Clinical Study of Acupuncture Treatment of Knee Osteoarthritis

Official title

Efficacy and Safety of Acupuncture in the Treatment of Osteoarthritis of the Knee: Study Protocol for a Randomized Controlled Trial

Overview

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.

Detailed 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.

Interventions

• Other Acupuncture
  The intervention was performed by two licensed acupuncturists with at least 10 years of clinical experience who received two weeks of training in standardized intervention methods prior to the trial. Acupoints location refers to the WHO Standard Acupuncture Point Locations in the Western Pacific Region (WHO Standard)〔41〕.The acupuncture group will receive the following acupoints (Figure 3, Table 2): the affected side of Chize(LU5), Quchi (LI11), Dubi (ST35), Fengshi (GB31), and Xiyangguan (GB33)
• Other Sham acupuncture
  The device's sham needling operation mimics real needling through appearance and tactile sensation, making it difficult for patients to distinguish, meeting the requirement of blinding and effectively controlling the patients' cognitive bias towards the type of intervention. Patients in the sham acupuncture group received this sham acupuncture intervention, which was designed to ensure that only the actual biological effects of acupuncture differed between the experimental group and the control

Primary outcome measures

• Numerical rating scale [Time frame: For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.]

Secondary outcome measures (7)

• WOMAC index [Time frame: For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.]
• 40m FPWT [Time frame: For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.]
• RMDQ [Time frame: For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.]
• Depressive condition [Time frame: For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.]
• Anxious situation [Time frame: For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.]
• Insomnia Severity Index [Time frame: For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.]
• Pain self-efficacy questionnaire [Time frame: For participants who completed baseline enrollment, efficacy observations were made at treatment enrollment, week 4, week 8, week 16, and week 24.]

Eligibility criteria

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 pain has lasted for at least 3 months
• diagnosed with osteoarthritis of the knee by magnetic resonance imaging (MRI) or x-ray in the last 3 years
• volunteering to participate in this trial and signing informed consent

Exclusion criteria

• Patients with a history of knee surgery
• Patients who had received any physical therapy related to osteoarthritis of the knee, such as corticosteroid injections, acupuncture, or moxibustion, within the past 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Single group

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine — Nanchang

Publications

• Wu Z, Hu Z, Xu Z, Xiao T, Huang Q, Zhou X, Zhang H, Fu Y. Efficacy and Safety of Acupuncture at Sensitized Acupoints for Knee Osteoarthritis: Protocol for a Multicenter, Single-Blind Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 24;14:e77336. doi: 10.2196/77336. PMID 40990366

Identifiers

NCT: NCT06805188 · JZFYLL20250103002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗