Efficacy and Safety Evaluation of Acupoint Application in the Treatment of Knee Osteoarthritis Joint Pain

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase: Enrolling; Phase 3

Conditions: Knee Osteoarthritis

Treatments: Other: placebo; Drug: acupoint application

Study type: Interventional

Funder types: Other

Identifiers

NCT05449613

2022-077-KY

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Western medicine diagnosed as knee osteoarthritis, clinical classification is primary, and conforms to the TCM syndrome of cold and wet obstruction;
2. Guidelines for the diagnosis and treatment of osteoarthritis 2018 criteria and Kellgren -Lawrence<Ⅲ;
3. VAS pain score ≥40mm (select the limb with the most obvious pain symptom);
4. For patients taking nonsteroidal drugs or other disease-improving drugs (such as cartilage protectants), the dose has been stable for at least 4 weeks;
5. Signed informed consent.

Exclusion criteria

1. Patients who underwent intra-articular therapy within 3 months prior to the trial or required relevant surgical treatment within 1 year；
2. Glucocorticoid and joint cavity injection were used 4 weeks before treatment;
3. swelling and heat of knee joint;
4. 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.
5. 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.
6. Patients with other mental diseases who are unable to cooperate or unwilling to cooperate.
7. 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.
8. allergic constitution or allergic to test drugs, excipients or similar ingredients.
9. Suspected or confirmed history of alcohol or drug abuse;
10. pregnant or lactating women or those who have planned pregnancy recently and do not want to use contraception;
11. Participants in other clinical trials within 3 months prior to enrollment;
12. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

acupoint application

Active Comparator group

Description:

The acupoint application is applied each stick apply time 2h, once each day. Acupoints selected: Yanglingquan, Dubi, Neixiyan. The treatment lasted for 4 weeks.

Treatment:

Drug: acupoint application

placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: placebo