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

NCT05449613 | Unknown Phase 3

• 1 other identifier: 2022-077-KY
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

  4 weeks

Study Arms (2)

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.

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.

Other: placebo

Interventions

acupoint application 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.

acupoint application

placebo 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.

placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

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

Study Sites (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100052, China

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

jian wang

CONTACT

15583757216; wangjian8904@163.com

yanglu gao

CONTACT

18002456893; 237604749@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 8, 2022
• Study Start: October 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2024
• Last Updated: July 8, 2022

Record last verified: 2022-07

Locations

CN (1)