (time frame: 2 week). 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 19 Nov 2024.