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

Primary Purpose

Knee Osteoarthritis

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

acupoint application

placebo

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.
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;
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.

Sites / Locations

Guang'anmen Hospital of China Academy of Chinese Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

acupoint application

placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in WOMAC scale scores from baseline

Health Measurement Scale (SF-36)

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.

Full Information

NCT ID

NCT05449613

First Posted

July 4, 2022

Last Updated

July 4, 2022

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05449613

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2021 (Actual)

Primary Completion Date

October 1, 2023 (Anticipated)

Study Completion Date

October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

acupoint application

Arm Type

Active Comparator

Arm 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.

Arm Title

placebo

Arm Type

Placebo Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

acupoint application

Intervention Description

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

Intervention Name(s)

placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes in VAS pain score from baseline 4 weeks

Description

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Changes in WOMAC scale scores from baseline

Time Frame

4 weeks

Title

Health Measurement Scale (SF-36)

Time Frame

4 weeks

Title

Number of Participants With Metabolic Abnormal Events at All Assessment Time Points.

Description

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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. 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; 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

jian wang

Phone

15583757216

wangjian8904@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

yanglu gao

Phone

18002456893

237604749@qq.com

Facility Information:

Facility Name

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100052

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jiang Quan, MD

Phone

86-010-88001060

doctorjq@126.com

12. IPD Sharing Statement

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

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