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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Drug: acupoint application; Other: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: jian wang; Phone Number: 15583757216; Email: wangjian8904@163.com
• Study Contact Backup: Name: yanglu gao; Phone Number: 18002456893; Email: 237604749@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100052
      • Recruiting
      • Guang'anmen Hospital of China Academy of Chinese Medical Sciences
      • Contact: Jiang Quan, MD; Phone Number: 86-010-88001060; Email: doctorjq@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in WOMAC scale scores from baseline		4 weeks
Health Measurement Scale (SF-36)		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.	4 weeks

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Arthralgia; Osteoarthritis, Knee
• Other Study ID Numbers: 2022-077-KY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No