Clinical Study of Acupuncture Treatment of Knee Osteoarthritis

Last updated: January 29, 2025
Sponsor: Wu zenan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Treatment

Sham acupuncture

Acupuncture

Clinical Study ID

NCT06805188
JZFYLL20250103002
  • Ages 18-70
  • All Genders

Study Summary

The main question of this study was to evaluate the efficacy and safety of acupuncture in the treatment of knee osteoarthritis (KOA) through a single-blind, randomized controlled trial divided into two groups. Patients in both groups received a total of 24 acupuncture treatments over an 8-week period. The differences in knee NRS score, WOMAC index, walking test, mental health assessment and other indicators between the acupuncture group and the sham acupuncture group before and after treatment were compared to provide high-quality evidence to support the effectiveness of acupuncture in treating KOA.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • aged 18-70 years old, regardless of gender

  • meeting the diagnostic criteria of the American College of Rheumatology (ACR) of KOA

  • patients with an NRS score of at least greater than 4 for knee pain, and the painhas lasted for at least 3 months

  • diagnosed with osteoarthritis of the knee by magnetic resonance imaging (MRI) orx-ray in the last 3 years

  • volunteering to participate in this trial and signing informed consent

Exclusion

Exclusion Criteria:

  • Patients with a history of knee surgery

  • Patients who had received any physical therapy related to osteoarthritis of theknee, such as corticosteroid injections, acupuncture, or moxibustion, within thepast 3 months

  • Patients who had a disease that could lead to pain in the knee, such as a fracture,a synovial cyst, or rheumatoid arthritis

  • Patients who had a history of knee surgery. or any significant neurological injury

  • Prior serious mental illness, organ failure, or malignancy

  • Planned knee surgery within the next 3 months

  • Pregnancy or breastfeeding

Study Design

Total Participants: 350
Treatment Group(s): 2
Primary Treatment: Sham acupuncture
Phase:
Study Start date:
February 15, 2025
Estimated Completion Date:
January 05, 2026

Study Description

Knee osteoarthritis (KOA) is a common clinical bone and joint disease.There is a lack of effective specific treatment for KOA.Acupuncture is increasingly being studied for the treatment of KOA, but its efficacy and safety are still controversial.This study aims to provide high-quality evidence by evaluating the results of studies on acupuncture for KOA.

A single-blind, randomized controlled trial design was used in this study, in which the generation and preservation of the randomized sequence was done by an independent follow-up researcher through R software. The random allocation method used was block group randomization to ensure a balanced allocation. At the same time, opaque sealed envelopes containing grouping information were prepared to ensure that the grouping process was concealed. The principle of blinding was strictly implemented throughout the study, and the outcome evaluator was blinded until the end of the trial, when participants remained unknown about their grouping information. The study population consisted of 350 patients with KOA who met the inclusion and exclusion criteria. These patients were randomized in a 1:1 ratio into the following 2 groups:(1) Acupuncture Group (AG) (2) False Acupuncture Group (FAG).Patients in both groups received a total of 24 acupuncture treatments over an 8-week period. The sham acupuncture group utilized a Takakura acupuncture simulation device to mimic acupuncture, where the needles would not penetrate the skin, and the duration of needle retention, treatment points, frequency of treatments, duration of treatment, and follow-up period were kept the same as that of the real acupuncture group. The primary outcome index was the Numerical rating scale (NRS), and secondary outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC),40m Fast-Paced Walking Test(40m FPWT), Roland-Morris Disability Questionnaire (RMDQ), Hamilton Depression Rating Scale (HAMD-17), Hamilton Anxiety Rating Scale (HAMA), Insomnia Severity Index (ISI), Pain self-efficacy questionnaire (PSEQ). Any adverse events during treatment will be recorded.

Connect with a study center

  • Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

    Nanchang, Jiangxi 330004
    China

    Active - Recruiting

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