Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points

Last updated: December 21, 2021
Sponsor: West China Hospital
Overall Status: Completed

Phase

N/A

Condition

Allergies & Asthma

Knee Injuries

Allergy

Treatment

N/A

Clinical Study ID

NCT03299439
20178159950025
  • Ages > 40
  • All Genders

Study Summary

The investigators plan to investigate the effectiveness of acupuncture at highly sensitive points, compared with lowly/non-sensitive points or no acupuncture (waiting-list), in improving pain, joint function and quality of life, among patients with KOA. The safety of acupuncture will also be assessed during the study period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants aged 40 years or older and diagnosed with mild or moderate kneeosteoarthritis(KOA) are eligible to participate in the study
  • The following criteria are used for diagnosis of KOA:
  • refractory knee pain for most days in the last month;
  • joint space narrowing, sclerosis or cystic change in subchondral bone (asdemonstrated in X-ray);
  • laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times)and white blood cell count < 2000/mm3;
  • morning stiffness continues less than 30 minutes;
  • bone sound exists when joints was taking flexion and/or extension. If a patientmeets criteria 1 and 2, or criteria 1, 3, 4, and 5, a diagnosis of KOA isconfirmed.

Exclusion

Exclusion Criteria: Patients will be excluded if they meet any of the following:

  • diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumorsor rheumatism of the knee joint and rheumatoid arthritis;
  • present sprain or trauma in the lower limb;
  • unable to walk properly due to foot deformity or pain;
  • present with mental disorders;
  • present with comorbidities including severe cardiovascular disease, liver or kidneyimpairment, immunodeficiency, diabetes mellitus, blood disorder or skin disease;
  • females who are pregnant or lactating;
  • using physiotherapy treatments for osteoarthritis knee pain;
  • have used intra-articular injection of glucocorticoid or viscosupplementation in thepast six months;
  • received knee-replacement surgery;
  • diagnosed with severe (stage 4, according to Kellgren and Lawrence radiographicclassification) or late clinical stage of KOA;
  • have a swollen knee or positive result of floating patella test; or'
  • are participating or have participated in the other clinical trials.

Study Design

Total Participants: 666
Study Start date:
October 25, 2017
Estimated Completion Date:
November 20, 2020

Study Description

Participants in the high sensitization group receive acupuncture treatment at the five highly sensitive points; Participants in the low/non-sensitization group receive acupuncture treatment at the five low/non-sensitive points and all other treatment settings will be the same as in the high sensitization group. Patients in the waiting-list group will receive standard acupuncture treatment after the study is completed.

Connect with a study center

  • the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • Wuhan Integrated Traditional Chinese Medicine and Western Medicine Hospital

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

    Chengdu, Sichuan 610075
    China

    Site Not Available

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