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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
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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.

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

First Posted
July 4, 2022
Last Updated
July 4, 2022
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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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
No
Studies a U.S. FDA-regulated Device Product
No

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
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.
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
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.
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
No
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
Email
wangjian8904@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
yanglu gao
Phone
18002456893
Email
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
Email
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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