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

NCT ID: NCT05449613

Last Updated: 2022-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2024-10-01

Brief 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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

acupoint application

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

Group Type: ACTIVE_COMPARATOR

acupoint application

Intervention Type: DRUG

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.

placebo

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

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.

Interventions

acupoint application

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.

Intervention Type: DRUG

placebo

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Quan Jiang

MD, PhD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

jian wang

Role: CONTACT

wangjian8904@163.com

15583757216

yanglu gao

Role: CONTACT

237604749@qq.com

18002456893

Facility Contacts

Jiang Quan, MD

Role: primary

doctorjq@126.com

86-010-88001060

Other Identifiers

2022-077-KY

Identifier Type: -

Identifier Source: org_study_id