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

Knee Osteoarthritis Clinical Trial

Official title:

Efficacy and Safety Evaluation of Acupoint Application in the Treatment of Knee Osteoarthritis Joint Pain: a Randomized, Double-blind, Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05449613
• Other study ID #: 2022-077-KY
• Status: Recruiting
• Phase: Phase 3
• Start date: October 1, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: July 2022
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: jian wang
• Phone: 15583757216
• Email: wangjian8904[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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<?;

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.

Related Conditions & MeSH terms

• Arthralgia
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
China	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Secondary	Changes in WOMAC scale scores from baseline		4 weeks
Secondary	Health Measurement Scale (SF-36)		4 weeks
Secondary	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.	4 weeks