Knee OsteoarthritisPhase 3NCT05449613
Efficacy and Safety Evaluation of Acupoint Application in the Treatment of Knee Osteoarthritis Joint Pain
A Phase 3 study testing acupoint application in people with Knee Osteoarthritis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
To evaluate the efficacy and safety of acupoint application of Traditional Chinese medicine in the treatment of KOA joint pain through a prospective, randomized, double-blind, placebo-controlled clinical study. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- acupoint application
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 1 Oct 2024
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Western medicine diagnosed as knee osteoarthritis, clinical classification is primary, and conforms to the TCM syndrome of cold and wet obstruction;
- Guidelines for the diagnosis and treatment of osteoarthritis 2018 criteria and Kellgren -Lawrence<Ⅲ;
- VAS pain score ≥40mm (select the limb with the most obvious pain symptom);
- For patients taking nonsteroidal drugs or other disease-improving drugs (such as cartilage protectants), the dose has been stable for at least 4 weeks;
- Signed informed consent.
Who cannot join
- Patients who underwent intra-articular therapy within 3 months prior to the trial or required relevant surgical treatment within 1 year；
- Glucocorticoid and joint cavity injection were used 4 weeks before treatment;
- swelling and heat of knee joint;
- other diseases causing knee pain; Such as acute joint injury, tuberculous arthritis, rheumatoid arthritis, rheumatoid arthritis, suppurative arthritis, osteomyelitis, psoriatic arthritis, gout, villi nodular synovitis.
- History or evidence of any of the following diseases during the screening period: serious cardiovascular and cerebrovascular diseases, active or recurrent ulcer of digestive system or other diseases at risk of bleeding, other serious diseases of digestive system, combined with malignant tumor, serious or progressive diseases of blood system or other systems.
- Patients with other mental diseases who are unable to cooperate or unwilling to cooperate.
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- Before screening, any of the laboratory test indicators met the following criteria: ALT and AST > 1.5 times the upper limit of normal value, Cr > 1.2 times the upper limit of normal value, and other clinically significant laboratory test abnormalities, which were determined by the investigator to be unsuitable for inclusion in the group.
- allergic constitution or allergic to test drugs, excipients or similar ingredients.
- Suspected or confirmed history of alcohol or drug abuse;
- pregnant or lactating women or those who have planned pregnancy recently and do not want to use contraception;
- Participants in other clinical trials within 3 months prior to enrollment;
- The investigator considered that the patients should not participate in the clinical trial.Other requirements for inclusion are willingness to participate for the duration of the trial. All patients will receive verbal and written information about the trial and sign a consent form before inclusion. The researcher obtains written consent before inclusion and randomisation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100052
Jiang Quan, MD, 86-010-88001060, doctorjq@126.com
About this study
Official title: Efficacy and Safety Evaluation of Acupoint Application in the Treatment of Knee Osteoarthritis Joint Pain: a Randomized, Double-blind, Controlled Study
To evaluate the efficacy and safety of acupoint application of Traditional Chinese medicine in the treatment of KOA joint pain through a prospective, randomized, double-blind, placebo-controlled clinical study.
- Conditions
- Knee Osteoarthritis
- Being tested
- acupoint application, placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupoint applicationDrug
During the trial, if patients can not tolerate the pain, meloxicam tablets can be added temporarily, and the total amount of medication for each patient during the observation period was recorded.
placeboOther
During the trial, if patients can not tolerate the pain, meloxicam tablets can be added temporarily, and the total amount of medication for each patient during the observation period was recorded.
| Study group | Role | What they receive |
|---|---|---|
| acupoint application | Active comparator | The acupoint application is applied each stick apply time 2h, once each day. Acupoints selected: Yanglingquan, Dubi, Neixiyan. The treatment lasted for 4 weeks. Receives: Drug: acupoint application |
| placebo | Placebo comparator | The placebo is applied the same acupuncture points, each stick apply time 2h, once each day. Acupoints selected: Yanglingquan, Dubi, Neixiyan. The treatment lasted for 4 weeks. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in VAS pain score from baseline 4 weeks
After treatment.researchers and investigators were assessed by VAS score (0-10cm) for the overall condition of the disease. Participants rated their current state of control from "very good" to "very poor." The researchers rated disease activity status from "no active rheumatism" to "most severe active rheumatism." The score is accurate to one decimal place.
Measured: 4 weeks
Secondary outcomes (3)
Changes in WOMAC scale scores from baseline
Measured: 4 weeks
Health Measurement Scale (SF-36)
Measured: 4 weeks
Number of Participants With Metabolic Abnormal Events at All Assessment Time Points.
The participants were tested with blood lipid [liver and kidney function [aspartate aminotransferase(AST), alanine aminotransferase(ALT), Urea(Ur), Crea(Cr)] for regular metabolic function evaluation .The number of participants experiencing metabolic abnormal events have been reported.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 Oct 2021
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2024 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449613
- Sponsor's protocol ID
- 2022-077-KY
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 8 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Acupoint Application in the Treatment of Knee Osteoarthritis Joint Pain: a Randomized, Double-blind, Controlled Study
- ClinicalTrials.gov ID
- NCT05449613
- Acronym / sponsor ID
- 2022-077-KY
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 8 Jul 2022 (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.
To evaluate the efficacy and safety of acupoint application of Traditional Chinese medicine in the treatment of KOA joint pain through a prospective, randomized, double-blind, placebo-controlled clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupoint application | Active comparator | Drug: acupoint applicationThe acupoint application is applied each stick apply time 2h, once each day. Acupoints selected: Yanglingquan, Dubi, Neixiyan. The treatment lasted for 4 weeks. |
| placebo | Placebo comparator | Other: placeboThe placebo is applied the same acupuncture points, each stick apply time 2h, once each day. Acupoints selected: Yanglingquan, Dubi, Neixiyan. The treatment lasted for 4 weeks. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Western medicine diagnosed as knee osteoarthritis, clinical classification is primary, and conforms to the TCM syndrome of cold and wet obstruction;
- Guidelines for the diagnosis and treatment of osteoarthritis 2018 criteria and Kellgren -Lawrence<Ⅲ;
- VAS pain score ≥40mm (select the limb with the most obvious pain symptom);
- For patients taking nonsteroidal drugs or other disease-improving drugs (such as cartilage protectants), the dose has been stable for at least 4 weeks;
- Signed informed consent.
Key exclusion criteria (12 listed)
- Patients who underwent intra-articular therapy within 3 months prior to the trial or required relevant surgical treatment within 1 year；
- Glucocorticoid and joint cavity injection were used 4 weeks before treatment;
- swelling and heat of knee joint;
- other diseases causing knee pain; Such as acute joint injury, tuberculous arthritis, rheumatoid arthritis, rheumatoid arthritis, suppurative arthritis, osteomyelitis, psoriatic arthritis, gout, villi nodular synovitis.
- History or evidence of any of the following diseases during the screening period: serious cardiovascular and cerebrovascular diseases, active or recurrent ulcer of digestive system or other diseases at risk of bleeding, other serious diseases of digestive system, combined with malignant tumor, serious or progressive diseases of blood system or other systems.
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 |
|---|---|---|
| acupoint applicationDuring the trial, if patients can not tolerate the pain, meloxicam tablets can be added temporarily, and the total amount of medication for each patient during the observation period was recorded. | Drug | acupoint application |
| placeboDuring the trial, if patients can not tolerate the pain, meloxicam tablets can be added temporarily, and the total amount of medication for each patient during the observation period was recorded. | Other | placebo |
Primary outcome
Changes in VAS pain score from baseline 4 weeks
Time frame: 4 weeks
After treatment.researchers and investigators were assessed by VAS score (0-10cm) for the overall condition of the disease. Participants rated their current state of control from "very good" to "very poor." The researchers rated disease activity status from "no active rheumatism" to "most severe active rheumatism." The score is accurate to one decimal place.
3 secondary outcomes
Changes in WOMAC scale scores from baseline
Time frame: 4 weeks
Health Measurement Scale (SF-36)
Time frame: 4 weeks
Number of Participants With Metabolic Abnormal Events at All Assessment Time Points.
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing acupoint application in people with Knee Osteoarthritis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site 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 5 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: status not confirmed, as of the sponsor's last update on 8 Jul 2022. 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jian wang (15583757216, wangjian8904@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in VAS pain score from baseline 4 weeks (time frame: 4 weeks). 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 8 Jul 2022.